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VOL .8 NO.19 PAGES 60

Market The rise of the orphans Management Fair decision Research Clinical trials in India in a crisis: Does it matter? 1-15 AUGUST, 2013, ` 40

V O L 8 . N O . 1 9 AU G UST 1 - 1 5 , 2 0 1 3


Chairman of the Board Viveck Goenka


Editor Viveka Roychowdhury*

HTA is still unstructured and nascent in the


Indian context

Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das


Viral hepatitis: The era of molecular assays

Bangalore Neelam M Kachhap


Patent protection for orphan drugs

Delhi Shalini Gupta




Clinical trials in India in a crisis:

Deputy General Manager Harit Mohanty

Does it matter?

Senior Manager Rajesh Bhatkal

Cheaper anti-cancer drug effective in


treating most common cause of blindness

PRODUCTION General Manager B R Tipnis

in older adults

Manager Bhadresh Valia


Asst. Manager - Scheduling & Coordination Arvind Mane

‘We have offered Square Foot’s flooring


solution to more than 100 facilities’

Deputy Art Director Surajit Patro


Evolution of nasal aerosol products with

Chief Designer Pravin Temble

focus on pain management


Senior Graphic Designer Rushikesh Konka

ETP-based on anaerobic technology treats

Photo Editor Sandeep Patil

API effluent efficiently

Layout Rakesh Sharma



‘Cipla seems to have stepped up the game in


leadership and managing talent’

Circulation Team Mohan Varadkar


Low hiring sentiments in pharma 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.

August 1-15, 2013



The rise of the orphans


Ranbaxy’s anti-malaria drug Synriam wins


‘Piramal Enterprises’ diagnostic division business is expected to touch `100-crore mark in next one year’

Innovation Award



IPA to partner with state pharmacist associations


UCB sues 15 companies over epilepsy drug Vimpat


Cipla India completes acquisition of Cipla Medpro SA


Novartis, Biological E sign agreement to protect against typhoid and paratyphoid fevers


MSD, Lupin announce strategic partnership


IPM grows 4.8 per cent in June, valued at `5899 crores




EDITOR’S NOTE Pharma regulations: Awaiting an elixir? If generic companies are constantly in the news for

against whistle-blowers especially in the pharma

gross violations of manufacturing norms, their MNC

industry, where Omerta (code of silence) holds


strong and whistle-blowers are discredited and






marketing practices. Take the latest scandal unfolding in China. The Chinese police has accused GSK executives of using


isolated. Thus there is a strong argument that the means justifies the ends, for the greater common good.

travel agencies as fronts for funneling bribes to

The greater common good of Ranbaxy paying

Chinese doctors and officials in return for using GSK

fines to the US FDA is that India’s regulatory

products. These practices hiked up GSK's sales in

authorities were also forced to review their own

China but the country's officials are concerned that

practices. Will we ever have our own regulators

they also raised the price of medicines in the country.

crack down like China? Both are desirable emerging

GSK executives in China have since confessed to

markets, trying to extract the best deal for their

bribery and tax violations.

populations. It is an unfair comparison, given the

And GSK is only just the tip of the iceberg. The

fact that the political systems in the two nations are

Chinese police have information that points to

poles apart but surely we can at least implement

similar money transfers made by other MNC pharma

fully the reforms already under way?

companies in China, signalling that everyone was using the same modus operandi.

For instance, one of the stories in this issue, 'Fair chance', reviews the proposal to hike patent

It is no different in India with Novartis India

application fees and a surcharge on hard copy filings.

executives being accused of using their incentives to

Obviously the attempt is to encourage e-filings but as

buy Galvus, Novartis’ medication for diabetes, thus

the article points out, will the authorities strengthen

artificially inflating sales numbers to meet their

the infrastructure to support these changes? True, India’s legal system is doing its bit to keep

targets. But such practices are routine among domestic

medicines affordable by stonewalling patents on key

companies as well; some would say bribing to boost

medicines like Glivec, etc. Clinical trial regulations

sales is standard operating procedure across industry

like the compensation guidelines for injuries/deaths

sectors. And to the charge that China is targeting

during trials are being reviewed but the pace of

overseas players, one could argue that almost every

reform is much too slow for industry, particularly

MNC pharma company has been pulled up and fined

because regulations often take time to bear fruit.

by regulators in Western markets for similar offenses.

For instance, the US was the first country to pass

It seems that patients are the losers either way. If

an Orphan Drug Act in 1983 but it took three decades

it’s a generic, they need to worry about the quality

for the few pharma companies who took a chance on

and safety of the product. If it’s an MNC brand, then

these drugs to see decent revenues, spurring further

they wonder if it was solely clinical outcomes that

interest in this field. Another story in this issue, 'The

dictated the choice of brand.

rise of orphans' takes a look at how the US, followed

Given this scenario, it is no wonder that the

by Singapore, Japan, Australia and the EU have put

pharma and healthcare sectors are probably the least

in place incentives to coax pharma companies to

trusted today. It is ironic that these sectors deal with

research cures for rare diseases affecting smaller

life and death, where trust is the cornerstone.

populations. Patients suffering from such disease

There is no doubt that whistle-blowers have played a very important role in most of these scams,

conditions got a new lease of life while industry discovered a different class of blockbusters.

tipping off regulators on where to look for

Will regulations in India spur or choke the

irregularities. Yes, whistle-blowers get a share of the

industry? We need to start now if we want to see the

spoils but should this diminish their halo? It is

results in a few decades. Too much hangs in the

equally true that the odds are weighed heavily

balance to leave this to chance. Viveka Roychowdhury


August 1-15, 2013

Join pharma professionals from all over the world to network and do business with pharma machinery, equipment and technology suppliers @ P-MEC India 2013!

Pharma Machinery, Equipment & Technology

3-5 December 2013 Bombay Exhibition Centre, Mumbai, India P-MEC India is part of the largest and most comprehensive pharmaceutical industry event in South Asia. Focused on pharmaceutical machinery, equipment, ingredients, outsourcing and bio-solutions, this is your ultimate one stop pharma shop! As the pharma industry is increasingly looking towards India to source low cost, high quality pharma solutions, P-MEC India and co-located events provide the perfect place to initiate and explore partnerships with key pharma companies from India and abroad.

Co-located with:

P-MEC is an excellent platform to see the latest products in action. Most of us would like to see the machine performance live and P-MEC is the best place to see the product and thus facilitates the decision making process. Hitesh Doshi, Indeus Life Sciences Pvt. Ltd.

This event is an excellent opportunity to keep abreast with new developments in the pharma industry. Dr Prakash U.Tahiliani, Prime Ever Ayurvedic Research Laboratories

Organised By:




‘Piramal Enterprises’ diagnostic division business is expected to touch `100-crore mark in next one year’ PG 12 IPA to partner with state pharmacist associations PG 13 UCB sues 15 companies over epilepsy drug Vimpat PG 14 Cipla India completes accquisition of Cipla Medpro SA PG 15 Novartis, Biological E sign agreement to protect against typhoid and paratyphoid fevers PG 16 MSD, Lupin announce strategic partnership PG 17 Speakers at Nasal and Pulmonary Drug Delivery symposium to discuss global regulatory trends PG 18 IPM grows 4.8 per cent in June, valued at `5899 crores PG 20






P Paroxysmal nocturnal haemoglobinuria, or PNH, is a rare blood disorder that affects one to two people in a million. Characterised by red urine and anaemia, it frequently leads to lifethreatening blood clots in patients who require blood transfusions. Currently, the only drug approved by FDA for treating PNH is Soliris from Alexion Pharmaceuticals, the world’s most expensive drug at $440,000 per year which clocked more than $1.1 billion in drug sales last year. Future projections are higher even as profits continue to soar. Welcome to the world of orphan drugs, which are redefining the blockbuster model for the pharmaceutical industry.

Unleashing the opportunity The Orphan Drug Act of 1983 in the US can be rightly termed as the catalyst that has helped foster growth in orphan drugs, followed by similar acts in Singapore (1991), Japan (1993), Australia (1997) and European Union (2000). As per estimates, there are 7,000 rare diseases as of today, with drugs approved for only 400 indications by the FDA even as 250 new ones are discovered every year. So technically, the scope is huge for pharma companies to come up with new drugs for these diseases. Expiring patents of blockbuster drugs, drying pipelines, stringent regulations across the globe along with incentives such as increased market exclusivity, tax credits, waiver on FDA fees and research grants for companies venturing into the business of



Principal Consultant (Business) Life Sciences, Thomson Reuters

rare diseases have helped propel growth even further. Orphan drugs then offer better return on investments for both small and large pharma alike in a market that has decreased R&D productivity, high regulatory barriers and evolving payer requirements. In a report released last year, Thomson Reuters estimated the rare disease market to be at $50 billion globally by 2011 which today occupy a meagre share of six per cent of the total pharma market. Data from Evaluate Pharma’s recent report indicates that this number is poised to grow at a whopping $127 billion by 2018, double that of the overall prescription drug market. Also orphans are climbing up the ladder of pharma industry’s drug output forming 15 of the 43 drugs approved by FDA last year. While there are companies that are single mindedly dedicated to orphan drug research such as Genzyme (acquired by Sanofi), Biomarin, Shire, Alexion pharmaceuticals, Big Pharma has also integrated a rare disease portfolio as essential in its kitty. Chips in Kiran Meekings, Principal Consultant (Business), Life Sciences, Thomson Reuters, “Companies have acquired rare disease portfolios either organically by setting up divisions or inorganically via acquisition. It’s worth bearing in mind orphan drug companies trade at a premium – they have higher valuation multiples than traditional primary care companies.” New chips on the block include Aegerion, which makes an orphan drug, Juxtapid, for a rare genetic cholesterol disorder called homozygous familial hypercholesterolemia, or HoFH and NPS Pharmaceuticals, which recently got FDA approval for Gattex, its ultra-orphan treatment for short bowel syndrome. Both treatments cost a staggering $295,000 per year and were approved by the FDA late last year. HoFH also has another drug called

PRASSANA KUMAR SHIROL President, Lysosomal Storage Disorder Support Society

Companies have acquired rare disease portfolios either organically by setting up divisions or inorganically via acquisition. It’s worth bearing in mind orphan drug companies trade at a premium – they have higher valuation multiples than traditional primary care companies

Organisation of Rare Diseases(ORD) will work at educating the medical fraternity by reaching out to doctors, identifying and registering diseases as well as associate and work with pharma companies while working on awareness programmes as we connect with all disease specific support groups in India at a local level

Kynamro, which was developed by Isis Pharmaceuticals and marketed by Sanofi's Genzyme unit. And then there is collaborative research. GlaxoSmithKline (GSK) recently announced an investment of $23.5 million in The Kurma Biofund II to develop new drugs that have the potential to target rare diseases in Europe. Shire also embarked on a research collaboration with TIGEM in October 2012 to research 13 non-disclosed rare diseases for which it announced a commitment of $22 million over a period of five years.

Rare Diseases, that has been at the forefront of the rare diseases movement. In the US it serves more than 200 disease-specific groups, helping patients work together to raise awareness and helping drug researchers access patient data and connect with trial participants. Prassana Kumar Shirol, President, Lysosomal Storage Disorder Support Society (LSDSS), the first national level rare disease group in India, aims to have something along the same lines in India, which neither has an orphan drug policy or a patient registry for such patients. “Organisation of Rare Diseases (ORD) will work at educating the medical fraternity by reaching out to doctors, identifying and registering diseases as well as associate and work with pharma companies while working on awareness programmes as we connect with all disease specific support groups in India at a local level.” While Meekings is not so hopeful of India as an attractive market for orphan drugs owing to the lack of regulations, Shirol is staunchly optimistic. India and China are the next markets for

A drop in the ocean? Even though rare diseases might be getting their fair share of attention, patients might still not have access to them, most might still not be diagnosed and worse many might not even have a drug for their particular condition and hence may have little or no chance of survival. Patient advocacy groups then have been the harbinger of hope for those afflicted with such diseases and have also helped pharma companies see a market where there was none. Take for instance NORD or National Organisation for

August 1-15, 2013


such drugs, he adds. He is in talks with companies in second and third stages of clinical trials to get them to enroll patients in India too as a part of their study. Genzyme which has already been present in the country through its charitable access programme is now being joined by Shire which will be implementing its humanitarian programme in India and has already selected 20 patients (10 in each of the two categories it works in). And even as orphan drugs might not exist for certain conditions, pressure is also mounting on the pricing strategy of companies. In Europe, the Netherlands is pushing back on Sanofi to reduce the cost of its Pompe disease orphan drug Myozyme ($900,000 a year per patient) after Ireland won a reduction in cost for Vertex Pharmaceuticals’ cystic fibrosis drug Kalydeco. Meekings suggests, “The solution will require more than just pricing; it requires a diligence approach

August 1-15, 2013

Table 1 Comparitive cost of drugs for various lysosomal disorders for a patient weighing 10 kgs Disease

Drug (same as enzyme absent)

Approximate annual cost (INR)*













DATA FROM EVALUATE PHARMA’S RECENT REPORT INDICATES THAT THE NUMBER IS POISED TO GROW AT A WHOPPING $127 BILLION BY 2018, DOUBLE THAT OF THE OVERALL PRESCRIPTION DRUG MARKET. ALSO ORPHANS ARE CLIMBING UP THE LADDER OF PHARMA INDUSTRY’S DRUG OUTPUT FORMING 15 OF THE 43 DRUGS APPROVED BY FDA LAST YEAR throughout the whole drug development process to ensure that trials are conducted appropriately to meet the ultimate needs of patients, regulators and payors/reimbursers. Those needs are:

industry (adequate ROI), regulators (the production of a safe,tolerable medicine) and payors (comparative effectiveness and value-based pricing which means the drug will get reimbursed).” It

remains to be seen if companies will be able to justify prices in the light of access to medicines worldwide having reached a crescendo. Only time will tell.




