Express Pharma (Vol.12, No.18) July 16-31, 2017

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CONTENTS Vol.12 No.18 July 16-31, 2017 Chairman of the Board Viveck Goenka

NEED FOR CONSTANT VIGILANCE Seven years after the launch of the Pharmacovigilance Programme of India (PvPI), patients’ interest are better protected. But a lot more still needs to be done | P20

Sr Vice President-BPD Neil Viegas Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das, Mansha Gagneja, Swati Rana New Delhi Prathiba Raju DESIGN

National Design Editor Bivash Barua

MARKET

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‘WE ARE INTERESTED IN EXPLORING OPPORTUNITIES IN UPCOMING PHARMA CITIES’

18

SIGNET & ROQUETTE CONDUCT TECHNICAL SEMINAR ACROSS FOUR CITIES

Asst. Art Director Pravin Temble

P25: INTERVIEW

Senior Designer Rekha Bisht Graphics Designer Gauri Deorukhkar Senior Artist Rakesh Sharma, Vivek Chitrakar Photo Editor Sandeep Patil

Dr GN Singh

Dr V Kalaiselvan

Long-term goal of PvPI is to develop e-reporting and reporting culture among HCPs

MARKETING Regional Heads Prabhas Jha - North Harit Mohanty - West Kailash Purohit – South Debnarayan Dutta - East

P30: REPORTS

Marketing Team Ajanta Sengupta Ambuj Kumar E Mujahid Mathen Mathew Nirav Mistry Rajesh Bhatkal

P43: VENDOR NEWS

PRODUCTION General Manager BR Tipnis Manager Bhadresh Valia Scheduling & Coordination Ashish Anchan CIRCULATION Circulation Team Mohan Varadkar

MANAGEMENT

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Indian pharma industry continues to face headwinds

Honeywell solution helps customers overcome automation lifecycle and efficiency challenges

RESEARCH

27

RESEARCHERS IDENTIFY VISUAL SYSTEM CHANGES THAT MAY SIGNAL PARKINSON’S DISEASE

‘INDIA SHOULD TAKE LEAD IN SETTING STANDARDS FOR ANTIBIOTIC CONTENT IN PHARMA WASTE’

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EXPRESS PHARMA

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July 16-31, 2017

EDITOR’S NOTE

A wake up call for serialisation laggards

P

harma companies exporting to the US market who had their eye on the November 2017 deadline to comply with the US Drug Supply Chain Security Act (DSCSA), have got a welcome breather. A draft guidance on June 30 announced that enforcement of the serialisation compliance would be delayed by a year, though the DSCSA will roll out as scheduled this November 27. Companies exporting to the US will be still legally required to print a unique product identification code (equivalent to the barcode on all items in a supermarket) on all prescription units of sale and homogenous cases distributed within the US market but the authorities will not take action against those which are yet to put in place these systems.

The US FDA’s draft guidance document comes in response to the feedback from manufacturers and their trading partners ‘expressing concern with industry-wide readiness for implementation of the product identifier requirements for manufacturers.’

Stakeholders specifically described challenges with implementation of product identifier requirements due to a limited number of vendors with the expertise to provide solutions related to information technology systems for data management or specific equipment for packaging or manufacturing lines.

The second challenge related to capabilities and readiness of contract manufacturing operations.

Some of these concerns were discussed at ISPE’s Inaugural Pharmaceutical Serialisation Workshops held over May 8-9 where solution providers and pharma companies recounted experiences of first movers in the serialisation world, like Turkey and India. Speakers included

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Industry sources warn that more stringent enforcement of the DSCSAcan be expected post November 27,2018,given the extra year of leniency

regulators like Richard Andrews, Unit Manager, Inspectorate Operations, MHRA, UK and Connie Jung, PhD, RPh, Senior Advisor for Policy, FDA/CDER/OC, US. These discussions evidently convinced the authorities that this grace period would ‘minimise possible disruptions in the distribution of prescription drugs in the United States.’

But experts caution that this is still only a draft guidance, and this delay does not change their legal responsibilities post November 27, 2018. The draft guidance clearly states that, ‘a manufacturer must still validate any applicable transaction history and transaction information in its possession if the manufacturer has determined that a product in its possession or control is a suspect product or if the manufacturer receives a verification request from the FDA or an authorised trading partner that is in possession or control of such product.’ The same goes for repackagers, wholesale distributors, and dispensers who have products without identifiers post November 27, 2018.

Thus contract manufacturers will have to use this additional time wisely and ensure they are compliant at least by the first quarter next year.

Industry sources warn that more stringent enforcement of the DSCSA can be expected post November 27, 2018, given the extra year of leniency.

Clients who view serialisation not just as a regulatory diktat, but a strategic opportunity to glean more insights from the mammoth quantities of data generated during serialisation, will be best positioned to meet the deadline.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET I N T E R V I E W

‘We are interested in exploring opportunities in upcoming pharma cities’ Ashish Pruthi, CMD, Rajasthan Antibiotics Limited (RAL), in an interaction with Prathiba Raju, elaborates on how APIs has become an important arm of the pharma sector and how GST will impact the API industry

Incorporated in 1986 and commenced commercial production in 1991, how has RAL evolved during these years?

RAL is a sterile injectible manufacturing unit and we manufacture sterile APIs. We have recently put up a new plant for sterile formulation as well.

This was the first company to launch chloramphenicol sodium succinate in 1991 and the technology was sourced from Europe. RAL has five lyophilisers and crystalline plants to manufacture sterile APIs. Currently, these are the only two technologies available in the international market, which are required to manufacture sterile bulk drugs and RAL has implemented both the technologies at its plant located at Bhiwadi, Rajasthan.

Since 2014, we started a new plant for sterile lyophilised vials and dry powder vials. Now, we have three segments — penicillin, cephalosporin, general formulations / APIs and all injectibles. The Bhiwaidi facility is spread across two acres and we will acquire some more land to set up a third unit with an investment of ` 15 to 20 crores. It will be a combination plant of formulations and APIs. Last year, we had a turnover of ` 163 crores and we target to achieve more than ` 200 crores this year.

How big is the API market in India? What will be the future growth rate and what are the potential growth factors?

It is niche market compared to oral tablet and capsules because these are injections only used in hospitals. It is not

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“

Five per cent for life saving medicines (zero earlier), twelve per cent on formulations and 18 per cent on APIs are more or less in line with what the industry was expecting but a larger concern for the industry is how the transition to the rates shall be made. The rate on APIs prior to GST was also more or less around 18 per cent with other taxes. So it makes a lots of difference Ashish Pruthi, CMD of Rajasthan Antibiotics Limited

for day-to-day use and mainly these are antibiotics. The antibiotics market are growing at the rate of 15 per cent.

registration fee is too high.It is easier to foray into the South East Asian countries and Central America.

You have a presence more in Latin American countries.

What is the reason?

In 2008, RAL’s prime focus was Latin America as the demand for the product and market was very conducive. As of now, RAL has 35 per cent export turnover from Latin American countries i.e. (` 30 crores). We want to increase it to 45 to 50 per cent this year by launching the formulations. The main focus countries in Latin America are Argentina, Brazil, Columbia and now we are venturing into Mexico as well. Apart from Latin American countries, RAL has well established clientele in several other countries like Europe, China, Brazil, Indonesia, Bangladesh and the UAE. We are not exploring the US market right now as the

Despite India being a leading player in generics, what is the reason for the overall dependence on China for API? Since the last 30 years, India has seen a faster growth in the pharma industry. When it comes to APIs, Indian pharma companies shifted its focus on high-end formulation where the profit is more. Gradually the focus shifted to China. In order to be self dependent, India has to do backward integration. For example, we plan to start manufacturing products like Tazobactum and Meropenem, which are high-value imports from China. India should emphasise on its own production capabilities and the government should give incentives. The government

gives a lot of tax holidays to formulations to create pharma industrial centre like Baddi.

