Express Pharma March 16-31, 2014

VOL .9 NO.10 PAGES 94

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Cover Story GMP Special Management Commercial Excellence 2.0 Advantage West Goa, Gujarat & Maharashtra 16-31 MARCH 2014,` 40

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CONTENTS Vol 9 No.10 MARCH 16-31, 2014

Chairman of the Board Viveck Goenka Editor Viveka Roychowdhury*

ADVANTAGE WEST

MARKET

A glimpse into some of the key advantages Goa, Gujarat and Maharashtra offer to India’s pharmaceutical industry | P46

BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das Bangalore Neelam M Kachhap Delhi Shalini Gupta DESIGN National Art Director Bivash Barua Deputy Art Director Surajit Patro

14

US FDA APPROVES MYALEPT TO TREAT RARE METABOLIC DISEASE

16

LUPIN RECEIVES APPROVAL FOR ACNE TREATMENT

17

STRAND RECEIVES US PATENT FOR VIRTUAL LIVER MODEL

22

IPC-IMA TNSB PHARMACO VIGILANCE CME HELD AT CHENNAI

24

INDUSTRY INTROSPECTS AT HEALTHCARE & PHARMA EXPANSION SUMMIT 2014

Chief Designer Pravin Temble Senior Graphic Designer Rushikesh Konka Layout Rakesh Sharma Photo Editor Sandeep Patil MARKETING Deputy General Manager Harit Mohanty Senior Manager Rajesh Bhatkal PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia Scheduling & Coordination Rohan Thakkar CIRCULATION Circulation Team Mohan Varadkar

P30: COVER An arduous endeavour?

MANAGEMENT

P32: INSIGHT cGMP implementation: From philosophy to practice

P56: RESEARCH FDA panel votes against approval of Medicines Co’s blood clot preventer

P84: AWARD L’Oreal Foundation, UNESCO to honour women in science

42

‘WE EXPECT MNCS TO BRING IN NEXT GENERATION PRODUCTS AND IMPROVE ACCESSIBILITY’

44

COMMERCIAL EXCELLENCE 2.0

TURN TO PAGE 17 TO FIND SPECIAL DEALS

Express Pharma Reg. No.MH/MR/SOUTH-77/2013-15, RNI Regn. No.MAHENG/2005/21398. Printed for the proprietors, The Indian Express Limited by Ms. Vaidehi Thakar at The Indian Express Press, Plot No. EL-208, TTC Industrial Area, Mahape, Navi Mumbai - 400710 and Published from Express Towers, 2nd Floor, Nariman Point, Mumbai - 400021. (Editorial & Administrative Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021) *Responsible for selection of news under the PRB Act. Copyright @ 2011. The Indian Express Ltd. All rights reserved throughout the world.

Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.

EDITOR’S NOTE

Bitter medicine

N

ame-Shame-Blame-Train. This has been the pharmaceutical

But beyond training and upskilling, the indus-

industry's mantra to manage

try needs to build an all pervasive culture of qual-

non-compliance. We’ve been

ity. We have to be prepared for inspectors knocking

through the first three phases;

on our factory gates at any time. A recent inspec-

now its time for the last to kick in. With news com-

tion started with a discussion between the key site

ing in of yet another import alert (Sun Pharma’s

personnel and inspectors. At the end of the brief-

Karkhadi plant), we have no more time to lose.

ing, when the personnel got up to leave, they were

The collective wisdom on successful and sus-

asked to leave behind their notes/dairies. Simi-

tainable execution of good manufacturing prac-

larly, inspectors asked to visit adjacent manufac-

tices (GMPs) exists in our industry but the key is that senior management has to take the lead; only then will the rest of the flock fall in line. So promoters and the C-suite have to invest both time and money in people, processes and systems.

Over the years, managements have invested in key personnel responsible for quality, using fat compensation packages as a retention strategy.

With experienced personnel few and far between, they had no choice. Today, we are facing a backlash. Non-compliance is resulting in import bans, leading to facilities closing down and job cuts. Its an open secret that when one such laid off employee failed twice in his attempts to get a new job, he chose to spill the beans on his former employee, leading to yet another ban. How else could he secure the future of his two children?

Its an open secret that when one such laid off employee failed twice in his attempts to get a new job,he chose to spill the beans on his former employee, leading to yet another ban

turing facilities and found gross violations in total contrast to the squeaky clean facility which was on the inspection list. Thus we need to go way beyond SOPs and experts writing for this issue tell us how. SM Mudda, Executive Director-Technical & Operations, Micro Labs believes that it is time that the Indian industry approaches this issue with a learning mindset as against a victim mindset and use this opportunity as a catalyst for change (pages 32-34). Ram Balani, CEO-Founder, FDASmart points out that SOPs created by Indian pharma companies don’t meet US FDA purposes because either they are not adequately mapped back to the respective statues or are not enforced diligently in practice (pages 35,36) Similarly, Swapna Narayanan, Managing Director, Information Mapping India focuses on the

But while disgruntled employees are a very

critical need for a good documentation system

compelling reason for managements to take care of

(pages 37, 38) while Dr Kavita Mehrotra, Head,

their personnel, there is a greater need to invest

Global Strategic Alliances, UL and colleagues

in developing and continuously updating their

make the point that quality and compliance is not

skills and knowledge. And that's where training

an event, but a culture driven by the management

comes in. This issue of Express Pharma, with a

(pages 39-41). We hope this issue of Express

GMP focus, has a cover story ('Train to Gain',

Pharma helps pharma companies in their journey

pages 26-29) on how training institutes focussing on

towards compliance. 'Comply or die' is truly the

GMP have seen a steady increase in business. Yet

only way forward.

another story (An arduous endeavour?, pages 30,31) highlights how our dismal non-compliance

12

history is holding back API exports to the EU.

EXPRESS PHARMA

March 16-31, 2014

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

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MARKET COMPANY WATCH

US FDAapproves Myalept to treat rare metabolic disease The safety and effectiveness of Myalept, an analogue of leptin made through recombinant DNA technology, were evaluated in an open-label, single-arm study that included 48 patients THE US Food and Drug Administration approved Myalept (metreleptin for injection) as replacement therapy to treat the complications of leptin deficiency, in addition to diet, in patients with congenital generalised or acquired generalised lipodystrophy.

Generalised lipodystrophy is a condition associated with a lack of fat tissue. Patients with congenital generalised lipodystrophy are born with little or no fat tissue. Patients with acquired generalised lipodystrophy generally lose fat tissue over time.

Because the hormone leptin is made by fat tissue, patients with generalised lipodystrophy have very low leptin levels. Leptin regulates food intake and other hormones, such as insulin.

Patients with both types of generalised lipodystrophy often develop severe insulin resistance at a young age and may have diabetes mellitus that is difficult to control or very high levels of triglycerides in the blood (hypertriglyceridemia) that can lead to

inflammation of the pancreas.

“Myalept is the first approved therapy indicated for treating the complications associated with congenital or acquired generalised lipodystrophy and provides a needed treatment option for patients with this orphan disease,” said Mary Parks, Deputy Director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research.

The safety and effectiveness of Myalept, an analogue of leptin made through recombinant DNA technology, were evaluated in an open-label, single-arm study that included 48 patients with congenital or acquired generalised lipodystrophy who also had diabetes mellitus, hypertriglyceridemia, and/or elevated levels of fasting insulin. The trial showed reductions in HbA1c (a measure of blood sugar control), fasting glucose, and triglycerides. Anti-drug antibodies with neutralising activity to leptin and/or Myalept may develop, which could result in severe in-

Patients with both types of generalised lipodystrophy often develop severe insulin resistance at a young age and may have diabetes mellitus fections or loss of treatment effectiveness. T-cell lymphoma has been reported in patients with acquired generalised lipodystrophy, both treated and not treated with Myalept, so healthcare professionals should carefully consider the benefits and risks of treatment with Myalept in patients with signifi-

Suven grants exclusive license to Taro Pharmaceuticals Taro will pay Suven a royalty SUVEN LIFE Sciences, a biopharmaceutical and contract research and manufacturing company has granted an exclusive license and right to distribute and market its Malathion Lotion USP 0.5 per cent w/v with US Patent #

14

EXPRESS PHARMA

March 16-31, 2014

8,138,366 and ANDA 091559 in the US, Canada and Mexico to Taro Pharmaceuticals North America, a subsidiary of Taro Pharmaceutical Industries.

Malathion lotion is indicated for patients infected with Pediculus humanus capi-

tis (head lice and their ova) of the scalp hair. Taro will pay Suven a royalty and the arrangement is effective until April 2028 unless otherwise terminated.

EP News Bureau – Mumbai

cant haematologic abnormalities and/or acquired generalised lipodystrophy. Myalept is contraindicated in patients with general obesity. Myalept is not approved for use in patients with HIV-related lipodystrophy or in patients with metabolic disease, including diabetes mellitus and hypertriglyceridemia, without concurrent evidence of generalised lipodystrophy.

Because of the risks associated with the development of neutralising antibodies and lymphoma, Myalept is available only through the Myalept Risk Evaluation and Mitigation Strategy (REMS) Program. Under this REMS programme, prescribers must be certified with the programme by enrolling in and completing training. Pharmacies must be certified with the programme and only dispense Myalept after receipt of the Myalept REMS Prescription Authorisation Form for each new prescription.

Myalept is also approved with a Medication Guide and in-

structions for use that provides patients with important information about the medication.

The guide will be distributed each time a patient fills a prescription.

The US FDA is requiring seven studies (post-marketing requirements) for Myalept, including a long-term prospective observational study (product exposure registry) of patients treated with Myalept, a study to assess for the immunogenicity (antibody formation) of Myalept, and an assessment and analysis of spontaneous reports of potential serious risks related to the use of Myalept. Eight additional studies are being requested as post-marketing commitments.

In clinical trials, the most common side effects observed in patients treated with Myalept were low blood sugar (hypoglycemia), headache, decreased weight, and abdominal pain.

Myalept is marketed by San Diego-based Amylin Pharmaceuticals.

EP News Bureau – Mumbai

Jubilant Life Sciences resolution for Montreal facility JUBILANT LIFE Sciences has received a communication from the US Food and Drug Administration (US FDA), classifying its pharmaceutical manufacturing facility at Montreal, Canada as ‘Acceptable’. This resolves all issues raised by the FDA on the facility in February 2013 and subsequent communications.

The development follows completion of FDA’s review of the company’s responses post the February letter and the subsequent re-inspection conducted at Jubilant’s Montreal facility in September, 2013. This development successfully resolves the FDA issues at the Montreal facility.

EP News Bureau – Mumbai

MARKET

Biomarker discovery presents opportunities for players in Parkinson’s Disease market: GlobalData

ous year. The PAT margins were at 13 per cent of the net sales for year ended on December 31, 2013.

The PAT for the quarter and year have dropped as compared to the previous year due to the transfer of the Infusion business in India and emerging markets to the joint venture.

LUPIN HAS received final approval for its Doxycycline capsules USP, 50 mg, 75 mg, and 100 mg from the United States Food and Drugs Administration (FDA) to market a generic version of Aqua Pharmaceuticals Monodox capsules 50 mg, 75 mg, and 100 mg.

Lupin’s doxycycline capsules 50 mg, 75 mg and 100 mg are the AB-rated generic equivalents of Aqua Pharmaceuticals, LLC’s Monodox capsules 50 mg, 75 mg and 100 mg and are indicated in the treatment of infections caused by various micro-organisms and as an adjunctive therapy in severe acne.

The company also received final approval from the FDA for its ciprofloxacin for oral suspension, 5 g/100 mL (250 mg/5 mL) and 10 g/100 mL (500 mg/5 mL) to market a generic version of Bayer HealthCare Pharmaceuticals (Bayer) Cipro for oral suspension 5 g/100 mL and 10 g/100 mL. Lupin’s ciprofloxacin oral suspension, 5 g/100 mL (250 mg/5 mL) and 10 g/100 mL (500 mg/5 mL) is the generic equivalent of Bayer’s Cipro oral suspension 5 g/100 mL (250 mg/5 mL) and 10 g/100 mL (500 mg/5 mL) and indicated for the treatment of infections caused by susceptible isolates of the designated micro-organisms in various conditions and patient populations.

Lupin is the first applicant to file an ANDA for Cipro oral suspension 250 mg/ml and 500 mg/ml and as such is entitled to 180 days of marketing exclusivity. Lupin Pharmaceuticals, the company’s US subsidiary would commence marketing the products shortly.

Monodox capsules had annual US sales of $180.6 million (IMS MAT Dec, 2013) whereas Cipro oral suspension had annual US sales of $8.6 million (IMS MAT Dec, 2013).

EP News Bureau – Mumbai

EP News Bureau – Mumbai

GlobalData predicts PD prevalence to increase from 2.5 million patients to 3.2 million across the seven major markets A RECENT collaboration between Berg Pharma and the Parkinson’s Institute and Clinical Center (the PI), and the degree of Big Pharma’s involvement in a separate programme, the Parkinson’s Progression Markets Initiative (PPMI), hint at the extent of commercial applications for biomarker discovery, says an analyst with research and consulting firm GlobalData.

According to Heather Leach, GlobalData's analyst covering immunology and central nervous system disorders, diagnostics is a particular area that has been lacking in the Parkinson’s Disease (PD) market. While GlobalData predicts PD prevalence to increase from 2.5 million patients to 3.2 million across the seven major markets (7MM: the US, France, Germany, Italy, Spain, the UK and Japan) between 2012 and

There are many additional implications for biomarkers in Parkinson’s Disease, which may be useful in a clinical setting or in diagnostics, and which will need to be validated individually for such uses 2022, Leach believes that a new diagnostic test could alter these numbers and expand the drug-treatable population through early detection.

The analyst says, “There has been considerable interest in the discovery of novel PD biomarkers from pharmaceutical companies to date, and the collaboration between Berg Pharma and the PI is not the first attempt at this discovery. The Michael J

Fox Foundation sponsored grants for biomarker discovery as early as 2002 and played an integral role in the formation of the PPMI.” “The discovery of a diagnostic test by either the Berg/PI collaboration or the PPMI initiative would serve as a tremendous breakthrough for the PD market, through the identification of prodromal patients, patients with early disease, or individ-

uals at high risk of disease.”

Leach believes that there are many additional implications for biomarkers in PD, which may be useful in a clinical setting or in diagnostics, and which will need to be validated individually for such uses. She continues, “It is hoped that these biomarkers will serve one of many purposes, either in helping to advance understanding of the disease, allowing stratification of patient populations, determining disease severity, or assessing patient responsiveness to drugs in clinical trials or in clinical practice.”

“With plenty of room within the biomarkers field for PD, all current players will have the opportunity to develop and launch products targeted at fulfilling these needs,” the analyst concludes.

EP News Bureau – Mumbai

Claris Lifesciences posts consolidated revenues at ` 7,084 million EBITDA margin reported at ` 2,100 million CLARIS LIFESCIENCES announced its annual audited financial results for the year ended December 31, 2013 at its recently held board meeting in Ahmedabad. The consolidated revenues for the full year; after transfer of the infusion business to the JV during the third quarter; stood at ` 7,084 million and for the Q4CY13 stood at `1,675 million compared to

16

EXPRESS PHARMA

March 16-31, 2014

` 7,777 million and ` 1,947 million; respectively; in the same period for the previous year.

The revenues for the quarter and year have dropped due to the transfer of the Infusion business in India and emerging markets to the Joint Venture.

Consolidated earnings before interest, depreciation, taxes and amortization (EBITDA) stood at ` 2,100

million for CY13 and ` 377 million for the Q4CY13.

EBITDA margins were at 32 per cent to net sales for the year ended on December 31, 2013.

Consolidated profit after tax (PAT) for CY13 and Q4CY13 stood at ` 844 million and Rs 178 million respectively, compared to ` 1039 million and ` 252 million for the same period in the previ-

Lupin receives approval for acne treatment

MARKET

Strand receives US patent for virtual liver model Announces release of the human version of the virtual liver model STRAND LIFE Sciences (Strand), a Bangalore and San Francisco-based bioinformatics and systems biology company has received patent protection for its 'method for predicting organ toxicity and a system thereof' in the United States (USPTO patent no 8,645,075) effective from February 4, 2014.

The method is currently employed in the form of a rat-based virtual liver model by the pharma industry to predict and assess hepatotoxicity of novel drug compounds in pre-clinical studies and by the cosmetics industry in the form of a skin and hair model.

Strand announced the release of the human version of the

Strand's virtual liver is based on a model of normal liver physiology, which provides mechanistic insights into how a drug compound or chemical impacts the liver virtual liver model with an even more direct application in human drug and chemical safety studies. Strand's virtual liver is based on a model of normal liver physiology, which, combined with targeted assays, provides mechanistic insights into how a drug compound or chemical impacts the liver. Work on the liver model began in 2007 and the ratbased model was ready for commercialisation in 2011.

“We expect interest in our

EXPRESS PHARMA

17

March 16-31, 2014

platform and subsequently business to increase and our labs to get busier,” says Kalyanasundaram Subramanian, Chief Sci-

entific Officer, Strand. “An estimated 50 per cent of drug failures in the clinical trial stage are attributed to toxicity, out of

which 60 per cent are attributed to liver injury. Using Strand’s rat model the pharma and cosmetics industry is able to reduce the

number of and cost associated with animal trials.

EP News Bureau – Mumbai

MARKET

GSK increases stake in local pharma subsidiary to 75 per cent after open offer GlaxoSmithKline accepts 20,609,774 shares of GlaxoSmithKline Pharmaceuticals FOLLOWING THE voluntary open offer undertaken by its subsidiary, GlaxoSmithKline, GlaxoSmithKline (GSK) has increased its stake in its publicly-listed pharmaceuticals subsidiary in India (GlaxoSmithKline Pharmaceuticals), from 50.7 per cent to 75 per cent.

GlaxoSmithKline Pharmaceuticals will remain publicly-listed.

David Redfern, Chief Strategy Officer, GSK said, “We are pleased with the outcome of this transaction, which further increases our exposure to a strategically important market. It is a significant vote of confidence in the future growth prospects of our pharma business in India and underlines GSK’s long-standing commitment to the country.”

GlaxoSmithKline accepted 20,609,774 shares from the shareholders of GlaxoSmithKline Pharmaceuticals, representing 24.33 per cent of the total shares outstanding through the open offer, which commenced on February 18, 2014 and closed on March 5, 2014.

The offer of `3,100 per share values the transaction at approximately `64 billion or £625 million (based on prevailing foreign exchange rates). The final payment for shares tendered and accepted will be completed on or before March 20, 2014, at which point GlaxoSmithKline will acquire full beneficial ownership of the shares tendered in the open offer.

The open offer was announced on December 16, 2013 and is being managed

by HSBC Securities and Capital Markets (India).

EP News Bureau – Mumbai

EXPRESS PHARMA

19

March 16-31, 2014

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MARKET DEALTRACKER

Focus on speciality pharma drives M&A activity in Feb 2014 Indian pharma sector witnesses no deals during February 2014 M&A ACTIVITY in the pharmaceutical sector was focused on speciality pharma segment, to accelerate growth, by acquiring blockbuster franchises.

In line with the above trend, Actavis agreed to acquire Forest Laboratories, a US-based speciality pharma company, for approximately $25 billion. This transaction would expand Actavis’ North American speciality portfolio with blockbuster product franchises in the CNS, gastroenterology, women’s health, urology and cardiovascular therapeutic categories.

The combined businesses will have emerging and sustainable portfolios in infectious disease, respiratory, cystic fibrosis and dermatology therapeutic categories.

This acquisition would allow Actavis to create a new business model, with size and scale, a balanced offering of strong brands and generics, a focus on strategic and lowerrisk drug development, to drive organic growth.

In addition, Actavis will gain access to more than half-adozen near and mid-term Forest Laboratories’ R&D products among which, five products are at the NDA stage of development. Forest Laboratories’ current position in primary care sales will allow Actavis to leverage its specialty brands portfolio to a broader physician base in the US. In another key deal, Mallinckrodt agreed to acquire Cadence Pharmaceuticals, a US-based biopharmaceutical company, for approximately $1.3 billion.

This transaction is in line with Mallinckrodt’s business strategy and accelerates growth in

20 EXPRESS PHARMA March 16-31, 2014

FIGURE: M&A (INCLUDING PRIVATE EQUITY) TREND ANALYSIS

Source:

FIGURE: VENTURE FINANCING TREND ANALYSIS

Source:

TOP M&A DEALS (FEB 2014) Rank

Date

Target

Acquirer

Deal value ($m)

1

02/18/14

Forest Laboratories, Inc. (US)

Actavis plc (IE)

25000

2

02/11/14

Cadence Pharmaceuticals, Inc. (US)

Mallinckrodt plc (US)

1300

3

02/24/14

Medpace, Inc. (US)

Cinven Limited; CCMP Capital Advisors, LLC

915

4

02/03/14

Precision Dermatology, Inc. (US)

Valeant Pharmaceuticals International, Inc. (CA)

500

5

02/10/14

Melinta Therapeutics, Inc. (US)

Vatera Healthcare Partners; Undisclosed Investors*;Falcon Flight, LLC

70

6

02/18/14

NovImmune SA (CH)

Rosetta Capital Limited; Undisclosed Investors*;Falcon Flight, LLC

67.31

7

02/17/14

Advanced Accelerator Applications, s.a. (FR)

HBM Healthcare Investments Ltd; Tamburi Investment Partners S.p.A.; Undisclosed Investors*;Falcon Flight, LLC

56.15

8

02/27/14

Bioniche Animal Health Canada Inc. (CA)

Vetoquinol SA (FR)

54.98

9

02/12/14

Arjun Products Limited; The Specials Laboratory Holdings Limited; Craig & Hayward Limited

Professional Compounding Centers of America (US)

38.61

10

02/28/14

Transition Therapeutics, Inc. (CA)

Perrigo Company plc (IE)

15

Source:

Mallinckrodt’s Specialty Pharmaceuticals segment.