‘Piramal Enterprises’ diagnostic division business is expected to touch `100-crore mark in next one year’ Recently, Piramal Enterprises’ diagnostic division launched three new innovative devices in the POC market. Among these was QdxA1c, India’s first voice guided diagnostic device which measures HbA1c QDx VitD, the world’s only device that helps detect Vitamin D in 10 minutes. This was a second launch in three months, reflecting the quick ascent of the company in the market. M Neelam Kachhap speaks to Vijay Shah, Executive Director and COO, Piramal Enterprises to track the growth path What is the size of the diagnostic division of Piramal Enterprises? Piramal Enterprises entered the diagnostic business by acquiring Boehringer Mannheim India (Roche Diagnostics) in the year 1996. After a negotiated settlement with Roche in 2005 the business has grown up from scratch to `75 crores. Currently, the diagnostic division caters to both traditional, lab-based diagnostic supplies and emerging point-of-care (POC) diagnostic market in physicians’ office. It is primarily present in clinical chemistry, haematology, immunology, urine analysis and rapid tests segments with leading brands like Diasys, Swelab, QDx etc. What is the size of POC market in India? Why are you focussed on this market? Recent estimates say that the size of POC market in India is approximately `600 crores, growing at attractive rate of 20 per cent CAGR. However, this does not reflect the true potential of POC opportunities. Indian diagnostic service is in the phase of decentralisation and is gradually moving from lab-based diagnosis to physician clinics diagnosis and finally, to home diagnosis. The transition is very prevalent in developed countries like the US and Europe; with India following the same trend. Few tests, for e.g. glucose monitoring, pregnancy screening have already travelled the path; many more tests will follow the same. In this scenario, POC is considered as an emerging segment. Introduction of various products and technology is helping the segment to shape up very fast. However, many multinationals, though they have high-end products, are struggling to meet price point expectations and reach out to more than five lakh physicians in India. There we find



our opportunity. Due to a long legacy of domestic formulation business (sold to Abbott) Piramal is a well known and respected brand amongst a network of five lakh physicians. Our objective is to bring affordable and instant diagnosis solutions to the physicians’ office and we are partnering with doctors to move from empirical to evidence-based treatment ‘Right-Here-Right-Now.’

prick, whole blood qualitative testing. We have also introduced a voice-guided HbA1c testing device, QDx A1c, with two per cent CV and point-of-care haemoglobin testing in just five seconds and 1µL blood with QDx HemoStat. We have been successful in offering products which are unique at a price point that is acceptable to the Indian market.

What are your investments in this segment so far? Currently, our focus is on introducing new products in the POC segment. We are looking at technological collaborations, in-licensing, exclusive marketing rights to reduce the time needed to get our products to the market. In the last seven months, we have launched four new products in POC under our in-house brand Qdx. At the same time, we have our R&D products in the pipeline which primarily focuses on diabetic and critical care testing. We expect to launch our R&D products in a couple of years. Our core strength is sales and marketing. We have a dedicated team for POC and will gradually scale up the team strength as we expand the business line.

How would you address the price point issue as India is demanding less expensive diagnostics? Indian diagnostic market is highly price sensitive. Unlike developed economies we don’t get reimbursement for diagnostic services. Everything is paid through the patients' pocket. The reason why worldwide well known POC products are struggling to get a share in the Indian market is that the cost per test to the patient is very expensive. We have introduced POC products at price points acceptable to the Indian market. We have managed to price the products by which the patients can avail the benefits of instant diagnosis at the same cost that they are currently paying to the labs.

How are your products different from the current products available in the market? While most of the current POC products are for cardiac, diabetes and critical care segments, we are the first to introduce a comprehensive hormone testing panel that covers 80 per cent of the diagnostic needs at gynaecology clinics. We also provide the convenience of TSH-whole blood screening in QDx Instacheck as well as rapid quantification of procalcitonin test for emergency septicaemia cases. Besides our products can provide rapid, Vitamin D, finger

What are your revenue expectations in India through POC portfolio? It is very early to project the revenue in POC. However, our growth driver for Piramal Diagnostic Division will be the POC segment. This year we have launched four POC products named QDx Instacheck, QDx A1c, QDx HemoStat and QDx Vit D. With these new launches our diagnostic business is expected to touch the `100-crore mark in the next one year. Are you are looking to expand POC presence in India. Please elaborate? Yes, we are looking to expand our POC presence in


India through the physician segment. We are in the process in making our POC product portfolio comprehensive and market acceptable. Focus is on making the concept of physician office diagnosis popular. Gradually, we will increase our reach to physicians. Would you be hiring new employees? We are not in a hurry to ramp up the POC team. POC sales and marketing requires some unique skill sets. Hence, we are being very careful in selecting people. Focus is on putting the right people in the right place and filling the current gaps in the system. However, we are not ignoring the market converge. We shall increase our coverage as business grows and may explore some alternative routes to scale up the business. Would you be launching any more new products soon? What are your future plans? We have six more products in our pipeline which would be launched very soon. We are looking at ipid profile testing, allergy testing, neonatal bilirubin testing, fever panel, complete blood count (CBC) POC analyser and coagulation analyser for physicians' office in the near future.

August 1-15, 2013


COMPANY WATCH IPA to partner with state pharmacist associations Associations from Karnataka, Kerala and Goa to be affiliated

IPA currently has state branch offices in Rajasthan, Gujarat, Jammu and Kashmir,

Chhattisgarh and Madhya Pradesh. IPA has recently set up a new branch office in

Nagaland members.



Usha Sharma – Mumbai iming to extend its reach to more states across the country, the Indian Pharmacist Association (IPA) has partnered with regional pharmacist bodies from Karnataka, Kerala and Goa. Abhay Kumar, President, Indian Pharmacist Association said, “Currently, we are in negotiations with these three state local bodies. We are trying to complete negotiations and are working closely with them to finalise the polices and identify different local issues and demands faced by these bodies. In future, we will represent these concerns from the local bodies to the Central Government.” Kumar said, “After the recent nationwide strike which was called by All India Organisation of Chemists and Druggists (AIOCD) on May 10, 2013, many local pharmacist bodies have shown an interest to partner with us. Both IPA and these regional bodies have similar objectives; i.e. to promote Indian pharmacists and give them a recognised platform in society.” IPA did not take part in the nationwide strike called on May 10 this year because they want only pharmacists to be allowed to dispense medicines which is clearly mentioned in the Drugs and Cosmetics Act. Owners of the pharmacy or proprietor of the shop should not be allowed to dispense medicines. However, AIOCD aimed to resolve the long pending shortage of pharmacists and suitably amend Rule 65(15)(c) of Drugs & Cosmetics Rules to permit the partner/proprietor as a qualified person to dispense medicines. In the past, IPA has also extended affiliation to pharmacist associations from Andhra Pradesh, Tamil Nadu, Puducherry and Maharashtra. In the case of Tamil Nadu, three to four local bodies were unified and then registered as per IPA norms.


August 1-15, 2013




UCB sues 15 companies over epilepsy drug Vimpat According to IMS Health data for the 12 months ending March 31, 2013, Vimpat tablets and Solution had total US sales of approximately $353 million CB, UCS Pharma, Research Corporation Technologies and Harris FRC Corporation have filed a suit against 15 drug makers, including Sandoz,


Watson, Mylan as well as Indian companies like Ranbaxy, Aurobindo, Zydus, Sun Pharma, Glenmark and Alembic Pharmaceuticals for allegedly infringing its patented drug Vimpat. The suit was filed on July 10, 2013, in the US District Court for the District of Delaware, seeking to prevent these companies from com-

mercialising its ANDA product prior to the expiration of US Patent No.RE 38,551. This lawsuit was filed under the provisions of the HatchWaxman Act. According to the petition filed, the patent on Lacosamide Tablets, 50 mg, 100 mg, 150 mg and 200 mg would expire on March 17, 2022. Reacting to the news, a

Glenmark press release said that if it is successful in its challenge of the patent, it will garner an 180-day exclusivity for its products. According to IMS Health data for the 12 months ending March 31, 2013, Vimpat tablets and Solution had total US sales of approximately $353 million. EP News Bureau - Mumbai

Sun Pharma announces US FDA approval for generic Prandin tabs Sun Pharma’s subsidiary, million in the US. un Pharmaceutical Repaglinide tablets. Company has 180-day tablets are being the first-to-file an Repaglinide tablets, 1 mg Repaglinide Industries announced that S marketing exclusivity the US FDA has granted its and 2 mg are therapeutic indicated as an adjunct to ANDA for generic Prandin subsidiary final approval for its Abbreviated New Drug Applications (ANDA) for generic version of Prandin,



equivalents of Novo Nordisk’s Prandin tablets. These tablets have annual sales of approximately $200

diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus.

with a para IV certification, is eligible for a 180-day marketing exclusivity in the US. EP News Bureau - Mumbai

August 1-15, 2013


Lupin receives FDA approval for generic Glumetza ER tabs Is indicated as adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus upin’s US subsidiary, Lupin Pharmaceuticals has received final approval for its Metformin Hydrochloride extended


Cipla India completes accquisition of Cipla Medpro SA The acquisition aims to strengthen Cipla’s commitment to South Africa and the broader African continent ipla has completed the acquisition of 100 per cent of the issued shares of Cipla Medpro South Africa ‘Medpro’, for an aggregate consideration of ZAR 4507 milllion (`707 crores). The listing of the shares of Medpro on the JSE has been terminated from the commencement of business on July 16, 2013. Commenting on the successful acquisition, Subhanu Saxena, Managing Director and Global Chief Executive Officer, Cipla said, “This investment is aligned with Cipla’s strategy to ascend the value-chain by managing a front-end sales force in a market outside India. The acquisition aims to further strengthen Cipla’s commitment to South Africa and the broader African continent. The integrated business will compete more effectively in the changing local and global pharmaceutical environments and as such there will be an increasing focus on key African markets.” Saxena further added, “Spanning nearly two decades, Cipla and Medpro enjoyed a long-standing symbiotic relationship and the acquisition will strengthen Medpro’s position in the South African pharma market by leveraging Cipla’s wide range of product portfolio and technological expertise. This will bring tangible benefits to consumers in South Africa, and increasingly the rest of Africa.” EP News Bureau - Mumbai

release tablets (HCl ER) 500 mg and 1,000 mg from the United States Food and Drugs Administration. Lupin’s Metformin HCl ER Tablets, 500

mg and 1,000 mg strengths are the AB-rated generic equivalent of Santarus's Glumetza HCl ER tablets, 500 mg and 1,000 mg strengths. Metformin HCl ER tablets is a biguanide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes

mellitus. Glumetza HCl ER tablets, 500 mg and 1,000 mg had US sales of approximately $144 million, for the twelve months ending March, 2013 (IMS Health data). Lupin had earlier received the tentative approval for generic GLUMETZA (Metformin Hydrochloride extended release tablets) 1,000

mg and 500 mg from the US FDA in January, 2012. Lupin believes that it is the first applicant to file an ANDA for Glumetza HCL ER Tablets, 500 mg and 1,000 mg strengths and as such will be entitled to 180 days of marketing exclusivity. EP News Bureau - Mumbai

A formulation is only as good as the ingredients that comprise it. When creating your drug, improving patient welfare is your mission. Every molecule that goes into your product matters. By providing the rightasmaterials for every stage of drug development, discovery to A formulation is only good as the ingredients that comprise it. Whenfrom creating your drug, production, we help you formulate, manufacture and innovate with confidence. improving patient welfare is your mission. Every molecule that goes into your product matters. By providing the right materials for every stage of drug development, from discovery to production, we help you formulate, manufacture and innovate with confidence.


August 1-15, 2013

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Novartis, Biological E sign agreement to protect against typhoid and paratyphoid fevers License agreement advances a Novartis goal to deliver accessible and affordable vaccines that address unmet medical need in endemic regions

ovartis has entered into a development and licensing agreement with India-based Biological E (BioE), a biopharmaceutical company, for two vaccines to protect against typhoid and paratyphoid fevers. The agreement advances the Novartis goal to deliver accessible and affordable vaccines that address unmet medical need in endemic regions. In just five years, the Novartis Vaccines Institute for Global Health (NVGH), part of the Novartis Institutes for BioMedical Research, has developed a typhoid vaccine with funding by the Fondazione Monte dei Paschi di Siena and Regione Toscana through the Sclavo Vaccines Association (Italy). In addition, a dual-acting vaccine with components against both typhoid and paratyphoid fevers is being developed with on-going support from the Wellcome Trust. Both could reduce the burden of


these diseases in endemic regions. "NVGH uses its innovative know-how to tackle important problems in public health," said Don Ganem, Vice President and Global Head of Infectious Diseases, Novartis Institutes for BioMedical Research. “BioE has a proven track record in vaccine manufacture, and capabilities to clinically develop and deliver WHO pre-qualified affordable vaccines to the developing world. We are pleased to be working with them to address this unmet need.” More than 21 million cases of typhoid fever and five million cases of paratyphoid A fever are reported worldwide in a year1, especially in areas that lack appropriate sanitation and access to clean water. Many victims are children under the age of two for whom there is no widely available typhoid vaccine, while no vaccine is available for any age group against paratyphoid

fever. Under the license, NVGH will transfer technology to BioE, which will have financial and operational responsibility for manufacturing, further clinical development, approval and distribution in the developing world. The typhoid vaccine (Vi-CRM197) has achieved Proof of Concept, had successful Phase II results, and will be transferred to BioE. A combined typhoid-paratyphoid vaccine will be transferred once Proof of Concept is completed through early, small-scale studies in humans to determine safety and immunogenicity. The Wellcome Trust continues to support the development of the dual-acting vaccine through a Strategic Award that was awarded in 2009. “Typhoid and paratyphoid are major causes of life-threatening disease worldwide and with the emergence of resistance to all of the commonly

used antibiotics, they are becoming increasingly difficult to treat,” said Ted Bianco, Director of Technology Transfer and Acting Director of the Wellcome Trust. “This licensing deal takes us a step closer to getting much-needed affordable vaccines into the communities that need them most.” BioE is committed to achieving World Health Organization (WHO) pre-qualification and fulfill specific obligations to meet Novartis standards2. The agreement is worldwide except for developed countries, where Novartis will retain rights.

References: 1. Bulletin of the World Health Organization 2004; 82:346-353 ( rden.pdf) 2.