Similarly, the API industry should be incentivised. We are interested in exploring opportunities in the upcoming pharma cities, but we have to check how cost-effective it is.

Incentives like cheaper power, common effluent treatment plants,central tax benefits are expected from such pharma cities.

Will GST benefit the Indian pharma manufacturers by rationalising the tax structure and optimising distribution? Which lifesaving drugs and APIs should be exempted from the GST regime?

Five per cent on life saving drugs (zero earlier), 12 per cent on formulations and 18 per cent on APIs are more or less in line with what the industry was expecting but a larger concern

for the industry is how the transition to the rates can be done. The rate on APIs prior to GST was also more or less around 18 per cent with other taxes. So, it makes a lotof difference.

What is your take on price capping of drugs by NPPA, as it caps prices for about 376 drugs, under the schedule I of Drug Price Control Order.

We have the cheapest medicine available in India, at the same time we maintain the quality and standards. When there is a price cap on a product everybody focuses on APIs. Unlike the packaging and other segments, API is the biggest part of pharma sector. So they should let APIs survive. We manufacture in very highly regulated quality atmosphere and invest a lot in technology.

Which cost-effective measures do you follow while manufacturing high quality and safe medicines?

We are sterile bulk manufacturers and we are into dry filling of the lyophilised or lyophilised viles which is NC2.

With our technology and trials we have converted lyophilised vail into lyophilised APIs. It has been a huge success and they are cost-effective. If you do NC2 lyophilisation of a vial you can do a batch size of 20,000 vials a day but with our product prelyophilised and ready to fill method, we make about 50 to 100 kg product per day and it can fill 100,000 vials a day. More such research is going on for example on teicoplanin, caspofungin, voriconazole. prathiba.raju@expressindia.com

MARKET GROWTH TRACKER

IPM clocks ` 115,644 crs in May 2017 The anti-diabetic market continued with a strong growth of 21 per cent valued at ` 790 crores THE INDIAN Pharmaceutical Market (IPM) was valued at ` 115,644 crores and the retail sector was valued at ` 97,269 crores as of MAT May 2017 with a monthly value of ` 9767 crores growing at seven per cent over last year.

Top 10 companies continued to have a 43 per cent share in the IPM and reflected a collective growth of eight per cent for the month with Lupin showing a strong growth (16 per cent) and an improved share over the last three months. Companies in the 11-20 and 21-30 bracket grew slower at six per cent and five per cent respectively.

Three of the top 10 companies grew in double digits while five of them grew faster than the market. MSD grew by 23 per cent and showed the fastest growth among top 30 companies.

Amongst the 11-20 companies, Pfizer (-9 per cent) and DRL (-3 per cent) reflected negative growth while Emcure (three per cent) grew slower than the market. Four of the 11-20 companies, Aristo (10 per cent), Glenmark (11 per cent), USV (11 per cent) and Micro Labs (11 per cent) grew in double digits.

Irrespective of the GST cloud, we do see a very strong trend for the Top 10 brands of IPM where all the brands valued at ` 326 crores have shown strong double digit growth rates at 21 per cent over last year. Mixtard and Glycomet-GP continues to maintain at number one and two positions respectively where Mixtard shows robust growths at 21 per cent and Glycomet GP maintains consistency. Janumet, Spasmo Proxyvon and Lantus maintain their position in top five whereas we do see Prevenar entering Top 10 brands list in May 2017. Galvus Met has revived their growths for the month which has also im-

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SNAPSHOT OF TOP 150 COMPANIES

Top 10 companies constitute ~ 43 per cent share of IPM on MAT and month basis The top 150 companies continue to account for 97 per cent of IPM on MAT and month basis ● For both MAT and month,Top 20 companies contribute to 64 per cent ● Growth of the top companies slowed down, highest growth is in the companies ranked between 31-40 Source: QuintilesIMS TSA & SSA, May 2017 ● ●

TOP 40 BRANDS

Mixtard continues to be the top brand with a MS of ~0.5% Janumet, Duphaston and Spasmo Proxyvon + have shown phenomenal growths in May 2017 ● Other brands with remarkable growth are Lantus, Pan D, Betnovate, Udiliv, Istamet and Synflorix Source: QuintilesIMS TSA & SSA, May 2017 ● ●

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MARKET proved its rank to number six compared to April. Other brands with remarkable growth are Lantus, Pan D, Betnovate, Udiliv, Istamet and Synflorix.

With a 78 per cent share in the IPM, Indian companies continued to dominate in the month of May 2017 with a growth of eight per cent which is slightly better than market.

MNCs reflected a six per cent growth for the month. However, top MNCs like Abbott (11 per cent), GSK (eight per cent) and Sanofi (nine per cent) grew faster than the market for the month. MSD (23 per cent) reflected a growth above 20 per cent for the fourth month in a row.

While acute therapies continue to hold a massive share of IPM with a 64 per cent contribution to the total market, the chronic therapies grew at a decent double digit growth of 11 per cent. While anti-infectives remains the largest super group on MAT basis, on a monthly basis anti-infectives has been stagnant and therefore cardiac and gastro intestinal move up to number one and two positions with eight per cent and six per cent growths respectively. Anti-diabetic continues very strong growth of 21 per cent valued at ` 790 crores for the month.

Amongst the top contributors, DPP IV Inhibitors and combination dominates at number one position with a robust 31 per cent growth. Except food supplements the other top contributors like Glimepiride+ Met, Insulin and Cough Prep have shown a strong 20 per cent growth rates for the month.

Cardiac therapy area is the number one therapy for the month, clocking a revenue of ` 1195 crores with a growth rate of eight per cent.

Amongst the top molecules of this segment, the plain molecules except Rosuvastatin and Olmesartan have shown degrowth for the month owing to impact of regulatory price reduction. However, we do see a good growth in combination molecules of Amlodipine Telmisartan and also with HCT with Telmi + HCT at 12 per cent followed by Amlodip-

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THERAPY TRENDS

Cardiac therapy and GI constitute the largest market share in IPM occupying 12 per cent share each Anti diabetics and vaccine registered a growth of around 21 per cent and 16 per cent respectively for the same period last year ● Hormones and oncology market have de-grown by eight per cent and three per cent respectively, while rest of the therapies grew over previous month Source: QuintilesIMS TSA & SSA, May 2017 ● ●

ine + Telmisartan at 20 per cent respectively.

Anti-infectives continued to be stagnant and showed a zero per cent growth in the month of May 2017, making it the only second therapy area other than Gynaec in top 10 to reflect a growth of less than four per cent for the month. It continued to be at the third position below gastro intestinal for the second consecutive month and was valued at ` 1098 crores for the month of May 2017. Among large molecules Ceftriaxine Injectables (10.2 per cent) and Cefixime Oral Solids (-6.7 per cent) and Piperacillin + Tazobactam (0.6 per cent) showed a value de-growth for the month while only Meropenam (11.5 per cent) showed a double digit growth.