With this acquisition, Mallinckrodt will gain access to OFIRMEV, a pain therapeutic. Since its introduction, OFIRMEV has experienced strong growth, and Cadence

expects net revenues of $110.5 million for OFIRMEV in calendar year 2013, compared to 2012 net product revenues of $50.1 million.

M&A activity in the pharma sector decreased in volume and increased in value

terms, when compared to the average of the previous six months (Aug 2013 – Jan 2014).

According to Datamonitor’s Medtrack database, the pharma sector recorded 25 M&A transactions in February 2014, against the previous

six months’ average of 32 transactions. In value terms, the sector recorded deals worth $28 billion, against the previous six months’ average of $6.7 billion.

The Indian pharma sector witnessed no deals during

MARKET February 2014, against the average of 0.8 deals over the previous six months.

Venture funding Companies in the pharma sector raised $142.8 million during February 2014, against the previous six months’ average of $254.1 million. In terms of volume, the sector recorded 15 venture funded deals, when compared to the previous six months’ average of 18.3 transactions.

Notes Medtrack is a comprehensive, fully integrated, global biomedical database providing information on companies, products, patents, deals, venture financing, and epidemiology. It is a live database, constantly updated with news, milestones, trial information, etc. Medtrack’s unmatched

TOP VENTURE FINANCING DEALS (FEB 2014) Rank

Date

Target

Investors

Deal value ($m)

1

02/18/14

Versartis, Inc. (US)

Sofinnova Ventures, Inc.; Aisling Capital; New Leaf Venture Partners; Advent Life Sciences Fund; Undisclosed Investors*

55

2

02/24/14

Thesan Pharmaceuticals, Inc. (US)

Novo Ventures; SV Life Sciences; Lundbeckfond Ventures; Novartis Venture Funds

49

3

02/13/14

Pronutria (US)

Flagship Ventures; Undisclosed Investors*

12.25

4

02/14/14

REGiMMUNE Corporation (JP)

Japan Asia Investment Co., Ltd.; Nippon Venture Capital Co., Ltd.; Mizuho Capital Co., Ltd.; Nissei Insurance; Mitsui Sumitomo Insurance Co., Ltd.; SMBC Venture Capital Co., Ltd.; Mitsubishi UFJ Bank Capital

9.2

5

02/11/14

Lithera (US)

Alta Partners; Domain Associates, L.L.C.; AKS Capital; Undisclosed Investors

8

Source:

coverage is supported by a userfriendly, highly dynamic set of decision support tools and analytics. In-house analysts and researchers add key insights and conclusions to provide you with the primary and secondary

information you need. Key uses of the database include competitive intelligence, target identification, screen potential licensing and investment opportunities, patent assessments, product due diligence, royalty

Definitions

2.Trend analysis excludes rumored and terminated deals.

3.Value and volume analysis excludes private equity exits.

1.Deal value trend is based on transactions where associate values have been disclosed.

For more information, visit us at www.medtrack.com

valuations, and developmental benchmarking.

EXPRESS PHARMA

21

March 16-31, 2014

MARKET POST EVENTS

IPC-IMATNSB Pharmacovigilance CME held at Chennai Saw participation of 75 clinicians and pharmacologists INDIAN PHARMACOPOEIA Commission, the National Coordination Centre for the Pharmacovigilance Programme of India recently organised a Pharmacovigilance CME for Practising Doctors, in technical collaboration with Indian Medical Association Tamil Nadu State Branch, at Chennai. The event saw participation of 75 clinicians and pharmacologists.

Dr J Vijay Venkatraman, Managing Director and Chief Executive Officer, Oviya MedSafe and Secretary Elect, Indian Medical Association – Coimbatore Branch, who was the coordinator of the CME programme welcomed the gathering and thanked the Indian Pharmacopoeia Commission and the office bearers of Indian Medical Association Tamil Nadu State Branch for making the event a reality. He mentioned that Indian Medical Association Tamil Nadu State Branch was the first professional association of clinicians with whom Indian Pharmacopoeia Commission had collaborated while organising the nationwide CMEs over the past few years.

Dr YK Gupta, National Scientific Co-ordinator, PvPI and HoD of Pharmacology, AIIMS, New Delhi inaugurated the CME and applauded the Indian Medical Association Tamil Nadu State Branch for partnering with the Indian Pharmacopoeia Commission to promote pharmacovigilance awareness. He congratulated the state of Tamil Nadu for achieving the highest level of health indicators across the country and for also being a leader in healthcare services in India.

Dr M Balasubramanian, President, Indian Medical Association Tamil Nadu State

22 EXPRESS PHARMA March 16-31, 2014

Branch expressed his happiness in partnering with the Indian Pharmacopoeia Commission.

He added that the Indian Medical Association has been playing a key role in all national health

programmes so far and henceforth, it will take an active part in the Pharmacovigilance Programme of India too. He emphasised that Indian Medical Association on its own too had been

trying its best to promote pharmacovigilance awareness among doctors by organising various CME programmes in the past.

Dr CN Raja, Secretary, In-

dian Medical Association Tamil Nadu State Branch appreciated the initiatives of Dr V Kalaiselvan, Principal Scientific Officer, Indian Pharmacopoeia Commission for his untiring efforts in making the Pharmacovigilance Programme of India more and more successful across the country. He also recognised the interest of Dr J Vijay Venkatraman which was one of the main reasons for the Indian Medical Association to get involved in organising this CME programme.

He committed that IMA Tamil Nadu will make pharmacovigilance an important part of its activities. Dr T Senthamil Pari, Vice President, IMA Tamil Nadu – North Zone, felicitated the function.

Dr J Vijay Venkatraman and Dr V Kalaiselvan spoke on the Basics of Pharmacovigilance and on the Pharmacovigilance Programme of India. Dr S Gunasakaran (Head – Clinical Research & Medical Affairs, Azidus Laboratories), Dr C Ramachandra Bhat (HoD of Pharmacology, KMC, Chennai) and Dr JV Srinivas (Senior Medical Officer – Clinical Research, SRM Institute of Medical Science, Chennai) spoke on patient safety monitoring in an out patient department, pharmacovigilance in a hospital set-up (tertiary and government) and pharmacovigilance in a hospital set-up (tertiary and private) respectively. Dr Bikash Medhi, Additional Professor of Pharmacology, PGIMER, Chandigarh elaborated on how to report ADRs using the suspected ADR reporting form and also provided an overview of the causality analysis methodology of the ADR reports.

EP News Bureau – Mumbai

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IPA-MSB,IPA-CPD organises training programme for pharmacists The programme had a mix of lectures, interaction, demonstrations and panel discussions

INDIAN PHARMACEUTICAL Association, Maharashtra State Branch (IPA-MSB) and Community Pharmacy Division (IPA-CPD), jointly organised a one-day training programme for community pharmacists in Panvel, Maharashtra. The programme had a mix of lectures, interaction, demonstrations and panel discussions. The programme had overwhelming response and a total of 137 pharmacists from Panvel and nearby areas attended the event.

Vijay Karande, Assistant

Commissioner, Food and Drug Administration, Raigad District inaugurated the programme. Dr Anand Shedge, Vice-President, IPA MSB welcomed all dignitaries and the participants. Also, present on the occasion were Nitin Maniar, Secretary IPA-MSB, Satish Shah, Joint Secretary, IPA-MSB and Supriya Patil from DIC-MSPC. Manjiri Gharat, Vice-President and Chairperson, IPA CPD conducted the first session on 'Need of patient counselling' and elaborated on the incorrect

use of medicines by the patients and role of pharmacists in correcting this situation by effective patient counselling. Dr Suresh Sarvadekar, Ex. Assistant Director, DMER (Directorate of Medical Education & Research) delivered a speech on the health situation in India and national health programmes.

District Health Officer Dr Sonavane spoke about the TB Control programme. Gharat briefed about the DOTS TB pharmacist, a public-private partnership developed by IPA

to engage pharmacists in TB control programme. A short documentary on the project was shown during the session.

The afternoon session was conducted by FDA Drug Inspector KG Gadewar, who demonstrated the newly introduced online services of FDA. DR Gahane, Assistant Commissioner, FDA HQ discussed in detail about the Schedule H1

and its requirements.

A panel discussion was organised on 'Community Pharmacy: Yesterday, today and tomorrow'. Dr Girish Gune, Past President IMA, DR Gahane, Gharat and Shedge participated in the panel discussion. The pharmacists were urged to provide patient- oriented services.

EP News Bureau – Mumbai

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Industry introspects at Healthcare & Pharma Expansion Summit 2014 Regulatory reform, need for practical roll out of new guidelines were key concerns Viveka Roychowdhury Mumbai COMING ON the heels of the visit of the Dr Margaret Hamburg, US FDA Commissioner, the recently held 2nd Healthcare & Pharma Expansion Summit 2014, Mumbai was an excellent opportunity for top industry professionals and service providers to discuss the learnings and move forward.

In his keynote address in the morning session, as well as while moderating the panel discussion later, TS Jaishankar, Managing Director, Quest Life Sciences, spoke about how regulatory issues are proving to be a challenge in the Indian pharma sector.

Jamila Joseph, Vice President and Head, Clinical Research Services, Reliance Life Sciences, spoke about the need for business process transformation to deal with regulatory challenges. The business model should be economically viable as well as compliant, and we need to improve infrastructure and the talent pool along with regulatory reform so that these reforms are implementable on the ground, was her solution.

Dr Anil Pareek, President, Medical Affairs & Clinical Research, Ipca Labs said that of all the many regulatory changes on the clinical research front, industry was most concerned about delayed approval timelines.

SV Veeramani, Founder and Chairman, Fourrts (India) Laboratories and President, Indian Drug manufacturers’ Association (IDMA) reassured the audience that India’s regulatory chief, the Drug Controller General (India), had in a recent meeting with association members and senior in-

24 EXPRESS PHARMA March 16-31, 2014

dustry personnel, promised to clear the backlog in the next three-six months. He made the point that India’s pharma products had a wider reach than the country’s IT services, if one considers that the former are exported to around 250 countries while the latter reach 150 countries. Be that as it may, on the compliance

front, Veeramani opined that continuous technical upgradation calls for continuous training.

In her concluding statement, Joseph stressed on the need to have a more practical roll out of regulatory reform.

Pareek too touched on this refrain saying that while new requirements like AV recording

of the informed consent process might be an issue initially, with time, they will become part of the process. Jaishankar summed up concluding that while our laws were good, implementation is difficult; partly due to the democratic process.

Winding up the pharma track of the event, Dr Rashmi

Hegde, Director Medical & Regulatory Affairs, Abbott India, in her presentation on the best practices for improving risk management and compliance in the healthcare sector, spoke about the need for harmonisation of regulations to avoid duplication of efforts. viveka.r@expressindia.com

EVENT BRIEF MARCH 2014 20

th

5 Edition of The India Pharma Summit 2013-14

21

Conference on Pharmacovigilance & Drug Safety ‘A New Era’

TH

5 EDITION OF THE INDIA PHARMA SUMMIT 2013-14 Date: March 20, 2014 Venue: Ramada Powai Hotel and Convention Centre, Mumbai Summary: Federation of Indian Chambers of Commerce and Industry (FICCI) in partnership with Department of Pharmaceuticals, Ministry of Chemicals and Fertilisers, Government of India and World Health Organization (WHO) is organising its 5th edition of The India Pharma Summit 2013-14.

The vision of this conference will be to set the motion for transforming India into a global hub for pharmaceuticals. The summit will connect the Indian life sciences sector stakeholders for facilitation of visionary policies in the areas of pharmaceuticals, biotechnology and clinical research.

Contact details Federation of Indian Chambers of Commerce and Industry Federation House Tansen Marg New Delhi - 110001 Tel: (011) 23487264 Email: Pharma@ficci.com Website: www.ficci.com / www.indiapharmasummit.in

CONFERENCE ON PHARMACOVIGILANCE & DRUG SAFETY - ‘A NEW ERA’ Date: March 21-22, 2014 Venue: Scitech Center, Jogeshwari, Mumbai Summary: Organised by DIA, this conference aims to cover topics including safety management of medical devices; medical information and safety integration, cosmetic vigilance; PV harmonidation in Asia; cardiac, hepatic and renal safety issues; drug and vaccine safety in public health; tete-a-tete with EU QPPVs; career opportunities potential in PV challenges in PV outsourcing.

Contact details Manoj K Trivedi Senior Manager Marketing and

Program Development, DIA Manoj.trivedi@diaindia.org Cell: +91-9820746323 Tel: (022) 67417625 DIA India 303, Wellington Business Park 1 Andheri Kurla Road Andheri (E) ,Mumbai-400059

EMERGING TRENDS IN DRUG DISCOVERY: AICADD – 2014 Date: July 23-28, 2014 Venue: AMRITA Vishwa Vidyapeetham - Amrita University, Coimbatore Summary: The emphasis of the conference will be on topics related to the Computer Aided Drug Discovery (CADD). The organisers are expecting more than 500 delegates including nobel laureates/ scientists/researchers/ students and professionals from academia and industries. A few identified thrust areas are: clinical pharmacy and pharmacy practice, natural products chemistry, medicinal chemistry, pharmaceutical technology, CADD, pharmacogenomics, pharmacoinformatics, SAR studies and machine learning, drug delivery system, nanomedicine, personalied drug design, bioinformatics and biomedical engineering.

Contact details Dr PK Krishnan Namboori Associate Professor, (Executive Coordinator), AMRITA Insight into Computer Aided Drug Discovery (AICADD) 2014, Computational Chemistry Group (CCG), Computational Engineering and Networking, AMRITA Vishwa VidyapeethamAmrita University, Amritanagar, Coimbatore-641 112 Phone: +91 422 2685000 Extn: 5592 Email: aicadd_2014 @cb.amrita.edu aicadd2014@gmail.com URL: http://www.amritaccg.in/ Conference URL: http://www.amritaccg.in/aicadd2014

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series of warning letters by the US FDA to Indian pharmaceutical companies have sent ripples of disquiet across the pharma sector. This development has come as no less than a humiliation for the industry that boasts of being the third largest in the world.

Indian drug companies will have to work even harder to regain ground.

Part of the reason for these issues is the ever changing regulations across various geographies. Hence companies will have to ensure their employees are in sync with developments across the globe.

Training is an important part of keeping up-to-date but it is vital that managements choose the right institute and trainers to meet Good Manufacturing Practice (GMP) compliance-related expectations of regulators ranging from the US FDA, MHRA, and the like. This business need has made pharma GMP training institutes a valuable partner for export-oriented pharma companies.

Growth drivers As expected, there has been a steady rise in the number of pharma training institutes in India over the last decade as more pharma professionals queue up.

Atul Shirgaonkar, Chief Executive Officer, Insight Systems, says, “The changing scenario in global GMPs has made training institutes a necessity. Many new requirements are being issued by regulatory agencies, particularly the US FDA, EU and WHO GMP. The challenge for successful organisations is to stay updated. This is not only for the pharma industry, but also for API, cosmetics, biotech, medical devices, R&D, clinical trial material manufacturers, excipients and packaging material manufacturers. Let us

28 EXPRESS PHARMA March 16-31, 2014

also not forget that our Indian regulations too are changing, though at a slower pace.”

Shirgaonkar feels that exports to such demanding markets need competent personnel. This competency or ability comes only from training. Such training builds faith in the minds of the regulator that the organisation is developing people for better quality products.

He adds that a wide gap between academia and industry is also making training institutes important. Pharmacy colleges in India do not mould pharmacists to meet industry requirements. Few companies have GMP training cells or competent staff and the required dedicated time to provide result-oriented training.

These are the main drivers for the increasing demand for training which is unlikely to reduce. Based on his estimates, by 2020, the GMP training business itself would be more than ` 2020 crores in the country.

As far as core GMP training institutes are concerned, besides selected training institutes, training activity was mostly carried out by industry associations like Indian Pharmaceutical Association (IPA), Indian Drug Manufacturer's Association (IDMA) and the like. “Since there is a slowdown as far as the pharma companies in the US and EU are concerned, they are outsourcing to India, China and other countries, i.e. the emerging markets. Hence, additional investments/ expansion plans are being put into place to cater to the training needs of pharma professionals in these markets. Training also needs to be provided to the staff of overseas companies which outsource products from such countries,” opines Shirgaonkar

Types of training Rajashri Ojha, Founder and Director, Raaj Global Pharma RA Consultants, informs that the deviation in standards and regulatory guidelines of different coun-

tries may result in non-compliance,and hence results in approval failures and refusal of dossier by Health Authority (HA). It has a negative impact on the company's image and results in delays in time-tomarket. “In most cases, reworking and corrections are required in the documentation which also adds to the delay. To avoid such situations, it is necessary to keep pharma professionals abreast with the latest GMP or regulatory guidelines,” says avers.

She adds, “Development of generic products(Formulations), manufacturing, control, BA/BE studies and registration of drug products into different countries, getting marketing approval as per country-specific requirements and meeting cGMP compliance is a challenge for any company. One should have perfect knowledge about ICH GMP, GLP in the pharma industry and ICH GCP during non-clinical and clinical development phases.”

“A good induction training is like a battle half done,” remarks Shirgaonkar. Making a pharma professional GMP compliant involves courses of different types. He elaborates, “Training topics include GMP and GLP fundamentals, good documentation practices, good distribution practices, hygiene and sanitation as basic training where as advanced training would include topics as validation, deviation management and change control, quality risk management, technology transfer or dosage form specific like aseptic practices and likes. Specialised training would further involve training the GMP trainers and training the GMP auditors. As a part of nonGMP training behavioural (soft skills) training would be an added advantage.” He asserts, “Consistency rather than a knee jerk approach is a key to compliance success.”

In house vs external training Pharma companies may have an option of providing in-

If training is expensive, try ignorance Atul Shirgaonkar Chief Executive Officer, Insight Systems

The deviation of standards and regulatory guidelines may result in non-compliance Rajashri Ojha Founder and Director, Raaj Global Pharma RA Consultants

Teaching methodology, explanation based on casestudies, evaluation pattern, availability of subject matter experts are the salient features of an external training programmes Anagha Maharao Managing Director, Institute of Pharmaceutical Management

house training. However, going with the latest trend pharma companies are preferring to send their professionals for external training.

So, what are the added benefits offered by training institutes?

“Pharma employees are occupied with their work. So, in-house training may or may not take place in true sense.

Effectiveness of in-house training may not be reviewed or monitored periodically.

Teaching methodology, explanation based on case-studies, evaluation pattern, availability of subject matter experts are the salient features of external training programme.

This gives clear understanding of the topic and helps them in implementation,” says Anagha Maharao, Managing Director, Institute of Pharmaceutical Management.

Shirgaonkar clarifies, “When you mention in-house training, these are of two types. One is conducted by the internal employees of the organisation and second by external faculty who visits the organisation. In the former case, the employee may have to perform training as additional job responsibility and hence cannot concentrate on the job at hand or a training cell would be in place but the skill and expertise may not be

( comprehensive or total.”

He adds, “Training institutes address different topics, are up-to-date and current and deal with training requirements in a professional manner. A participant / learner-oriented institute does not treat it as a task but focuses on transfer of learning. Secondly, due to participation by various industries the concerns are known and understood with a path in sight. In addition, varied expertise that is not available inhouse may be available with training institutes. Having opinions of subject matter experts and commonality of GMP issues becomes an added advantage which may not always be possible with an in-house training.”

Ready for additional expenses?

Recruiting an employee and his subsequent absorption within the company is the process where a pharma company would invest a considerable chunk of money. Moreover, GMP implementation asks for a lot of functional changes which in turn would mean infrastructure-related expenditure. Considering this

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Few companies have GMP training cells or competent staff and the required dedicated time to provide result-oriented training. These are the main drivers for the increasing demand for training which is unlikely to reduce scenario, will a company stretch its financial resources further to ensure its employees are trained in GMP from external institutes?

“We always maintain if training is expensive, try ignorance,” says Shirgaonkar. In his opinion, there are three categories of pharma companies in our industry. The first category has MNCs and lead players who invest and spend money on training. The second category has mediumsized companies where awareness is on the rise and who are now moving forward in terms of training investments. The third category, small companies, are still not very serious enough and are not really keen to spend money on training.

According to Maharao, one

reason why pharma companies may not be keen to spend money on training is because attrition rates are pretty high in the pharma industry. Also, additional time and money allotted to training hampers routine work. However, senior management do get an opportunity to attend seminars and conferences.

“There are so many regulatory changes happening at the international level and those who want to stay afloat on the global map need to upgrade themselves with the latest regulatory changes. As far as Indian pharma companies are concerned, they are members of one of the largest pharma industries in the world. I don't think they will think twice while spending money to train their employees,” opines Ojha.

Measuring credibility Pharma training institutes are mushrooming across India. Many of these are run by experienced pharma professionals but this may not always be true. Factors such as type of participants, quality of infrastructure and experience of faculty members/trainers contribute to the perceived standards of an institute.

“As far as we know, there is no authority to accredit training institutes. However, bodies like Indian Society for Training and Development (ISTD) can accredit individual trainers to qualify them,” informs Shirgaonkar.