Venus gets GMP approval from Ukraine for nine manufacturing facilities The recognition has opened more opportunities for Venus Remedies, to expand its product portfolio in the remaining Pharmaceutical Inspection Convention/Cooperation Scheme (PIC/S) member nations enus Remedies, a leading research-based pharmaceutical company, has got all its nine manufacturing facilities approved for good manufacturing practices (GMP) by Ukraine, a Pharmaceutical Inspection Convention/Cooperation Scheme (PIC/S) member nation. Venus is the only Indian company to get Ukrainian GMP approval for large volume parenterals for its Panchkula plant in Haryana. The certification was granted by the National Agency for Food and Drug Administration and Control (NAFDAC), Ukraine after three rounds of audit. The nine facilities cater to the manufacture of cephalosporin injection, car-




bepenem, oncology liquid injection, oncology lyophilised injection, ampoules, liquid vials, general lyophilised vials, prefilled syringes and intravenous (IV) fluids. Hailing the achievement, Dr Manu Chaudhary, Joint Managing Director, Venus Remedies and Director, Research, Venus Medicine Research Centre (VMRC), said, “This certification is an extended recognition for our manufacturing facilities, which are on a par with international standards in terms of the quality system set by PIC/S member nations. This is the third time that we have got a PIC/S recognition for quality manufacturing standards. Now, all the nine facilities of Venus, eight in Baddi and one in Panchkula, are certified with GMP by the NAFDAC, Ukraine, thereby opening more opportunities for Venus to expand its product portfolio in the remaining PIC/S member countries.” “Venus is in the Ukrainian

market for the past 11 years. It has been regularly exporting its various oncology products, cephalosporin, carbapenem and other research products and speciality injectables to Ukraine. Today, we have 69 product registrations in Ukraine. In 2012, the total volume of our exports to Ukraine was around $5 million. We aim to double this figure in the current fiscal year by strengthening our export line in Ukraine,” said Dheeraj Aggarwal, Chief Financial Officer, Venus Remedies. Venus has got 65 market authorisation approvals from the Ukraine authority for its Baddi unit, while 35 applications are in the process. Besides, the Panchkula unit of the company has also been granted four market authorisations and seven are still awaited. Venus Remedies has already been granted 23 international certifications. These include recognitions by the European Union GMP, Gulf

Cooperation Council (GCC), Saudi Food and Drug Authority (SFDA), the Therapeutic Goods Administration (TGA) and the Tanzania Food and Drugs Authority (TFDA). With a population of 46.6 million, Ukraine is one of the largest countries in Europe, thus making it a potentially lucrative pharma market. The pharma market in Ukraine is expanding at a rapid pace. The $3 billion market is expected to grow at a compound annual growth rate (CAGR) of 16 per cent. India is the second largest exporter of pharma products to Ukraine after Germany. According to a research report, 55 per cent of the medicines sold in Ukraine are prescription drugs, while the rest are over-the-counter (OTC) products. Only about a quarter of the drugs consumed in Ukraine are produced domestically, while the rest are imported. EP News Bureau - Mumbai August 1-15, 2013


MSD, Lupin announce strategic partnership To co-market MSD's 23-valent pneumococcal polysaccharide vaccine for Indian market SD and Lupin announced the forming of an India-specific strategic partnership. Within the scope of the partnership, Lupin will have a non-exclusive license to market, promote and distribute MSD’s 23-valent Pneumococcal Polysaccharide Vaccine under a different brand name in India. Announcing the partnership, KG Ananthakrishnan, Managing Director, MSD in India said, “MSD has a rich legacy of developing vaccines to prevent some of the world’s leading diseases. This partnership is aligned with our commitment towards patients in India and also addressing treatment challenges for high risk patients by providing broader access to our innovative medicines and vaccines. It is a perfect amalgamation as MSD brings the research and scientific excellence for Pneumococcal Polysaccharide Vaccines, and Lupin brings their marketing excellence, significant reach among key clinician categories to drive product access. MSD and Lupin both share the same commitment of providing broader access to a larger at risk adult population, driving vaccination rate and reducing fatality, which is core to this unique collabo-


ration in vaccines.” Shakti Chakraborty, Group President, India and CIS countries, Lupin said,

“We are pleased to be associated with MSD in India. This partnership bears testimony to Lupin’s leadership credentials in the Indian Pharmaceutical Market (IPM), 2.8 per cent market share of the overall IPM (IMS

TSA MAT, March 2013), not to mention leadership specifically in the cardiovascular, diabetes and respiratory therapy segments as also our existing market reach within the IPM. We believe that the partnership is an important

step-forward as both companies share a common passion and commitment to make a meaningful difference to the lives of patients suffering from pneumococcal diseases in India.” EP News Bureau - Mumbai





PRE EVENT Speakers at Nasal and Pulmonary Drug Delivery symposium to discuss global regulatory trends Indian Pharmaceutical Association (IPA) is organising the biennial 'Nasal and Pulmonary Drug Delivery' symposium on October 24-25, 2013 in Mumbai. This time's theme is ‘Global Regulatory Trends’ with a focus on Asia, LATAM, South Africa and European markets apart from the US market. Aptar Pharma is the principal sponsor and co-organiser for the event. Scheduled to present at the event, Dr Amit Misra, Scientist and Associate Professor AcSIR, CSIR-CDRI and Dr Julie Suman, President, Nextbreath LLC speak to Usha Sharma highlighting regulations and market potential of this sector, the key topics to be discussed at this event Globally, what are the regulations for nasal and pulmonary drug delivery system? And does India follow similar regulations or are there a different set of regulations in place? Dr Julie Suman (JS): The US, EU and Brazil have the most defined requirements for these dosage forms. In my experience, we’ve worked with Indian companies looking to bring products into more regulated markets than India. So they are naturally following these regulations. Within India, the regulatory expectation is less. Dr Amit Misra (AM): Central Drugs Standard Control Organization (CDSCO) has recently announced the guidelines under Penal Provision for what it calls Category A Defects as follows: i) Aerosols/Inhalations: Assay below 70 per cent for thermolabile products and below five per cent of the permitted limits for thermostable products. ii) Leak test: With reference to the existing regulations, the provision of 10-year jail terms and fines of millions of rupees is intended as a deterrent to unethical practices. This, in my opinion, is far more stringent in scope, if not necessarily in application, than almost any other regulated market that I am aware of. Do you think developing countries should have a different set of regulations for nasal and pulmonary drug delivery? JS: I think that the concept of harmonisation for all countries is most beneficial for all and ultimately the most cost effective. As the Western world’s consumer buying power decreases and the need for affordable




Dr Amit Misra, Scientist and Associate Professor AcSIR, CSIR-CDRI

Dr Julie Suman, President, Nextbreath LLC

healthcare increases, it facilities India’s ability to enter other markets. Harmonisation provides a level on continuity within India as well. However, I believe there is room to select which tests are most appropriate for a given country. AS: Yes, I strongly advocate a more pragmatic regulatory regimen for countries such as mine. I suggest that the Western countries have regulated themselves into a highly restrictive situation, discouraging small and medium manufacturers from production and distribution of medicines. I feel that this situation has arisen partly because of inputs given to regulatory agencies by interests supporting large pharma corporations. I believe that the appropriation of the word ‘Good’ in respect of Organisation for Economic Co-operation and Development (OECD) and other guidelines on laboratory, manufacturing and clinical

practices is overly presumptuous. There is nothing inherently ‘good’ about GLP, cGMP or GCP-- the documents merely present a way of doing things that is obsessively focused on keeping records, mathematising observations and following routine procedures. I think that we in India should jettison the entire concept of 'good' practice driven regulation, and approach the problem of assuring quality of medicines in the marketplace using an approach that addresses intent, ethics, exigency and appropriate technology.

Will nasal and pulmonary drug delivery system be the next important area for Indian pharma companies? JS: The best way to treat locally acting conditions such as allergies, asthma and chronic obstructive pulmonary diseases (COPD) is by these routes of administration. So certainly

this is an important area for development. AS: Not the single 'next' important area, but certainly for asthma and COPD, as well as in a limited way for cystic fibrosis and tuberculosis. Therapeutic peptides and vaccines administered by nasal or oro-pharyngeal inhalation are likely to find interest in the industry setting. Besides India, which other markets have the potential for this therapeutic and why? JS: Cost effective medication will become important globally which opens the door to almost any market. AM: I don't know much about markets, but patients are certainly in need of good inhalation products worldwide. What are your suggestions/ changes for the Indian nasal and pulmonary drug delivery system JS: I would turn that question around. What can we learn from India? The concept of a single dose system such as purchasing a single tablet is quite common in India. Nasal and pulmonary products typically contain 30 or more doses. Development of delivery systems that contain fewer doses is both a challenging and interesting area. AM: I suggest that we work on making cheap inhalation devices, avoid unessential add-ons like fancy shapes, dose counters, blister-reels, etc., and favour powders filled in hard capsules rather than MDI. The only reason why DPI are more expensive than corresponding pMDI is device costs, which, in my view, are inflated far beyond research and production costs. August 1-15, 2013


Pharma Tech Expo 2013 to be held in Indore from Oct 6-8, 2013 Will be a great opportunity for machinery and equipment suppliers to showcase their products harmaTechnologyIndex. com, a KNS group of company and Indian Drug Manufacturers' Association (IDMA) will jointly organise Pharma Tech Expo 2013 in association with Pharmexcil. The event will be held at Brilliant Convention Centre Indore, from October 6-8, 2013. It will be a great opportunity for machinery and equipment suppliers to showcase their products at the event. Express Pharma is the media supporter for the event. CEOs, engineers, and technocrats; pharmacists and scientists; R&D professionals; academicians, teachers and students; equipment suppliers and distributors; policy makers and decision makers; foreign commercial corporations; regulatory officers; purchase officers of pharma companies and trade delegates of various countries will attend the event. Exhibitors who will take part in the event will include processing plant and machineries; packaging materials and machineries; lab equipment, instruments and lab wares; water treatment, waste water treatment and waste management; biotechnology research organisation and clinical research organisations; bulk drugs, intermediates, and formulations; excipients and additives; R&D, quality control laboratories; healthcare products -ayurvedic and neutraceutical manufacturers; cosmetic and personal care;

IPR standards and patent formulations bodies; environment and pollution control

bodies; trade associations, trade promotion bodies; safety equipment and software

manufacturers for pharma industry and management. EP News Bureau-Mumbai


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he Indian Pharma Market (IPM) has been valued at ` 5899 crores in June 2013, registering a growth of 4.8 per cent for the month. Of the top 10 companies this month, Alkem registered a growth of 19.3 per cent, followed by Sun Pharma (11.9 per cent) and Cipla (11.5 per cent). Amongst the top 50, 24 corporates have crossed the growth of IPM in June. Amongst the top 50 corporates, Eris has the highest growth of 30.3 per cent followed by AstraZeneca at 29.2 per cent and Akumentis at 21.9 per cent. Amongst the 11-20 ranked companies Aristo has shown a high growth at 18.2 per cent followed by Ipca at 14.2 per cent and USV at 10.6 per cent. Amongst upcoming corporates Corona Remedies has grown at 162.8 per cent, Eris at 30.3 per cent and Akumentis at 21.9 per cent. Astra moves on with second consecutive month on positive growths. Corona Remedies and Tablets India has entered the ` 200-crore club. 11 regions have outgrown the IPM growth rate. Mumbai has shown the lowest growth in the last 13 months with a growth of -7.7 per cent. From a therapy perspective nine therapies have outgrown the IPM growth. The anti-infective market has a growth of 7.5 per cent whereas respiratory market is at 17.8 per cent growth. The anti-diabetic market grows at 4.3 per cent and cardiac at 12.9 per cent in chronic business.






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Val in Crs




MAT June -13




Val (Cr)



Val (Cr)









Abbott + Abbott HC + Novo









Sun Pharma


















Zydus + Biochem




































Alkem + Cachet + Indchemie









Pfizer + Wyeth




































Emcure + Zuventus


















Dr. Reddys









Sanofi-Aventis + Universal



























Micro + Bal


















Val in Crs


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Terminologies used MAT – Moving Annual TotalMTH – MonthVal(Cr) – Value in CroresMS per cent – Market Share in PercentageGR per cent – Growth in percentage For more information, visit

August 1-15, 2013


EVENT BRIEF Pharmac India 2013 Date: September 5-7, 2013 Venue: Hitex, Hyderabad Summary: Pharmac India 2013 is 4th International pharma machinery, equipment, bulk drugs, API and material exhibition, which is going to be held in Hyderabad, Hitex. It has successfully brought together manufacturers and buyers on a common platform and contributed substantially towards the growth of the industry. Pharmac India 2013 is jointly organised by Orbit Exhibitions and IDMA (GSB) and actively supported by BDMA and CIPI. Contact details: Varsha Surve. Manager - Operations Exhibitions Orbitz Exhibitions 402, Navyug Industrial Estate, TJ Road, Sewri (W), Mumbai 400 015. Tel: +91 22 2410 2801-03 | Fax: +91 22 2410 2805 | Cell: 09322037955. /

Clinical Trials Asia Summit Date: September 26-27, 2013 Venue: Hyderabad Summary: Clinical trials are being conducted globally however outsourcing them to emerging economies like India provides competitive advantages in terms of lower operational costs and faster conduction of clinical trials. India has a steady supply of patients and medical facilities for conducting clinical trials at very competitive proposition. The Indian pharma industry is growing at the annual rate of 11 per cent while the clinical research industry is growing an annual rate of whopping 84 per cent. Clinical Trials Asia Summit is a platform for key stake holders to engage and critically analyse the road map for furAugust 1-15, 2013

ther growth towards establishing sustainable leadership of India in global clinical trials scenario. Contact details: Tikenderjit Singh Makkar Dy Mktg. Manager India Fleming Gulf 605, City Tower Boat Club Road Pune - 411001 Maharashtra (India) Tel: (020) 67276403 Fax: (020) 6607 0061 Email: Website: URL: onferenceview/Clinical-TrialsAsia-Summit-/485

PHARMAbiotika 2013 Date: September 16-18, 2013 Venue: Mahatma Mandir Convention and Exhibition Centre, Gandhinagar, Gujarat Summary: PHARMAbiotika is an exhibition and conference revolving around emerging challenges and trends in pharma, allied and clinical research related industry. This is the first time in India that an exhibition on Medical Tourism will be co located with PHARMAbiotika 2013. Contact details: Atanu Bhattacharya Director Human Crayon Management Services Address : C-28, Sector -4, Noida - 201301, India Tel : +91- 120 – 6528801 +91 - 11-65378800 Mobile : +91 9810303916 (Delhi) +91 9167280126 (Mumbai) Email : Website:

16th PAC-2013 Date: September 27 - 28, 2013

Venue: Hotel Hyatt Regency, Sahar Airport Road, Mumbai Summary: Indian Drug Manufacturers’ Association (IDMA) and Association of Pharmaceutical Analysts (APA) have announced the 16th Pharmaceutical Analysts’ Convention (PAC) 2013. The main theme for this year’s convention is ‘Generics The Game Changer’. Dr B Suresh, Vice Chancellor, JSS University, Mysore and President, Pharmacy Council of India New Delhi will be the Chief Guest. Experts in analysis, research, academia and regulatory spheres from the Indian pharmaceutical industry, will converge and gettogether to interact on various recent developments. The convention will be held in order to update and exceed the current regulatory requirement and science-based systems approach in pharma industry. The convention is designed to cater to all those involved in: pharma industry; biopharmaceutical industry; biotechnology industry; nutraceutical industry; microbiological industry; Government laboratories; research institutions; academic institutions; business consulting companies; contract manufacturing organisations; contract research organisations; R&D equipment / machine manufacturers; supply chain management; API, excipients and intermediates manufacturers and CROs. Heads of strategy and business development, R&D, regulatory affairs; analytical development laboratory; quality control / assurance; production; packaging; purchase; exports; medical affairs; pharmacology and toxicology; outsourcing; supply chain; pharma product development; logistics and clinical research services are likely to attend the convention. Contact details: Prachi,Sr Manager Publications & PR,IDMA 102-B, ‘A’ Wing, Poonam Chambers Dr Annie Besant Road, Worli Mumbai - 400018 Tel: (022) 24944624/ 24974308 (Extn. 103) Mob: 9867634383 Email: Website:

PharmaTech Expo 2013

65th IPC, 2013

Date: October 6-8, 2013

Date: December 20-22, 2013

Venue: Brilliant Convention Centre, Indore

Venue: Amity University, Noida

Summary: and Indian Drug Manufacturers Association are jointly organising the second edition of PharmaTech Expo 2013 in association with Pharmexcil.