Gastrointestinals maintained its second rank for the second consecutive month with a revenue of ` 1130 crores and continued to show a steady growth of eight per cent over SPLY. Pantoprazole + Domperidone continued to show a strong growth of 14.3 per cent with the top brand PAN-D growing impressively with 24 per cent growth for

the month of May 2017. Pantoprazole oral solids (4.6 per cent) reflected growth slower than the therapy area for the month while Ranitidine Oral Solids (-12 per cent) continued it’s de-growth trend of the last few months. The Bacillus Clausii market continued its high growth trend with a 50 per cent value growth on the basis of many new launches.

Anti-diabetics continued to be the number four ranked therapy in IPM for the month of May 2017 growing at 21 per cent over SPLY. Amongst the Top 10 brands in entire IPM six brands belong to this category and all are growing robustly. While DPP4 inhibitors remains as the top contributor to the entire category we see SGLT2 inhibitor showing a massive growth of 134 per cent for the month. Except Metformin which has shown de-growth of two per cent we do see strong higher double digit growths across Top 10 molecules indicating expansion of this therapy.

Teneligliptin and combinations have reflected a robust growth (51 per cent) with Top brands like Tenglyn (41 per cent) Dynaglipt (94 per cent)

and Tenlimac (104 per cent).

Dermatology, the second fastest growing therapy area in IPM clocked a growth of 14.5 per cent SPLY with a value of ` 701 crores. Emollients continues to be the largest sub category with a 12.5 per cent growth while Itraconazole remains to be the fastest growing molecule at robust 101 per cent growth for the month. Luliconazole amongst the newer entrants has made an entry amongst the Top 10 molecules in dermatology with 16.5 crore value for the month. All the top 10 brands of Itraconazole market are growing above 40 per cent growth rates with IT-MAC at number two position with highest growths of 176 per cent for the month.

Neurology grew at par with the market with a 7.2 per cent growth for the month over SPLY, Levetiracetam remained the largest molecule in the therapy area with a value of ` 45 crores with a seven per cent growth for the month which has been declining over the last three months. Escitalopram + Clonazepam reflected a healthy growth of 15 per cent with a

value of ` 21 crores for the month while Betahistine grew strongly at 19 per cent. Plain Escitalopram was the only molecule in the top 10 to reflect a value de-growth to the tune of -2 per cent for the month while clonazepam also showed a stagnant growth of just one per cent.

Global (April 2017) The global pharma market is valued at $1071 billion growing at 3.8 per cent. The US continues to dominate the market with 42 per cent market share with growth of 3.3 per cent.

Amongst the top market, India has moved a couple positions down and is ranked 11th.

Only markets in the top markets with more than 10 per cent growth are Venezuela, India, Russia and Brazil. All Top 5 EU markets are de-growing as per April 2017 data.

Indian companies hold 1.4 per cent share in the global market as per April 2017 data.

For the month of April 2017, the IPM showed growth and all top 10 companies showed growth. Top 10 companies contributed to 43 per cent market share in India.

MARKET POST EVENT

Signet & Roquette conduct technical seminar across four cities The seminar aimed to impart knowledge about Roquette’s excipients used for solubilisation, coating, oral films and other novel drug delivery systems SIGNET AND Roquette recently conducted technical seminar in four different cities — Mumbai, Hyderabad, Bengaluru and Ahmedabad. The event was attended by 390 participants from 107 pharmaceutical companies. The seminar aimed to impart knowledge about Roquette’s excipients used for solubilisation, coating, oral films and other novel drug delivery systems.

Five eminent speakers shared their expertise and experience in their respective fields. Dr Rikhav Gala from Department of Pharmaceutical Sciences, Mercer University presented on ‘Oral dissolving film and Nanovaccines for infectious diseases and cancer via novel delivery techniques such as microneedles.' He explained the use of Lycoat in oral dissolving films containing vaccine microparticles.

Philippe Lefevre, Global Tech. Application Specialist of Roquette shared his views on

‘Pregelatinized Starches in Pharmaceutical formulations’.

He detailed on the use of Lycatab C and Lycatab C-LM in different processes like capsule filling, wet granulation and direct compression.

‘Understanding Tablet Compaction: Correcting the elastic-plastic balance’ was

elaborated by Dr Paul WS Heng from National University of Singapore. He explained the importance of understanding excipient properties to achieve robust tablet manufacturing.

Dr Bing Tan from Roquette presented ‘Solutions for Solubility Enhancement and Taste

Masking’ by using Kleptose HPB and Kleptose HP. He also introduced Kleptose Linecaps, a pea maltodextrin having molecular encapsulation ability used in different process including Hot melt extrusion.

Dr Xavier Parissaux introduced Lycoat and ReadiLycoat in his topic ‘Modified starches

in coating applications’. It provides low viscosity and high solid content solution for quick coating without the use of fillers ensuring perfect stability and film strength. The sessions catered well to the current formulation needs of the industry.

EP News Bureau

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EXPRESS PHARMA

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cover )

n 2010, Dr Surinder Singh, Former DCG(I), launched the Pharmacovigilance Programme of India (PvPI) with the objective of studying the adverse effects of drugs, to strengthen the number of drug inspectors and to maintain quality parameters in countries from where India imported drugs. In observance of Pharmacovigilance Day, let’s examine the progress of the PvPI programme so far.

I

Improved ADR reporting Commenting on the progress so far, Dr Renuka Munshi, Coordinator, AMC, TN Medical College & BYL Nair Hospital says, “In the last seven years, the programme has been progressing in leaps and bounds. Recently, PvPI has also taken the responsibility of reporting adverse events due to medical devices and has initiated the process of reporting adverse events due to drugs used for vector-borne diseases like Kala-azar.

We have more than 250 ADR monitoring centres, which have been involved in the activity. Programmes like Revised National Tuberculosis Control Program (RNTCP) and ART and their respective centres have been roped in to report ADRs.”

Enhanced Data Collection PvPI has contributed numerous data to the WHO-Uppsala Monitoring Centre (UMC) and Central Drugs Standard Control Organization (CDSCO). Quality checks of the submitted ADRs is done by National Coordinating Centre (NCC) and queries sent to respective ADR Monitoring Centre (AMC). There has been a positive impact on the quality of Indian

20 EXPRESS PHARMA July 16-31, 2017

NEED FOR CONSTANT VIGILANCE An analysis on the progress of India’s pharmacovigilance programme

By Usha Sharma

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THE MAIN FOCUS

EXPRESS PHARMA

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July 16-31, 2017

cover ) Society for Clinical Research (ISCR) submitted to AMC at Uppsala. During 2014-2015, the completeness score of the ISCR reports submitted by India to Uppsala has been as high as 0.92 out of a total score of 1. The fact that the Medical Council of India (MCI) has also made it mandatory for medical colleges to incorporate ADR reporting to PvPI as a Minimum Standard Requirement (MSR) for those medical colleges seeking MCI recognition has given added impetus to the programme.

Private sector participation Munshi informs, “Another feather in the cap of the PvPI programme is the involvement of private hospitals and physicians into the system.

The NCC has signed an MoU with NABH to promote monitoring and reporting of ADRs

by National Accreditation Board for Hospitals & Healthcare Providers (NABH) accredited hospitals to PvPI. Similarly, an MoU has been signed with the Indian Medical Association (IMA) to encourage private physicians to submit ADR reports. The programme also encourages patients/consumers to report ADRs directly into the PvPI system using the PvPI toll free number.”