Ojha opines, “A person or a company who undergoes training programme with any institute builds the credibility/authenticity of respective

GMP training institutes.” She adds, “Participant's satisfaction would automatically endorse the credibility of the training institute. The participants or customer provide feedback after training and also start applying their knowledge in day-to-day work. Their satisfaction is important for any GMP training institute.”

Changing regulatory requirements in the global market have forced pharma companies with global ambitions to modify their functions accordingly. Such a development is significant for the Indian pharma industry as many players are already tapping different global markets.

This scenario provides a very good platform for pharma training institutes and pharma companies to work together. Knowledge sharing between these two entities at all levels will only help pharma professionals train better and ensure their companies measure up to the toughest scrutiny. At stake is not only the health of the industry, but also patients across the globe. sachin.jagdale@expressindia.com

Initiatives by IDMA SV Veerramani, President,IDMA, Chairman and Managing Director, Fourrts (India) Laboratories elaborates on endeavours taken by IDMA to help the pharma industry become GMP compliant

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DMA has been conducting several training programmes and workshops for raising the quality and GMP compliance over the years.

Now, we will do it with much more vigour in order to strengthen the confidence of

the international community on the safety and efficacy of pharmaceutical products produced in India. Besides the recent India Pharma Regulatory & Compliance Summit 2014 conducted by us in coordination with UL India, we are planning to have several such initiatives jointly with UL India.

We are also planning to have a seminar on 'Managing Risk for Quality Compliance'

with the support of our Quality Management & Technical Committee in various centres of India. IDMA has also instituted Quality Excellence Awards in order to encourage and celebrate quality. A team of experts from the industry visits participating pharma plants and evaluate them on several parameters of quality systems, documentation, best practices for GMP adherence, etc.

Every year, we have a Phar-

maceutical Analysts Convention (PAC) to discuss on the current trends with respect to Regulatory Compliance and Quality adherence. Besides, we are also planning to work with our CDSCO, India, US FDA and UK MHRA on workshops with respect to cGMP. We also have a Regulatory Affairs Committee which constantly guides our members on the current regulatory requirements.

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An arduous endeavour?

Indian pharma companies are pushing for 'third country' status from the EU regulatory authorities for India's Schedule M and GMP guidelines. The recognition will definitely reduce the hassles of API exports to the EU but given the recent compliance issues and import bans, is this is pipe dream for now? BY USHA SHARMA

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n order to prevent the entry of substandard medicines, the European Commission (EC) had issued Directive 2011/62/EU in June 2011. Also called the Falsified Medicines Directive (FMD), the Directive laid down European Union (EU)-wide rules for the import of active pharmaceutical ingredients (APIS).

As per Article 46b(2) of Directive 2001/83/EC, all imported APIs need to be accompanied by a written confirmation from the competent authority of the exporting third country confirming that the plant in which the API was manufactured conforms to the standards of good manufacturing practice (GMP) in the EU. The Directive provided a 'short cut' for selected countries: in accordance with Article 111b of Directive 2001/83/EC the requirement of a written confirmation is waived for ‘third countries’ listed by the EC. The EU has since notified Switzerland, followed by Australia and lastly Japan and the US in June 2013, (just before the Directive became law on July 2, 2013) as third countries.

These waivers effectively mean standards of manufacture of APIs in these countries are accepted as equivalent to those of the EU. Likewise, requests from

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other countries like Brazil, Israel and Singapore were under examination by the EU for equivalence assessment. Representatives of the Indian pharma industry are of the view that the hassles of issuing written confirmations (certificates) to each company exporting APIs can be avoided, if India's regulators, the Central Drugs Standards Control Organisation (CDSCO), headed by the Drug Controller General (India) (DCGI) also follows suit and applies to the EU authorities for ‘third country’ status.

Currently, the process is that the CDSCO issues written confirmation based on valid Certificate of Pharmaceutical Product (COPP), as per WHO GMP guidelines, US FDA or EDQM or TGA inspection certificates. In cases where a company has not had prior inspections or certificates, the CDSCO will conduct an inspection.

Repressive regulation?

The impact of the FMD on API exports to the EU is sure to be felt by the industry. Dr Gopakumar G Nair, Chief Executive Officer, Gopakumar Nair Associates says, “90 per cent of Europe’s API needs are met by Indian pharma companies.

Thus the EU is a very valuable customer for Indian APIs.” In fact India and China meet 90 per cent of the global demand

for APIs. As Dr Milind Antani, Head, Pharma and Life Sciences, Nishith Desai concedes, “At present there are administrative issues regarding certificates and confirmations being issued for each company exporting APIs to the EU.“ Putting these stringent regulations into the larger context, Nair says, “What EU is apparently doing is understandably undertaking preventive and prophylactic measures to ensure quality in its supply chain management. The recent trends of USTR/USITC (United States Trade Representative/ the United States International Trade Commission), as well as the EU Parliament restoring the rights to the EU customs for seizure of counterfeit goods including trademark infringing goods, indicates the hard-line which developing countries, more particularly India, is likely to face increasingly in the coming years. However, to meet the EU-GMP guidelines having thousands of API manufacturers with non-uniform standards, both EU and India need each other in the pharma space.”

Nair feels that we are responsible, at least to some extent, for this backlash explaining, “Two factors have dampened the prospects, especially for India. One, the squandering

India cannot treat itself as an “island” with its own standards. We must be prepared to join the quality and GMP “continent” with world class standards if we aspire to be the leader in global pharma front Dr Gopakumar G Nair Chief Executive officer, Gopakumar Nair Associates

There are administrative issues regarding certificates and confirmations being issued for each company exporting APIs to the EU Dr Milind Antani Head, Pharma and Life Sciences, Nishith Desai

Indian pharma industry and DCGI must make a joint presentation to EU authorities for equivalent and acceptable assessment of Indian GMP and COPP of API for EU B R Sikri Director, ABS Mercantiles

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away by the powers that be, the “India Shining” “Incredible India,” “Apna Bharat Mahan”, sloganeering, red tapism and acute lack of “good governance practices” (GGP). Secondly, excessive slogans like “Generic Capital and Pharmacy of the World” has invited strong reactions and counter-measures from the US and Europe.”

API market and will improve relationship with EU API market. And there would also be comfort as regards to the quality of APIs.” The irony is that Australia, which has far fewer API manufacturers, has taken the pains to ease API, whereas India which is a far larger source of APIs still has not moved on this front.

Making the case Burdened with the extra documentation required by the FMD, industry observers point to the obvious benefits of the Indian regulator trying for third country status. Indian pharma companies are of the view that Schedule M of Drugs and Cosmetics Act is equivalent to EU GMP, as it has all the provisions to take care of cGMP compliance. The point is, is the CDSCO/ DCGI ready or equipped to meet this challenge? Are API manufacturers who currently meet only Indian GMP standards ready to equate themselves to EU GMP standards?

Top API manufacturers who export to the US and the EU and whose facilities are inspected and approved as per US FDA and EU GMP standards will welcome the move to equate Indian GMP to EU GMP standards.

The current approval process in India is complex yet is in line with the parameters of various global regulatory agencies.

Outlining the multi-step process, BR Sikri, Director, ABS Mercantiles says, “Indian API manufacturers get drug licenses from state drug controllers on condition that they follows the provisions of Schedule M of Drugs and Cosmetics Act. After compliance with Schedule M, the manufacturer has to get GMP certification for which there is a provision of joint inspection by state licensing authority and central licensing authority. After getting GMP certification, one has to apply for COPP for each API. Indian manufacturers feel that, WHO GMP and COPP is equivalent to EU GMP and CEP / EDMF of EU.” Thus EU recognition of WHO GMP and COPP will help the Indian pharma industry to grow faster because then the industry can be saved from the hassles of issuing written confirmations (certificates) to each company exporting APIs, says Sikri.

Such a move would obviously reduce the timeline and results will be more efficient and accurate. Antani feels, “Indian GMP standards for APIs are at par with global standards and if EU notifies India as third country as regards to standards of manufacture and supervision of APIs equivalent to those of the EU, it will be a major boost for the Indian API industry due to simplified process. This would lead to significant increase in the growth of the

Working to global standards If India claims to be the “pharmacy of the world” or “the “generic capital”, it cannot allow itself to be left behind as far as “quality standards” and “cGMP” benchmarks are concerned and Indian authorities need to keep pace with global norms.

Commenting on the issue, Nair says, “India cannot treat itself as an 'island' with its own standards. We must be prepared to join the quality and GMP “continent” with world class standards if we aspire to be the leader on global pharma front. For the emerging global scenario, in APIs and formulations, India is perceived as an island with lax regulatory framework. India needs to look at this scenario seriously and take the needed measures while at the same time retaining the national pride and goal of self-reliance.”

Emphasising on whether India too gets a similar recognition from the EU authority, Sikri says, “This will also help Indian manufacturers of finished drug products to source API from India instead of importing from EU approved sources either within India or from abroad. This will give recognition to our country because we are the largest producers of pharma products in the world and this recognition will further strengthen our position.”

Sikri suggests, “Indian pharma industry and DCGI must make a joint presentation to the EU authorities for equivalent and acceptable assessment of Indian GMP and COPP of API for EU. This can be supported by the fact that many Indian manufacturers of API are EU GMP approved and have CEP / EDMF. The number of such manufacturing facilities in India has grown in numbers in the last two decades. This proves that compliance of Indian Schedule M and GMP is equivalent to EU guidelines of cGMP.” On one side, Indian drug manufacturers are falling short of US FDA GMP standards and are facing import bans. On the other, companies seem to be confident that they are already meeting higher standards and are demanding recognition of this fact. The former is a reality, the latter seems to be wishful thinking … at least for now.

Experts in Pharmaceuticals, Cosmetics and Nutraceuticals Products

u.sharma@expressindia.com

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cGMP implementation: From philosophy to practice

SM MUDDA, Executive Director-Technical & Operations, Micro Labs

Advocating a quality systems approach for cGMP implementation, SM Mudda, Executive Director-Technical & Operations, Micro Labs, introspects and re-visits some of the basic issues related to c GMP compliance that would help to create a roadmap for sustaining the excellent growth achieved so far

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n the pharmaceutical industry the basic responsibility of the manufacturer is to provide the drugs which are of the intended quality standard, and are safe and effective. In order to ensure consistency of the quality of drugs, it is necessary that they are produced by strict adherence to the current Good Manufacturing Practices (GMPs).

The Indian pharma industry has made remarkable progress in the global market with several achievements to its credit. It prides in being the third largest manufacturer of the world with an estimated 40 per cent share of generic drugs sold in the US. UK licenses of generics use 40 per cent of APIs from India and has to its credit the highest number of GMP approved facilities by MHRA and FDA outside of the UK and the US. The industry could achieve this growth through its efforts of creating state-of-the-art facilities, comprehensive systems and controls over the period of last 10 years.

Despite these accomplish-

32 EXPRESS PHARMA March 16-31, 2014

ments, the industry has had occasional unpleasant surprises in the recent past. Serious lapses in GMP compliance were observed by the regulators in some of the leading Indian companies. This has created a lot of adverse publicity and has cast a shadow on the ability of the Indian pharma industry to remain in an ongoing state of GMP compliance.

While the issues are similar to those seen in companies across the world, it is time that the Indian industry approaches this issue with a learning mindset as against a victim mindset and use this opportunity as a catalyst for change to bring in required improvements in the management of quality. This is also important from the point of view of building our abilities to deal with ever increasing pressures of cost and regulatory compliance and to be able to deliver quality medicines keeping the ultimate objective of patient safety in mind.

It is therefore important, at this stage to introspect and re-visit some of the basic is-

While the issues are similar to those seen in companies across the world, it is time that the Indian industry approaches this issue with a learning mindset as against a victim mindset and use this opportunity as a catalyst for change

sues related to compliance that would help us to create a roadmap for sustaining the excellent growth achieved so far.

Understanding GMPs Although the Indian pharma industry has been complying with the requirements of GMPs specified in Schedule M of the Drugs and Cosmetics Act, with increasing export opportunities, the leading players of the industry voluntarily raised their standards to comply with the GMP requirements of, what we refer to as regulated market countries such as UK MHRA, EU and US FDA. However, since GMP compliance was a pre-requisite to get access to these markets, an excessive emphasis was seen to been placed on the success in GMP inspections.

This possibly appears to have led to adopting a riskaverse, inspection-oriented approach towards GMPs rather than adopting a quality system-based holistic approach for implementation of GMPs. It is therefore invariably observed that an an-

nouncement of an audit by regulatory agencies is often a trigger for reviewing the levels of GMP compliance by many companies, while it is expected that it should be an on- going process.

GMP, as the name suggests, is a practice and practices are followed by tradition.

Invariably, the “How” of a practice is known while “Why” is rarely known. Accepting a practice without questioning is considered as compliance hence many traditional practices go unchallenged. Practices also may not be uniform within the company due to diverse backgrounds and cultural differences of the people responsible for implementation. While adherence to GMP should result in consistency of practices, due to lack of uniform understanding and implementation of the GMPs, the good practices are seen to be consistently inconsistent.

It is, therefore, the time to look beyond mere practices and understand the philosophy or the concepts behind the practices. Practices

( without the support of the philosophy cannot be implemented consistently since the concepts teach us the purpose behind the practice and thus ensure consistent compliance.

A well-designed Quality Mangement System (QMS) provides the concepts behind the good practices that is described in some detail in the subsequent part of the article.

Understanding product quality Another important issue has been the traditional understanding of the product quality that is believed to be determined by testing. It is proved beyond doubt that quality has to be built into the product and testing alone cannot determine it.

However, finished drug products are tested for quality by assessing whether they meet the manufacturer’s proposed and the approved specifications of the regulatory agencies without looking into compliance with the QbD requirements. Besides, overcommitments if made in development and regulatory filing timelines, invariably impact the assessment of the product quality and stability before filing of the product dossier. This will consequently impact the quality during commercial manufacture of the products.

Over-emphasis on GMPs, for the reasons stated above and not on the design of the product has widened the gap of quality parameters between development and scaleup. GMP without product quality is futile; by the same token, a well-designed product can be ruined, if GMP is not followed. Assurance of product quality is built on the solid foundation of product design. In other words, even before manufacture, the safety, efficacy and stability of a product must be unambiguously established and this can only be achieved by adopting a QbD approach. QbD approach lays a solid foundation for achievement of product quality through the life cycle

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INITIATIVES TAKEN BY ISPE International Society for Pharmaceutical Engineering (ISPE), is the world’s largest notfor-profit association serving its members by leading scientific, technical and regulatory advancement throughout the entire pharmaceutical lifecycle. Founded in 1980, the ISPE has 25,000 members across 90 countries representing industry academia, regulators and suppliers.

KNOWLEDGE SHARING ISPE, in close collaboration with US FDA, has published several baseline guidelines and best-practice guides on several innovative and current topics such Good Automated Manufacturing Practices- GAMP, PQLIProduct Quality Lifecycle Implementation, and most recently, Quality Metrics.

ISPE publications are invaluable resources for GMP best practices, technical information, emerging pharmaceutical industry trends, and industry and ISPE news.

These include, discussion papers, knowledge briefs and white papers etc.

ISPE INDIA AFFILIATE ISPE India Affiliate, headquartered in Mumbai, was started in 2004 by Ajit Singh, Chairman, ACG Worldwide. He is the Chairman Emeritus of the Affiliate. ISPE has chapters in Ahmedabad, Hyderabad and Bangalore. The current chairman of ISPE is Gopal Nair, who retired from GSK as Executive Director. The other board members include Dr AK Singhal Ex MD, NNE Pharmaplan, India, R Raghunandanan,

Consultant, Ex- VP,Quality,GSK South Asia, Kapil Bhargava, Ex- DDC, CDSCO, Mumbai, Sipahimalni, renowned Analytical Expert and Consultant, SM Mudda, Executive Director, Technical & Operations, Micro Labs Bangalore.

ISPE India has organised several seminars in India. It also organises seminars for the young professionals as YPEP- Young Pharmaceutical Professional Education Programme to educate student members and new entrants to the industry. One of the important Global COPs, GCLP- Good Control Laboratory Practices was started in India and is run by a competent Steering Committee.

On the occasion of the 10th Anniversary of ISPE India, a two-day conference was recently organised in Mumbai. The theme of the conference was 'Creating a Sustainable Quality Culture' focusing on recent topics such as developing and sustaining data integrity, Carrying out effective investigations and proposing CAPA, using quality metrics towards the desired state and developing and sustaining a quality culture.

The speakers included top officials from MHRA, Central Drug Control Administration and international speakers from ISPE Forum.

The conference was preceded by a preconference dinner meet of senior leadership and CEOs of the industry with the regulatory head of UK MHRA and Indian regulators to discuss the current issue of data integrity challenges before the industry and the way forward.

with approved regulatory filings) and other internal and external customers.

The regulatory agencies also expect the industry to adopt the QMS approach. The following two guidelines issued by the US FDA and International Conference on Harmonisation (ICH) provide the details.

US FDA announced the Pharmaceutical cGMPs for st the 21 Century Initiative with an intent to integrate quality systems and risk management approaches to meet the requirements of the current GMP regulations. The outcome of this initiative was the guidance for industry, “Quality System Approach for Pharmaceutical cGMP Regulations’ issued in September 2006.

The FDA guidance document recommends a riskbased and quality systembased approach to be adopted for CGMP regulation by emphasising management responsibility for quality systems and brings to the fore the key concepts of modern quality systems such as quality by design, quality risk management, change control, CAPA- Corrective And Preventive Actions, quality unit and a six-system model.

The six-system model

The management has to create a quality mindset (quality owned by all), capabilities of the key personnel for active engagement and accountability in the matters of quality and adoption of intelligent systems and processes to establish a best-practice PQS of the product.

It is now mandatory to demonstrate that products are developed by following the principles of QbD. Following the principles of QbD for product design becomes even more important in view of the recent US FDA guideline that has a provision to issue RTR (Refuse-to-Receive) letter if the application is deficient in

development aspects.

Adoption of quality systems approach The industry needs to respond to these challenges with a paradigm shift in its approach towards GMP compliance and product quality and adopt quality system-based and risk- based approach for implementation of GMPs.

This calls for creating a formally documented QMS for consistent implementation of cGMPs through out the product lifecycle.

The QMS approach will allow the delivery of products with the quality attributes appropriate to meet the needs of patients, healthcare professionals, regulatory authorities (including compliance

Similarly, the ICH Q10 Guideline describes the model for an effective quality management system for the pharma industry, referred to as the Pharmaceutical Quality System (PQS). The PQS recommends enhancing the quality and availability of the medicines, facilitating innovation and continual improvement and strengthening link between pharma development and manufacturing.

It focuses on achievement of the quality of product through the product lifecycle starting from development and includes technology transfer, commercial manufacture and product discontinuation and also lays emphasis on management

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cover ) review of performance and product quality.

PQS - Regulatory expectations The regulatory deficiencies observed in the recent times are indicative of the lack of adoption of QMS approach by the industry. The focus of inspection has mainly been on how companies react when things go wrong or are changing under pressure. It is expected that the companies investigate the failures with a view to find root cause rather than building arguments for release of the products. The benchmark of investigations performed has not been found to be of required standards, with particular reference to complaints, rejects, deviations and out-of- specification data.

Detailed root-cause analysis is invariably not done leading to inadequate CAPAs. The following statement from Dr Janet Woodcock, Director of FDA, CDER brings out the regulatory expectation: “Pharmaceutical quality management is lacking and we are not anywhere near where we need to be. And it seems as though industry’s objective today is to continue to meet regulatory standards which are minimal expectations, versus adopting a commitment to high-quality medicines.”

Thus, adoption of quality systems approach and riskbased approach by introducing the best - practice PQS appears to be the way forward for demonstrating commitment to manufacture highquality medicines.

The management’s responsibility It is often said that “Quality is too important to be left to the Quality Controllers alone.” This statement underlines the importance of the quality function and expects it to be a management function driven by the commitment of the top management.

The PQS (ICH Q10) places the ultimate responsibility for

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the quality of the products on the senior management. It is the onus of the management to establish a quality policy that depicts the overall intentions and direction of the company and provide leadership to establish and maintain a company-wide commitment to quality.

While every one talks about the need to change towards quality culture, it is not something like manufacturing component which can be changed or replaced and has to be gradually built. An organisation’s culture consists of values, norms and practices of its people and is seen in the behaviour of the people.

The management has to create a quality mindset (quality owned by all), capabilities of the key personnel for active engagement and accountabil-

ity in the matters of quality and adoption of intelligent systems and processes to establish a best-practice PQS. An active engagement of the top management helps in effective implementation of the PQS, conducting periodic management review of quality systems, encourages transparency in reporting of deviations and implementation of necessary CAPAs. Thus, it will be seen that the bestpractice PQS helps in improving the competitive edge of the company, since each and every individual in the organisation, understands his responsibility for protecting the quality and safety of the products manufactured by the company.

The advantages of the best-practice PQS are seen in favourable quality and compli-

ance trends such as increase in process capability, investigation free lots, compliance risk reduction, internal audit performance and decrease in product complaints and product recalls. It further helps in value creation in terms of reduction in cost of quality by investing in cost of prevention rather than paying dearly for internal and external failures.

It thus ensures continuous improvements and protects the firm’s reputation and business.

Globally, there has been a focus on creating a quality culture as evidenced from the title of the ISPE Second Annual Conference topic ‘Re-defining the ‘C’ in CGMP’ as creating, implementing and sustaining a culture of compliance. Implementation of PQS helps in integrating all functions within the

organisation that results in creating an exemplary culture of compliance.

Conclusion Systems and controls do not provide assurance of product quality if a culture of compliance is not maintained.