Summary: Indian Pharmacy Graduates’ Association will host the 65th IPC, 2013 from December 20-22 this year. Express Pharma has been chosen as the ‘Exclusive Official Media Partner’ for the 65th IPC, 2013.The event will be organised by Indian Pharmaceutical Congress Association. The academic partner for the event is Amity University, Noida.

Contact details: Keena Shah 702, Corporate House, Opp. Dinesh Hall, Income Tax, Ashram Road, Ahmedabad - 380009. M: 09825698756 Ph.: 079-27541142 / 27540493 E-mail: Website:

Contact details: Dr Arun Garg General Secretary-IPGA Director-PDM College of Pharmacy, Bahadurgarh, Haryana Mob: 09416056213

CPhI India Date: December 3-5, 2013 Venue: Bombay Exhibition Centre, Mumbai Summary: Reflecting the continued growth in the API, generics, fine chemicals and bio-pharmaceuticals industries on the Indian sub-continent, CPhI India and related pharma services events saw an increase in visitors and exhibitors. CPhI India will bring pharma professionals from all over the world to Mumbai and facilitates initiating and closing business deals. Take this opportunity to showcase your products and services while enhancing your brand at South Asia’s leading pharma industry event. Contact details: Chaitali Patil UBM India Times Square Unit No 1 and 2, B Wing, 5th Floor, Andheri Kurla Road, Marol,Andheri (East) Mumbai - 400 059 T +91 22 61727162 F +91 22 61727273 E





HTA is still unstructured and nascent in the Indian context PG 25 Viral hepatitis: The era of molecular assays PG 27 Patent protection for orphan drugs PG 29



August 1-15, 2013



feels that it does not impact the Indian pharma industry's growth, “considering the number of players.”

Extra fees = extra services? With the draft Patent (Amendment) Rules, 2013 most likely to come into effect, industry observers hope to get

better service and infrastructure which is sorely lacking. As Ameet Hariani, Managing Partner, Hariani and Co rationalises, “My fundamental view is that the original fee structure was itself on the lower side since 2005 and one only hopes that if there is any proposal to levy higher fees, it should correspond

with an increase in current level of service.” Hariani says, “One would be willing to bear the additional burden provided it results in modernisation of system and proper utilisation of funds so as to reduce the TAT i.e. the turnaround time for each application. Every applicant today yearns to have their

respective applications processed faster. We all know the issue of pendency at the patent office. The proposed levy should have a direct impact on reduction of pendency.” Agreeing with this fact, Jasti says,“The increase in fee is very much needed to improve the infrastructure of

A gazette draft notification released by the Department of Industrial Policy and Promotion (DIPP), Government of India, on June 12 has announced a proposal to increase the filing fees for pharmaceutical patents. While the proposal calls for a doubling of the current amount, reactions from industry have been fairly measured so far. Dr Gopakumar G Nair, Founder, Gopakumar Nair Associates says, “Increasing the official fee for various office actions is absolutely justified. India provides a two-tier fee structure, with a 1:4 ratio between “Natural persons” (individuals or group of individuals) vis a vis ‘other than natural persons’ (corporates, institutes etc.) for patent application fees and all other fees.” The recent draft on proposed hike in patent fees may directly impact pharma companies as they are the ones who are going to be directly affected. Dr Manu Chaudhary, Joint Managing Director, Venus Remedies, and Director, Research, Venus Medicine Research Centre (VMRC) whose company has bagged many international patents very recently, expresses this view and says, “As far as the fee hike in the Indian patent system is concerned, it is difficult to ascertain the objective behind it. Historically, innovations in pharma industry and patents have always been a costly affair. Lack of swift addressal/redressal of issues at the patent office makess things even more cumbersome and often goes against the incentive theory of patent monopoly. Keeping in mind the cost of advice from a patent attorney, which is often crucial, small/individual innovators will particularly feel the pinch when the patent fee shoots up.” Like Venus Remedies, Suven Life Sciences has received many global patents. Unlike his counterpart, Dr Venkat Jasti, Chairman and Chief Executive Officer, Suven Life Sciences is in favour of the proposed fee hike and August 1-15, 2013





Founder, Gopakumar Nair Associates

Joint Managing Director, Venus Remedies, and Director, Research, VMRC

In the latest proposal, this fee is proposed to be doubled and considered to be valid for e-filing

the Indian Patent Offices (IPO). Increasing the number of examiners will help in quick scrutiny of patent (applications) saving valuable time rather than waiting for years. As long as the desired outcome is there, we don't mind paying the increased amount.” Analysing the working pattern of the IPO, Chaudhary tries to measure its efficiency saying, “Although the IPO has taken some measures and made progress in bringing about efficiency and transparency in its working pattern in the past few years, there is still a long way to go before the difference can be actually felt. Given that the IPO has become a profit centre, we sincerely hope that the hike in fees should help in disposing of issues in a timely manner, as mandated in the Patent Act and Rules.”

Right move ... The draft Patent (Amendment) Rules, 2013 also proposes to levy a 10 per cent surcharge on physical filings with the patent office. This is the first time in the history of filing of Indian pharma patents that such a surcharge will be levied, indicating that the authorities are trying to encourage applicants to use the e-filing mode. Most industry observers feel the move is in the right direction and in order to make the system more applicant friendly it should be implemented to its fullest extent. Analysing this aspect of the draft proposal, Nair remarks, “In the latest proposal, this fee is proposed to be doubled and considered





Chairman and Chief Executive Officer, Suven Life Sciences

Managing Partner, Hariani and Co

IPO has become a profit centre, we sincerely hope that the hike in fees should help in disposing of issues in a timely manner

As long as the desired outcome is there we don't mind paying the increased amount

One would be willing to bear the additional burden provided it results in modernisation of system and proper utilisation of funds

to be valid for e-filing. For filing physical (hard copies only), an additional 10 per cent over the newly doubled efiling fee (retaining the 1: 4 ratio) is proposed. This is justified. India is considered to be the leader and outsourcing provider for IT and e-jobs across the world. However, India has remained “poor” at home in e-practices. It is a high time that Indian applicants and IPOs becomes e-enabled. Indian IP has to be e-practiced and e-transparencied in all respects by eenabling all stakeholders, practitioners and the PTO.”

tion. Even though, the website of Patent Office ( became operational on January 26, 2005, the “teething problems” have continued too late “past-infancy”. Most information are unavailable, unreliable, outdated or simply missing from the website. The 'down' time of the website is too frequent and often long. The 18-month publication and even the “fee paid” early publication are often (many many examples of even delay in two to three years are available for 18month publication) delayed. These with other delays and deficiencies need to be rectified. If the proposed fee increase is used to address these perennial problems, which cause extreme inconvenience and loss to the users, the fee increase is well-justified.”

However, it would be unfair to make such comparison with fee structure as the only denominator. There are many factors such as quick disposal, efficient system, etc which needs to be taken into consideration.” He once again stresses that the increase should be justified by the resultant outcome.

…but implementation is key E-filing itself could pose some problems. As Hariani says, “As per my knowledge, the e-filing systems is supported by limited banks. Further, the server is slow and system cumbersome. Thus, the number of banks supporting e-filing and the payment options should be broadened and system overhauled. The system if implemented in the right spirit will not only act as a catalyst to increase efficiency through digitisation but also increase transparency. Therefore in my opinion, implementation of the increase in fee structure would be justified only if the operational issues are solved and the additional funds proposed to be collected are applied for right purposes to reduce pendency issues and upgrade the existing systems.” Nair too emphasises the crucial need for thorough implementation saying, “An honest and committed effort for e-enabling is required from the patent office

Unfair comparison In developed countries, the patent fees is much higher, sometimes as much as five times higher than in India but is this a fair comparison? Voicing his opinion, Nair stresses, “We cannot and should not increase Indian fees to international levels. The US and the EU have steeply increased the fees, especially for selected office actions. India should be fair and reasonable in its Indian patent policy of private-public parity, equity and balance of rights and obligations (which it is, even after the proposed increase).” Hariani adds, “It is true that the patent fees in developed countries are higher than the Indian fees structure.

Net impact Summing up Nair says, “The fee increase is a routine exercise. This will not in any way hamper the growth of the pharma companies. Increase in the patent fees is the least of the worries for the Indian pharma sector. Growth of Indian pharma companies will positively be affected by the proactively negative policies of the government which is forcing most pharma-industry leaders to sell-out and get out of this 'pharma mess'. The 'well' meaning NGOs and critics of Indian pharma sector are ably assisting the “ill-willing” government departments and ministries to ring the ‘death-knell’ for Indian pharma and bury its high and lofty ambitions. That is another story.” With an aim to encourage the e-filing procedure, both legal luminaries as well as pharma companies agrees with the draft notification of Patent (Amendment) Rules 2013, proposing an increase of fees for pharma patents. One hopes that the DIPP will consider the concerns raised by industry while firming up the final amendment. After all, no one pays money for nothing. August 1-15, 2013


HTA is still unstructured and nascent in the Indian context The current churn within healthcare ecosystems will require all stakeholders to work more closely to achieve better patient outcomes at lower costs. According to a recent KPMG report, “More than medicine”, pharma companies which can demonstrate the value their products (and increasingly services) bring to emerging healthcare systems, will be able to access broader patient populations in both developed and emerging markets. Utkarsh Palnitkar, Partner & Head, Transactions & Restructuring & National Leader - Life sciences practice at KPMG India reveals more in an interview with Shalini Gupta

Pharmaceutical companies need to be more engaged with the rapidly changing healthcare system. How far have pharmaceutical companies in India adapted to this? The healthcare landscape in India has evolved with a renewed focus on primary care coupled with rural healthcare. A shift in disease patterns from infectious to lifestyle related has also led to a treatment based approach to disease management: wherein a patient is not addressed only during an ailment but is taken through the entire care life cycle, from education of a disease to monitoring post treatment. This along with a thrust from the government on preventive healthcare in terms of budgetary allocation of funds have led companies to diversify their portfolios to include focus on drugs that address NCDs. These include CVS drugs, ant diabetics, anti-obesity drugs etc. With the thrust on rural areas and hinterlands, companies have partnered with NGOs or initiated their own programmes to address the healthcare needs of the population with limited access to healthcare. Novartis’ Arogya Parivar, a social initiative that offers education on diseases, treatment options and prevention as well as increased access to affordable medicines to the rural poor. Indian biotech players are continually investing in the development of new generation vaccines. How much do medicines contribute to healthcare bills in India vis-a-vis (US and Europe at 10 and 9 per cent respectively)? Also in the absence of a suitable reimbursement system as in developed countries, how can the pharma industry deliver value to the patient? The per capita spending on August 1-15, 2013


drugs in India increased from 29.77 per cent (2005) to 46.86 per cent (2010), while hospitalisation costs went up from 11.20 per cent to 22.47 per cent during the same period. In the absence of a robust reimbursement scheme (where a primary portion of healthcare spending is out-of-pocket), it is imperative the pharma companies deliver value to the patient. Value can be defined by the following metrics: availability, quality, improved efficacy and increased effectiveness/superior delivery. Indian companies should strategise their business models to ensure that quality products are on the shelf at right time, right place and price. Strict measures against counterfeits to prevent the market being flooded with ineffective products and commissioning drug development organisations to cater to the unmet needs of the patients are also important. They are taking measures to streamline supply chains and manage costs so that the end customer doesn’t bear the brunt of these expenses. Also, players are embracing innovation as is indicated by the




shifting focus of R&D towards Super Generics (DRL’s Fondaparinux, Cadila’s Diclofenac etc.) physicochemical properties etc and eventually gain better patient acceptability. Unlike developed countries what is the status of Health Technology Assessments (HTA) in India and other Asian countries? How can such assessments help pharma companies deliver better? HTA is directly linked with Health Economic Outcome Research (HEOR) and enables maintenance of real time health data that can be used by pharma companies to arrive at a number of strategic decisions. It would also eliminate the need and

IN INDIA, PRICING POLICIES ARE DEVISED FROM AN AFFORDABILITY PERSPECTIVE TO ENSURE THAT A LARGER PART OF THE POPULATION HAS THE MEANS TO ACCESS HEALTHCARE AND MEDICATIONS cost involved in conducting heavy pilot group studies to gather patient health data. As is seen in developed countries – HTA is still unstructured and nascent in the Indian context. In China, the Ministry of Health expressed interest in HTA and established the Division of Technology Administration in 2002. The Department of Hospital Administration uses HTA in conjunction with a growing licensing mechanism (assisted reproduction, prenatal care, joint implants, organ implants, etc.). Some Asian countries focus on HTA through insurance, for example, South Korea, Philippines, Taiwan. In Malaysia, the Ministry of Health decided to establish an HTA unit - an experienced civil servant assigned to the task (quality assurance, equipment acquisition) in 1995. How does India with its new pricing policy compare to the US and the UK, which have a value-based pricing mechanism? How does this impact innovation and encourage investment in areas with unmet needs? In India, pricing policies are devised from an afford-



ability perspective to ensure that a larger part of the population has the means to access healthcare and medications. However, they are evolving as we are moving towards a per capita incomelinked reference pricing mechanism for drugs. There is a huge challenge in terms balancing affordability, availability and access. The other area where novel pricing mechanisms are needed are in the case of pricing of patented drugs. The challenge of affording a reasonable return to innovators in a manner that does deprive the masses of essential drugs is a key issue. The Government has invoked compulsory licensing in the recent past. However, this should be an exception and not a rule. In the long run, incentivising domestic innovation and encouraging collaborative R&D is the only way out. What sort of risk-sharing agreements and patient registries in particular do we have in India? How have these helped restructure the approach of pharma companies? Risk-sharing agreements, under which payers and pharma manufacturers agree to link payment for drugs to health outcomes achieved, rather than the volume of products used offer an appealing payment model for pharmaceuticals. The concept is likely to gain traction in the US as payers and product manufacturers acquire experience with the concept and as measurement techniques and information systems improve. In addition networked patient registries also act as evidence for the concept. But for the foreseeable future, the concept in India is likely to remain an exception as India doesn’t have reimbursement model for pharma and more importantly has disjointed registries. In India, only two registries exist at a National/Central level: The National Cancer Registry Programme (NCRP) started by the Indian Council of Medical Research (ICMR) in 1981 and a stroke registry at National Centre for Disease Informatics and Research, Bangalore this year. At the state-level, registries exist in pockets and data may not be equally comprehensive. In developed economies, patient registries are more structured and maintained for a large