T

he World Health Organization (WHO) defines pharmacovigilance (PV) as the science and activities related to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.The significance of PV is well acknowledged in both, developed and developing countries. Still the word is more prevalent and practiced in Western countries than India. During the 70s, there were several incidents of adverse drug reactions (ADRs), which prompted the decision to formulate a discipline to measure the safety of drugs. During 1989-2004, several attempts were made to start a PV programme in India.

report is captured in order to have better assessment of the benefit-risk ratio of the drugs that are present in the Indian market. They have toll free numbers to report any side effects as well as forms in many languages that can be filled up by patients/healthcare professionals and submitted to the nearest centre.

Dr Subhash C Mandal, Chairman, Regulatory Affairs Division, Indian Pharmaceutical Association updates, “The pharma industry is already providing PSUR data to the CDSCO as per the requirement of the Drugs Act & Rules. As a result of the recent mandate, ones which do not have PV system for ADR reporting are in the process of setting up the same.”

Though PV is well practiced in developed countries, multinational pharma companies operating in India realised that they too need better understanding in this arena.

Introducing post-marketing PV

Educating the industry

An entire foundation was set up by the regulators to introduce post marketing PV into PvPI, an endeavour which had failed in the previous two attempts. Most of the post marketing PVs such as assessing Periodic Safety Update Reports (PSUR), every adverse event report generated from the market, signal management and further increasing awareness of PV among the general public, are now being assigned to PvPI. This programme is centered in more than 170 medical colleges and hospitals of India to ensure that every

Indu Nambiar, Senior Manager – Local Pharmacovigilance/LPVM, Boehringer Ingelheim India shared, “Being a part of a multinational company with the headquarters being regulated by EMA, our association with this word came in much earlier though we were based out of India.

Being associated with this function for the past 11+ years, I can confirm that a lot has been achieved. In the initial stages of my association with this function, I would admit, I hardly knew about this function. The start was to internalise the concept of PV; self

22 EXPRESS PHARMA July 16-31, 2017

understand the importance of this function, how it helps in protecting a company’s credibility and data and how it touches and safeguards the biggest customer pool of any pharma company – the patients followed by the healthcare professionals.”

Growing regulatory role PV remains a dynamic clinical and scientific discipline. It continues to play a crucial role in meeting the challenges posed by ever increasing range and potency of medicines. Robust regulatory arrangements are undertaken to strengthen PV activities. PvPI encourages reporting of all drug-related adverse events, even if they seem to be insignificant, keeping in mind that it may be important since it may highlight a widespread prescribing problem. In addition to regular medicines, the safety of complementary and traditional medicines, vaccines and biological medicines is carried out.

New developments Dr Raman Mohan Singh, Director, Central Drugs Testing Laboratory (CDTL), Mumbai, shares information about new developments initiated under the programme and says, “Under the umbrella of PvPI, two more programmes, Haemovigilance Programme of India and Biovigilance Programme of India are taken care by NIBNoida.”

He further informs, “PvPI system in India has been declared functional with a maturity level of four by

WHO-NRA team which is the highest level as per the currently evolved definitions.

Standard guidelines for PV in India will truly serve the purpose of ensuring safety of our patients. It is important that medicines developed for treatment, actually do not do more harm than good, and that is the pre-requisite for the progress of the medicine.

PV organisations should evolve in future by embracing the conservative approach of precluding direct patient contact and taking inputs from all platforms, right till the nursing staff, paramedical staff and end users.”

Ushering a new era for PV Both the industry as well as regulatory bodies are working towards instrumenting a system which will work effectively. Deepa Arora, Vice President-Pharmacovigilance and Global Head- Drug Safety and Risk Management, Lupin states, “CDSCO’s release of draft revised PV guidelines for industry signals the start of a new era for PV in India.

PvPI has relentlessly worked with the industry for preparing these guidelines.”

She elaborates with an example that PvPI is regularly sharing signals detected by them with industry through newsletters as well as text messages. Intensive monitoring is especially important with new drugs like Bedaquiline. It is a new antitubercular drug and as India is the biggest market for this drug, collaboration of PvPI and Central TB Division is useful in particular for fully understanding the safety of Bedaquiline.

The above moves are sign of actions that have been taken at the right time, however, a country like India where health and medicine literacy is not well developed, self-medication and incorrect use of non-prescription as well prescription medicines is common. In such a scenario, pharmacists play a significant

In the last seven years, the programme has been progressing in leaps and bounds. Recently, PvPI has also taken the responsibility of reporting adverse events due to medical devices and has initiated the process to report adverse events due to drugs used for vector-borne diseases like Kala-azar Dr Renuka Munshi Coordinator, AMC, TN Medical College & BYL Nair Hospital

As a result of the recent mandate, ones which do not have PV system for ADR reporting are in the process of setting up the same Dr Subhash C Mandal Chairman, Regulatory Affairs division, Indian Pharmaceutical Association

( role in early detection, reporting and most importantly prevention of ADRs.

Pivotal role of community pharmacists

India is one of the largest user of alternate medicines, would be particularly useful if PvPI and AYUSH can collaborate to identify adverse reactions associated with use of various alternate therapies commonly used in India like Ayurveda, Unani and homeopathy Deepa Arora Vice PresidentPharmacovigilance and Global Head- Drug Safety and Risk Managment, Lupin

There are many loopholes that need to be addressed, which will take time. With the kind of start that has been witnessed, it can be ensured that success is not very far

According to a research study titled, 'Improving pharmacovigilance and the role of the pharmacists’ research studies, the highest percentage of pharmacists' reports received via spontaneous reporting systems were recorded among community pharmacists in Canada

(89 per cent), Australia (41 per cent), The Netherlands (40.2 per cent), Spain (26 per cent) and Portugal (24 per cent). Presently, India has more than 250 ADR monitoring centres (AMCs) across the country, which are functioning under the PvPI monitored by NCC at IPC Ghaziabad. Since the objective of the programme is to deliver safe medicines to consumers, pharmacists have an important responsibility in monitoring the ongoing safety of

THE MAIN FOCUS

medicines.

Manjiree Gharat, VicePresident, Indian Pharmaceutical Association, Chairperson-Community Pharmacy Division, and Vice-Principal, Prin KM Kundnani Pharmacy Polytechnic, Ulhasnagar, Maharashtra, says, “Community pharmacists are the first point of contact for people with symptoms and the last point of contact for those who buy medicines having prescriptions. Since the incidence of ADRs is more

than 50 per cent in community settings, community pharmacists overseas are playing a vital role in monitoring and reporting ADRs to their respective national PV programme.”

Research evidence suggests that on a global scale, major improvements can be made and the extent of ADR and other drug-related problems under reporting can be considerably reduced by actively involving pharmacists in surveillance of drug

OUTCOME OF PHARMACOVIGILANCE PROGRAMME OF INDIA (PVPI) On the basis of ADR identified by PvPI, the following steps have been takena. National coordination Centre (NCC) of PvPI advises Healthcare Professionals, Patients/Consumers to closely monitor the possibility of certain adverse events while prescribing/consuming 49 drugs. b. NCC-PvPI has made several evidence based recommendations on Drug safety, which are given in the Table-I

TABLE-I Sl. No.

Drugs

Adverse Reactions

Recommendation of PvPI to CDSCO

CDSCO initiative

1

Lamotrigine

Steven Johnson Syndrome,Toxic Epidermal Necrolysis

For Label change

In process

2

Ceftriaxone

Steven Johnson Syndrome

For Label change

In process

3

Betamethasone

Photosensitivity Reaction

For Label change

In process

4

Azithromycin

Acute Generalized Exanthematous Pustulosis

For Label change

In process

5

Cloxacillin

Acute Generalized Exanthematous Pustulosis

For Label change

In process

6

Ranitidine

Cardiac arrest

For Label change

In process

8

Surfactant

Pulmonary Haemorrhage

For Label change

In process

REGULATORY ACTION ON THE BASIS OFADR REPORTS a. On the basis of PvPI recommendations CDSCO has taken the following actions as in Table-II

TABLE-II Sl. No.