Quality system and riskbased approach help in creating a quality culture Focusing on the management aspects of quality rather than adherence to practices and implementation of Good Practices driven through Philosophy of Quality Management will help create and sustain a quality culture within the organisation.

It is time the industry focuses on implementing the best-in-class PQS and re-defines it as the vital Business Management System (BMS).

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INSIGHT

US FDAcGMP regulatory compliance by Indian pharma: An impossible dream?

RAM BALANI, CEO-Founder, FDASmart Inc

Ram Balani, CEO-Founder, FDASmart Inc, sheds some light on the compendium of errors committed by Indian pharma manufacturers and how these can be avoided by following cGMP compliance that meets US FDA standards

C

urrent Good Manufacturing Practices (cGMP) compliance that meets US FDA standards is both easy and hard ! Seriously. We’ll explain how below.

Dr Margaret Hamburg, US FDA Commissioner, as we all know by now, recently visited India.

Imagine what most Indian pharma manufacturers must have been thinking about at the eve of this high-profile trip and controversial time for the US FDA Commissioner’s visit to India.

Maybe a mental picture like this one? (See Fig 1) The US FDA Commissioner’s visit to India had a dual purpose, i.e. acknowledge India’s strategic and vital role in the US drugs supply while at the same time bringing in a regulatory ‘whip’. There was a firm acknowledgement from Hamburg that the US is indeed highly dependent on India for its drug supply but vehemently emphasised that there is zero tolerance for drugs manufactured in India

FIG 1

destined for American medicine cabinets if they do not comply with US FDA cGMP. US FDA GMP inspectors now show up without announcement or scheduling at Indian pharma manufacturing gates as they do domestically in the US, what with the increased presence of multiple FDA offices in India. Recently, the Indian pharma industry has been hit with one GMP inspection fiasco after another beyond run-of–the mill Form 483 observations including at once esteemed Indian pharma industry players. We won’t name names, you all know who they are. That said, why is this happening? The answer all points back to our earlier claims of 'easy' yet at the same time ‘hard' above.

Easy, because the US FDA lays out clearly and in great detail the blue-print or compliance road-map via its cGMP statutes or regulations. The US FDA website, www.fda.gov contains extensive links to the cGMP regulations, guidance documents, and various resources to help drug companies comply with

the US drug laws.

Specifically, the US FDA publishes the 21 CFR 210 and 211 regulatory statutes (the ‘WHAT’) clearly defining what the US FDA mandates pharma companies should follow plus all sorts of guidance documents to shed more light on the statutes with additional resources to assist drug manufacturers for ‘WHAT’ is expected of them, but NOT the HOW! Guidance documents published on the US FDA website represents its current thinking on a statute or topic.

They describe FDA’s interpretation of US FDA policy on a regulatory issue (21

CFR 210/211). These documents usually discuss more specific products or issues that relate to the design, production, labelling, promotion, manufacturing, and testing of regulated products.

Therein lies the rub, i.e. the hard part. In India, recently, however, there are increasingly two ways ‘hard’ is manifested, to be specificthere’s what I call (a) ‘hard lite’ and (b) ‘hard core’– we’ll address the first kind below, i.e .the ‘hard lite’ type.

‘Hard lite’ are innocent but remain US FDA-intolerable incidents, occurrences or infractions of cGMP , i.e. caused by lack of cGMP

MENTION FDA WHAT COMES TO MIND? This?

Or perhaps this....

Or even this?

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cover ) know-how, an honest mistake or lack of understanding, loosely maintained Quality Control (QA), etc. (no malicious intentions). Since the US FDA does not specifically define ‘HOW’ a pharma manufacturer needs to comply with cGMP statutes, it’s left up to every pharma manufacturer to do ‘HOW’ on their own. Enter ‘SOP’ Standard Operating Procedures, defined as 'written procedures for repetitive use as a practice based on some specifications.'

SOPs are the KEY for bridging the gap between US FDA cGMP statutes (21 CFR 210/211) and a specific pharma drug manufacturing plant site for each drug made. SOPs at the minimum, are written procedures adapted by a specific pharma manufacturer for their own unique products, equipment, people, process and manufacturing location and environment. The SOPs, to be clear, tells the US FDA how each pharma drug manufacturer does its ‘HOW’. The US FDA mandates that if SOPs are not documented or written anywhere, it will assume there are no standards for doing things, and that’s clearly unacceptable. Documenting validated SOPs then putting them to practice thereafter is mandatory at the very least.

Most if not all Indian pharma manufacturers have SOPs in place and are documented more or less so why all these Indian pharma cGMP 483s post cGMP audits or worst, GMP fiascos?

There are several reasons why SOPs created by Indian pharma companies do not do the job as far as the US FDA is concerned and therefore raises concerns or doubts that a specific Indian drug manufacturer is cGMP compliant.

Here’s some of the obvious ones First and key, the SOPs are not mapped back adequately to the CFR 210/211 statues or in other words the Indian pharma manufacturers ‘HOW’ are inadequately mapped back

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‘Hard core’ incidents are clearly a corporate management and moral imperative challenge, i.e it requires a re-calibration of ethics, adequate oversight and maybe investments on personnel training and preemptive and timely governance to prevent cGMP malfunctions . Trust and verify seems like the cure for these times with pharma India one-to-one to the US FDA cGMP CFR statues (the ‘WHAT’)?

Second reason why SOPs might fail is because they’re not enforced diligently in practice, i.e though company specifically have SOPs in writing and done correctly once in a while, new personnel or hires are not trained for example, hence they deviate from the practice of the official documented SOPs, i.e. creates exceptions and inconsistency leading up to adulterated drugs sooner or later.

Third reason could be that SOPs after documenting are left alone to gather cobwebs while in the meantime new drug products or delivery are put in place (e.g. liquids instead of gelatin capsules), new manufacturing steps are introduced or old controls replaced (e.g. new equipment commissioned on-line). FDA expects you to document what you say you’ll do and do what you write, easier said than done.

SOPs, if enforced help maintain safe and effective drug manufacturing consistency apart from validating to the US FDA that a manufacturer is cGMP regulations compliant during audits. They are mandatory to the ultimate goal of any Indian pharmaceutical drug manufacturer to manufacture safe and effective medicines with assured quality each and every time.

What ‘hard lite’ is can best be understood with examples.

Below is an actual US FDA 483 observation from the US

FDA website contained in a warning letter issued to an Indian pharma company: US FDA 483: “Written records of major equipment cleaning and use are inaccurate and do not provide assurance that persons doublechecked the performance of equipment cleaning, because there is no assurance that those persons responsible for determining that work was performed were present at the time of equipment cleaning [21 CFR 211.182].”

And here below straight out of the US FDA website is an extract defining 21 CFR 211.182, the relevant matching cGMP statute to the warning infraction above: PART 211: Current good manufacturing practice for finished pharmaceuticals Subpart J--Records and Reports Sec. 211.182 Equipment cleaning and use log.”

Sec. 211.182 Equipment cleaning and use log.”

“A written record of major equipment cleaning, maintenance (except routine maintenance such as lubrication and adjustments), and use shall be included in individual equipment logs that show the date, time, product, and lot number of each batch processed. The persons performing and double-checking the cleaning and maintenance (or, if the cleaning and maintenance is performed using automated equipment under 211.68, just the person verifying the cleaning and

maintenance done by the automated equipment) shall date and sign or initial the log indicating that the work was performed. Entries in the log shall be in chronological order.”

A good SOP as you can deduce, would include references to accuracy of the log, some mechanism that assures the US FDA that persons cleaning the equipment and additionally one assigned to double-check the cleaning process and its maintenance must sign and date cleaning entries into the logs thus confirming the cleaning process. Not rocket science but more often than not, most pharma companies fail to accomplish such procedures for one reason or another.

The second type (b) ‘hard core’ is all together an entirely different matter i.e. not only is cGMP not observed but there is deception or malicious intent to cover up lack of compliance, a mistake or worst, falsify data. All are big ‘no-no’s with the US FDA. Sorry, but there’s no SOPs for cheating with the US FDA, I’m afraid.

The US FDA has zero tolerance not only for adulterated drugs but not surprisingly also for omissions, deception and creative, false reporting. Doing that could very well help turn Hamburg’s and her US FDA brigades’ whip into a hangman’s noose. And from what we’ve observed lately in India, it has!

Below is another actual US FDA 483 observation from another warning letter off the

US FDA website: From US FDA 483 “a. On March 18, 2013, an FDA investigator identified the presence of torn raw data records in the waste area and asked one of your firm’s QA Officers to remove these torn raw data records for the investigator’s review. This QA Officer presented the FDA investigator with approximately 20 paper records, none of which included raw data entries identified in the waste area earlier during the inspection. The FDA investigator asked three times if there were any more records found in the waste area, and the QA Officer responded to each question, "no, this is all of the records”. The FDA investigator then revisited the waste area and found that the raw data records had been removed and placed in a different holding bag.”

Withholding or falsifying drug manufacturing quality control data has been a recurring theme at facility inspections that the US FDA has discovered recently in India. It emerged as recurring problems at a facility owned by India’s poster company referenced above for which the company eventually pleaded guilty.

‘Hard-core’ deviations ‘Hardcore’ incidents are clearly a corporate management and moral imperative challenge, i.e it requires a recalibration of ethics, adequate oversight and maybe investments on personnel training and pre-emptive and timely governance to prevent cGMP malfunctions . Trust and verify seems like the cure for these times with pharma India.

It’s been reported that cGMP quality management translates to 25 per cent or more of product manufacturing costs. Indian pharma manufacturers surely need to wake up and understand that even with such steep costs, these days, it’s a small price to pay to do-or-die so to speak. And that’s why cGMP for Indian pharma companies is both easy and hard.

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INSIGHT SWAPNA NARAYANAN, Managing Director, Information Mapping India

Surviving a regulatory audit

In the regulatory compliance domain, one of the common failures cited by the regulatory authorities in their warning letters is lack of adequate documentation. Can your organisation’s documentation system survive a regulatory audit tomorrow, asks Swapna Narayanan, Managing Director, Information Mapping India

I

ndian pharmaceutical industry is going through a rough patch today, predominantly, in the regulatory compliance domain. One of the common failures cited by the regulatory authorities in their warning letters is lack of adequate documentation. They basically repeat the message that pharma manufacturers have failed to create and maintain written procedures for:

● Production specifications ● Quality control operations ● Master manufacturing

records ● Returned goods and equipment etc.

This has resulted in: Financial risk such as huge penalties ● Legal risk such as criminal proceedings against members of top management ● Reputation risk such as publicrelations disasters, and ● Risk of business disruptions including closures, loss of productivity, and/or loss of contracts and clients. ●

Why is it happening?

There are very many reasons for this. Some of the key issues related to ineffective documentation are listed on (Table 1).

What are the regulatory agencies looking for?

The regulatory authorities have clearly defined GMP guidelines that the manufacturer must adhere to while developing their products. Basically they want to see clear written documentation with respect to: ● Quality management – control, assurance etc. ● Personnel management ● Production facilities and equipment ● Documentation and records ● Production and in-process controls ● Packaging and identification labelling ● Storage and distribution

● Laboratory controls and validation ● Complaints and recalls etc.

What do the regulatory agencies see today?

Common refrain heard from a regulatory agency is – ‘All organisations promise to provide written procedures and then fail to produce them.’ This is what leads to warning letters and eventually to seizures and injunctions.

How do we cross the divide?

The pharma industry faces the task of meeting all regulatory compliance requirements and compliance standards.

Given the fact that ensuring quality assurance is an intensive exercise - from discovery to clinical trials to patient delivery of

safe and effective products, one must stay on top of the regulatory requirements.

To do so, companies must develop a comprehensive Compliance Management System that is agile and adaptable – considering the ever changing regulatory environments. Developing and maintaining documents is a key component of this system.

The system must encompass clear documentation across the core aspects of quality by design, quality product development, quality risk assessment and management, audits and approvals and structured root cause analysis, corrective/preventive action etc.

What does a regulatory agency expect in a Compliance Management System (CMS)?

All regulatory agencies specify that pharma manufacturer must maintain good documentation and records as per the GMP guideline. For them–if it is not written, it did not happen. They expect documents that are: ● Developed, prepared, reviewed accurately ● Approved, signed, and dated by authorised stakeholders ● Unambiguous in nature – with clear title, purpose etc. ● Distributed efficiently ● Stored in an easy to retrieve manner ● Regularly reviewed and kept up-to-date ● Effectively version controlled with a clear traceability etc.

How do we set up an effective CMS? Companies that want to reduce corporate exposure and improve employee productivity need to ensure that their documents are clear, accurate, and accessible. The list below describes seven requirements for effective documents that meet the needs of a compliance initiative: ● Accurate - Content needs to be verifiably correct and match

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cover ) up with how employees actually perform their work. ● Accessible – Users and auditors- need to be able to access the document they need quickly and then easily locate the information they need. ● Comprehensive - Documents must include the required content at the right level of detail for the employees who rely on it, and satisfy the regulators who examine it. ● Clear and user-focused - Employees must understand what they need to do without having to ask supervisors, call for help, or take their best guess on proceeding. And regulators need to clearly understand how document content matches up with what employees actually do. ● Agile and adaptable - If it’s not easy to revise and update in response to changing regulations or changing practices, documentation will quickly become obsolete– in other words, useless and non-compliant. ● Technology-compatible - Increasingly, users access their documentation online. Knowledge management systems offer the promise of centralised control, as well as quick and easy repurposing of content. This means that companies need to organise and structure content in ways that are compatible with how knowledge management systems work. ● Standardised and scalable In some organisations, there are still teams of technical writers who create documentation, but there is a clear trend towards giving responsibility for authoring to employees who are not professional technical communicators. Even when there’s a writing team, their content is likely to come to them from engineers, research professionals or other subject matter experts whose expertise doesn’t include writing.

How can information mapping help?

Information mapping is a method that has become the standard for creating policies, procedures and documentation that help companies across all industries achieve and maintain compliance. Its principles pro-

38 EXPRESS PHARMA March 16-31, 2014

TABLE 1: REASONS FOR INEFFECTIVE DOCUMENTATION Ineffective documentation

Although most companies blame employees when errors are made repeatedly, the root cause is usually inadequate quality policies and procedures that are poorly written, hard to find, incorrect, or out-of-date.

Interpretation issues

Because of inconsistencies in quality policies and procedures, there are confusing business communications that fail to convey important messages or bury key points.They also lead to mistakes made because employees misunderstood the documentation.

Lack of easy access

Most of the times employees find it easier to pick up the phone and ask for help than to search through existing documentation to find the information on their own.Though there are lots of documentation available, but is not getting used primarily because of lack of easy access to written documentation and support information.

No time to search for information

Whenever employees are reviewing, updating, or documenting compliance information they fail to find an accessible, reliable source of information that tells them: ● what they need to do, ● how they need to do it, and ● when the work needs to be completed

Lack of clarity on the process

There are scenarios where a simple process gets slowed down and takes weeks to complete. Invariably because: ● an employee does not know how to fill out a form, where to submit it, and when to expect a response ● a manager is not aware of how the approval process works or where they fit in the chain of command for authorisation, or ● an assistant is not sure how to enter information into a database and generate and route necessary reports.

Not addressing the diverse needs of the users

When it comes to information - one size does not fit all. Employees need different information based on their roles - the information needed by security personnel, the executive management, or an audit team is not the same.When information for different audiences is placed into a single document without considering their needs or how the information will be used - it creates confusion, inefficiencies, frustration, and, usually, mistakes.

vide writers with a common set of guidelines for breaking information into manageable chunks, organising those chunks into topics, and using labels to make information accessible and usable. This standard approach to maintain documents in a compliance management system lends consistency to company documents and meets the requirements for effective documentation, accessibility, ease of use and modular design.

What should companies do?

Companies should adopt a three pronged approach to address the issue of ineffective documentation.

1. Audit current processes As a first step, companies must take stock of the situation.

They must do a comprehensive audit of their existing quality policies and procedure documents. The audit parameters should be from the perspective of users: For employees:

● Are my documents educating my employees - both in the overall processes as well as in the specific procedures that tell them how to do their jobs? ● Is the documentation capturing the cumulative learning of the workforce and spreading it across all workers? ● Is it ensuring consistency in activities and contributing towards a quality end-product? ● Are they able to find, understand, and execute evolving policies and procedures so the company is not put at risk?

For auditors ● Is the documentation recording the company’s activities accurately? ● Is it providing an audit trail not only for staff and customers, but also for auditors? ● Is it reliable with clear and concise evidence that the company is operating in compliance with their requirements?

2. Compare against a global standard Information mapping is a

global content standard. Our research and implementations across various companies has found that information is easiest to find and understand when it is categorised into types and separated based on the purpose for the information for the reader.

We use six distinct information types that account for as much as 90 per cent of the content in most business documentation. They are: ● Procedure – how to do something ● Process – how something works or what happens ● Principle – policies, guidelines, rules ● Fact – specifications, data ● Concept – ideas, or terms that need to be defined ● Structure – a physical representation of parts, boundaries, relationships 3. Transform your content Once identified, adopt the following approach and transform your content as per the information mapping standard:

● Identify the targeted audiences; create documentation at the ‘right’ level detail for each audience. ● Ensure information is categorised by type and purpose. ● Break information into manageable units/topics and label each unit/topic. ● Check for consistency. ● Determine if information is accessible. ● Identify reusable information modules.

In a nut shell For compliance strategies to be effective, employees and auditors must be able to effectively use your documentation. Documentation is an essential part of meeting expectations of regulatory agencies. If companies stringently adhere to the basic premise of quality – “Document what you do. Do what you have documented”, and supplement it with an effective documentation standard - they can regain their credibility with the regulatory agencies as well as the marketplace – both Indian and global.

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INSIGHT

Creating a culture of quality and compliance Dr Kavita Mehrotra, Head, Global Strategic Alliances, UL (Underwriters Lab), Scott Barnard, VP & Practice Leader, Advisory Services, UL EduNeering and Ellen Leinfuss, SVP, Life Science Practice Leader, UL EduNeering, talk about the need for all of us to not give in to the easier interpretation of being targeted and use this attention to our advantage by enhancing ourselves and becoming a force to contend within the global stage

P

icture this scenario: You are an employee in a pharmaceutical company that manufactures drugs which are exported all around the world. As you report to work, you find out that there is a FDA inspector at your door, asking to see the GMP practices being observed at your organisation by walking through your facilities. If you were writing this story, how would the next lines read?

This scenario is no longer a hypothetical one, and if you have been following the news, or are in this industry in any capacity, or have been sick and trusted the efficacy of the medicine you have been prescribed, this applies to you closely.

Lately, Indian pharma companies have received large amount of critical global attention due to certain evasions, violations and avoidances during US FDA inspections, and the subsequent enforcement actions against individual Indian pharma companies are threatening the reputation of India’s $19 billion pharma sector

DR KAVITA MEHROTRA, Head, Global Strategic Alliances, UL( Underwriters Lab)

SCOTT BARNARD, VP & Practice Leader, Advisory Services, UL EduNeering

ELLEN LEINFUSS, SVP, Life Science Practice Leader, UL EduNeering

India is a global powerhouse in the production of generic drugs, being the second-largest supplier of pharmaceuticals to the US. Last year, pharma exports from India to the US rose 32 per cent to $4.2 billion. India accounts for about 40 per cent of generic and over-the-counter products and 10 per cent of finished dosages used in the US. Given those numbers, it is not surprising that India’s government and foreign regulatory agencies are emphasising the need to ensure consistent quality of the country’s drug products.

There is a need for all of us to not give in to the easier interpretation of being targeted and use this attention to our advantage by enhancing ourselves and becoming a force to contend with in the global stage.

In a dubious way, the reassuring news is that India is not the only country facing drug quality problems or GMP non-compliance. Virtually every country, including the US, struggles to maintain the quality of medical products, whether they are im-

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cover ) ported or produced domestically. And there are no short cuts to excellence. There is a need to create a culture of quality and compliance in order to meet our highest commitment to patient safety, one pill at a time. And that is a commitment to embrace actionable steps to use information and learning as a tool for cultural change.

The value of GMP compliance GMPs are required for the manufacture of products regulated by the FDA and other regulatory agencies, but they also serve as a useful roadmap of quality assurance, operational efficiency and employee performance for all drug manufacturers. In an ideal scenario, a single manufacturing and product quality standard would apply globally, allowing for seamless movement of consistently high-quality products. Although harmonisation of GMPs globally has not yet been fully embraced, there is growing cooperation among national authorities on GMP standards, facility investigations and enforcement actions.

In fact, in the recent signing of the Statement of Intent between the US FDA Commissioner Dr Margaret Hamburg, and the Government of India represented by Keshav Desiraju, Secretary, Department of Health and Family Welfare, among other things, US FDA and Indian regulatory bodies agreed to: 1. Sharing of information relevant to lack of compliance with accepted current Good Manufacturing Practice, Good Clinical Practice, or Good Laboratory Practice, as appropriate, by manufactures and sponsors of medical products and manufacturers of cosmetics, in their respective countries, or any other information as mutually decided upon.

2. Engaging collaboratively as observers in medical and cosmetic product and inspections conducted by the other participant as per specific

40 EXPRESS PHARMA March 16-31, 2014

BUSINESS BENEFITS OF GMP GMP compliance facilitates drug approvals and sales in multiple markets. Even though some countries may have slightly different GMP requirements, the FDA’s GMP standards are generally accepted by their regulatory counterparts, minimising the time needed for additional market entry. In addition, demonstrated GMP compliance is a requirement for ‘preferred supplier’ status with global customers.

GMP compliance provides customers, confidence in the quality of a company’s products. Customers, patients and prescribers all rely on the company’s

terms to be agreed and as time and resources allow.