spectrum of diseases. These registries are a rich mine for knowledge on patient histories, disease epidemiology, drug reactions and responses etc. How are Indian companies reshaping their R&D to deliver better shareholder value while also ensuring better outcomes to patients? Indian companies are reorganising their R&D structures to increase efficiency, cost effectiveness and better coherency. The main objective being to deliver better shareholder value and consequently deliver better outcomes to patients. From a process point of view players are seeking out best practises from MNCs and establishing autonomous but accountable R&D units with integrated information flow and sharing of best practices. They are organising R&D units so they are aligned with market developments and can focus on developing products that are of most need/ have maximum demand. Companies have also begun to realise the importance of effective project management and are therefore establishing overlay management structures for the same purpose Companies are also focusing on managing R&D interfaces and also increasingly leveraging analytics & ICT as enablers in R&D to make processes more efficient. Some tech-enabled tools aid companies in lead identification and other stages of drug development. The objective is to gain maximum return on investment with risk assessment at the outset. R&D in India is evolving in the field of develop new drug delivery systems, varied dosages and diverse formulations that provide quality and effective healthcare to the patient. Finally, how do you see the adoption of big data and mobile health as a game changer for the pharma industry? Reportedly, 44 million health-related smartphone apps were downloaded worldwide in 2011 – indicating the rampant presence of technology and its use in healthcare and pharma. With the challenges that healthcare faces globally such as accessibility, affordability and quality – technology intervention as a plausible solution cannot

be discounted. Be it telemedicine networks, telediagnosis, call centres that aid healthcare service or mobile apps – technology intervention has helped aid accessibility and convenience by leap and bounds. In India especially, where access in hinterlands is limited to a greater extent: the possible reach of tele networks cannot be underestimated. In the global context mobile health has other interpretations: the combination of transformative technology trends like smart mobility, social networking, and cloud computing and big data analytics lay the basis by which patients will get access to healthcare not only in hospitals and clinics but in their very own micro-environment. The adoption of Big Data in healthcare cannot only revolutionise the delivery of healthcare but impact pharma research and drug development. In the present scenario, healthcare entities around the world have started using big data analytics for analysing the claims and clinical data they have about patients to arrive at conclusions on the risk exposure to patients and the drug of choice subsequently. Taken to another level this analysis could be extrapolated to arrive at conclusions on personalised medicine and customised care. Big Data on healthcare and the insights generated therein can help pharma companies with marketing insights, commercial pointers to guide R&D decisions, real time evidence to gain better access to healthcare outcomes that will aid in the improving the development strategies, identify unmet medical needs and limitations of current therapies and positioning an evidence based value proposition and in enhancing lifecycle value and enhancing asset maximisation. But the power of data, lies in how it is used. Amidst the current ambiguity over transparency, compliance and apprehensions over big data in pharma industry, the players need to ensure strong coordination between commercial and R&D entities, develop analytical rigour and formulate critical hypotheses that need to be tested systematically. Else big data might lead to erroneous conclusions that may have detrimental effects on a product or an entire portfolio. August 1-15, 2013


INSIGHT Viral hepatitis: The era of molecular assays Dr Faisal Khan, Sr Research Officer-Knowledge Management R&D, SRL gives an outlook on the burgeoning morbidity and mortality associated with hepatitis B and opines that the solution lies in adequate screening measures coupled with the use of modern molecular approaches to diagnose and monitor n the heels of World Hepatitis Day, observed on July 28, the exponentially high global burden of this disease continues to be a growing public concern. In 2012, the WHO revealed an alarming set of global statistics. A whopping 2000 million people were estimated to have fallen prey to hepatitis B infection globally with chronic infections documented in 240 million cases. Hepatitis B-associated deaths were estimated to be around 500000 to 700000 worldwide. Approximately 150 million individuals were estimated to suffer from hepatitis C infection; with an estimate of 350,000 hepatitis C-related deaths all over the world. Statistics put forth by the WHO project that five million hepatitis-related deaths could occur in South East Asia alone, in the coming decade. This region is home to approximately 100 million hepatitis B and 30 million hepatitis C patients; 65 per cent and 75 per cent of these respectively, are unaware of their hepatitis status owing to the silent nature of the disease. The WHO has confirmed that hepatitis prevalence has superseded HIV infection in this part of the world. Greater than 50 per cent of the global burden of hepatitis E is from South East Asia alone.1 The number of chronic hepatitis B carriers in India alone was estimated to be around 40 million in 2006, which increased from 36 million reported in 1996. 2,3


Changing diagnostic landscape of viral hepatitis July 28, regarded by the WHO as World Hepatitis Day, indeed presents an apt occasion to delve deeper into the various facets and nitty-gritty of this infectious disease; its diagnosis being one of the most extensively researched areas. ‘Screening’, ‘diagnosis’ and ‘diagnostic monitoring’ are crucial parameters in the clinical management of viral hepatitis. The key to reducing the burgeoning morbidity and mortality associated with this disease lies in adequate screening measures coupled with the use of modern molecular approaches to diagnose and monitor. The diagnostic landscape of viral hepatitis testing has witnessed a notable change. In the recent past, molecular diagnostic approaches August 1-15, 2013

have received phenomenal acceptance within the medical fraternity; for the diagnosis and monitoring of viral hepatitis. Emphasising the importance of these molecular assays, Dr BR Das, President – Research and Innovation, SRL said, “Molecular assays represent a highly precise and sensitive diagnostic tool with growing acceptance within the medical fraternity. The realm of molecular diagnostics holds great clinical promise and is the backbone of the diagnostic work up for viral hepatitis.”

Growing acceptance of molecular assays: A new diagnostic paradigm The exponentially high rates of prevalence and mortality associated with viral hepatitis, present a dire and urgent unmet medical need: the need to beef up diagnostic facilities, diagnostic measures and clinical intervention based on sound diagnosis. Diagnostic measures for hepatitis B and C can be broadly divided into serologic tests and molecular assays. Enzyme-linked immunosorbent assay (ELISA) or immonoblot-based serologic tests detect antibodies to hepatitis virus or its antigens; their clinical utility being mainly limited to screening and initial diagnosis. Though serological methods can be employed for periodic monitoring of virologic response, they lack the superior precision, sensitivity and specificity offered by newer molecular diagnostic methods. Several crucial questions necessary for robust diagnosis and treatment planning; remain unanswered in a purely serology-based diagnostic menu: What is the load of the infection? What is the genotype of the virus involved? Is the genotype a mutant or a known drug resistant one? What are the patient’s best possible therapeutic options based on viral load and genotype? Clinicians often grapple with these queries during confirmatory diagnosis and treatment planning phases in the management of viral hepatitis. Molecular assays provide the answer to these key questions and represent a confirmatory diagnostic plus monitoring aid in viral hepatitis. They score over serologic tests in terms of superior precision, sensitivity and specificity. Qualitative molecular assays are




Dr Faisal Khan, Sr Research OfficerKnowledge Management R&D, SRL

DR BR DAS President, Research and Innovation, SRL

“Molecular assays represent a highly precise and sensitive diagnostic tool with growing acceptance within the medical fraternity. The realm of molecular diagnostics holds great clinical promise and is the backbone of the diagnostic work up for viral hepatitis”

References 1.Prevention and control of hepatitis infection: A framework for global action. WHO publication 2012 available at HP_Framework_En.pdf 2.Acharya SK, Madan K, Dattagupta S and Panda SK. Viral hepatitis in India. The National medical Journal of India. Volume 19, Number 4, July/August 2006 3.Tandon BN, Acharya Sk and Tandon A. Epidemiology of hepatitis B virus infection



hepatitis cases.”

test result indicates whether the patient has an IL28B CC, CT, or TT genotype. Patients who have the IL28B CC genotype are more likely to have an SVR with peg-IFN and RBV treatment, whereas patients who have the TT genotype are more likely to be non-responders. This information can prove useful for clinicians in tailoring the peg-IFN/RBV regimen as per the patient’s IL 28B genotype, targeting to obtain SVR.7

employed to determine the presence or absence of the hepatitis virus; a task that can also be performed with serological testing. However, due to high sensitivity and specificity of polymerase chain reaction (PCR)-based qualitative HBV DNA and HCV RNA assays; the medical fraternity is showing a lot of inclination towards qualitative molecular assays for confirmation of the diagnosis of viral hepatitis. Response guided therapy of viral hepatitis represents a widely accepted treatment approach in clinical practice. Dose titrations, treatment durations and stopping criteria for treatment are based upon the virologic response elicited by treatment. This virologic response can be measured with utmost precision and sensitivity, through quantitative molecular assays performed at pre-specified time points during treatment.4 Achieving prolonged and sustained suppression of the virus, at least six months from discontinuation of therapy, a concept termed as 'sustained virologic response' (SVR) has emerged as one of the cornerstones of hepatitis treatment. This further increases the demand and significance of quantitative molecular assays, which are performed not only during treatment but also during follow up, to measure treatment efficacy in achieving SVR. Such quantifiable, objective and tangible monitoring of treatment can be easily achieved through quantitative estimation of HBV DNA and HCV RNA by PCR-based methods.5 Commenting on the role played by quantitative molecular assays in response guided therapy and SVR estimation, Dr Das stated, “Novel commercial real-time PCR assays like Roche Cobas Taqman and Abbott Real Time assay are highly sensitive techniques for viral quantification, and present a much broader and dynamic range of quantification than routine methods. The advent of such new technologies will give a major impetus to the monitoring of

Mounting clinical evidence supports the fact that different genotypic strains of the hepatitis virus respond differently to antiviral therapy. Also the course of the disease and its severity is largely impacted by the genotype of the infecting virus. Hence, identifying the genotype of the virus provides a very useful insight into planning the correct and the most sensitive anti viral regimen for a patient. This, in turn improves overall prognosis. HCV and HBV genotyping are diagnostic tests that reveal the genotypic strain of the causative organism and play a cardinal role in therapy decision making.2,6 “Genotyping of the viral strain along with a real time PCR-based quantitative estimation of the viral load; can be very instrumental in treatment planning and monitoring,” Das added. Besides, identifying genotypes on large samples of patients at a community level provides insights into the prevalence of the most common strains in a given geographical area or ethnicity. Thus, genotyping of HBV and HCV is not only an effective tool in treatment planning but is also a promising epidemiological marker. 2,3 The current mainstay and gold standard of treatment for HCV is a combination of pegylated-interferon (peg-IFN) and ribavirin (RBV). However, response to this therapy can be influenced by genetic polymorphisms. Highlighting the impact of genetic polymorphism on treatment outcomes, Das infomed, “Patients with a particular type of genetic polymorphism in the IL28 B region have higher viral replication rates and are thus poor responders to treatment. These patients require a longer duration of treatment and a higher RBV dose.” Given this rationale, the IL28B genotype test can be used to predict response to peg-IFN and RBV in HCV genotype 1 and 4 patients. The

Drug resistance has been a daunting challenge in the treatment of hepatitis B. A notably high level of drug resistance has been associated with older anti-virals like lamivudine. Resistance has been reported towards newer anti viral agents to a lesser extent. Such drug resistance compromises the efficacy of the treatment and often precipitates breakthrough hepatitis. Therefore, timely detection of mutation in HBV cases, through PCR and direct sequencing; can assist in therapy decision making, prevent the occurrence of resistance and save the patient from the agony of breakthrough hepatitis. Upon identification of the mutant through PCR-based assays, the patient can be switched over to a drug therapy other than the resistant one, early during the course of the treatment.8 The other clinically significant mutated viral strains are the core and pre core mutants. These strains cause hepatitis E surface antigen negative hepatitis (HBeAg negative). This form of the disease is more severe, long standing and with a high risk of cirrhosis. It requires more aggressive and prolonged treatment. A recently promulgated widely accepted treatment guideline has recommended very specific anti viral therapy (adefovir, entecavir or peginterferon) for the treatment of HBeAg negative hepatitis.9 Molecular assays can effectively detect core and pre-core mutants, therapy can be customised to

in India. Gut 1996; 38 (suppl 2): S56-S59 4.Ferenci P Best Pract Res Clin Gastroenterol. 2012 Aug;26(4):463-9. Response guided therapy in patients with chronic hepatitis C - yesterday, today and tomorrow 5.Chen J, Florian J, Carter W, Fleischer RD, Hammerstrom TS, Jadhav PR et al. Earlier sustained virologic response end points for regulatory approval and dose selection of hepatitis C therapies. Gastroenterology 2013 Jun; 144(7):14501455

6.Lin CL and Kao JH. The clinical implications of hepatitis B virus genotype: Recent advances. J Gastroenterol Hepatol. 2011 Jan;26 Suppl 1:123-30 7.Christine M. Nguyen, Margaret Mendes, Shirley Tsunoda, Joseph D. Ma et al. Interleukin-28B genotype testing to determine response to the combination of pegylated-interferon and ribavirin for the treatment of hepatitis C virus. PLoS Curr. 2011 January 8; 3: RRN1207 8.S. O’shea R. Hepatitis B. Accessed at

icalpubs/diseasemanagement/hepatology/he patitis-B/ 9.Lok and McMahon. AASLD practice guidelines on chronic hepatitis B. Hepatology (Feb 2007); Volume 45, Issue 2, pages 507–539 10.BCC Research market report on: Global market for infectious disease diagnostics, vaccine and treatment products (2013). Accessed on 3rd June 2013 at eb10742989.htm 11.RNCOS market report: Global infec-

Deciphering viral blueprint: Genotyping hepatitis virus

Tackling drug resistance and mutation testing

meet the needs of these high risk cases and prognosis can be improved.8

Market perspective: A bird’s eye view As per a market analysis report by BCC Research, the demand for hepatitis-based diagnostics is expected to witness a major upward leap in countries like India and China which have higher rates of viral hepatitis.10 RNCOS released a market research report last year, projecting substantial growth for the 'infectious diseases' segment of the global molecular diagnostics market during 20122015.11 Another market report published by Renub Research, reiterated the substantial growth prediction for the global molecular diagnostics market. As per the findings of this report, the global molecular diagnostics market is set to grow at a swift pace of a CAGR of 19 per cent with a prediction to touch the $15 billion mark by 2014. The most notable finding of this report is the fact that 'diagnostics of infectious diseases' is the fastest growing segment of this market with a robust 21 per cent share.12 The findings of these various reports can be further extrapolated to infer that a sizeable market share of the infectious diseases diagnostic market will certainly come from the large prevalence of viral hepatitis cases. This is a robust pointer towards the fact that the demand for more advanced and more economical diagnostic tools will continue to rise in this domain. Thus, it lays unprecedented responsibility on large diagnostic firms in the global market to constantly keep reinventing technology and keep upgrading the spectrum of their diagnostic services for infectious diseases like viral hepatitis; while striving to offer competitive pricing as well. The diagnostics industry will have to meet this challenge to converge medical advancements, patient welfare and commercial growth. tious diseases molecular diagnostics market to remain strong (2012). Accessed on 3rd June 2013 at al-Infectious-Diseases-MolecularDiagnostics-Market-to-Remain-Strong.htm 12.Renub market research report: Global molecular diagnostic s market and future forecast 2010-2014. Accessed on 3rd June 2013 at