Drug

ADR

CDSCO action

1

Carbamazepine

Stevens Johnson Syndrome and Toxic Epidermal Necrolysis

CDSCO instructed Marketing Authorizing Holder (MAH) to comply the same

2

Mannitol

Hypokalaemia

Approved in the Subject expert committee ( SEC) of CDSCO

3

Rotavirus Vaccine

Intussusception

Approved in the SEC of CDSCO

Indu Nambiar

4

Piperacillin & Tazobactam

Hypokalaemia and Bronchospasm

CDSCO instructed to MAH to comply with the same

Senior Manager – Local Pharmacovigilance / LPVM, Boehringer Ingelheim India

5

Anti Rabies Vaccine

Erythema Multiforme

CDSCO instructed to MAH to comply with the same

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cover )

Since the incidence of ADRs is more than 50 per cent in community settings, community pharmacists overseas are playing a vital role in monitoring and reporting ADRs to their respective national PV programme Manjiree Gharat Vice-President,Indian Pharmaceutical Association and Vice-Principal, K M K Pharmacy Polytechnic, Ulhasnagar

Under the umbrella of PvPI, two more programmes, Haemovigilance Programme of India and Biovigilance Programme of India are taken care by NIB-Noida Dr Raman Mohan Singh Director, Central Drugs Testing Laboratory (CDTL), Mumbai

24 EXPRESS PHARMA July 16-31, 2017

safety. She adds, “Sensitisation of consumers by the pharmacists to talk about the side effects if any, experienced by them can help in increasing ADR reporting and for further prevention of such ADRs. Pharmacists can actively counsel patients on responsible use of medicines, which will improve safety profile of the drugs and will in turn reduce ADRs.”

Towards a bright future Success of the programme has already begun and all stakeholders have started noticing it. Munshi informs, “The biggest benefit to AMCs is access to Vigiflow, which is a WHO software where entries can be made on adverse drug reaction reports. In previous programmes, hard copies of reports were submitted to the NCC, which were hand written and resulted in errors.

Now with the centres doing it directly, the responsibility and ownership lies with individual AMCs. The programme has also appointed PV/Technical Associate/s (PvA0) to various AMCs to help them in the task of collecting ADR reports and submitting the same to NCC. NCC also organises training programmes for newly recruited AMC co-ordinators and PvAs at regular intervals. It also provides funds for selected regional AMCs to organise training workshops in PV in that region.”

Nambiar mentions, “The concept of PV is still an area

Way forward

A

survey conducted by TN Medical College & BYL Nair Hospital, AMC among patients/consumers from different age groups and educational level regarding the PV programme and the importance of reporting ADRs made us realise that the impact has not yet reached the end user i.e. the patient.Although most of the consumers/patients interviewed were aware that drugs can cause adverse reactions, most of them, irrespective of the age group or education level, had very little information (max 20 per cent had some knowledge) regarding the PV system and the need to report ADRs.Although 70 per cent of the responders felt that patients too should report ADRs; however, majority (95 per cent) said that they were more comfortable reporting the ADRs to their family physicians. Most of the responders, in the younger age group (1835 years), were willing to report ADRs in the future; however, they wanted access to more information regarding how, what and where to report ADRs.The mobile app for reporting ADRs prepared

by PvP would be a useful alternative to this generation to encourage reporting.

of fear for a majority of the stakeholders, which is self-created. Every possible opportunity and forum will be utilised to clear this misconception. In an effort towards this, the Indian Society for Clinical Research (ISCR) forum was convinced to form a PV Council that was established in early 2015.

Many other bodies have been formed in order to strengthen this function and bring about a revolution in this field. The PvPI team is also involved in developing guidelines on good PV practices which will soon see the light of the day. The team also offers courses for professionals in order to make them enlightened on this subject and understand their responsibilities. PvPI has now teamed up with industry bodies as well and this collaboration would definitely be beneficial for India.”

Gharat highlights, “Recently, PvPI has constituted

a national level advisory committee consisting of various experts to engage community pharmacists in PvPI. Training module will be finalised and conducted for pharmacists. Posters to create awareness about the ADR reporting, helpline numbers will be displayed in pharmacies. This is a welcome step and was most needed for initiating involvement of community pharmacists in PV. Pharmacy Practice Regulations 2015 (PPR 2015) released by Pharmacy Council of India also include ADR reporting as one of the professional responsibilities of the pharmacists. Indian Pharmaceutical Association (IPA) has been running a Campaign on Awareness on Responsible Use of Medicines (CARUM) and role of pharmacist. Thus, efforts from various stakeholders have begun to develop the new role of the pharmacist.”

According to a research study, the highest percentage of pharmacists’ reports received via spontaneous reporting systems were recorded among community pharmacists in Canada (89 per cent), Australia (41 per cent), The Netherlands (40.2 per cent), Spain (26 per cent) and Portugal (24 per cent)

In the last seven years, many activities have been undertaken to improve PV in India and build it into a robust system. Yet, there is a long way to go for PvPI. Arora suggests, “Information about adverse reactions of alternate therapy, as India is one of the largest user of alternate medicines, would be particularly useful if PvPI and AYUSH can collaborate to identify adverse reactions associated with use of various alternate therapies commonly used in India like Ayurveda, Unani and Homeopathy.”

Munshi point outs, “The downside is that in spite of all these efforts, it is still difficult to change the mindset of the clinicians and get them to submit ADR reports, especially those in the private sector.

The ground reality is that physicians are reluctant to complete the ADR forms and sign the same for various reasons – fear of litigation and medico-legal repercussions being the main issues. Often the reply received when requested for ADR reports is that they see only the common, known adverse reactions and so don’t feel the need to report the same again.

Another area that needs focus is the end user i.e the patient.”

She further says, “PV programme is definitely moving in the right direction and has taken giant steps to live up to its motto of ‘Let’s join hands to promote patient safety' wherein it has taken efforts to bring together all stakeholders, both public and private, regulators, industry, academicians, physicians, pharmacists, nurses and other paramedical staff and most of all the patient on one common platform to promote safe use of drugs.”

Nambiar points out, “There are many loopholes that need to be addressed, which will take time. However, with the kind of start that has been witnessed, it can be ensured that success is not very far.” u.sharma@expressindia.com

(

THE MAIN FOCUS

I N T E R V I E W

Long-term goal of PvPI is to develop e-reporting and reporting culture among HCPs Dr GN Singh, DCG(I) and Secretarycum-Scientific Director, IPC and Dr V Kalaiselvan, Principal Scientific Officer, IPC, in an interview with Swati Rana speak on PvPI’s progress, various skill development programmes and steps taken to spread awareness in rural areas on ADR reporting Pharmacovigilance Programme of India (PvPI) was initiated in July 2010 with an aim to monitor and report ADR across the country. Brief us on the current status of PvPI and PvPI's short term as well long goals?

A robust and stable system of PvPI has been established under the aegis of Indian Pharmacopoeia Commission (IPC) to monitor, report, collate and analyse adverse drug reactions. In order to ensure a stable PvPI system, the guidance and support from MoH&FW, commitment and support from DCG(I) and CDSCO officials is

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cover ) overwhelming. Hence, the current pharmacovigilance system in India has reached an advanced stage.