3. Collaborating in relevant scientific meetings, symposia, seminars, and other appropriate venues that may be organised either in the US or in India.

All these go to show that all responsible regulators globally are willing and intent coming to a globally acceptable standard of GMP collaboratively and productively.

Achieving GMP compliance Although an effective, comprehensive compliance programme involves multiple components, GMP violations

reputation for quality and compliance. At the same time, GMP compliance reduces the risk of quality failure, legal liability and reputational damage.

GMP compliance promotes operational efficiency, workforce performance and cost effectiveness.

Costs associated with product waste, operational inefficiency and poorly controlled ingredient use all contribute to unnecessary operational expenses. In addition, recalled products, repeat inspections and investigations, fines and penalties, remedial actions and legal liabilities all add up to the total cost of production.

frequently involve cases where policies and procedures are not written, comprehensible or complete or the individuals involved do not have the necessary knowledge to perform their job functions accurately and in compliance with written procedures or the required documentation is inadequate, non-existent or inaccurate.

Regulatory compliance is an ongoing activity and requires management support.

Consistent GMP compliance requires the right people with the right knowledge to perform their jobs responsibilities, including validation and documentation. Creating an

effective compliance programme doesn’t happen overnight. It requires commitment, resources, discipline and continuous improvement.

Recent emphasis among regulators on risk-based action offers a rough roadmap of steps to pursue. Here are some of the most important steps.

Risk assessment: Companies should assess the risks they face based on their products, production processes, facility conditions and workforce. It is especially important to conduct an assessment of the knowledge required for job functions and the level of knowledge held by individuals

charged with fulfilling those functions.

Adequate written procedures: Standard Operating Procedures (SOPs) are often found to be inadequate or inaccurate, leaving employees without clear knowledge or direction. Written procedures must be understandable, in the language used by workers, accurate and regularly updated to comply with changes in regulation, equipment, processes or workforces. It is essential to remember that SOPs must be regularly updated, distributed and available for reference.

Knowledge gaps: Employees should be assessed for their level of knowledge and whether it meets the requirements of their job responsibilities. Assessments must be made of both long-time employees and new-hires to determine knowledge gaps and develop appropriate tools to address those gaps.

Training: A guideline does not change the culture of the organisation, but learning and a shared understanding of priorities does. Learning can be used both as a tool for offering foundational training, as well as a vehicle for cultural change and change management.

Training and learning should be targeted to the job role of each employee. It should involve activities that are tracked and recorded and ready to present to an internal auditor or regulatory investigator. Importantly, the training activity must be effective, and trainers should perform an assessment or monitor a production employee to make sure the employee retained the knowledge.

To help foster a culture of quality, many companies expand job-role 'training' GMP topics to include the most recent regulatory expectations around corrective actions, complaints, documentation, and many other areas.

Documentation: Recent violations have centered on misrepresentations in documentation. While these viola-

( tions appear to have been intentional, many companies fail to establish effective electronic record keeping that cannot be falsified. It is often said, “If it isn’t documented, it did not happen.�

With projected export figures of finished drug products from India to the US expected to grow by 40 per cent, Indian pharma companies are in dire need to achieve regulatory compliance to minimise organisational risk and improve quality and business performance through training on GMP compliance. The key factor to consider is that quality and compliance is not an event. It is a culture that is driven from management.

Quality metrics: When a company measures specific

THE MAIN FOCUS

With projected export figures of finished drug products from India to the US expected to grow by 40 per cent, Indian pharma companies are in dire need to achieve regulatory compliance to minimise organisational risk and improve quality and business performance through training on GMP compliance. The key factor to consider is that quality and compliance is not an event indicators such as product error rates, CAPA ( Corrective and preventive actions) initiations, complaint rate, etc, they can build a stronger quality culture by addressing these metrics over time. That is, establishing a continuous im-

provement programme that targets these specific performance issues. As a best practice, companies should make these quality metrics visible to both senior management and production personnel, to help them see positive

trends and aim for a common goal.

Conclusion The highest offering of information and knowledge is that is affords us the opportunity to change-- a direction

and a roadmap to where we can be with focus and relentless commitment. In this case, the stakes are the highest they can be: the commitment patient life, health and safety.

And then, one of the ways that the story we started writing together in the beginning, could end like this: The audit went well. The manufacturing procedures are in place: The GMP training has been taken and implemented. Your company has a programme committed to training. The FDA inspector requests reports of topic covered, completions, and implementations of best practices, and the commitment to excellence is demonstrated it the only way it can: leading by example.

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MANAGEMENT I N T E R V I E W

‘We expect MNCs to bring in next generation products and improve accessibility’ Mahesh Singhi, Managing Director, Singhi Advisors shares his views and offers insights on the changing regulatory environment in the Indian pharma industry, growing number of MNC players in Indian pharma, M&A activity in the sector and more, in an interaction with Usha Sharma Globally, pharma companies are facing increased regulatory scrutiny and government pressure to bring down the price of medicines. How are they looking at developing/ emerging markets like India in terms of takeovers, etc.?

Despite the regulatory scrutiny by other countries or restrictive pricing policies being adopted by our government, pharma sector still remains a lucrative space for takeovers or strategic investments, but with a cautious approach. Even after factoring the relative slow-down and dearth of visible large-sized transactions, the underlying industry drivers, including substantial advancement by the Indian API manufacturers, make India an attractive destination for global pharma companies.

Pharma companies in India are also under a lot of stress given the increased regulatory scrutiny of global regulators like the US FDA as well as pricing pressures by the Indian regulator. Are they stressed enough to contemplate exiting the sector?

Many Indian pharma companies are developing fatigue, not only due to high regulatory scrutiny from global regulators such as US FDA but also because of margin pressure in the domestic market. As the result,

42 EXPRESS PHARMA March 16-31, 2014

many Indian companies which lack the required sustaining capital, organisational strength, access to advanced technologies and global exposure, are generating some level of stress in certain companies, mostly mid-sized, leaving some of them open to accept strategic options, either to survive or to partially/fully exit/monetise and de-risk themselves.

If so, what could be the possible solutions for such companies in the near and long term?

Global players can bring their global experience and access to the global market, advanced product lines and scale of operations to benefit such Indian companies and in turn benefit themselves by getting access to low-cost, fast-growth markets like India. Such synergies and mutual needs may result into multiple joint ventures (JVs), strategic investments and staggered/planned buyouts between the global players and Indian companies wherein the strength of each can be leveraged to stitch a win-win investment structure. In the past we have successfully completed many such transactions across different geographies.

As per your estimates, how many such cases exist and are actively looking for options?

Are the valuations meeting

We believe that as the number of serious MNC participants in the market increases, it will create a healthy competition that will in turn benefit the patients, and the industry

expectations from both sides?

I cannot put down the exact number of cases at this stage.

But, we are in the know that many companies from India and abroad are in constant touch to explore these options and even Singhi Advisors is currently handling three such assignments. Certainly other firms would also be engaged in similar transactions. The rate of buyouts will certainly have an upward trend this year also.

Apart from pure domestically-oriented or branded generics formulation companies, most of the independent API players and sub critical sized pharma companies, including contract manufacturers, are facing multiple pressures and resultant stress. The key issues being faced by most of them is below optimal level of operations, stretched working capital cycle and above all lower RoCE, much in the range of 8-12 per cent, which doesn’t even cover the cost of borrowing (12-13 per cent), making the enterprise succumb to financial pressures and eventually becoming available for sale. In a distressed situation as above (APIs, contract manufacturers), there are many valuable assets which are potentially available for acquisitions but would make it difficult for many global companies to acquire the same as many of them are in default/non performing assets

(NPAs) with lenders or under corporate debt restructuring (CDR), making it quite cumbersome to take it out of the clutches of stakeholders with diverse interest. There are about six critical sized API players and a couple of contract manufacturing units. Their cumulative exposure towards lenders are in the range of ` 10,000 crores. This has been referred to CDR or are already NPAs with the lenders. However, some of the business, despite facing financial distress have been able to attract fantastic valuations, based on the earning capabilities of the underlying business or brands, such as Elders' acquisition by Torrent.

At the end of it, transactions take place at a level where either party doesn’t have an option better than what comes as a result of the negotiations.

What kind of global entities have already targeted such stressed Indian pharma companies and why?

The indicators show that more mid-sized companies will be targeting Indian firms in the time to come. Especially those looking for a global generic route will eye the Indian companies. Financial stress, and as a result, cheap valuations in the Indian market would not be sufficient enough reason for any global company to look for

an acquisition in India but it would depend largely on the value-building capability or possible integration to the global business chain. Even for Indian companies, the stress itself would be a result of the lack of organic growth or sub-optimal level of operations or cashflow mismatch, and unless the transaction results into fulfilment of such gaps, the principal stakeholders would never come to terms with the transaction As such, business integration, market access and complementary needs added by fulfilment of financial obligations towards the seller’s creditors would be the key drivers for transactions between global and Indian companies under stress.

Some recent M&As would further explain this. ● Mylan acquired SMS Pharma to expand its oncology API product portfolio. Deal valued at $32.5 million. ● Hospira acquired certain API manufacturing and R&D facilities of Orchid Chemicals and Pharmaceuticals. Orchid being in deep financial stress. ● Mylan acquired the sterile injectable business of Strides Arcolab’s Agila Specialties in a $1.75 billion deal. Agila would bring a portfolio of 300 global filings, including 61 abbreviated new drug applications (ANDA) in the US, and a marketing network covering 75 countries.

Strides was not in immediate financial stress but they were hugely invested and leveraged which could have posed future stress. ● Mylan also acquired a new formulation facility from Unichem Laboratories (Madhya Pradesh) for $26 million. ● Rohto Pharmaceuticals, a over $2 billion Japanese company, being the largest OTC healthcare company in Japan, entered into a JV with Sunways Group, India to set up a stateof-the-art global manufacturing facility in Gujarat for manufacturing advanced eye care and skin care products. Advised by Singhi Advisors, Sunways was not in a financial stress but didn’t have the required financial resources and matching global access to be in a position to do the same on their own.

● Similarly, $700 million

ARKRAY from Japan acquired the In Vitro Diagnostics (IVD) business from India’s largest player in IVD, Span Diagnostics, a deal advised by Singhi Advisors, whereby Span was a prominent player in India but the margins were in constant pressure and sales stagnating in the absence of next level of product lines, which Arkray had to its advantage.

Do you think that promoters of pharma companies who opt for takeovers/buyouts will regret their decision?

Any promoter including those of pharma companies would assess existing risks associated with their businesses, possible future growth or stagnation with the company and relative valuations/options in hand while factoring in their limitations and challenges before concluding any transaction.

So there could still be some who may find it otherwise. But most often, post 100 per cent sale, Indian promoters usually align themselves to reality. The exceptions are in the JVs or partial sell situation, where both parties as continuing partners may get stuck with each other if the intended plans don’t materialise. It is difficult to comment whether these deals would disappoint or content the promoter. Only time will tell.

Will such deals have an adverse impact in the future from the point of view of patients, the pharma industry and finally the country’s economy?

We believe that as the number of serious MNC participants in the market increases, it will create a healthy competition that will in turn benefit the patients, industry and the country as a whole. Apart from this, we also expect these MNCs to bring in next generation products and improve accessibility to expand its generic and patented portfolio to the Indian patients. On the other hand, we also hear a lot of voices/opinions on the possible future cartelisation in the pharma industry by a few MNCs, like one seen/heard in many other industries. However, positive and

proactive monitoring by the regulator can help in avoiding such a situation.

Do you sense any big deals in the offing, like the RanbaxyDaichii or Piramal-Abbott deals? Why India not only has strong expertise in manufacturing high quality, complex pharma products, it also has a large underserviced market which is driving the growth of the Indian market. Acquisitions in India makes strategic sense from a broader and longer term view, however given that most of the global players now have their presence in India and the targetted Indian companies are few in number, the pace would slow down for sure as far as big ticket deals like RanbaxyDaichii are concerned. Hence, we firmly believe that the M&A action in mid-size companies is going to be far more than in the large companies.

What is the market sentiment for buyouts between Indian companies like the one between Elder and Torrent?

Market sentiments may not be the best in terms of financial structuring, but strategically we think it was very positive.

There is a clear trend of consolidation and good assets/brands shifting/transferring from weaker hands to stronger hands. We saw a similar situation last year when Cadila Healthcare bought out Biochem. Consolidation is inevitable and we strongly believe that the government and banks should support such domestic transactions. In cases like that of Elder, the banks were among the happier lot. With the high multiple being enjoyed by many

mid to large sized companies.

Will the US FDA ban on drugs manufactured at Ranbaxy facilities hamper the image of the Indian pharma industry globally and how much? Will this dampen investor sentiment?

It hampers the image to an extent, but ideally this should not dampen the sentiment of long term investors as this was a one-off event/situation. Mylan, Hospira, Abbott, Reckitt Benckiser and many other MNCs who have done M&A in the last decade are happy with their deals. And ‘caveat emptor’ or ‘Let the Buyer Beware’ is the contract law principle. The law tells us that based upon this principle it is important, as a prudent purchaser, to make a careful inspection of the assets/company you are considering to buy.

Indian regulators are at an early stage of formalising regulations for medical devices and incorporating it under the Drugs and Cosmetics Act. Throw some light the global framework and its relevance in India?

Medical devices are heavily regulated globally and regulations touch every stage of the life-cycle: R&D, clinical trials, pre-market approvals, manufacturing, labelling, and ultimately, marketing. Under the US FDA and the European CE Marking agencies, medical devices are regulated for quality and patient safety under a separate pathway from pharma drug regulations. Although pharma products have been regulated since 1940, medical device regulation is relatively new in India. The Indian gov-

ernment proposed regulatory guidelines for medical devices in 2008, through amendments to the 1940 Drug and Cosmetics Act (DCA). The new Drugs and Cosmetics (amendment) Bill, 2013, which was introduced in the Parliament already, has some solid provisions and it is a right step forward. The parliamentary standing committee, which already examined the bill, has practically denounced the central drug authority but did not turn down the proposed clauses for the medical devices sector. Since the Central Drugs Standard Control Organisation (CDSCO) currently ensures pre-market reviews of only certain devices, all other devices do not require registration prior to sale in India. Imported medical devices on the notified list, those that have already obtained approval in the US (by the FDA) or the European Union (by CE Marking) are allowed in the Indian market without undergoing separate conformity assessment procedures.

Recently, the Government of India has allowed 100 per cent FDI in the existing pharma firms while mentioning that the ‘non-compete’ clause would not be allowed except in special circumstances with the approval of the FIPB. Is more clarity required on this issue?

As earlier, 100 per cent FDI is allowed in both greenfield (new) and brownfield (existing) projects through automatic and approval route respectively.

However, the recent change has a rider, a ‘non-compete clause’ which would not be allowed except in special circumstances with the approval of FIPB. The non-compete clause is a customary part of any M&A and carries a strategic logic whereby it restricts the promoters of target companies from venturing into the same line of business for a specified period. Singling out an industry and putting restrictions without clarity will create confusion in the market although the sensitivity of this sector in view of its human cause can’t be ignored altogether. u.sharma@expressindia.com

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March 16-31, 2014

MANAGEMENT BART JANSSENS, Partner and Director, BCG

INSIGHT

Commercial Excellence 2.0 Bart Janssens, Partner and Director, BCG and Rahul Guha, Principal, BCG, in this three part article series, challenge some of the fundamentals of the selling model and propose a new way to think about engaging with customers, as well as maximising the return from the commercial spend. Insights from the first series

THE PHARMACEUTICAL selling model has been established for decades. Much has been done on improving the model and squeezing efficiency from the model using sales force effectiveness tools and IT-enabled solutions. The authors propose six tenets to Commercial Excellence 2.0 which will be elaborated in this three part article series.

In brief, these six tenets are: ● Move beyond share of voice: Engage with the customer to drive value in his business and ensure the messages delivered are differentiated, relevant and absorbed ● Manage performance, not

incentives: Understand the behaviour of the sales force segments and then customise incentives and coaching to address specific patterns ●

Let the market drive marketing: Zero-base your marketing spend and then align your initiatives with where your brands are in the product lifecycle

● Integrate to differentiate:

Align the commercial model across sales and marketing and close the loop effectively ● Middle managers manage

a business: Equip Zonal / Regional managers with the right skills to manage a business vs. just managing sales ● Sharing is caring: Pockets

of excellence exist, but best

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practice sharing is rarely institutionalized, getting teams to learn from each other is key.

In the first of our series, we focus on the sales model, essentially looking at how to change the value proposition of the sales force from share of voice to a business partner, as well as a deeper look at the selling model to understand what can be done to manage performance better.

RAHUL GUHA, Principal, BCG

EXHIBIT I: MOVING BEYOND THE SHARE OF VOICE MODEL Treatment reach = (Number of patients X % treated by the doctor) / Time spent per patient Drive more patients In the catchment area of the physician, help reach unaddressed patients Diagnostic camps and patient awareness programmes

Expand the treatment set Education packs and continuing education programmes Help prescribes treat more complex diseases

Improve the throughout Patient support / patient engagement solutions Literature explaining basic points of the treatment In-clinic resource for patient education Help-line for answering follow up questions

lies in understanding the customer. The traditional model has always been ‘company out’ i.e. we have a product and we need to communicate the benefits of the product to the market. Over the last three years, we have been fleshing out this concept through almost 500+ doctor interviews to determine what it is that doctors want to see leading pharmaceutical and for that matter Med-tech companies do differently. We have all done our bit in terms of assertiveness coaching, closing the call well and tracking but must also recognise that almost everyone has the same playbook to learn from. From our conversations with doctors, we find that they do not see much differentiation across the sales teams. We spent time in doctor’s cabins across specialties and observed the pitch from many sales teams, sometimes

15 of them at a time. The sales pitch is undifferentiated, and recall often times was very poor.

In such circumstances, how does one drive recall?

Overwhelmingly a single theme emerges – customers want companies to engage with them to improve their ability to help more patients.

We present a simple equation to understand potential options which work in Exhibit I. When it comes to increasing awareness, we see models such as diagnostic camps and patient awareness programmes having significant traction with doctors. While difficult to execute on a scalable basis, once established, these models enjoy significant mind-space with the doctors (and for that matter patients) that they are targeted at.

Companies can also help the doctor expand the patient

Support younger physicians in reaching patients Certification programmes

Topic I: Moving beyond share of voice The commercial model today is overwhelmingly skewed towards share of voice with the customer. As companies expand their sales forces [estimates indicate almost 100,000 reps have been added in the last five years], the cabin is increasingly getting crowded. However, the time allocated to MR’s hasn’t increased. We have observed that today, the time per detail has dropped to less than one to two minutes on average. In fact, for the busier doctor set, this often is the outer limit of the time you get in the cabin.

The key question is how sustainable is this model going forward and for how long will the ROI per call make sense in this environment?

Our view is this business model is ripe for disruption.

Return from investments in field force will continue to decline unless companies do something radically different.

The solution, we believe,

Return from investments in field force will continue to decline unless companies do something radically different

MANAGEMENT pool that he is treating. Education packs (particularly in chronic diseases) and continuing education programmes expand the treatment set for the doctor and more importantly, makes healthcare more accessible to the general population. This model we find is meeting with a lot of traction, particularly with younger doctors.

Finally, doctors find, especially when starting new therapies with patients, significant gaps in the patient education literature, both in the clinic as well as online or on the phone. This increases the time the doctor needs to spend explaining basic points of the treatment or answering follow up questions and less time treating patients. Building patient support / engagement solutions is the third area where companies can add value to the doctor.

While hopefully, companies will shift and start thinking ‘customer in’, we must recognise this shift in the model will take time, but clearly the first movers will enjoy significant traction and sustainability in their model.

Topic II: Incentives don't always result in performance Incentives drive behaviour – the old adage has been quoted time and again. However, companies rarely manage this well. The design of incentives is top-down using a one size fits all approach.

However, the corrective actions in a territory and development needs are bottom-up i.e. at an individual rep level.

E.g. a territory manager needs to coach reps based on the territory nuances and at the end of the year explain the reasons for getting / not getting incentives to the rep.

This top down approach in design and fragmentation in implementation at the bottom leads to challenging outcomes. Many a time the rep does not fully understand the incentive scheme and therefore rarely demonstrates the behaviour expected, but also the territory manager improvises on messages leading to a

EXHIBIT II: PATTERNS OF PERFORMANCE BEHAVIOURS AMONGST SALES REPS

maximise the bonus payout to them overall.

Hopefuls

Consistent

Consistency

‘Laggards’ Struggle to meet targets typically because of poor brand position in the territory, strained relationship with the trade or are new in the territory

Inconsistent

95%

‘Conistent workhorse’ Work for minimum target to capture the incentive payouts, rarely push above the target regardless of incentive slab design

‘Reliable Star’ Typically outperform their targets by 5-10 per cent consistently over a longer period of time ie one year+

‘Hopefuls’ Best efforts to drive the sales in the month but don’t have the right guidance and judgment

‘Gamer’ Optimises bonus payout e.g. misses M1 but hits Q target, hits Q1, Q2 targets 100 per cent+

95-100 per cent+Performance

100 per cent+

Development conversations are often more focused, driving the right kinds of behaviours in the organisation and penalising the wrong. The simplicity of the segments makes it easy to understand, communicate to the ground level teams transparently the perception of performance and to ensure the right incentives translate to the expected behaviours on the ground

dilution of the intent of the incentive scheme.

We propose an approach that segments the field force on the basis of performance and consistency and then design incentives and interventions at the field level for each segment of performance.