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Patent protection for orphan drugs With the increase in orphan drug registrations and high revenue potential prediction; it has become crucial for companies to re-evaluate their patenting strategy for these drugs. Priyanka Gupta, Solution Consultant, IP & Science Business, Thomson Reuters, gives an outlook rphan diseases, generally known as rare diseases, are conditions that affect fewer than 200,000 individuals at any given time. Most orphan diseases like cystic fibrosis, muscular dystrophy, Huntington disease etc. are life-threatening and are primarily caused by genetic alterations. The treatment of such diseases is complex and essentially requires the development of drugs to effectively treat the rare disorders. However, despite the urgent and unmet needs for these drugs, due to small patient populations, pharmaceutical and biotechnology companies did not take active initiatives to develop drugs for treating the rare or orphan disorders. Keeping in view the above described scenarios, several government regulations including the Orphan Disorder Act by the US were formulated to provide multiple incentives to drug developers for promoting drug development that could aid treatment of orphan diseases. The most prominent encouragement so far has been the seven-year marketing exclusivity period for drugs approved by the Food and Drug Administration (FDA) to treat the rare disorders. Development trends of orphan drugs has steadily been moving towards greater interest in the recent years, as pharma companies perceive a huge revenue potential in the development and launch of orphan drugs. FDA statistics suggest that at the time of authorisation of the Orphan Drug Act in 1983 until June 2013, Orphan Drug designations have been awarded to 2,843 compounds, and of these, there have been 442 approvals for orphan indications alone. Of the 39 drugs approved by the Agency in 2012, approximately one-third carried Orphan Drug status, and nearly 200 orphan drugs per


August 1-15, 2013

year enter development. Complementing the FDA statistics, Thomson Reuters analysis also suggest that the orphan drug market was worth more than $50 billion worldwide at the end of 2011, and currently accounts for about six per cent of total pharma spending. In 2012, the pharma industry’s most expensive drug, Alexion Pharmaceuticals’ Soliris (eculizumab) which was launched in the US in April 2007 for the treatment of paroxysymal nocturnal haemoglobinuria (PNH), attained blockbuster status with total sales of $1.134 billion. This is particularly significant as PNH, a rare life-threatening blood disease, only affects about 4,000 to 6,000 individuals in the US; Soliris is estimated to cost more than $409,000/patient per year. According to Consensus data from Thomson Reuters Cortellis for Competitive Intelligence, Soliris is predicted to grow at a compound annual growth rate (CAGR) of 18.5 per cent, rising from $1.806 billion in 2013 to $ 3.561 billion by 2017. As more orphan drugs reach the market, industry analysts predict that the growth rate of these products will significantly outpace non-orphan drugs, with high price premiums offsetting the impact of smaller patient populations. It is needless to say that with such revenue potential, the rare disease niche market poses a unique opportunity for pharma and biotech companies. Initially, orphan drugs meant smaller markets; thereby they posed less risk or had less vulnerability to direct or generic competition. As a result, patent protection was usually viewed as an expensive luxury, while marketing exclusivity was considered the most cost-effective option to protect the drug from direct

competition. Recent trends, however, present a different picture. With the increase in orphan drug registration and high revenue potential predictions; it has become crucial for companies to re-evaluate their patenting strategy for these drugs. When a drug receives the status of ‘orphan’; it is bound to attain a benefit of 10-12 years of protection from market competition with similar medicines with similar indications. In the US and EU, orphan drug designation grants marketing exclusivity rights for seven and 10 years respectively, subject to approval. In such a scenario, the question of patent protection may become irrelevant to companies, as orphan drug designation alone provides market exclusivity against competition. However, when painting the revenue picture of the orphan drug, companies should take into account a critical aspect of protection that can only be provided by patents. To increase the possibility of high revenue for increased years, companies should include this 'term of protection’ as an extension to the already existing market exclusivity. For example, a European patent, when granted, provides 20 years of absolute monopoly to the patented drug molecule. It may be already known, that the patent duration can also be extended up to 25 years with a supplementary protection certificate (SPC) in the EU, thereby allowing the patent owners to increase the ‘monopoly period’ of the orphan drug. For instance, the patent for the active ingredient of Glivec, imatinib mesylate, was filed in March 1993. Under normal circumstances, this patent would have expired in March 2013 i.e., in 20 years from the date of filing of the patent for the Glivec active ingredient. However, imatinib mesylate

was provided SPC protection, which has extended the patent protection until mid 2016. Considering the fact that the marketing exclusivity for Glivec expired in November 2011, Glivec drug with patent protection did receive an extended monopoly period of five years. Even if marketing exclusivity extends to a maximum of 12 years, patent protection can help in providing a significant additional protection time for high revenue potential orphan drugs like Glivec. In conclusion, patents for orphan drugs provide additional protection of the capital invested into the drug’s research and development, launch, and marketing. The combination of marketing exclusivity, coupled with financial incentives, has been and will remain a powerful driver of the development of orphan drugs. It may indeed provide sufficient incentive alone to lead to such drugs being developed. However, analysis of successful orphan drugs also provides insights that regulatory marketing exclusivity may not be sufficient protection for these drugs and that patents ensure the maximum protection period for maintaining the exclusivity of the orphan drug. EXPRESS PHARMA



Cheaper anti-cancer drug effective in treating most common cause of blindness in older adults PG 32

RESEARCH INSIGHT Clinical trials in India in a crisis: Does it matter? Dr Prem Pais, Head, Division of Clinical Research and Training, St John’s Research Institute, Bangalore, makes a powerful case for the Ministry of Health to have a re-look at its notified revised regulations governing clinical trials in the country n January 30 this year, the Government of India issued a gazette notification modifying the regulations for conducting clinical trials in India. The purpose of these new regulations was to protect the rights and safety of Indian subjects participating in clinical trials. This is a laudable and required objective. Changes and tightening of oversight into how clinical trials are being conducted was needed. While many of the regulations are unexceptional such as the need to register ethics committees and the need to compensate trial subjects who suffer harm due to their participation in the trial, some are unscientific and seem to have been put together in haste without adequate thought. The result is that the regulations threaten to kill the conduct of clinical trials in the country. This would be a great pity and would be detrimental to the health of our people.


What are clinical trials?



A prospective drug has to go through a long process before becoming available for the doctor to prescribe to his or her patients. Many fall by the way side. The molecule is first born in a biochemistry laboratory where biochemists synthesise a large number of molecules tailored to fit into receptors in human cells normal or abnormal or cells of disease causing germs to promote their function, decrease their function or destroy them. Molecules that seem promising are then tested in animal models to see if they behave as expected and to study how a living body handles the molecule, its side effects at various

doses and to estimate what doses would be likely to be useful in humans. The few molecules which pass this phase enter the phase of human clinical trials. Initial human trials are in a few normal volunteers to test human handling of the molecule at various doses and any side effects. After this phase a series of trials are done in patients with the disease in question to test whether the drug is safe and effective. The most important phase is the so called phase three trial which replicate more or less usual practice situations. These trials are required by drug regulatory agencies, including India’s before a new medication can be approved for general use. The usual requirement is for a double blind placebo controlled trial. What do these terms mean? Controlled means that there will be at least two groups – one which receives the new treatment and the other a comparison control group. Randomisation ensures that a trial subject enters the experimental or control arm randomly to ensure the arms are truly comparable. A double blind trial is one in which neither the subject nor the doctor knows which treatment the participant is getting using identical appearing tablets or injections. Finally a placebo is a tablet/injection which looks like the trial medicine but is inactive and inert.

Death and complications in clinical trials It is obvious that just as patients with serious conditions like cancer, heart attack or infections like cerebral malaria will die or have

ous complications as part of usual clinical practice, those participating in trials are also going to have such unfortunate events. Media headlines that many patients died in clinical trials can be misleading. The important question is how many of these died because of being in a trial. These could be called trial related death (or complication) and be considered for compensation. A clear example of a complication not arising from a trial is if a trial participant is involved in a car accident. Conversely if such a participant develops liver damage from the trial medicine that would be a trial related “adverse event”.

Regulation of clinical trials Clinical trials are regulated. As a first step every clinical trial has to be approved by a research ethics committee. An ethics committee is a group of people from different backgrounds – physicians, scientists, lawyers, sociologist and lay members of society – who review any research project in which human will be subjects. Their main duty is to protect the rights and safety of the research participant while at the same time permitting relevant and ethical research. The approval of this committee is essential. Even if the DCGI (Drugs Controller General of India) gives approval for a study, the local ethics committee has the final word. The committee has also to review any untoward events that may happen in projects that it has permitted and report them to the DCGI with its opinion on possible causality. At a national level permission for a trial

and its oversight is the responsibility of the DCGI. The permission of both the DCGI and the institution's ethics committee is a prerequisite for starting the trial in any site in the country. Both these bodies are supposed to periodically monitor if the trial is being conducted appropriately. The prime responsibility for this lies with the local ethics committee. This has been a problem area because of shortage of trained manpower.

Problems with the new regulations The new regulations (Drugs and Cosmetics (First Amendment) Rules, 2013) for clinical trials have some problematical clauses. One clause states that for an injury/illness occurring to a clinical trial subject, he or she shall be given free medical management as long as required. Notice that this does not specify what type or cause of injury. Thus a trial participant may be involved in a traffic accident or assaulted by someone. Under this clause the trial sponsor has to cover all costs in an open ended fashion. This clause is unreasonable. Moreover the clause is unethical as it is an inducement for people to participate in a trial even if it is risky merely to get what amounts to free health insurance. Another clause calls for financial compensation to be paid over and above costs of any medical management in the case of an event occurring that is considered trial related. This is certainly justified. However the key question is what constitutes a trial related injury. These are defined in subsequent clauses August 1-15, 2013


most of which are unexceptional. There are however some which are confused. One such is “failure of investigational product to provide intended therapeutic effect”. This is counterintuitive. Regulatory authorities require a trial to be carried out to prove that the medication works. Earlier phases of clinical trials give a fairly good idea of the medication being likely to be effective but it is the large phase three trial that has to prove this. Some medications may not meet the required standard. Again, even if a medication works it may not work 100 per cent of the time. A person whose cancer was not stopped from progressing may claim compensation under this clause even though in the trial as a whole the treatment was effective. Further, the elaborate information sheet given to the patient prior to his/her entry into the trial is required to clearly explain the experimental nature of the trial. By agreeing to participate in the trial the participant accepts that there is a chance the medication may not be as effective as anticipated. Further, at the time of giving permission to conduct the trial the regulator should review existing data of preceding experiments. If permission is given it implies that the regulator feels that there is a good chance the medication will be effective. The regulator should not shirk this responsibility. August 1-15, 2013

A second definition of a trial related injury in the regulations is use of placebo in a placebo-controlled trial. A placebo controlled trial is usually a requirement by regulatory agencies to ensure lack of bias in a trial being done to prove effectiveness of a new medication. It should be made clear that in any condition in which treatment already exists, all subjects in the trial should get this treatment. The new treatment or placebo is given in addition as an add – on. Thus no group should be denied best available treatment especially in a potentially serious condition. The use of a placebo cannot be considered as equivalent to a trial related injury unless it is shown that the subject was denied existing standard treatment. A third confusing clause calls for compensation for an “adverse effects due to concomitant medication excluding standard care, necessitated as part of approved protocol”. This clause seems to imply that if the patient has a reaction or complication not due to the trial medication but to one of the other medicines that he/she is taking or advised to take, the trial sponsor is responsible not only to pay for any treatment but also to pay compensation in addition. How can the trial sponsor take responsibility for drugs that the patient has been taking all of which have been approved for marketing and are in common use? Often

trial protocols advise investigators to make sure that trial participants are taking the best available treatment for their illness apart from the trial medication. These are all approved marketed medication. This clause may discourage such steps to ensure best treatment for study participants.

Does it matter if clinical trials stop in India? Since the notification, clinical trials in India have almost come to a halt. Scientific agencies such as the National Institute of Health of the US have stopped trials in India. For the academic community in India it will now be near impossible to carry out trials of important low cost treatments that may have great impact in a poor country like ours which may not of interest to industry. There is no way such an investigator can take the risk of the kind of liability these regulations put him or her at. The pharmaceutical industry has become hesitant. A number of multinational trials by such companies have now excluded India from their list of participating sites. They can find willing sites in other countries in the region. Halting of clinical trials in India will result in quite a few people losing their jobs and the country losing foreign investment. Apart from this relatively less important consequence does it matter if clin-

ical trials are no longer done in India? It does. The great advances in medicine that have occurred over the last 60 years have largely been the result of clinical trials. Trials have not only identified new and effective treatments but have also identified harmful treatments that have saved many lives. As an example, 60 years ago 30 per cent of people who suffered a heart attack died in the first month. Today about 8 per cent do. In the absence of clinical trials new treatments will not be available for our people unless the DCGI accepts only evidence collected from other countries. This means that either we will stop getting new medication to use of we will have to use them without definite evidence of how they work in our people and whether Indians will react differently to the medication compared to others. It is important for the Ministry of Health to have a re-look at its notified revised regulations and consult people with the knowledge and experience in the ethics as well as the science of clinical trials both from India and abroad. It is most important that the rights of trial participants be protected while at the same time ensuring that the greater good of our people is not harmed by killing off clinical trials. Other countries have found the right balance. There is no reason we should not be able to do the same. EXPRESS PHARMA



CLINICAL UPDATE Cheaper anti-cancer drug effective in treating most common cause of blindness in older adults Two drug treatments Lucentis and Avastin are equally effective in treating neovascular or wet age-related macular degeneration

n anti-cancer drug has been proven to be equally as effective in treating the most common cause of blindness in older adults as a more expensive drug specifically formulated for this purpose. The results of a two-year trial, led by Queen’s scientist Professor Usha Chakravarthy, and published in The Lancet, show that two drug treatments Lucentis and Avastin are equally effective in treating neovascular or wet age-related macular degeneration (wet AMD). Wet AMD is a common cause of sight loss in older people with at least 23,000 older people diagnosed with the condition in the UK each year. Without treatment two thirds of people with this condition will experience severe loss of sight within two years of being diagnosed. Lucentis, the drug most commonly used in the UK at present to treat wet AMD, costs about £700 per injection and Avastin costs about £60 per injection. The NHS could save £84.5 million annually based on injecting 17,295 eyes each year by switching from Lucentis to Avastin. Avastin is already used to treat wet AMD in some parts of the UK and extensively elsewhere in the world and also for other eye conditions. Over the past five years, a


team of scientists and eye specialists from 23 hospitals and UK universities, including Queen’s University Belfast, University of Bristol, University of Liverpool, University of Southampton and University of Oxford, have investigated whether Lucentis and Avastin and the way they are given are equally effective and safe. 610 people with wet AMD entered a two-year trial known as IVAN which is one of the largest ever carried out in the field of eye disease in the UK. Patients received injections of the drug into the affected eye every month for the first three months. Patients were then subdivided to receive the injections at every visit (monthly group) or only if the specialist decided there was persistent disease activity (as needed group). The IVAN study’s two year results show that sight was equally well preserved with either of the two drugs. Giving the treatment regularly every month, resulted in slightly better levels of sight which was detected through testing of near visual acuity and contrast sensitivity. The ‘as needed’ group received on average 13 injections over the two year period compared to 23 for the monthly treatment group. However, continuous treatment caused a higher proportion of eyes to develop a condition known as geographic

atrophy which is a thinning of the retina and its blood supply. Professor Usha Chakravarthy of Queen’s University Belfast’s Centre for Vision and Vascular Science, who led the research study team said, “The IVAN results at the end of year two show that Lucentis and Avastin have similar functional effectiveness regardless of the drug received. With respect to monthly versus as needed treatment, while there was marginally better eyesight in the former, the development of atrophy is a matter of concern in the longer term.” The IVAN study was funded by the National Institute for Health Research Health Technology Assessment (NIHR HTA) programme. The Belfast Health and Social Care Trust sponsored the clinical trial. Professor Ian Young, Director of Research and Development at the Trust said, “The findings of the IVAN study will be of great importance for the management of patients with wet AMD throughout the world. Research to improve patient care is a key aspect of the work of Belfast Trust, and we are committed to sponsoring and leading important clinical trials of this kind which allow our patients early access to new treatments.” Dr Janice Bailie, Assistant