Our short-term goals are to develop and implement pharmacovigilance system in India, recognising MCIapproved medical colleges as ADRs monitoring centres and encourage healthcare professionals (HCPs) in reporting adverse events associated wit the use of pharma products. Long-term goals are to expand the PvPI to all hospitals and centres of public health programmes located across the country, to develop electronic reporting system and develop reporting culture among the HCPs. It's being seven years since PvPI was launched in India.

How was the journey so far and what were the challenges?

Yes. PvPI is seven-year-old and has become a flagship programme in the country.

When we took charge as NCC, we realised that there is a huge need of capacity building at NCC and also AMC. Therefore, efforts were taken to develop infrastructure, appointing manpower etc., both national and regional level - we succeed! Also, there was a great need of training and education needed on pharmacovigilance for those working in PvPI. In addition to this, to impart pharmacovigilance education and training, 10 zonal training centres have been identified, which are functioning under the umbrella of PvPI. PvPI also integrates with various public health programmes to monitor the safety of drugs and vaccines used in their respective programmes. NCC has introduced various tools for ADR reporting by the HCPs and patients such as reporting form in vernacular languages, mobile app and helpline (tool free). The biggest achievement, is the amendment in Schedule Y of

26 EXPRESS PHARMA July 16-31, 2017

At present there are around 250 Adverse drug Monitoring Centre (AMC) across the country. Explain the functioning of AMC and tell us about the number of upcoming AMCs in 20172018.

The AMCs are responsible in monitoring and reporting ADRs. They are routinely engaged in motivating HCPs to monitor adverse events.

AMCs are the backbone of PvPI in providing clinicaloriented and India-specific ADRs so that the meaningful information shall be used for protecting the safety of the population. In the upcoming year 2017-18, NCC plans to recognise 50 more hospitals as AMCs.

PvPI data is effectively utilised by the CDSCO for taking regulatory decisions Dr GN Singh DCG(I) and Secretary-cum-ScientificDirector, IPC

D&C Rules 1945 for establishment of pharmacovigilance system at marketing authorisation holders.This provides a huge opportunity to the industry to participate in PvPI. Since quality management system has been put in place to manage the PvPI activities, the completeness score of the date generated from Indian patients is ahead of other countries. SMS facility (drug alert) is being well received among the HCPs. Interestingly, the PvPI data is effectively utilised by the CDSCO for taking appropriate regulatory decisions.

monitor the safety of medicines used in private sectors.

Any further collaboration or MoU that will be signed globally?

IPC, NCC-PvPI is going to be declared as WHO collaborative centre for pharmacovigilance in national health programmes and regulatory capacity-building for pharmacovigilance in public health programmes and regulatory services in the WHO South-East Asia Region.

What are the plans to expand pharmacovigilance programme to govt as well as private hospitals? At present, how many hospitals report on ADR? IPC, NCC-PvPI is planning to enrol all government and private hospitals to participate in PvPI. A circular from MoH&FW has been sent to states and UTs to adopt pharmacovigilance in the practice of HCPs. In January 2017, IPC signed an MoU with National Accreditation Board for Hospitals (NABH). Tell us more on this initiative.

What are the numbers of ADR reported from NABH hospitals till date?

After having an MoU with NABH, series of training programme for the NABH hospitals in reporting ADRs is conducted across the country. In order to promote ease of doing pharmacovigilance by the hospitals, reporting of ADRs to PvPI will only be accountable during the NABH accreditation or renewal (no need of duplicate reporting). Now NABH accredited hospitals begin reporting to their nearby or preferred AMCs. This arrangement will boost to

IPC, NCC-PvPI plans to recognise 50 more hospitals as AMCs Dr V Kalaiselvan Principal Scientific Officer, IPC

How PvPI is planning to expand its scope of activities to widen its reach to other healthcare professionals?

The current system of PvPI, engages with HCPs such as

doctors and clinical pharmacists. Since nurses and community pharmacists are important stakeholders of pharmacovigilance, steps are being taken to motivate/empower them in reporting ADRs. What kind of training and skill development programmes are organised under PvPI? As we mentioned, NCC and AMCs are jointly conducting CMEs (pharmacovigilance) programme, orientation/induction-cum training programme etc. for better pharmacovigilance and harmonised pharmacovigilance practices.

In addition to this, to provide an opportunity to the HCPs and students across the country, a nationwide 10-day skill development programme is conducted by the IPC. So far, four skill development programmes have been successfully conducted where 220 participants were benefited.

What steps have been taken to spread awareness on ADR reporting in rural areas?

AMCs in association with NCC are taking keen interest to promote PvPI in rural areas. To make public aware about the benefits of PvPI, the concept and importance of ADRs reporting is covered in regional newspapers and also transmitted through radio. IPC is working with Doordarshan to spread the message of pharmacovigilance, which will go a long way to educate the public particularly in rural areas.

Road ahead for PvPI a.Expansion of PvPI outreach to district and below level hospitals b.Self sustainability of the programme c.IPC to become a centre of excellence in pharmacovigilance swati.rana@expressindia.com

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EXPRESS PHARMA

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10166 0317

MANAGEMENT today, including India, it is important to assess the impact of AMR and what it is costs to the exchequer. It is necessary to develop new antibiotics, diagnostics, and vaccines as well as identify current gaps in knowledge and data on AMR by improved surveillance, which should focus on human health, agriculture and environment.

Next steps on the NAPAMR involve finalising a national research agenda and operational research plan on AMR. Governments across the globe are beginning to recognise the importance of funding and piloting research projects and developing new models to curb AMR in humans, animals, food and environment. Evidence-based AMR research will have a huge impact on the way the issue is viewed by policymakers and public alike. To strengthen India’s leadership on AMR, it has to build awareness across all stakeholders and improve its knowledge base.

Do companies in India need to work on technological improvements and requirements to measure Active Pharmaceutical ingredients (API) and antibiotic content in effluents?

While at present there are no minimum standards and guidelines for antibiotic content and guidelines in effluents, the NAP-AMR has expressly listed devising such standards as a target. However, even in the absence of such standards, it is important for pharma manufacturers to proactively monitor and treat their effluents to remove traces of antibiotics, in order to ensure the longevity of antibiotics and secure modern healthcare, which is key for our business continuity.

As pointed out by several reports from NGOs and academia, many manufacturers, especially around pharma hubs in Andhra Pradesh and Telangana do not have proper discharge controls in place, leading to the release of untreated waste into the environment or to common treatment plants, which are not adequately equipped to treat

28 EXPRESS PHARMA July 16-31, 2017

for antibiotic residues.

With some Indian players having signed the United Nations General Assembly UNGA Industry Roadmap for AMR, the situation will hopefully change. Already, the signatories have started to review their supply chains on environmental management and discharge performance, while improving their manufacturing and waste treatment processes. By doing so, we hope to set a benchmark for the rest of the industry.

The technology to treat antibiotic content in waste is not expensive and for sure much more economical than the costs caused by AMR. This needs to be highlighted among all concerned. With standards for antibiotic levels in pharma waste expected soon, the industry will need to up the ante and comply with the regulations.

Is there a global standard for the containment of antibiotic content in effluents? Any examples like Sweden?

Over the years, Sweden has established itself as the world leader in sustainable antibiotic use and production. Recently, it became the first country to notify standards on maximum antibiotic residue levels that can be discharged by pharma industry. Also, they have introduced mechanisms that include environmental criteria in sourcing decisions of buyers.