Think of field force performance in two critical dimensions: 1. Performance and 2. Consistency and you will see a few segments of reps emerge as illustrated in Exhibit II.

Exhibit II: Patterns of performance behaviours amongst sales reps You will observe three segments in across the reps who deliver consistent performance either strong or weak. ● Bankable stars: Typically

outperform their targets by five to 10 per cent and do that consistently over a longer period of time i.e. one year+ ● Consistent workhorses: Work to achieve the minimum target to capture the incentive payouts. Rarely push themselves above the target regardless of incentive slab design. ● Laggards: Struggle to meet targets typically because of poor brand position in the territory, strained relationships with the trade or are new in the territory.

Many of us would have observed these segments in the field force and traditionally most territory managers would segment their people along these dimensions.

Equally important and often ignored is a deep dive into in-

consistent performance.

You will observe two types of behaviour with reps who deliver inconsistent performance and it’s important to separate intent from results to drive behaviour accordingly.

Gamers Typically manage effort vs. reward ratio as much as possible e.g. will drive sales in the last month of the quarter to hit the target but will miss sales in the first month of the next quarter knowing that the quarterly bonus higher than monthly payouts. Additionally will hit targets in the quarters where there is slack and the payout the same e.g. Q1 target will be lower vs. Q4 target but companies typically do not differentiate quarter payouts.

Net-net these players will

These reps typically do their best effort to drive the sales in the month but don't have the right guidance and judgment on where they spend their time leading to higher effort for sub-optimal results. These are reps that spend their time on the wrong doctors / channel partners and therefore see wide variability in their performance month on month.

Identifying these segments is relatively easy using the analytics available today. It is important to design the coaching and development messages appropriate for each segment and to coach territory managers on the relative performance and bucketing of their team across these categories.

This will allow for a segmented approach to development of sales reps and ensure that performance is categorised and managed appropriately across the field force.

Often the interventions for each of these are different with a mix of carrot and stick, but will need to be designed with the full understanding of the underlying behaviours.

Having done this, development conversations are often more focused, driving the right kinds of behaviours in the organisation and penalising the wrong. The simplicity of the segments makes it easy to understand, communicate to the ground level teams transparently the perception of performance and to ensure the right incentives translate to the expected behaviours on the ground.

We hope this article encourages you to challenge the current thinking on the sales model and to bring in new concepts to manage performance effectively. In the second part of our series, we focus on the marketing model, particularly ensuring marketing initiatives are aligned to the state of the market in which the brand competes and outline a concept of an integrated approach to sales and marketing.

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ADVANTAGE WEST

A MARKETING INITIATIVE

Advantage

West A glimpse into some of the key advantages Goa, Gujarat and Maharashtra offer to India’s pharmaceutical industry

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March 16-31, 2014

ADVANTAGE WEST/GOA I N T E R V I E W

Pharma hub has shifted towards Goa Goa FDA's consistent efforts have made the state a favourite destination for domestic as well as the global pharma industry. Salim Veljee, Director, Goa FDA, reveals more to Sachin Jagdale With almost all major pharmaceutical companies operational in Goa, would you claim that the pharma hub is now shifting from Maharashtra to Goa? Looking at the number of pharma companies in Goa, I would definitely say that the pharma industry hub has already shifted to Goa from Maharashtra. Maharashtra has many labour related issues. In 1996, the Central Government provided Goa with special tax incentives, which prompted many pharma companies to move to Goa. We have a good environment and we do not permit any bulk drug or API units. Goa is exclusively known for its formulation units, which allowed pharma companies to set up facilities. Moreover, not only tax incentives, but as I have mentioned, environmental benefits and friendliness of people over here have also attracted many pharma companies to the state. Today, we have around 80 pharma units in Goa, out of which 90 per cent are involved in exports. Goa’s pharma sector has a turnover of around Rs 10,000 crores, which includes both domestic as well as exports.

Describe the efforts of Goa FDA to increase pharma exports from the state?

All these years, drug manufacturers used to head to Nhava Sheva port in Maharashtra for export business.

Under the Drugs and Cosmetics Act, designated ports are notified and only from these ports import and export

48 EXPRESS PHARMA March 16-31, 2014

activities can be carried out. It was a long standing demand of the industry to declare Goa's Mormugao Port Trust (MPT) as the designated port under the Drugs and Cosmetics Act. But, somehow the feasibility reports were not favourable.

But in 2012, Surendra Singh, the then DCGI, along with P Mara Pandiyan, Chairman, MPT, facilitated the process and in 2013, Mormugao was declared as a designated port under the Drugs and Cosmetics Act. Now, exports can be done from here. However, export business has not fully shifted to MPT and Nhava Sheva port is still being used to a greater extent. Moving the containers to Nhava Sheva port entails a lot of money and time. Moreover, there are risks involved during the transport of consignments.

So, Goa has become the ideal place to manufacture and export drugs. Goa Pharmaceutical Manufacturers' Association (GPMA) has also played a greater role in making MPT a designated port. However, this provision is not completely utilised. Once bigger companies start importing from this port, vessels can dock here and the same vessels will go back with the export material. Now, we are convincing manufacturers that export facility has come at your door step and they should utilise this opportunity. Out of the ` 10000-crore pharma business, ` 6500 crore to ` 7000 crore comes from exports.

What are the major achievements under your leadership?

We have a single office for the entire state. It brings all the services under one roof.

Without compromising on requirements of law these services are disposed off on fast track basis

Commissioning an independent FDA building is a major achievement. Through my department, the Goa Government represents pharma, as well as the food industry to the tune of ` 15000 to ` 18000 crores. This building will help facilitate pharma and the food industry related work to a greater extent. Despite the pharma and food sector being such large industries in Goa, the infrastructure to look after their functioning was not up to the mark. Now, with the new building, the image of Goa's FDA will get a boost, not just in India but outside the country as well.

As far as the quality is concerned, you will not find serious complaints about our companies, which indicates that they are quality-oriented and are sensitive to the changing times.

The US FDA have send warning letters to big Indian pharma companies for not complying with the GMP norms. Which efforts have you taken to make pharma companies in Goa GMP compliant?

Around 80-90 per cent of our companies are engaged in exports. They are subjected to audits by overseas auditors and regulators during the process of granting permissions for exports. Round the year they are subjected to various audits. Local FDA also conducts their own audits. So industry and facilities are kept under a lot of surveillance, which allows them to

upgrade and update themselves.

Tell us about the benefits offered by Goa FDA to pharma companies that other FDAs in India may not be offering.

We have a single office for the entire state. It brings all the services under one roof.

Without compromising on requirements of law these services are disposed off on fast track basis. If we come across any bottlenecks at the zonal level then we are ready to address them through dialogues as well. We are very flexible with the industry and within the parameters of the law.

Is Goa Government offering any special schemes for the pharma industry?

As of today, there are no special schemes and tax incentives. However, we hope that within the next two to three months, a new industry policy may be announced by the State Government. The pharma industry needs three critical things, land, water and power. The Government is seriously looking at addressing these issues. This will motivate new pharma units to set up their plants in Goa. Even FDA is following up with the State Government for the same issue. Manohar Parrikar, Chief Minister, Goa is looking at the possibility of identifying new industrial places where the pharma industry would also get a chance to set up the units. sachin.jagdale@expressindia.com

ADVANTAGE WEST/GOA

NEW GOA FDA OFFICE

O

n February 18, 2014, Manohar Parrikar, Chief Minister, Goa, inaugurated Goa FDA’s new building in Bambolim. The ground floor caters to the food industry while the first floor is exclusively used by the drug industry. This facility has a provision for specific storage of confiscated and seized drugs as well as food. Drug inspectors draw samples from various places. As per the law, these samples need to be stored in a proper way till the test reports come. Controlled conditions have been ensured for the storage of these samples. These are some of the regulatory features of the new FDA building.

The building has key public-friendly features where one need not visit individual sections of FDA. All public-related services would be catered from main entrance lobby which has a cash counter, help desk, manned by senior food safety officer who will address all the issues. After the money is paid, the visitor will get an opportunity to deposit money at the counter itself. The receipt of all the delivery services in terms of licenses issued/renewed can be collected from there. This arrangement ensures the minimal disposal time.

There is a provision of waiting area. In order to maintain the facility in a better way adequate storage for files and file inventory system is organised in such a manner that files can be retrieved within five minutes. In the older facility space was an issue. The new building has been constructed keeping in mind the requirements for the next 25 years. This again helps in addressing public-related services. Also, there is a dedicated canteen facility.

Currently, Goa FDA has around 120-130 employees.

The added advantage of the new building is that the test-

Built over 3500 sq mts, the newly commissioned Goa FDA building is a blend of traditional Portuguese architecture with modern corporate facilities

ing laboratory is right opposite to the FDA facility. Samples drawn can be delivered to the laboratory within minutes.

Goa FDA is looking at upgrading and strengthening the laboratory structure also. There are efforts to upgrade the microbiology section. Some improvements can be done in food testing as well.

A conference room has been set up which can accommodate around 85 people where awareness programmes can be held for both the pharma and the food industry. DCGI workshop was held on medical devices regulation on March 3-6, 2014.

Around 60 drug inspectors from seven states participated where discussions were held to understand the medical requirements of medical devices.

Employees at the Goa FDA office

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ADVANTAGE WEST/GOA

ADVANTAGE GOA

F

rom being tourist attraction for its beautiful and scenic beaches, Goa is slowly becoming the Mecca of Indian pharma industry. Almost all major pharma companies have operations in Goa. Many pharma companies landed in Goa to take the benefits of tax incentives that it had offered.

However, much to the surprise of industry analysts, despite the tax holidays being over, pharma companies continued to have their manufacturing base in Goa. Dr Nitin Borkar, Chief Executive Officer, Vergo Pharmaceuticals, which is based in the Verna industrial cluster in Goa, informs why Goa has been able to attract pharma companies. He says, “The state of Goa with its great cultural and ecological heritage attracts the best talent from the country to work in the 80plus export-oriented pharma plants. The state offers good educational and healthcare facilities which has helped families of the pharma professionals to a greater extent. The state-run industrial parks provide water and electricity at reasonable rates. The cost of land is reasonable compared to

other major Indian pharma hubs. Goa is well connected to other Indian states by rail, road and air. Direct shipment of products through air and natural port is also possible.”

Rajendra Naik, Past Presi-

dent, Goa IPA and current Deputy Director, FDA, Goa, says, “Goa FDA has one of the strongest regulatory mechanisms in the country. It shouldn’t come as a surprise that our pharma companies

are known for their quality products.”

Not only modern medicine manufacturers but ayurvedic medicine manufacturers can bank heavily on Goa. The state already has six ayurvedic

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50 EXPRESS PHARMA March 16-31, 2014

units and according to Salim Veljee, Goa FDA Director, ayurvedic companies should come forward and set up their units in Goa. Goa is also abundant in numerous medicinal plants.

Umesh Sandu, Director, Sandu Pharmaceuticals, says, “Goa is ideally and strategically located and can cater to domestic and export markets.

The regulators are not just friendly but go out of their way to guide and help companies.

Further, the government has taken pro-active steps towards establishing green house, which will promote medicinal plant cultivation. In addition to this, the Western ghats are biodiversity hot spots, where one can find a host of many endangered species. So, Goa is an ideal destination for ayurvedic companies.”

Tourism remains the backbone of Goa's economy. However, the Goa Government also realised the importance of industrialisation for its overall growth. While changing with times it was ensured that Goa's eco-system never gets affected due to growing industries. As a result, Goa is still an attraction for global tourists whereas on the other hand industrialisation is making significant contributions to its economy.

ADVANTAGE WEST/GUJARAT I N T E R V I E W

Our administration generated positive, vibrant environment for pharma sector Gujarat Food and Drug Control Administration (FDCA) has been striving for the growth and regulation of the pharmaceutical industry in the Gujarat state. Dr HG Koshia, Commissioner, FDCA gives Usha Sharma more details of the initiatives and achievements of FDCA over the years

You have been associated with the Gujarat FDCA office for the last 24 years and last five as the commissioner, what paradigm shift have you witnessed in Gujarat FDCA? The major shift has been in e-governance and administration. The Gujarat FDCA has been able to establish it as a watchdog and custodian of healthcare as against a mere enforcing agency. The other major shift has been in the approach and style of governance. With the utilisation of electronic gadgets and e-governance tools, administration has been networked across the state for effective and harmonised administration. Be it licensing for sales or manufacturing, be it sampling, analysis and cognitive corrective actions or proceedings –the FDCA administration has followed a result-oriented and businesslike approach.

The XLN network system has been a path-breaking step by the Gujarat FDCA which has been subsequently adopted by other state administrations. This e-tool has integrated the headquarters with all district centres as well as all the testing laboratories of Gujarat. The data so compiled and generated has not only provided quick clearances for licences, renewals, product permissions and pharmacovigilance but has also been a great tool to ensure compliance by trade and industry as per the Drugs and Cosmetics

Act and various rules thereunder. This has also helped the administration, and especially the vigilance branches of FDCA, to control the menace of spurious and look-alike drugs.

At one point of time Gujarat was a pharma manufacturing hub, however the industry has slowed down lately.

What have been the reasons for the slowdown? Have you planned any strategies to revive and attract more domestic and multinational pharma companies in the state?

It is not true that the Gujarat-based pharma industry has slowed down. In fact, Gujarat-based pharma units have expanded their activities outside Gujarat but their effective control and management has been from their Gujarat headquarters. The move of Gujarat's big pharma houses to expand their facilities outside the state has been a strategic approach to concentrate Gujarat operations for higher value added and regulated markets. This in turn has achieved higher growth in value terms from Gujarat.

More and more investments in Gujarat’s pharma sector has come from USbased pharma companies that already have their presence in India. Many more are in the process of establishing facilities for specialised APIs and finished dosages for regulated markets.

What are the issues pertaining to regulatory compliances that you had to overcome as the head regulator of the Gujarat FDCA? Simplified and smoother administrative functions by use of e-governance, especially e-licensing has spared the technical resources and manpower of my department to focus more on compliance monitoring, vigilance, sampling and analysis. This has obviously brought a sense of compliance readiness in the minds of trade and industry captains.

The move of Gujarat’s big pharma houses to expand their facilities outside the state has been a strategic approach to concentrate Gujarat operations for higher value added and regulated markets

What responses did you receive for the pharma sector from the Vibrant Gujarat initiative, run by the Gujarat Government and how encouraging were they? Do you have any plans to run more programmes like this to encourage more investments in the pharma sector?

Vibrant Gujarat has attracted the greater attention of pharma sectors from across the world. There has been ancillary investments, leveraging on the growth of pharma sector in Gujarat, especially in the area of pharma machineries, pharma automation support systems, primary packaging component manufacturing and high-tech packaging sector, to cater to modern and state-of-the-art pharma manufacturers of Gujarat.

There has been a tremendous pull for highly skilled

manpower, catering to the demand of soft skills for the pharma sector. All these have been due to the biennial Vibrant Gujarat over the last 10 years.

I look forward to developing more innovative schemes and models to attract further investments in pharma sector through Vibrant Gujarat seminars by working in close cooperation with the industry department of the Gujarat state.

Under your leadership, the department has managed to break the glass ceiling and has introduced various programmes like e-governance, brain storming sessions with US FDA drugs regulators, high-end drugs testing labs, scanning drugs procurement process under the Jan Aushadhi programme etc. How have these helped Gujarat-based pharma companies to grow fast?

The initiatives from our administration has generated a positive and vibrant environment for existing pharma entrepreneurs to expand, grow and forward integrate.

They have been marching towards global markets and high end regulated markets.

They have been investing in research and intellectual properties with confidence and assurance due to the supportive environment that Gujarat as a state provides. u.sharma@expressindia.com

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ADVANTAGE WEST/GUJARAT

Gujarat FDCA— Partnering progress Since its formation, the Gujarat FDCA has received tremendous response and managed to continuously benchmark its success

W

hen the discussion is about state-wise development, Gujarat cannot go unmentioned. Its progress has been due to the result of the growth achieved by its key sectors. The pharmaceutical sector has been the key contributor and Gujarat FDCA has played a significant role in making it attractive and lucrative. It has earned and set a benchmark for other FDA offices in India in terms of complying with regulations.

One of its key developments, which has been followed by other states, mainly Karnataka and Maharashtra, is e-governance. These states have successfully implemented e-governance and Gujarat FDCA is also considering to enhance it further and share it with other FDA offices.

Since 1960 Drugs Control Administration (DCA), Gujarat came into existence on May 1, 1960 after separation of Gujarat State from Greater Bombay State with BV Patel as the first director. DCA, Gujarat was entrusted with the implementation of Drugs and Cosmetics Act – 1940 & Rules 1945 and Drugs Magic Remedies (Objectionable Advertisement) Act – 1954. Patel played a vital role in establishing the well defined administrative structure, policies and procedures of DCA, Gujarat. He seeded the present culture of this department - industry friendly, prompt and strict action against law breakers. He also took the initiative to

52 EXPRESS PHARMA March 16-31, 2014

ADVANTAGE WEST/GUJARAT establish a state-of-the-art drug laboratory equipped with latest equipment at Vadodara.

BV Patel Pharmaceutical Education and Research Centre was inaugurated in Ahmedabad in October 1990 in his memory.

He is the only government officer whose name has been associated with such an institute.

SC Shah, MR Sharshtri, BM Patel and Dr MA Patel as the directors of DCA, Gujarat. During the tenure of MA Patel, Director of DCA, Gujarat, considering the performance of DCA, Gujarat, the Government of Gujarat shouldered one more responsibility by implementing “Prevention of Food Adulteration Act, 1954” (PFA). The department was renamed as “Food & Drugs Control Administration” (FDCA) in December 5, 1979.

MA Patel became the first Director of FDCA, Gujarat. A separate wing of food inspectors and senior food inspectors was formed at all circle offices and head offices for the implementation of PFA. Later on, the post of director of FDCA was upgraded to commissioner of FDCA and MA Patel became the first commissioner of FDCA with effect from December 20, 1985. Dr MA Patel was followed

by AG Shah, GR Bhagat, Dr SP Adeshara, Mona Khandhar, (IAS), S Murlikrishna, (IAS) and Dr Hemant G Koshia as Commissioners of FDCA, Gujarat.

Since January 22, 2009, Hemant G Koshia is the Commissioner, FDCA, Gujarat.

FDCA TEAM Class

I

II

III

IV

Total

No. of posts

69

213

730

239

1251

e-Governance STATISTICAL INFORMATION

FDCA, Gujarat makes optimum use of information technology for achieving excellence in performance. It is the first state to initiate online software for sales and manufacturing licenses.

Manufacturing units in the Gujarat as on May 31, 2012 Allopathic

Ayurvedic

Cosmetics

Homoeopathic

Total

2538

712

373

14

3637

Awareness programmes SALES UNITS IN GUJARAT AS ON MAY 31, 2012 Retail

Wholesale

Retail/wholesale

Total firms

13234

11756

2718

27708

2009-2010

2010-2011

2011-2012

Total sample

NSQ

%NSQ

Total sample

NSQ

%NSQ

Total sample

NSQ

%NSQ

2567

325

12.66%

4465

317

6.29%

5333

463

7.99%

Testing laboratories Gujarat has its Food and Drug Laboratory (FDL) located in Vadodara, which is the first National Accreditation Board for Testing and Calibration Laboratories (NABL) accredited Government laboratory in the country. In addition to FDL, Vadodara, FDCA has two other food laboratories for testing food samples, one at Rajkot and the other at Bhuj. FDCA is also setting up one more state-ofthe-art Food and Drug Laboratory at Dethli, in Patan district of north Gujarat. This new FDL laboratory has been planned with the latest designs as per good laboratory practice (GLP)

norms and has the latest equipment and instruments. Constant upgradation of facilities and equipment in laboratories have been on the priority list of FDCA, Gujarat.

The new FDL laboratory has been planned with the latest designs as per GLP norms and has the latest equipment and instruments. Constant upgradation of facilities and equipment in laboratories have been on the priority list of FDCA, Gujarat

Apart from its routine activities, the state FDCA has moved one step ahead and formulated various programmes. ● Commissioner FDCA and other senior level officers periodically give informative programmes, interviews / demonstration of testing kits on Doordarshan, other television channels and in All India Radio. ● An informative and educative presentation, Drug – ‘Dev’ or Devil, depends on how you consume, was prepared by the headoffice and has been sent to all circle offices for periodically arranging awareness programmes at various schools and colleges and to educate and sensitise youngsters regarding the misuse of drugs. ● Two exhibition vans and one sample testing van are equipped with necessary equipment, testing kits, exhibition materials and audio-visual displays etc. ● The details of sample declared as “Not of Standard Quality” (NSQ) is sent through SMS to all retailers, wholesalers, district health officers (DHO), PHC / CHC, CMSO and State Drugs Controllers of India. SMSs are sent by the Asst Commissioner (IB) from the head office.

Example of NSQ Alert message : FDCA-GJ Alert: LOPRO TABLETS Batch:LP-03 Mfg:042011,Exp:03-2014 Mfg by: DANISH LABORATORIES declared SUBSTANDARD, STOP USE/ SALE/ DISTRIBUTION, RECALL URGENTLY This is the first ever initiative taken by any Drugs Controller to ensure effective recall of such NSQ medicines.