Director, Health and Social Care Research and Development Division of the Public Health Agency, which supported the trial said, “With increasing life expectancy and a growing proportion of older people in the population, slowing the progress of conditions like AMD is key to maintaining their independence. The IVAN trial is an example of research led from Northern Ireland with international significance - the findings have the potential to influence how AMD is managed in the future.” The IVAN study also monitored the drugs for serious adverse events which included death, heart attacks, strokes, and any other event that was life threatening, disabling or resulted in hospitalisation. These were similar for the two drugs. However, deaths occurred less frequently in the group that received monthly treatment, although there were fewer deaths overall among people taking part in the trial than were expected based on their age and gender and national death rates. When these safety results were combined with those of a similar study called the CATT trial which was performed in the US, the resultant findings continued to indicate fewer deaths when treatment was given monthly. Queen's University

RESEARCH UPDATE Roche’s new leukaemia drug superior to Rituxan in study Zurich oche's experimental leukaemia drug known as GA101 delayed disease progression in people with one of the most common forms of blood cancer longer than its top-seller Rituxan, the Swiss drugmaker said. Roche is hoping GA101 will help fend off cheaper competition for

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Rituxan, which loses patent protection in Europe later this year, threatening a blockbuster product with nearly $7 billion in annual sales. A late stage study showed GA101, or obinutuzumab, used in combination with chemotherapy, helped people with a particular form of leukaemia live longer without their disease worsening when compared

with Rituxan which is also known as MabThera. The drugs were given in conjunction with the commonly used chemotherapy chlorambucil to previously untreated patients with chronic lymphocytic leukemia (CLL) who also had other health problems, such as heart disease. Roche said specific sugar molecules in GA101 were modified to

change its interaction with the body's immune cells, creating a unique antibody designed to engage the patient's own immune system to help attack the cancerous cells. Roche said final data from the study would be submitted to the American Society of Hematology's annual meeting in December. Reuters August 1-15, 2013

PHARMA ALLY ‘We have offered Square Foot’s flooring solution to more than 100 facilities’ INTERVIEW

Square Foot has offered flooring solutions to Kemwell Biopharma since 2004 and has aggressive growth plans in the clean room market. Gaurav Saraf, Joint Managing Director, Square Foot shares some of the company's plans with Usha Sharma

Biocon India, Bangalore, Zydus Cadilla, Ahmedabad, Ferring Pharma, Mumbai, and Vaibhav Healthcare, Baddi. What is the difference between a flooring solution installed within a pharma facility and one installed in other sectors? The floor in other sectors is more design-oriented and also at the same time can shed particles, does not need to have chemical adherence and need not be seamless. We do a lot of products for retail, hospitals and work place interiors.

Tell us how big is the Indian clean room market? What percentage of growth has been recorded in the last three to four years? The Indian clean room market would be approximately five million sq ft per year. It is growing at an average of 10-15 per cent year-on-year. The estimated number 80 per cent includes new facility flooring and 20 per cent for renovation of old facilities. Kemwell, a known name in the pharma industry, both in the domestic as well as in the international market, is one of your clients. Tell us about your other clients and the services you offer to them? Kemwell is a contract drug manufacturer and we have done the flooring for them in their facilities. Our other client list includes August 1-15, 2013

Who are your major clients ? We have offered Square Foot's flooring solution to more than 100 facilities and our client list includes all major pharma companies like DRL, Shantha Biotech, Cadilla, Claris Life Sciences, Wockhardt, Ranbaxy and other big names among pharma companies today. Tell us more about Square Foot’s flooring solution for Kemwell Biopharma? We have offered Kemwell Biopharma seamless vinyl flooring which has been coved. The corners of any room remain unclean as it becomes tiresome and difficult to clean every corner of room. Therefore, it may be a reason to develop fungi or bacteria. To avoid this problem, the corners of room - where the joint of wall and flooring comes – are shaped in curvature style in order to make cleaning easier. This curvature shape at the corner of the flooring is called coving. There are no wall and floor

joints seen as there is no 90 degree joint to the wall and flooring. The joint comes above the skirting of the flooring and wall. We have also offered them wall solutions which are vinyl wall coverings wherever they have civil walls. What is the USP of this product? This is a maintenance free product and comes with a 10-year guarantee. It is particularly useful for the pharma sector depending on the changes in production lines and processes rooms which are prone to be changed. Pharma grade vinyl companies need not replace the whole room instead of replacing a part of the area. These products are machine made in Sweden by our partner Tarkett and are not in situ like epoxy so the consistency and quality is guaranteed. Can this be considered as a cost-effective solution for pharma companies? It is a very cost effective solution as these products have a minimum life of 10 years. When customers compare this with epoxy wherein the top 1-2 mm needs to be relaid every two years, this is much more cost effective. In epoxy, the client spends initially and also spends 25 per cent of that cost every two to three years to refurbish. The hidden loss in this cost is the closure of production for two weeks while it is being renovated. In vinyl our oldest installation in India was in 2001 and still has the same flooring. The life cycle cost of pharma grade seamless vinyl

flooring is half that of epoxy.


Evolution of nasal aerosol products with focus on pain management PG 34 ETP-based on anaerobic technology treats API effluent efficiently PG 36 Fisher Scientific launches new imaging system for life science applications PG 37

What has been Kemwell’s experience with Square Foot ? Kemwell has been using our products since 2004. They have been currently used in the manufacturing of drugs and medicines at their recently inaugurated plant at Bangalore as well as they are happy with the work done and products installed in 2004 are still lasting. Which other products are available and how do you want to differentiate your products from others? Presently there is epoxy and we have a special pharma certified vinyl flooring. The market is huge and to make it cost-effective, some companies would use epoxy for their domestic manufacturing facilities. Epoxy as a product also works in some areas like active pharmaceutical ingredient (API) wherein we don’t have a solution today. Primo Premium and Eclipse Premium will be relaunched in the next year. A lot more subtle colour palettes are being introduced. What environmental, health and safety norms do you adhere to? Most of the products earned two LEED points and gases emitted by flooring standard is 10 times less than the acceptable European Standard. What is the targetted grow rate? This year we are targeting to grow at 25 per cent.



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VALUE ADD Evolution of nasal aerosol products with focus on pain management Dr. Gerallt Williams, Director, Scientific Affairs, Aptar Pharma, gives an overview on the past, present and future of nasal aerosol products and their growing applications, especially in pain management lthough nasal aerosol products to treat pain have been around for a number of years, recent developments have brought renewed interest to this market. In addition, estimated at over $1.2 billion in 2011, the world market for nasally administered systemic drugs has seen strong growth in the last few years. This article will look at the past, present and future of this particular aerosol application with a focus on some of the devices used to deliver the aerosolised drug. Potential advantages of the nasal route of administration compared with parenteral or oral administration include a non-invasive approach removing any associated pain or anxiety related to injection, rapid onset of action, good bioavailability, and hence high levels of acceptability resulting in improved comfort and compliance for patients. As compared to oral forms of pain management treatments, intranasal delivery also benefits from the avoidance of first pass metabolism. From a managed care perspective, reduced medical staff supervision or intervention is needed to administer the medication, leading to potentially significant cost savings which is a very strong driver for over burdened health care system worldwide.


The applications of nasally administered treatments for management of severe pain, as opposed to OTC pain killers, are numerous and include in-hospital treatments such as postoperative pain management, burns and breakthrough pain associated with cancer, multiple sclerosis and other types of pain episodes. Out of hospital applications include amongst others, palliative care, paramedic retrieval medical services and anti-migraine treatments. Some of these treatments will use potent drugs and may be managed under the controlled substances regulations. A review1, 2 of the pharmacokinetic (PK) properties of intranasal, intravenous and oral treatments in three classes of drugs (opioids, benzodiazapines and antimigraine agents) which are potentially suitable for intranasal delivery reveals the attractive PK benefits for this mode of delivery, see Table 1. A typical PK profile for a nasally administered drug as compared to an intravenous formulation clearly demonstrates the potential of this drug delivery mode. The PK properties of intranasally administered drugs lie between those of intravenous and orally administered drugs with the added advantages of self adminis-

tration versus intravenous and avoidance of first pass metabolism versus oral administration.

Nasal spray device evolution One of the first generation of devices used to deliver pain medication via a specifically designed nasal spray system were the antimigraine treatments Diergospray/Migranal and Imigran (Imitrex) products in the early 90s. The device for the Diergospray / Migranal was an adaptation of a standard nasal spray pump coupled to a glass ampoule containing the product. The glass ampoule was opened just before use, the nasal spray pump dip tube was inserted in the drug solution, the product was primed several times and the dose was then delivered into the nasal cavity (Figure 1). The Imigran device used a specifically developed ready to use unidose system which did not need priming before use (Figure 1). These kinds of devices are very effective for acute treatments such as migraine attacks. Other devices that followed later appeared with a more customised and patient oriented designs such as Zomig (Figure 1). Evolving needs for drug delivery systems for use in treatments for chronic pain

Table 1 â&#x20AC;&#x201C; Some pharmacokinetic properties of nasally administered drug classes Tmax, min

Bioavailability, %





10 to 25

38 to 98

Anti-migraine agents

25 to 90

5to 40

*as compared to intravenous



management where numerous doses have to be taken over a prolonged period of time has given rise to the development of nasal multidose delivery systems for pain management. One of the first to reach the marketplace was Stadol NS where the active ingredient is Butorphanol which can deliver up to 14 or 15 doses per container. Two recent examples to reach the marketplace in Europe are PecFent from Archimedes Pharma and Instanyl from Nycomed, where the active ingredient is Fentanyl (Figure 2). Here the delivery devices can deliver multiple doses and can be selfadministered by the patients thus meeting two of the requirements for improved delivery devices to meet these needs, a reduced cost per dose as compared to unidose systems and the possibility for self administration thus reducing healthcare professional supervision costs.

New developments, challenges and future opportunities An evolving regulatory landscape has brought its own challenges and opportunities with regulatory authorities both in EU3, US4 and further afield5 (e.g. Brazil) increasing their regulatory requirements around nasal aerosols products with the issuance of several guidance documents. Some of these are focused on usability (& avoidance of misuse) and chemistry, manufacturing and control (CMC) activities which require increased understanding of product performance such as dosing, droplet size distribution, spray pattern and plume geometry. Increasing regulatory requirements mean that devices have been obliged to evolve to meet the more stringent demands put on the CMC aspects of the drug delivery systems. As a result there has been a lot of August 1-15, 2013

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Figure 1 – Early generation of anti-migraine nasal spray devices

References 1.Clinical Therapeutics, 31(12):29542987, 12/2009, Veldhorst-Janssen, N.M.L.; Fiddelers, A.A.A.; van der Kuy, P.H.M.; Neef, C.; Marcus, M.A.E., A review of the clinical pharmacokinetics of opioids, benzodiazepines, and antimigraine drugs deliv-

August 1-15, 2013

activity in these areas over the last few years, for example, the development of sophisticated techniques for controlling extractables and leachables from nasal spray devices. Device manufacturers have reacted by improving the quality, robustness and their understanding of key quality attributes that impact aerosol spray performance. This has resulted in a quality by design approach being applied systematically to the development of new generation of nasal spray delivery devices. More frequent use of potent molecules as well as controlled substances in nasally administered products means that more scrutiny is being placed on issues such as potential overdosing or side effects. As a result more attention will be paid to any potential risk for aerosol particles to pass through the nasal cavity and into the lungs inadvertently. Particles greater than 10µm will be deposited in the nasal cavity, however, particles less than 10µm could potentially be inhaled into the lungs. As a consequence product developers need to monitor and minimise the amount of particles less than 10µm in such products using suitable aerodynamic particle sizing methods. Other innovations in the device area include the novel Optinose device currently in development for anti-migraine treatments6 amongst others, where the patient delivers the dose using a unit-dose device (containing either a liquid

or powder dose) by blowing from the mouth into the nasal cavity. Another challenge for device manufacturers related to the use of powerful pain management treatments are potential misuse, diversion and overdosing. These issues can largely be negated by using tamper or child resistant packaging solutions and using lock-out mechanisms on the delivery devices and these features can be electronically or mechanically based. Patient compliance is another challenge during product development and with increased pressure on health care costs more focus is being placed on getting the patients to use the devices correctly according to the correct dosing regime and in the prescribed way. New innovations in devices to tackle the above challenges could either be mechanically based or elec-

tronically based and many ideas are emerging in these areas. Dose counters will be another feature of future nasal drug delivery devices in this treatment area as they will assist patients in identifying when their products are about to run out and that they need to renew their prescriptions. Lockout systems will become obligatory where potent molecules or controlled substances are to be used to ensure against overdosing or diversion. The ultimate advantage of using electronic solutions is that they could be integrated in future into a telemedicine approach where the healthcare professionals can monitor virtually how the patients are using the devices and make necessary adjustments for maximum efficacy and efficiency on a patient by patient basis, this approach could also significantly reduce associated healthcare costs.


ered intranasally 2.Current Drug Delivery, 5(1):55-58, 1/2008, Paech, Michael James; Shelley, Katherine, The Clinical Applications of Intranasal Opioids 3.EMEA-Heath Canada: Joint Guideline on the Pharmaceutical Quality of Inhalation and Nasal Products

EMEA/CHMP/QWP/49313/2005 4.Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products Chemistry, Manufacturing and Controls Documentation, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), May

1999 5.Guidance for Pharmaceutical Equivalence and the Bioequivalence of Nasal Sprays and Aerosols, Agência Nacional de Vigilância Sanitária [National Health Surveillance Agency], Brasil, 2008 6.Intranasal sumatriptan powder delivered by a novel breath-actuated bi-directional

device for the acute treatment of migraine: A randomised, placebo-controlled study, PG Djupesland, P Docekal, 50th Annual Scientific Meeting of the American Headache Society, Boston, US, June 2008.