These standards have now been taken up for consideration by the European Union.

While no other country currently has residue limit standards for antibiotics in pharma effluents, India’s NAPAMR recognised this gap and has targeted setting up of such standards. It needs to be kept in mind that India along with China contribute to nearly 8090 per cent of the world’s antibiotic manufacturing, and accordingly bear the burden of pharma effluent-led AMR. It is therefore of prime importance for India to take the lead in setting standards for maximum limits of antibiotic content in pharma waste, so as to allow our citizens to lead healthy lives, without compromising our flourishing pharma

To strengthen India’s leadership on AMR, it has to build awareness across all stakeholders and improve its knowledge base manufacturing industry.

The AMR phenomenon is assuming the form of a serious public health issue in many developing and developed countries today.

What is the current scenario globally and where does India stand?

AMR is considered as one of the biggest threats to public health and global health security. This has been reiterated by the the World Health Organisation (WHO) and several UN agencies. The situation is such that Government of India has identified AMR as one of the top ten priorities for the Health Ministry’s collaborative work with the WHO. AMR has far reaching consequences and knows no geographical boundaries. The case of New Delhi metallo-beta lactamase-1

reaching practically all countries including the UK, the US and Sweden is a testimony of antimicrobial resistance travelling across the globe.

The only difference between developed and developing countries is that stricter rules and regulations along with national action plans have been initiated in most of the developed economies, barring few. Meanwhile, developing countries have delayed producing and formulating national action plans on AMR due to lack of resources and focus on other health and societal concerns. Except India, Vietnam and a few others, South Asian countries lag in giving attention to the issue it warrants. With the signing of the Delhi Declaration and the National Action Plan, a new phase of combating AMR has started. This has been a timely development since AMR contributes to over 7,00,000 annual deaths globally, and in India alone, more than 58,000 children die due to resistant infections every year. It must also be kept in mind that India and China contribute to almost 80-90 per cent of antibiotic production, so the burden of disease in these countries is higher due to impact of pharma effluents. Government reports state that the NAP-AMR too have stated that an estimated 4,10,000 children, aged five years or less, die from pneumonia in India annually. It is startling to observe that pneumonia accounts for almost 25 per cent of all child deaths in India. The crude mortality from infectious disease is 417 per 100,000 persons in India, which is huge and the impact of AMR is higher in the Indian setting.

The Red Line Campaign by the Government of India, which mandated having a red vertical line on the packages of all antibiotics is one such step to mitigate the risk of AMR and ensure availability of quality antibiotics.

Do you think a national consultation with various stakeholders and industry representatives like pharma companies is necessary?

The NAP-AMR calls for a multi-sectoral or a one-health

approach. This is much like the approach that is being taken in countries such as the Netherlands and Sweden that are leading in tackling AMR. Combating AMR through a multi-sectoral approach has been well taken in the National Action Plan, 2017. AMR occurs due to many reasons and it is imperative to look at it the various causes that lead to AMR. Some leading causes include inappropriate use of antibiotics among humans and animals, pharma pollution and hospital waste. The NAP document, through its six strategic points, recognises the need for involving industry bodies, both for developing and implementing a strategy and operational plan and defining standards for effluent plants to reduce environmental impact of AMR. The onus on the pharma industry and healthcare organisations to take this initiative forward, therefore, is very high as they are one of the most important stakeholders in tackling AMR. Impact of pharma pollution to AMR has been documented and studies have proven that pharma waste is a key breeding ground for resistant bacteria.

How important is it to regulate the pharma/ medical sector, with regards to the prescription of medicines. How dangerous is it to irrationally use antibiotics. Give some examples?

India is the largest manufacturer and consumer of antibiotics globally. The OTC sales of drugs and medicines is very high in India due to several factors such as easy access to drugs, high disease burden of TB, pneumonia and weak regulations. Also, it has a strong cultural element. What India needs at this point of time is to have stronger education fuelling awareness levels and stricter regulations where sale of antibiotics will be only through proper prescription from physicians. Presently, many of the last line of antibiotics such as carbapenems can be easily purchased from pharmacies in India without prescriptions.

Thus, it is imperative for the

MANAGEMENT government and the regulatory bodies to enforce stricter rules to prevent long-term negatives.

The recent report on 'The Selection and Use of Essential Medicines,' specifically touched upon reviewing antibacterials.

The report has added 10 antibacterials into essential medicines and 12 to the essential medicines for children and a new categorisation of antibacterials into three groups.

The classification is as follows: ACCESS – first and second choice antibiotics for the empiric treatment of most common infectious syndromes; WATCH – antibiotics with higher resistance potential whose use as first and second choice treatment should be limited to a small number of syndromes or patient groups; and RESERVE – antibiotics to be used mainly as ‘last resort’

treatment options.

What is the impact on AMR if pharma effluents or waste released during production process are not treated properly? Do you think Indian pharma companies don’t have proper waste treatment plants?

Various studies done by both Indian and global research organisations have stated that non- treatment of effluents or low or negligible use of treatment plants contribute to the rise of AMR. Recent studies by the scientific journal Infection have found “excessively high” levels of antibiotic and antifungal drug residues in water sources in and around a major drug production hub in the Indian city of Hyderabad, as well as high levels of bacteria and fungi resistant to those drugs. A

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study by IIT Bombay too substantiates the fact that pharma production discharges released into the environment are endangering aquatic life. A recent German report revealed that the Musi River in Hyderabad is emerging as a hotspot for 'superbugs' because of pharma waste dumping in the Bollaram-Patancheru area.

Some of the reasons for nontreatment of effluents at the source by most of the companies are to save costs, though it is mandated to have treatment plants. The added technologies to remove active pharma ingredients are relatively economical, and several corporations who are co-signatories to the UNGA Industry roadmap have already started reviewing their supply chain and started revising their discharge policy and treatment processes.

How is pharma waste responsible for increasing AMR in the country? What contribution can pharma manufacturers make to reduce it?

Almost all the samples taken from Bollaram-Patancheru area in the vicinity of Hyderabad city contained bacteria and fungi resistant to multiple drugs. The pharma industry needs to be a key stakeholder in an effort to develop a state action plan and its implementation of NAPAMR in mitigating the risk of AMR by following a zero discharge policy, acting as per guidelines, adopting global best practises in sustainable sourcing, manufacturing and supply so as to reduce environmental and health impact of antibiotics. Leading pharma players can come together to agree on maximum

tolerance levels for antibiotic discharge and advocate within the industry for support. This in one way to reduce the cost and resources involved and at the same time help in containment of AMR, while securing modern health care.

What are DSP’s initiatives to prevent and control antibiotic resistance?

DSP has long maintained its practice to follow clean and sustainable manufacturing practices throughout its operations. It is one among the pharma companies that are signatories to the 'Industry Declaration on AMR' held in Davos in the month of January, 2016. DSP uses clean technology with dedicated state-of-the-art affluent treatment plants in all its plants across the globe. The waste water treatment plants used

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MANAGEMENT across its operations reduce the antibiotic content and through the application of regular antibiotic water tests, clean water is disposed. As DSP is the leading supplier of antibiotics in the world, it is in the best interest of DSP to adhere to clean and sustainable manufacturing practices. The basic approach that DSP follows across its operations in China, India and elsewhere is to ensure that its manufacturing process is sustainable. DSP’s manufacturing process makes use of green, enzymatic technology. As one the signatories to the UNGA industry roadmap and also as a member of AMR Industry Alliance, DSP supports the WHO call to action: Combat Antimicrobial Resistance and Preserve Antimicrobials for Future Generations. WHO call to action is supported by “The Ecumenical Pharmaceutical Network (EPN, a faith-based organisation, which includes over 100 members from over 30

countries across five continents). DSP also advocates the issue with governments for more stringent regulation for pharma manufacturing.