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ADVANTAGE WEST/MAHARASHTRA

ADVANTAGE MAHARASHTRA

M

aharashtra has always remained the financial hub of India. Various industries started their plants in the state and grew substantially cashing in on the favourable industrial policies offered by the state government. However, among all the industries the pharma industry might have been the biggest gainer of these policies. Today almost all the major pharma companies have been headquartered in Mumbai. Pharma industry stalwarts unanimously vote for

54 EXPRESS PHARMA March 16-31, 2014

the FDA Maharashtra as a key facilitator of their growth in the state. The pharma industry in Maharashtra is the largest in the country. To address its grievances and prepare it for the global challenges is a tough job, which FDA Maharashtra has been successfully doing for a long time.

While projecting Maharashtra as a favourable destination for the pharma industry, Mahesh Zagade, Commissioner, FDA, Maharashtra, opines, “Despite the tax holidays given by other

states we continue to host largest number of pharma facilities. Now, as the tax incentives given by other states been over, many pharma companies are again tapping Maharashtra to set up their manufacturing bases. Mumbai is the major exporter of pharma drugs.

Regulatory system in Maharashtra is one of the best in the world.” He adds, “India has the highest number of USFDA approved plants outside the US. Maharashtra has the highest number of these plants in India. We have

employed a proper regulatory mechanism. We try to help companies if they face any kind of difficulties. Quality pharma production has always remained Maharashtra's feature. The percentage of substandard drugs produced in Maharashtra is very less. Besides this, Maharashtra has skilled man power, reputed pharma colleges, laboratories etc. We are also becoming leaders in recombinant DNA technology and stem cell technology.”

Maharashtra is home to around

ADVANTAGE WEST/MAHARASHTRA 3,139 pharmaceutical units and corporate offices, with major centres in Mumbai, Thane, Tarapur, Nashik, Aurangabad and Pune. The state also leads in vaccine production. A number of Special Economic Zones (SEZs) have also been notified, like Navi Mumbai Ajanta Projects and Wockhardt at Aurangabad, a dedicated SEZ at Nanded, and Serum Bio Pharma Park at Pune. Maharashtra is also the first state to set up independent Intelligence Branch with separate police wing to assist investigation under Acts enforced by FDA Tax incentives offered by other states definitely convinced many pharma companies to move out of Maharashtra. However, despite this transition Maharashtra continued to dominate India's pharma market. As informed

by Zagade, many pharma companies are slowly relocating themselves in Maharashtra. In the years to come situation would improve further provided the Maharashtra government and FDA work together to offer special benefits to the pharma industry.

About FDA Maharashtra FDA Maharashtra, the state's prime instrument for consumer protection, is a scientifically based law enforcement agency. Initially, this administration came into being as Directorate of Drugs Control meant for enforcing mainly the Drugs and Cosmetics Act. In 1970, the government entrusted the responsibility of enforcement of the Prevention of Food Adulteration Act, 1954, to this Directorate and then it was renamed “Food and Drug Administration�. The post of the Director of Drugs Control Administration was designated as the Commissioner, Food and Drug Administration (M.S.) on April 6, 1970.

During this period, the Commissioner, FDA, was the Licensing Authority for the grant of the drug manufacturing licences under the Drugs and Cosmetics Act, 1940 for the entire state and Assistant Commissioners at Divisional

places were Licensing Authorities for grant of the drug selling licenses under the said Act for the respective divisions. In 1971, circle offices at places like Akola, Kolhapur, Nashik, were created and the Assistant Commissioners at these circle offices were declared as the Licensing Authorities to grant selling licenses under the Act, for the respective circles. During this period the district office was headed by a drugs inspector.

In the year 1975, there was considerable expansion of the administration and posts of the Joint Commissioners and Assistant Commissioners were created at divisional places and district places respectively. The Joint Commissioner (HQ) was declared as the Licensing Authority for grant of manufacturing licenses under Drugs and Cosmetics Rules, 1945, for the entire state and the Joint Commissioners/ Assistant Commissioners were declared as the Licensing Authorities for grant of selling licenses under the said rules, for their respective area. From 1990, the divisional Joint Commissioners are declared as Licensing Authorities for grant of drug manufacturing licenses for their respective divisions.

Thus, Maharashtra is the only state where the work of licensing pertaining to manufacturing licenses under Drugs and Cosmetics Rules, 1945, is de-

Mahesh Zagade, Commissioner, FDA, Maharashtra

centralised at seven divisional levels places. From 1996 FDA took the task to computerise the entire structure of the system. The drug sample coding and analysis reporting has been computerised.

Vision 2020...

FDA Maharashtra does not want to lag behind in the global race. By 2020 it’s objective is to be a strong sciencebased agency to accurately detect and assess health risks of various drugs and food, and set appropriate standards. It also wishes to be a trusted agency to enforce statutes

relating to food, drug, and cosmetics, and protect the welfare of consumers, and a collaborative agency to strengthen ties with the scientific world, healthcare providers and regulatory communities, both nationally and internationally.

Towards this vision, FDA strives to ensure that drugs and medical devices are safe and effective, cosmetics are safe, products in compliance with the law and FDA regulation; non-compliance is identified and corrected. Regulatory decisions are based on a strong, legal, scientific and

analytical base. FDA will be the proactive force in making safe and effective products available to the consumers. It provides clear standards of compliance to the industry and advise on how to meet them.

Identification and effective address of critical public health problems, if any, arising from use of FDA regulated products is also an FDA responsibility.

Itworks in close collaboration and co-operation with local authorities, national and international agencies, industry and academia, consumer groups and health professionals to realise its vision.

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RESEARCH RESEARCH UPDATES

FDApanel votes against approval of Medicines Co’s blood clot preventer The panel voted 7-2 against approving the drug, cangrelor AN INDEPENDENT advisory panel to the US Food and Drug Administration said a blood clot preventer developed by The Medicines Co should not be approved due to a lack of data to prove its efficacy.

The panel voted 7-2 against approving the drug, cangrelor, for use during angioplasty — a heart surgery for widening narrow or clogged arteries. The panelists also voted unanimously against allowing cangrelor's use in patients with stents, who are at an increased risk of events such as stent thrombosis a blood clot that forms at the site of the stent.

Panelists said they were not convinced that data from an 11,000-patient trial was enough to prove cangrelor's efficacy, especially given the failure of two prior trials.

"I am not sure if it could count as a pivotal trial," said Scott Emerson, a panel member and a professor of biostatistics with the University of Washington. The trial, named Champion-Phoenix, had shown that those on cangrelor had a reduction in the combined risk of death, heart attack, repeat procedure or stent thrombosis.

The two failed late-stage trials were stopped in mid-2010 after data showed that the drug was ineffective. The company had tweaked the study design for the latest trial to differentiate between heart attacks associated with the drug and those that may have been associated with the procedure. The Champion-Phoenix trial was testing cangrelor against a rival drug, Plavix, made by Bristol-Myers Squibb Co. Plavix is generically

56 EXPRESS PHARMA March 16-31, 2014

The panelists also voted unanimously against allowing cangrelor's use in patients with stents, who are at an increased risk of events such as stent thrombosis a blood clot that forms at the site of the stent known as clopidogrel.

"I don't think they are going to develop cangrelor further.

Because they would have to run another 10,000-15,000 patient study," Jefferies analyst Biren Amin said. Amin said there is probably very little prospect for the drug at least in the US. "They could try to file in Europe and try to get approval. That is still a potential," he said.

He had expected the drug to reach US sales of $224 million by 2020. In briefing documents put out ahead of the meeting, FDA's medical team leader Thomas Marciniak recommended that cangrelor not be

approved, saying data on the drug did not show it was as good as or superior to a rival drug.

A US consumer group also urged the FDA to reject cangrelor, citing ethical issues with the way the company conducted the trials. Public Citizen alleged that many patients on the trial received clopidogrel — usually given before cardiac stent procedures to prevent clot formation — after the procedure, likely resulting in a larger number of clots and heart attacks.

Reuters

FDAprobes cognitive impact of new cholesterol drugs THE FOOD and Drug Administration has asked Regeneron Pharmaceuticals and Sanofi SA to assess potential neurocognitive side effects of their experimental cholesterol drug, Sanofi said in its annual report. Amgen, which is developing a similar drug, said it has also been in communication with the agency. The FDA said it could not discuss specific development programs, but is "aware of concerns raised with neurocognitive adverse events and other lipid-lowering therapies, including statins, and as part of our oversight of new drug development, we are carefully monitoring these events." The new drugs are part of an experimental class known as PCSK9 inhibitors designed to block a protein that maintains "bad" LDL cholesterol in the bloodstream.

"We have not seen a neurocognitive adverse signal in the alirocumab data," Dr Michael Aberman, Regeneron's vice president for strategy and investor relations, said. He said the alirocumab trials have been overseen by independent safety monitors. "What the FDA asked us to do we don't expect to be difficult or time consuming," Aberman added. Sanofi and Regeneron said they did not know how the FDA learned of the potential side effects, and they were not aware of any such side effects with alirocumab. Pfizer, also in the late stages of developing a PCSK9 drug, said that it has not received a similar request from the FDA but is already assessing potential neurocognitive side effects in late-stage trials of its drug, bococizumab. "At this stage of our bococizumab development program, we are not aware of any neurocognitive safety signals," the company said.

Amgen, which has said it could file for regulatory approval of PCSK9 drug

The new drugs are part of an experimental class known as PCSK9 inhibitors evolocumab this year, said it has been proactively monitoring for cognitive impairment in its trials. "Similar to other companies developing PCSK9 inhibitors, Amgen has been in communication with the FDA, and we will continue to investigate the potential for cognitive impairment in our program," Amgen said.

The company said it has not seen any such signal so far.

Sanofi's report echoed a filing made by Regeneron last month, in which the company said the FDA advised it was aware of adverse neurocognitive effects associated with PCSK9 inhibitors.

Rare side effects such as memory loss, impaired concentration, and paranoia have been associated with the use of statins for lowering LDL cholesterol, and their labels include warnings about cognitive impairment. Statins, such as AstraZeneca PLC's Crestor and generic forms of Pfizer's Lipitor, are the most widely used cholesterol-lowering treatments and work by blocking the liver's production of LDL cholesterol.

"While we continue to believe the PCSK9 class has multi-billion dollar potential, we note that increased speculation on adverse events may increase the probability that the FDA could require outcomes data prior to full approval," JP Morgan analyst Geoff Meacham said in a research note.

Reuters

RESEARCH

J&J,Pharmacyclics drug wins US approval for leukemia US HEALTH regulators approved the Johnson & Johnson and Pharmacyclics cancer drug Imbruvica to treat chronic lymphocytic leukemia, a slowly progressing form of blood cancer. The Food and Drug Administration decision marks the second approval recently for the oral medicine, known chemically as ibrutinib. In November, the drug won US approval to treat a rare and aggressive form of nonHodgkin lymphoma called mantle cell lymphoma in patients who have received prior treatment with at least one other therapy. The latest approval is also for so-called second line therapy after at least one prior treatment fails or

stops working, the FDA said.

"Today's approval provides an important new treatment option for CLL patients whose cancer has progressed despite having undergone previous therapy," Richard Pazdur, head of the FDA's Office of Hematology and Oncology Products, said. "The FDA completed its review of Imbruvica's new indication under the agency's accelerated approval process, which played a vital role in rapidly making this new therapy available to those who need it most," Pazdur said.

About 15,680 Americans were diagnosed with CLL and 4,580 died from the disease in 2013, according to the National Cancer Institute. There

had been some disappointment in the market when the original approval of the drug did not include both types of cancer.

RBC Capital Markets analyst Michael Yee has been forecasting long-term annual worldwide sales of $5 billion for Imbruvica. According to

long-term follow-up data from a midstage clinical trial presented at a major medical meeting in December, the drug maintained its effectiveness in keeping the disease at bay for most patients. With a median follow-up of more than 27 months of treatment, nearly all of the previously untreated patients and almost three-quarters of the relapsed patients in the study had no evidence of their CLL progressing.

"Patients receiving ibrutinib are doing much better than historically what we're used to seeing with CLL," Dr John Byrd, a co-leader of that study, said.

Reuters

FDAto review possible heart risks with AstraZeneca's diabetes drug

Bayer’s Nexavar misses target in liver cancer trial

THE US Food and Drug Administration said it will review possible heart risks associated with AstraZeneca Plc's widely-used diabetes drug saxagliptin, marketed as Onglyza and Kombiglyze XR. The health regulator said it requested for data from clinical trials after the New England Journal of Medicine published data that showed a small rise in hospitalisations for heart failure among patients using saxagliptin. (link.reuters.com/ven76v) The data was published by NEJM in September and was based on a study supported

by AstraZeneca and BristolMyers Squibb Co, with whom AstraZeneca co-developed

GERMANY'S BAYER said a final stage Phase III clinical trial of cancer drug Nexavar as an adjuvant therapy for liver cancer did not meet its main target. Nexavar, or sorafenib, is made

by Bayer and Onyx Pharmaceuticals, and is already approved to treat advanced kidney cancer and liver cancer that cannot be surgically removed.

Bayer is testing the drug, taken orally, as an additional treatment for liver cancer patients who had no detectable disease after surgery. It said that the trial did not meet its main goal of improving recurrence-free survival.

"We are disappointed that the trial did not meet its primary endpoint," said Joerg Moeller, member of the Bayer HealthCare Executive Committee.

Heart-related problems, such as ones seen with GlaxoSmithKline's Avandia pill, are a concern with diabetes drugs, especially as diabetics also have an increased risk of heart troubles the drug before buying all rights in a deal completed earlier this month. That study did not find an increase in the rate of deaths or other major cardiovascular risks, includ-

ing heart attacks or strokes, in patients who received saxagliptin, the FDA said on its website. The FDA said it asked for the trial data to be submitted by early March, af-

ter which it would analyse and publicly report the findings. The FDA said it considers the information in the NEJM study to be preliminary and that healthcare professionals should continue to prescribe the drug according to the recommendation on the drug's label. The review of the saxagliptin trial data was part of a broader evaluation of all type 2 diabetes drugs and cardiovascular risk, the FDA said. Heart-related problems, such as ones seen with GlaxoSmithKline's Avandia pill, are a concern with diabetes drugs, especially as diabetics also have an increased risk of heart troubles.

Reuters

Reuters

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PHARMA ALLY VENDOR NEWS

New liquid chromatography column separates challenging glycans and glycan isomers Are compatible with fluorescence and mass spectrometry detection methods THE GROWING legion of scientists investigating glycans as disease markers and antibodybased biopharmaceuticals (nearly 800 publications in five years) now have an effective new tool for the challenging separations of glycans and glycan isomers. Thermo Fisher Scientific has showcased the GlycanPac AXR-1 column at booth #2441 during Pittcon 2014, being held at McCormick Place in Chicago.

“-Until now, glycan isomers could not be separated by conventional HPLC,” said Ilze Birznieks, Product Marketing Manager, Biocolumns, for

Thermo Fisher. “This new column helps users achieve greater resolution of glycans using HPLC, providing easier profile characterisation. This is useful

for characterising glycans from monoclonal antibodies being developed for therapeutics.”

The GlycanPac AXR-1 columns are designed for excel-

lent resolution of labelled and unlabelled glycans, and are compatible with fluorescence and mass spectrometry detection methods. Mass spectrome-

try has emerged as a powerful tool for determining the structures of glycans, and this new column is designed to enable researchers to harness the power of high-resolution accuratemass (HRAM) mass spectrometry at high-throughput rates.

This column is designed to separate both labelled and native glycans based on the availability of samples. Native glycan separation allows researchers to eliminate the fluorescent labeling step and increase throughput without eroding performance.

EP News Bureau-Mumbai

Cirrius App is now available on Windows devices Will enable the representatives to detail medical content inside the clinic and report each call by utilising the time spent waiting for a meeting PHARMACEUTICAL COMPANIES can now empower medical representatives with information on their fingertips before, during and after a doctor’s call with the Cirrius Platform on Windows 8. This application enables the representatives to detail medical content inside the clinic and report each call by utilising the time spent waiting for a meeting. Managers can access real-time data to take informed tactical and strategic decisions.

The Cirrius Platform offers a unique combination of SFA

58 EXPRESS PHARMA March 16-31, 2014

(Sales Force Automation), CRM (Customer Relationship Management) and CLM (Closed Loop Marketing) all bundled into one seamlessly integrated mobility solution.

The platform caters to the needs of the medical representative comprehensively with feature rich functionality that includes daily reports, edetailing, tour planning, inventory, order management, expense tracking etc. all on their devices anytime anywhere. Rich analytics on the platform’s web portal as well as devices allows managers to

monitor field activities and self-service administration consoles enable changes to field users and structure. The platform easily integrates with other systems like ERP, CRM, HRMS etc to exchange information across the enterprise. The Cirrius platform forms an integral part of the Enterprise Information ecosystem.

Joseph Landes, General Manager – Developer and Platform Evangelism, Microsoft Corporation (India) said, “The Cirrius app leverages the best of Windows to

empower the pharma sales force and their managers and make their lives simpler. The app underscores Microsoft’s commitment to consistently evolve and deliver quality solutions using technology to our customers.”

Kapil Kuwelkar, Chief Executive and Founder, Cirrius Wireless Technologies said, “At Cirrius, we are really excited to partner with Microsoft as this provides value to our customers. They will now have the opportunity to use Microsoft Windows 8 devices that can empower their

sales force for better productivity and effectiveness. Many customers have shown interest to implement this offering and we will soon have case studies to share.”

With over 25+ customers and over 50,000 users with a 90 per cent+ adoption in 16 countries with a multilingual platform, the Cirrius Platform is the largest Indian pharma sales force platform. The platform has been in operation since 2007 and is stable and mature and is customisable to country or company needs.

EP News Bureau-Mumbai

Triple or Phenomenex expands four layered selectivity of Kinetex Core-Shell Alubags Line with new Biphenyl columns PRODUCTS

PHENOMENEX, A global leader in the research and manufacture of advanced technologies for the separation sciences, has launched new Kinetex Core-Shell Biphenyl HPLC/UHPLC columns, giving researchers the ideal orthogonal selectivity to traditional C18 phases. This new phase is excellent for a broad range of complex-mixture analyses in clinical and forensic toxicology, food and environmental testing, and pharmaceutical, bioanalytical, and DMPK studies.

Kinetex Biphenyl

columns deliver all the benefits inherent with Phenomenex’s Core-Shell Technology including better resolution, higher efficiency, sharper peaks, and greater sensitivity than traditional HPLC/UHPLC media. In addition to 100 per cent aqueous stability and enhanced polar basic selectivity, the Kinetex 2.6 μm Biphenyl offers the greatest versatility for HPLC/UHPLC methods while the Kinetex 5 μm Biphenyl offers excellent HPLC performance at extremely low backpressures.

Kinetex

Biphenyl is initially available in 2.6μm and 5μm with a 1.7μm option expected next.

Contact details Raj Kiran CH Marketing Communication Associate Phenomenex India Laxmi Cyber City, Ground FloorB Block, Survey no: 10Kondapur, Hyderabad 500 084 Tel: 040-3012 2400 Fax: 040-3012 2411 Email: RajK@phenomenex.com Website: http://www.phenomenex.com

Cryo Bath byLabtop Instruments

FROM 50 years, Bernhardt has developed solutions for manual, half automatic or full automatic applications with all kind of specifications from pharmaceuticals, cosmetics, chemistry and food industry. From small machines to huge automatic lines, Bernhardt products are reliable, strong and efficient.

High quality multilayer foils The layers used are made from assembling of different complementary materials.

Inner layer Polyethylen (Pe) or Polypropylen (PP) from 75μm to 150 μm.

Additives such Evoh or Siox, Alox, increase barrier efficiency.

Outer layer Polyester (Pet), White or Brown Paper, Polyamide (Pa), metallised Polyester, Polypropylen.

Middle layers LABTOP INSTRUMENTS' constant temperature baths are designed for research work at desired temperature with high accuracy. The temperature is controlled by specially designed micro-controller based temperature controller with an accuracy of 0.2°C. The unit is provided with a circulating pump to ensure uniform temperature.

Advanced LABTOP Cryo Bath offer a contemporary cabinet design, advanced micro-controller and a range of accessories to suit your specific laboratory or process application. High-strength cabinet construction with 316 stainless steel interior tanks withstand the most

critical applications in demanding laboratory environments. The unit is mounted on castor wheels for ease of mobility.

Features ■ Audio visual alarm if temperature deviates from preset temperature.

■ Display of set value and process value.

■ Integrated pump for internal circulation to maintain precise temperature.

■ Temperature uniformity throughout the liquid medium.

■ Rounded corners for better water circulation, improved uniformity and easier cleaning.

■ Foam in placed PUF in-

sulation improves temperature stability and energy efficiency.

■ 316 stainless steel construction resists chemicals, simplifies cleaning.

■ Long-life healing elements for quick response to controller.

Documentation For GMP compliant models LABTOP offers DQ IQ, OQ and PQ with documentation, reports, calibration and test certificates.

Calibration The equipment is calibrated with the help of master calibrator, which is certified for its accuracy by Electronics Regional Testing

Laboratory (ERTL West) Government of India recognised testing laboratory with traceable reference to National Physical Laboratories (NPL).

These layers increase mechanical or barrier efficiency (Aluminium, Polyamide, Metallised Polyester)

Contact details Byju George, Director Labtop Instruments Labtop House, Plot No 59, Opp Amarson, Waliv Phata, Sativali Road, Vasai (E), Dist - Thane- 401 208, Maharashtra, India Tel.: +91 250 6457 376 - 99 (24 Lines) Email: byju@ labtopinstruments.com Web: www.labtopinstruments.com

and pouches. ● Suitable for API/Formulations ● High barrier multilayer foils are efficient for packing of sensitive products under vacuum or gas flushing.