Figure 2 – Recent multi-dose nasal treatments introduced to the marketplace

Managing pain using nasally administered treatments has many benefits that will surely be exploited in the coming years. Administrating aerosols nasally provides numerous opportunities to introduce innovative drug delivery devices that can meet the increasing pressure on healthcare costs coupled with improved patient compliance and comfort. Nasal drug delivery devices have advanced over the years in line with evolving regulatory requirements and to meet the needs of the current products either already marketed or in development. Many opportunities lie ahead in this aerosol application and the best maybe yet to come with a new generation of electronically or mechanically based devices meeting the needs of the evolving market for pain management.



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CASE STUDY ETP-based on anaerobic technology treats API effluent efficiently Dr Jaideep Dudhbhate, General Manager, Applications and Services, Wastewater Solutions, Clean Technology Group, ATE Enterprises in the case study depicts how ATE achieved the task of treating the complex API effluents with innovative application of anaerobic-aerobic combination at one of the client’s site in central India ith a legacy of over 75 years in the generic API industry, this success story belongs to one of the leading international supplier of active pharmaceutical ingredients. With the industry’s broadest portfolio of over 300 API products, this multinational employs over 5,000 professionals at over 20 sites worldwide. This case study depicts how A.T.E. achieved the task of treating the complex API effluent with innovative application of anaerobic-aerobic combination at one of the client’s site in Central India.


effluent that was expected to be generated out of this unit. Also the energy cost involved in treating the effluent was a prime concern. One of the renowned project management companies were consultants to the project.

Solution After a series of discussions with the client and consultant, an anaerobic and aerobic combination was selected. This is considered as a first-of-its-kind solution for pharma effluent treatment.

Result Challenge While going for their new factory in Central India, the client was concerned about the treatability of the complex

A.T.E. successfully designed, installed and commissioned a 250 m3/day effluent treatment plant based on anaerobic-aerobic

combination. Following are the advantages of this unique solution for pharma effluent● Reduces over 40 per cent COD in anaerobic stage thus reducing the power

consumption for aerobic treatment. Improves biodegradability of COD entering aeration tank. Overall 90 per cent reduction in COD.

VENDOR NEWS Phenomenex Phree Phospholipid Removal Plates wins R&D 100 award This is the ninth Phenomenex product to receive this award in the last 10 years



henomenex, a leader in the research and manufacture of advanced technologies for the separation sciences, announced that its Phree Phospholipid Removal Plates have been recognised as one of the top innovations of 2012 by 'R&D Magazine.' This is the ninth Phenomenex product to receive this award in the last 10 years. The awards, determined by an


independent judging panel and the editors of 'R&D Magazine,' recognise the 100 most technologically significant products introduced during the past year. According to the magazine, the awards are widely regarded as the 'Oscars of Innovation.' The winners represent a cross-section of industry, academia, private research firms and government labs.

Winning technologies are used in medical, industrial, research, consumer and manufacturing applications. According to Fasha Mahjoor, President and Chief Exectutive Officer, Phenomenex, “These awards reflect the depth of our product development pipeline and the fast pace at which we are able to bring new technologies to market.” Phree Phospholipid Removal Plates provide fast clean up of plasma samples in pharmaceutical and clinical research laboratories. In one step, Phree removes both proteins and phospholipids and delivers the prepared plasma to a collection plate. The highcapacity Phree sorbent can process up to 400 µL per well and remove 99.0 to 100 per cent of lysophosphatidyl and

phosphatidyl cholines, which are not removed when a simple protein precipitation is performed. Successful chromatographic analysis of plasma samples requires the removal of both proteins and phospholipids, which can clog HPLC/UHPLC columns. Phospholipids can also cause ion suppression and over time will reduce sensitivity due to build up on the mass spec source. Phree removes both proteins and phospholipids in one step, eliminating timeconsuming method development. The plate format enables the simultaneous processing of 96 samples, for significant time savings. Winners will be recognised at the R&D 100 Awards Banquet on November 7. EP News Bureau-Mumbai August 1-15, 2013

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‘Cipla seems to have stepped up the game in leadership and managing talent’ In a study based on a unique peer ranking methodology, global management consultancy firm Hay Group has released the findings of the second edition of India’s Most Admired Companies (IMAC) across 16 sectors. It is to be noted that not a single pharma company made it to the Top 25. Shalini Gupta finds out more in a chat with Gaurav Lahiri, Managing Director, Hay Group India What is the reason that pharma companies do not feature among the top most admired companies in the country? Are they going down the curve? It is hard to generalise this, looking at the overall rankings, wherein we ask companies to rank other companies across industry, so it tends to go a lot by the brands, shares etc. as opposed to a real deep understanding about a company or in-depth view of the organisation. Yes, it does mean that from a branding point of view the sector is less attractive to other corporates. Within the industry, there is significant disruption, most of the Indian and global MNCs are going through an identity crisis, trying to figure out their business models, MNCs are hitting a patent cliff, ability to have premium medicines at high price point is going down and R&D needs to be transformed to have new drugs coming in the pipeline. The industry is in transition. Are pharma companies still not brands, have they not positioned themselves, if not why? Or have they not been perceived as brands?

For this we’d need to understand, what is the brand sense of a company. For some companies, the focus is more on product brand or the category brand, where the strategy is more on creating a product brand rather than a corporate brand. Whereas if you look at ITC, it is a corporate brand. Most product brands have come to realise that corporate branding is much more effective as compared to product branding. Pharma companies on the other hand are promoting products (consumer healthcare and OTC) rather than positioning themselves as brands. Cipla seems to have stepped up on some parameters whereas GSK slid down. Explain. Two major areas where its peers think Cipla seems to have stepped up the game is in leadership and managing talent. Leadership is well documented and well known, not only has Cipla brought in somebody of a very high calibre like Subhanu Saxena as a Managing Director, but also there is an array of leaders coming across the organisation. They are going out of

their way to enhance leadership, giving people the autonomy to chart their own paths. Last year it was ranked fifth on leadership, this year it is in the second position. Similarly a lot more structure and process in the way people are being managed have been implemented and so it has gone up from rank sixth on talent management to second this year. GSK’s biggest slip is in innovation so it has slid down from No 1 last year to the fifth position this year in industry ranking. Who ranks high on leadership? When we talk of leadership in pharma, is the view different? What sort of leadership would be required in pharma? Dr Reddy’s labs ranks highest on leadership. Fundamentals of leadership remain the same, having leaders who are empowered to give direction to the company. As opposed to other industries, life sciences is much more family-oriented, For e.g. Cipla, Dr Reddy’s, Piramal, Biocon, Sun Pharma, Ranbaxy, Glenmark, Cadila, Torrent etc. These companies had a good 20-30 year run with first gen-

eration, passionate entrepreneurs who took the company to great heights by focussing on low cost drugs, leveraging human capital. The key issue now is managing generational change. Could innovation be a deal breaker, given that most Indian firms are into generics and not new drug discovery, although they do have drugs in the pipeline? That could be if you are looking at GSK’s case, there is a perception that they don’t have a strong enough pipeline. In life sciences, the need for innovation is higher from a business point of view, but the point is, that is more of an evolutionary thought process. Currently, India is still a largely generic market. Innovation is more in sense of processes to keep the cost low and having a good supply chain, with a high emphasis on reducing operational costs. Increasingly, as more and more high-end speciality hospitals come into place, consumers will look for higher end medication, so if we are not innovative, we’d have lost the game. Also, the pipeline in innovation for life sciences is longer as

compared to say FMCG. Pharma companies have dedicated CSR programmes. Where do they rank on CSR? What is missing is a broader CSR strategy, what we tend to find is more tactical CSR, some initiative, grant etc. Look at TATA Steel which ranks highest on CSR, CSR and the brand go hand in hand, it is linked to the strategy of the company. Pharma companies manufacture the most crucial products in terms of life saving medicines. Could the fact that not even one company is a part of the top 25 be a sign of mistrust in such companies? I think people are unclear on what is the company’s promise to the customer, this is what they need to think and reflect upon. Pharma companies need to build their reputation, corporate identity and then communicate it to people.



552 respondents from various industries participated in the study Seven per cent of the total companies covered in the study were pharma companies Dr Reddy’s Labs is the first pharma company to appear in the overall IMAC ranking at


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rank 26 In the sector list for Drugs, Pharma, and Healthcare, Cipla was the top ranked company and Biocon ranked 10th Dr Reddy’s Labs has remained steady at rank 2, last year as well as this year The new participants in phar-

ma this year include Abbott India and Mylan Laboratories Amongst the pharma companies, Dr Reddy’s Labs has top score on both Leadership and CSR parameters Overall, pharma companies did not score higher than (average scores) on any of the 10 parameters, when com-

pared to the average scores of the overall study Please note All participating companies for a particular sector were ranked in 2012. This year, only the top ten companies in each sector have been ranked.

August 1-15, 2013

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JOB TRENDS Low hiring sentiments in pharma sector Hiring dips by 18 per cent in June 13’ over previous month

iring activity in the pharmaceutical sector has not been optimistic in the month of June. The Naukri Job Speak index shows an 18 per cent dip in recruitment in June-13 over May-13 and a two per cent dip in comparison to what it was a year ago. This indicates cautiousness in the environment and suggests that recruiters are


adopting a wait and watch mode.

About, 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, 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. is a recruitment platform that provides hiring-related services to Corporates/recruiters, placement agencies and to job seekers in India and overseas. It offers multiple products like resume data-

base access, listings and response management tools. With 230000 jobs live at any point and over 33 million CV’s, 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 Executive -Maintenance Mechanical Company: Exp: Location: Job Id:

Gland Pharma Ltd. 3-8 Hyderabad / Secunderabad 030613001464

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BAL Pharma Limited 2-6 Delhi 080113003189

Production Manager Company: Exp: Location: Job Id:

Biogenetic Drugs Pvt.Ltd. 15-20 Baddi 030613001408

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August 1-15, 2013

Charak Pharma Pvt. Ltd 7-12 Hyderabad / Secunderabad 230413000737

Data Analyst Company:

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Naprod Life Science Pvt. Ltd. 4-6 Mumbai 260413003218

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10-15 Mumbai 030613001411

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Officer Regulatory Affairs Company:

Bakson Drugs Pharmaceuticals Pvt. Ltd. Exp: 2-5 Location: Delhi Job Id: 010513001628

Factory Manager/Works Unit Head Company: Exp: Location: Job Id:

saurav chemicas limited 10-20 Chandigarh 070113003105

Junior Research Scientist - Formulation Company: Exp: Location: Job Id:

Piramal Enterprises Ltd 3-5 Mumbai 200513001988

Anglo French Drugs & Industries Ltd 3-6 Bengaluru/Bangalore 030613000624



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AWARDS Ranbaxy’s anti-malaria drug Synriam wins Innovation Award The drug is used for the treatment of Plasmodium falciparum malaria, in adults

anbaxy Laboratories has been conferred with the Innovation Excellence Platinum Award at the ASSOCHAM Innovation Awards 2013 in the science and technology category for its new anti-malaria drug, Synriam. The award was given by Jaipal Reddy, Minister for Science & Technology and Earth Sciences. India’s First New Drug, Synriam, was launched by Ranbaxy last year on April 25 (World Malaria Day). The drug is used for the treatment of Plasmodium falciparum malaria, in adults. Ranbaxy is


working to make this new treatment available in African, Asian and South American markets where malaria is rampant. The company plans to submit new drug applications for market authorisation of Synriam in various African countries in 2013. The company also has plans to extend the benefits of Synriam to children in the malaria endemic zones of Asia and Africa. Last year, Synriam won the Golden Peacock Innovative Product/Service Award. EP News Bureau-Mumbai

(Left to right) Dr Nilanjan Saha, Vice President - Medical, Global Marketing, Ranbaxy and Umang Chaturvedi, Global Head, Corporate Affairs, Ranbaxy receiving the award

Jamshedpur, Delhi, Mangalore students excel at Novartis BioCamp The inaugural address was Hoppenot, President, Novartis hreetam Subhrankar, an To represent India at International BioCamp in alumnus of XLRI delivered by Ninad Karpe, Oncology spoke to students S Basle, Switzerland Jamshedpur took top honours Chief Executive Officer and on addressing unmet oncoloalong with Nehul Saxena of International Centre for Genetic Engineering and Biotechnology, (ICGEB) Delhi and Dr Ankith Rai of Fr Muller Medical College, Mangalore at the recently concluded Novartis Biotechnology Leadership Camp (BioCamp) that took place in Hyderabad. The three participants were selected after an intense threeday programme to represent India at the International BioCamp being held at the Novartis Campus in Basle, Switzerland from August 25 28, 2013.

Managing Director, Aptech who provided food for thought by touching upon current events and ethics that are much debated in today’s times. Other speakers included Krishnan Raghunathan, Vice President Solutions & Practice, Genpact; Anu Acharya, Chief Executive Officer, who shared her entrepreneurial experience and Dr Prabuddha Ganguli, Chief Executive Officer – Vision IPR, who focused on the value of intellectual property rights. Herve

gy needs. Speaking on the occasion, Ranjit Shahani, Vice Chairman and Managing Director, Novartis India said, “Novartis Biotechnology Leadership Camp - BioCamp, now in its fifth year, continues to provide students the opportunities to engage with leaders in the pharmaceutical area outside their area of study. It is a good opportunity for students to interact with leaders in the field and network with students coming from different faculties across the country.” EP News Bureau-Mumbai

NEW COURSE Tamil Nadu Dr MGR Medical University to start course in MSc (Regenerative Medicine) Grants affiliation to Nichi-In Centre for Regenerative Medicine (NCRM) he Tamil Nadu Dr MGR Medical University has granted affiliation to Nichi-In Centre for Regenerative Medicine (NCRM), Chennai to start a two year full time Masters in Science (M.Sc) in Regenerative Medicine Degree Course under the

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Allied Health Sciences Category for the academic year 2013-14. The course will start in October 2013. Regenerative medicine is the future of medicine and its true potential can be tapped only when there is an amalgamation of multi-disciplinary expertise and knowledge of both scientists in the allied field and the physicians of all relevant specialities. Therefore this MSc

gramme has been designed to impart the current knowledge and expertise on regenerative medicine to the students of basic sciences, medicine, dentistry, veterinary sciences and allied fields and this is the first such course in this discipline in the state of Tamil Nadu. The course will be conducted at the NCRM Campus in Chennai. Examinations will be conducted by the

Tamil Nadu Dr MGR Medical University which will award the Course Completion Certificates to those candidates who complete the course successfully as per the prescribed norms and regulations. The admission to this course is based on merit. The last date for online submission of applications is August 24, 2013. EP News Bureau-Mumbai August 1-15, 2013


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August 1-15, 2013