Features ● For moisture sensitive products. ● High barrier triple laminated Alubags

Contact details Nilesh Phadnis, Director, Accura Pharmaquip, Plot No B-16, TTC Industrial Area, MIDC, Digha, Navi Mumbai - 400 708 Maharashtra Tel: +91 22 2779 1333 / 0334 Email: nilesh.phadnis@accurappl.net Web: www. accurappl.net

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PHARMA ALLY

Ecoflux corrugated tube heat exchangers by HRS CORRUGATED TUBE heat exchangers are shell and tube heat exchangers which use corrugated tubes instead of plain tubes. This kind of tube combines the best features of both the plain tube and the plate heat exchanger. The tubes are corrugated to induce turbulence in both flows (product and service) at lower velocities. This increases thermal efficiency and eliminates product channelling. Thermal efficiency is so improved, that for typical thin film applications heat transfer area can be reduced to less than half

of that required in a plain tubular heat exchanger.

Salient features / USP: ● Compact tubular heat exchanger; ● Long running times due to turbulent flow ● Very low maintenance costs, minimum spares requirement. ● Lower heat transfer areas. ● Minimal fouling and hence high response to CIP ● Wide choice of MOC. Heat exchangers can be made in SS 304 / L, 316 / L, Cu Ni, Hastelloy, Alloy 20, Duplex, Titanium, etc.

●

Uniform thermal processing. ● More flexibility in annular space sizing.

Product application Ecoflux corrugated tube heat exchangers are used in various industries for processing of pharmaceutical, chemical, petrochemical, fertilisers, edible oil, paper and pulp, cosmetics, steel, cement, power, rubber, paints, breweries and distilleries, waste and waste water management, sugar, automotive, fruit pulp, beverage, particulate ready-toeat foods, milk and milk-

based products, nutraceuticals and probiotic supplements. Ecoflux is used for an extensive range of applications like heater, cooler, condenser, re-boiler, regenerator, hot water generation, chiller, pasteuriser, steriliser, aseptic filler and evaporator.

Contact details HRS Process Systems 201/202 Karan Salene, 851, Bhandarkar Institute Road, Pune 411004, Tel: 020-2566 3581 / 82 Fax: 020- 2566 3583 Email: info@hrsasia.co.in Web: www.hrsasia.co.in

MODELS AVAILABLE: K – SERIES, DT - SERIES, MI- SERIES, AS- SERIES HEAT EXCHANGER

K- Series

MI - Series

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DT- Series

AS- Series

Cognexadvances industrial ID with newdataman software release COGNEX CORPORATION announced its DataMan 5.2 software release with expanded tuning and scripting capability, as well as a new test mode for its popular DataMan 300 and 503 series of barcode readers. The new software significantly increases read rates by decoding lower resolution 1-D codes and extending intelligent tuning capabilities to all symbologies, including Aztec, MaxiCode and PDF417. The software release includes the high-performance Hotbars algorithm, which handles both 1-D and PDF417 barcodes.

The DataMan 5.2 software release extends the easy-to-use 2-D intelligent tuning capability that was introduced by the popular DataMan 300 Series.

This intelligent tuning capability decreased set up time while increasing read rates for Direct Part Mark (DPM) code reading applications. This software release extends that advanced capability to other symbologies, such as 1-D barcodes, MaxiCode and QR codes. These new tuning capabilities bring proven, industry-leading technology to code reading applications in consumer products, logistics, food, beverage and automotive. This new release also includes added capabilities to the scripting feature of the DataMan 300 for advanced logic and decision making in the reader, and 1-D barcode quality metrics for users to optimise their processes.

Contact details Sunil Vaggu Cognex Corporation +91 9881466003 vaggu.sunil@cognex.com

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Some of the most prestigious institutions from a number of vital sectors use Identification Systems (Access Control and Time & Attendance)

Banking

Insurance

Govt

Petroleum

PHARMA

Mfg.

Aviation

Mega Retail

IT & Data Centers

Several ready solutions to assist the Pharma Sector in Good Manufacturing Practices (GMP) such as: Door Interlock for the Clean Rooms and other Production facilities

with an OTP (One Time Password) to maximise authentication of fingerprint registration

Access Control measures to restrict movements of personnel across production facilities to prevent contamination, as per the US FDA guidelines

A number of very useful MIS Reports and analysis for the management Some more Solutions

Biometric logical access for critical pharma machinery (PLC integration possible).

21 CFR Part 11 compliant software Rack level Access Control in the Data Centre and Server Room Access Control at any other vital point where it may be necessary to restrict or regulate entry.

Centralised multi-location recording and analysis of staff attendance in factories, branches, warehouses, etc

SMART I ELECTRONICS SYSTEMS PVT. LTD. (An ISO 9001:2008 Certified Company) Corporate Office: 308 Puranik Capitol, Opp Hypercity Mall, Ghodbunder Road, Thane (W) Tel: +91 22 6464 6500 Email: enquiry@smartisystems.com

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We care for your family . . .

Anti-Inflammatory Enzymes Serratiopeptidase Peptizyme (enteric coated serratiopeptidase granules) Trypsin Chymotrypsin mix ( 6:1)

Probiotics Saccharomyces boulardii Lactic acid basillus sporogenous

Circulatory Health Nattokinase

Bio Catalysts Immobilized Cal B

Digestive Aids Alpha amylase / fungal diastase / fungal amylase Alpha galactosidase Bacterial alpha amylase Bromelain Hemicellulase Lactase Lipase Ox bile

Papain Pepsin Pancreatin Protease ( acid / alkali)

Advanced Enzyme Technologies Limited Sun Magnetica, 'A' wing, 5th Floor, Accolade Galaxy, LIC Service Road, Louiswadi, Thane(W) - 400604, India Tel: +91 22 41703200, Fax: +91 22 25835159 • E-mail : info@enzymeindia.com • Website: www.enzymeindia.com

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Non-GMO ISO CERTIFICATION

GOTS CERTIFICATION

Products

WHO cGMP

FDA

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Want to simplify your

Capsule filling and Direct

Compression process LYCATAB速 C LYCATAB速 C is a multifunctional excipient, ideal for hard gelatine capsule filling, and as direct compression filler.

LYCATAB速 C has also proven to be an efficient binder for wet granulation.

We deliver!

ROQUETTE, through its production units (in Europe, in Asia and in the United States) and its international distribution network, will assure a constant quality of products and services throughout the whole world.

www.roquettepharma.com For your local contact : Roquette India Pvt Ltd Email : pharmabiz.india@roquette.com - Tel : +91 22 2570 6775 Our local Distributor : Signet Chemical Corp. Pvt Ltd - Email : sales@signetchem.com

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Designers, Engineers & Manufacturers of Machinery & Filteration Equipments for:

es Decad ies. ustr Over d In to ice of serv ing Stronger Grow t & Integrity us with Tr

Pharmaceuticals, Packaging, Chemicals, Food, Beverages, Distilleries, Breweries, Paints, Food, Oils & Consumers

MAJOR PRODUCTS MANUFACTURED AT UNIPACK Linear Vial/Bottle Washing Machines Sizes: vials 2ml to 100 ml & Bottles 15 ml to 500 ml Scramblers/Unscramblers Sizes:24” dia, 36” dia. 48” dia 60” dia Hydraulic Loading Platforms Inspection Tables Loading and unloading Conveyors Liquid Filling, Rubber Stoppering & aluminium Cap sealing Machines for Vials Powder Filling, Rubber Stoppering & aluminium Cap sealing Machines for Vials

Sterlity Testing Units in S.S. Sizes: Single Place, Three Place & Six Place Plate and Frame Type Filter press in SS Size: 20 cm X 20 cm, 40 cm X 40 cm, 60 cm X 60 cm, 100 cm X 100 cm Zero hold up/Sparkler Filter press Size : 600 LPH to 15500 LPH Sterile Pressure and Storage Vessels Size : 10 ltrs to 500 ltrs Membrabe Filter Holders (Size: 293 mm, 142mm, 90mm) Inline Filter Holders (Size:47mm, 25mm, 13mm) Basket/Bag/Catridges Filters

We Supply different sizes of Filter Sheets and Filter Modules of Major International Brands

Our Achievements: Over 2500 installations of our major products manufactured in-house are supplied to all Leading Companies in India & Multinationals abroad

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Optical Particle Analyzers

F O R H IG H P U R IT Y AP P L ICATIONS

DMF NO: 26710

If you are looking for state-of-the-art optical particle analyzers, look no further than RETSCH TECHNOLOGY.

1 1 1 1 1 1 1 1 1 1 1 1 1

US FDA regulations CFR 177.2600 for contact with food USP class VI requirements European Pharmacopoeia 3.1.9 Animal derivative free Imported state of the art machine ed Highly advanced auto-curing system rtifi e C Excellent heat resistance (-50°C to 250°C) m nroo Clea Odourless Completely nontoxic Repeatedly autoclavable No leaching of particles Does not support bacteria growth Retains elasticity even after prolonged use

n Particle size and particle shape analysis n Size range from 1 μm to 30 mm n Analysis of powders, granules and suspensions

www.retsch-technology.com

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Manufacturers of Pharmaceutical Machinery

39/2A, Purna Das Road, Kolkata - 700 029. Gram : Techpharma. Tel : 91 33 2464 4568 / 0457 7253 Fax : 91 33 2464 7254. Email : mails2neomachine@gmail.com, neocota@sify.com Website : www.neocota.com, www.neomachine.in Mumbai : 91 22 2261 4088, Chennai : 91 44 2432 2243 / 2432 8128, Delhi : 91 11 2546 0255

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CLEANING, SANITISING EQUIPMENTS CLEAN ROOM ACCESSORIES ASEPTIC PIPING , PW / WFI DISTRIBUTION LOOPS

Floor Drain Traps

Hand Sanitiser

Water Saver Cleaninng Nozzles(self-rotating) Nozzles

Shoe Cover Dispenser

Foot Sanitiser

Split Butterfly Valve

Pendents(Service Shafts) CIP/ SIP MODULE We also design & manufacture # IBC Washing/ Drying Modules # Containers/ Glass Ware Wash Modules # FBD Bag Washing/ Drying Modules # Cannisters Washing Modules # Drums Washing Modules 82

March 16-31, 2014

Wash Down Hose Station

SIP MODULE

8/B, Surat Singh Est ,SV Rd, Jogeshwari(W), Mumbai-400102 Tel; 022-26797941 Telefax:022-26798066 Cell: 9869231815 email: iewi@mtnl.net.in website : www.iewi.net

Top Tank / Reactor Sampler

Flush Bottom valve

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PHARMA LIFE AWARDS

L’Oreal Foundation,UNESCO to honour women in science Five exceptional women scientists to receive L'Oréal-UNESCO For Women in Science Awards FIVE OUTSTANDING women would be honoured with the L'Oreal-UNESCO For Women in Science award on March 19. Organised by The L’Oreal Foundation and UNESCO, the awards recognise the women scientists for their considerable talent, choice of an unusual career path in a male-dominated arena and commitment to their profession.

Europe’s Professor Brigitte Kieffer for her contribution to neurobiology; North America’s Professor Laurie Glimcher and Professor Kayo Inaba from Asia/Pacific for their work in Immunology and Medicine; Latin American, Professor Cecilia Bouzat for her research in Biophysics; and Dr Segenet Kelemu from Africa and the Arab States for her research in Biology and Plant Pathology are the recipients of the L'Oreal-UNESCO For Women in Science awards this year.

Prior to the awards ceremony, the five laureates and fifteen International Fellows will address a press conference to be held at 14 rue Royale in Paris, wherein the findings of a report on the current status of women in science will also be revealed.

The report, compiled by the Boston Consulting Group (BCG) for the L'Oreal Foundation, highlights the under representation of women in scientific professions and reveals that there has been only marginal improvement in the situation over the past 10 years.

It will held on the evening of March 19 at the Sorbonne in Paris, The L'Oreal-UNESCO For Women in Science 2014 Awards Ceremony will be presided over by Professor Guenter Blobel, Nobel Prize in

84 EXPRESS PHARMA March 16-31, 2014

WINNERS OF L’ORÉAL-UNESCO FOR WOMEN IN SCIENCE AWARDS 2014 PROFESSOR BRIGITTE KIEFFER

DESIGNATION: Professor, University of Strasbourg, France; Research Director, Institut de Genetique et de Biologie Moleculaire et Cellulaire (IGBMC), Illkrich, France; Scientific Director, Douglas Institute Research Center, McGill University, Montreal, Canada AREA OF EXCELLENCE Neurobiology Prof Kieffer is being honoured for her decisive work on the brain mechanisms involved in pain, mental illness and drug addiction.

In 1992, she was the first to clone and isolate the gene for an opioid receptor in the brain that plays a key role in alleviating pain, a puzzle which scientists around the world had been attempting to solve for the previous 15 years. Her findings led the way to new treatments for fighting pain, addiction and depression.

PROFESSOR LAURIE GLIMCHER

Suzanne Weiss Dean, Weill Cornell Medical College, New York, NY, US; Provost for Medical Affairs, Cornell University, Ithaca, New York, US. AREA OF EXCELLENCE Immunology and Medicine Prof Glimcher is a pioneer and leader in the field of immunology.

She is being honoured for discovering key factors involved in controlling immune response (Tbet) in allergies and in autoimmune, infectious and malignant diseases. Her findings are paving the way for the development of new treatments for allergies, asthma, multiple sclerosis, childhood diabetes and cancer.

Prof Bouzat is an international leader in neurotransmitter pharmacology. She is being honoured for her contribution to our understanding of how brain cells communicate among themselves and with muscles. Her discoveries enabled the identification of the communications problem between the brain and muscles that causes major neurological disorders. Prof. Bouzat's work has opened the door to potential new treatments for Alzheimer's disease, depression and certain addictive behaviours.

DR SEGENET KELEMU

PROFESSOR KAYO INABA

PROFESSOR CECILIA BOUZAT

DESIGNATION: Member of the National Scientific and Technical Research Council (CONICET), Buenos Aires; Professor, Universidad Nacional del Sur, Bahia Bianca; Deputy Director, Institute of Biochemical Research of Bahia Bianca (INIBIBB), Argentina

as a virus or bacteria or by abnormal cells such as cancer cells. Specialised in the study of dendritic cells, Prof. Inaba was the first scientist to prove that these cells could be treated outside the body and then reintroduced into the organism to stimulate immune system response. Her discovery marked a turning point in cellular therapy and has already led to a new type of anti-cancer treatment.

DESIGNATION: Director General, International Center for Insect Physiology and Ecology (ICIPE), Nairobi, Kenya.

DESIGNATION: Professor, Graduate School of Biostudies, Kyoto University, Japan; VicePresident for Gender Equality and Director of the Center for Women Researchers, Kyoto University, Japan

DESIGNATION: Stephen and

AREA OF EXCELLENCE Biophysics

AREA OF EXCELLENCE Immunology a nd Medicine Prof Inaba is being honoured for her critical discoveries concerning the mechanisms triggered by the immune system when it is faced with a threat such

Medicine. Irina Bokova, Director-General of UNESCO, JeanPaul Agon, Chairman and CEO of L’Oreal and Chairman of the

L’Oreal Foundation, will be in attendance. Since 1998, The L’Oreal-UNESCO For Women in Science Awards has recognised

more than 2,000 women around the globe for their contribution to major scientific advancements that help tackle some of

AREA OF EXCELLENCE Biology and Plant Pathology Dr Segenet Kelemu is being honoured for her research on how microorganisms living in symbiosis with forage grasses can improve their capacity to resist disease and adapt to environmental and climate change. Her work is providing new solutions for ecologically responsible food crop production, especially by local, small-scale farmers.

greatest challenges of the society, including cancer, depression and addiction.

EP News Bureau - Mumbai

Indus Health Plus wins ASSOCHAM CSR Excellence Award in SME Segment 2013 – 14 Bags award as its business revolved around CSR, sustainable development and corporate citizenship ASSOCHAM HONOURED Indus Health Plus with CSR (Corporate Social Responsibility) Excellence Awards in SME and other category in recognition for the outstanding CSR activities undertaken by the company. Harish Pillai, Chief Executive Officer, Indus Health Plus recently received the award from Kapil Sibal, Communication Minister in New Delhi.

CSR is the integration of business operations and values, whereby the interests of all stakeholders including investors, customers, employ-

ees, the community and the environment is reflected in the company’s policies and actions. Indus Health Plus bagged this award as its business revolves around CSR, sustainable development and corporate citizenship.

This is achieved through special discount coupons for senior citizens on preventive healthcare check-ups. Indus also conducts number of seminars and workshops pan India to generate awareness, through delivery channels.

Special citizen camps, police camps, blood donation camps,

society checkups are part of CSR activity by Indus. Pillai said, “We are happy and honoured to receive ASSOCHAM award for our CSR initiatives which we believe in and conduct throughout the year.

The entire Indus team thanks the jury members for selecting us as the winner in this category. Our aim has been to provide quality healthcare at affordable prices to the masses through preventive healthcare checkups.

EP News Bureau - Mumbai

APPOINTMENT

IDAIreland appoints John Kilmartin as Director for India business Will spearhead efforts to promote Ireland as an operations base for Indian companies IDA IRELAND, the Irish Government’s foreign investment agency, has appointed John Kilmartin as the Director of India business. His role involves spearheading the Indian operations of the IDA Ireland organisation which involves promoting Ireland as an operations base for Indian companies expanding their presence in European markets.

Kilmartin joined IDA Ireland in July 2007. Prior to being appointed to lead the IDA India team, John held a num-

ber of roles including Business Development Manager in the Emerging Companies Division where he was responsible for assisting high growth companies to set-up operations in Ireland.

On his new appointment Kilmartin said, “Indian companies are increasingly assessing Ireland as an attractive investment destination. As part of my new role, I look forward to strengthening IDA Ireland’s outstanding position in the Indian corporate mind-set.”

Prior to joining IDA Ireland, Kilmartin was a Technology Consultant with Deloitte Consulting for seven years where he was involved in numerous projects such as Oracle systems development, System implementations, Change Management, Strategy Definition and Project Management. John holds a Degree in Common Law and MBS (Masters in Business Studies) in Managerial Accounting and Managerial Information Systems from University College Cork.

Barry O’Leary, Chief Executive Officer, IDA Ireland commenting on Kilmartin’s appointment said, “India is a strategic market for IDA Ireland and is thus being accorded high priority within the organisation. We are confident that John’s leadership skills and experience will hold us in good stead in the Indian market and his tenure will help establish the investment credentials of Ireland among Indian corporates.”

EP News Bureau - Mumbai

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PHARMA LIFE NAUKRI JOB SPEAK INDEX

Hiring activity in pharma sector grows at modest two per cent in Feb’14 over Jan’14 NAUKRI JOB Speak Index for the month of February 14 reflects muted growth for the pharmaceutical sector. An month-over-month analysis reveals that index has grown by two per cent in February 2014 over January 2014. Yearly comparison shows a nine per cent increase in February 2014 over February 2013 if compared to same month of previous year.

About Naukri.com Naukri.com, India’s No. 1 job site and the flagship brand of Info Edge introduced the concept of e-recruitment in India. Since its inception in 1997, Naukri.com has seen continued growth while outperforming its competitors in every sphere. Info Edge was the first Internet company to be listed in India. The site enjoys a

traffic share consistently over 60 per cent as per the Comscore data. Naukri.com is a recruitment platform that provides hiring-related services to Corpo-

rates/ recruiters, placement agencies and to job seekers in India and overseas. It offers multiple products like Resume Database Access, listings and

Response Management Tools.

With 230000 jobs live at any point and over 33 million CV’s, Naukri.com serviced over 48000 corporate clients in 2012-2013.

The company has over 2500 people operating through 57 offices in 36 cities in India and overseas offices in Dubai, Riyadh, Abu Dhabi and Bahrain.

JOBS FROM Naukri.com Accountant Assistant Company: Martin and Harris Exp: 2-7 Location: Delhi Job Id: 100314001512

Customer care Executive Company: ATS Genetech Exp: 0-2 Location: Hyderabad / Secunderabad Job Id: 100314001327

Pharmaceuticals LimitedExp: 6-8 Location: Mumbai Job Id: 010114000895

Regional Training Manager Company: DKT India Exp: 2-3 Location: Kolkata Job Id: 240913003675

TEAM Leader - Medical Division Assistant Manager - Purchase Company: Alembic

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Company: MediAnalytika India Exp: 3-5 Location: Mumbai

Job Id: 100314000945

Production Chemist

Job Id: 100314000617

Formulation Solid Orals R&D Associate Scientific Manager

Company: Alchem International Limite Exp: 4-7 Location: Faridabad Job Id: 100314000703

Senior Engineer Mechanical Maintenance

Company: Biocon Exp: 6-9 Location: Bengaluru/Bangalore Job Id: 210813000995

Eng III Software Company: Thermo Fisher Scientific Exp: 4-9 Location: Bengaluru/Bangalore Job Id: 100314000767

Regional Business Manager Company: Claris Otsuka Exp: 10-16 Location: Pune Job Id: 100314000668

Front Office Executive Company: VaishaliPharma Exp: 0-5 Location: Mumbai

Company: Jubilant Life Sciences Exp: 3-6 Location: Mysore Job Id: 100314000564

Area Business Manager Company: Naprod Life Science Exp: 3-8 Location: Mumbai Job Id: 070314001714

REGD.WITH RNI NO.MAHENG/2005/21398 REGD.NO.MH/MR/SOUTH-77/2013-15, PUBLISHED ON 5TH & 20TH EVERY FORTNIGHLY & POSTED 6-7-8 & 21-22-23 OF EVERY FORTNIGHLY. POSTED AT MUMBAI PATRIKA CHANNEL SORTING OFFICE.