The Davos Declaration* signed by >100 companies and trade associations in January 2016, called for collective action to create a sustainable and predictable market for antibiotics, vaccines and diagnostics, that enhances conservation for new and existing treatments.

What role should a state government and the pollution control boards in the centre play when it comes to AMR? The six NAP strategic priorities capture the importance of collaboration among national and subnational agencies for containment of AMR. Now that the NAP has been formulated, state action plans in all the states need to be activated. The Central Pollution Board and

State Pollution Boards are the monitoring and implementing agencies to ensure environmental rules/maximum standards/discharge guidelines are set and met as formulated by the government. State pollution control boards should have regulatory powers to not allow pharma plants located at different settings to flout environmental norms. In some instances, state pollution boards have waved the red flag against pharma companies flouting norms but the broader picture is lack of surveillance mechanisms and skilled human resources acting as an impediment for not taking action.

What are the main myths about antibiotics and resistance that you would like to dispel?

Myths around AMR are huge given the lack of awareness and any sustained campaign around the issue. A report published by World Health

Organisation (WHO) shows that 64 per cent of people surveyed say that AMR is a problem, but they are clueless about how it affects them and what they can do about it. Some of the myths circling around AMR are as follows: You don’t have to take all the antibiotics you’re prescribed: Many people are of the view that when one feels or gets better, they should stop taking antibiotics. But the fact of the matter is that the full dose over the prescribed time frame should be taken.

AMR means the body no longer responds to drugs: It is not the human body that has become resistant to antibiotics, it is the bacteria that live outside and inside us and that become resistant and spread illness.

AMR risk happens to people who use antibiotics regularly: The World Health Organisation (WHO) has categorically stated that anyone can get an infection

that’s resistant to antimicrobials.

For the treatment of cold and flu, antibiotics are necessary: Cold and flu are caused by viruses and antibiotics are meant to be used for treating bacteria. Using antibiotics inappropriately, like for viral infections, can lead to resistance problems.

There's nothing you can do to lower your risk: Everyone from the common public, medical professionals, hospitals and organisations can reduce or lower the risk of spreading AMR. The US Centre for Disease Control and Prevention (CDC) says people should take their antibiotics exactly as the doctor prescribes them, should not share or use leftover or dated antibiotics, should not ask for antibiotics if the doctor doesn't think they're necessary and should prevent infections by practising good hygiene and getting necessary vaccines. prathiba.raju@expressindia.com

REPORTS

Indian pharma industry continues to face headwinds According to ICRA, aggregate growth in pharma sector is expected to come down to single digit ICRA EXPECTS growth trajectory for Indian pharmaceutical industry to moderate on back of slowing growth from the US, increased competition, and regulatory overhang along with base effect catching up.

As per ICRA’s sample study, revenue growth from US during FY11-15 period, experienced CAGR of 33 per cent though growth from the US has come down to 15 per cent in FY2016 and 12 per cent in 9M FY2017 despite consolidation and currency benefits. In ICRA’s view, going forward the growth momentum is likely to face further pressure. Increased regulatory scrutiny and consolidation of supply chain in the US market resulting in pricing pressures along with increased R&D expenses will have an impact on profitability of Indian pharmaceutical companies. In spite of

30 EXPRESS PHARMA July 16-31, 2017

these ongoing challenges, several Indian pharma companies have ramped up their R&D spend, targeting pipeline of specialty drugs, niche molecules and complex therapies.

The domestic pharma industry has gained adequate scale and drug development capabilities over last decade of growth which will keep them in good stead to capture new opportunities in the US market.

Aggregate revenues of ICRA sample of leading players grew by nine per cent in Q3 FY2017 y-o-y with 9M FY2017 growth at 8.9 per cent as against 10.1 per cent growth in FY2016.

According to Subrata Ray, Sr Group Vice President, ICRA, “The revenue growth for Indian pharma industry remains moderate for the US, with base business in the US

continuing to face high single digit price erosion, regulatory overhang for select companies and temporary impact of demonetisation on domestic growth to an extent. The domestic formulations business of companies within our sample registered growth of 9.3 per cent in Q3 FY2017 as against 14.1 per cent in Q2 FY2017 with demonetisation resulting in channel de-stocking though the growth should come back in the next few months.”

Growth from key emerging markets benefitted from currency tailwinds though macroeconomic challenges remain. In ICRA’s view, continued regulatory interventions in domestic market are expected to put some pressure in near term though long-term growth prospects for domestic pharma market remain healthy given

increasing penetration, accessibility and continued new launches. There are limited major FTF launches in the US market in near term and base business is expected to continue to face competitive pressures affecting growth from the US market. Aggregate revenue growth for ICRA’s sample is projected at 9-11 per cent over FY2017 to FY2019 after mid to high double digit growth over last five years.

Despite growth pressures along with increased R&D and compliance related investments, profitability for the industry has remain relatively stable with aggregate EBITDA margins for ICRA’s sample at 24.8 per cent for Q3 FY2017.

Certain companies has been facing margin pressure on back of slowing growth in US along with remediation costs though

improving product mix and productivity improvement has provided overall cushion to margins.

Over the past few years, pharma companies have increased their R&D budgets significantly in view of their growing focus both on regulated markets and complex molecules/therapy segments. The aggregate R&D spends of top few companies in domestic pharma market have increased from six per cent of sales in FY2011 to close to nine per cent now. ICRA expects this trend to continue as most of the leading companies are in the midst of expanding their presence in complex therapy segment such as injectables, inhalers, dermatology, controlled-release substances and biosimilars.

EP News Bureau

MANAGEMENT

Dermatology space to benefit most from five potential blockbusters According to GBI Research, Dupixent is expected to face very little competition and as a result will generate the second highest revenue of any drug in the therapy area SINCE 2014, five potential blockbuster drugs have been approved in the dermatology therapy area, within which they are forecast to achieve aggregate annual revenue of $12.4 billion by 2023, according to GBI Research.

The company’s latest report states that four of the five market-driving drugs — Cosentyx, Otezla, Eucrisa and Taltz — were approved for psoriasis, and one, Dupixent, became the first and only biologic to be approved for the treatment of atopic dermatitis. Indeed, Dupixent is expected to face very little competition and as a result will generate the second highest revenue of

any drug in the therapy area.

Ross Wilkinson, Associate Analyst, GBI Research, explains: “In terms of pipeline products, the dermatology space contains 850 with a disclosed stage of development, but the majority of these are at an early stage.

Biosimilars only make up six per cent of the dermatology pipeline, but are more common at the later phases of clinical development, accounting for 24 per cent.

“Biosimilar manufacturers are attracted to the dermatology therapy area following the patent expiration of a number of commercially successful products. By 2023, AbbVie’s Risankizumab and Johnson &

To subscribe: bpd.subscription@expressindia.com

J&J, AbbVie, Amgen, Novartis and Pfizer were the successfull companies in therapy area in 2016 Johnson’s Guselkumab are expected to be in the market, but these products will fail to achieve the same level of commercial

success as early market entrants because the psoriasis market now contains a number of branded biologics and will become further saturated as new biosimilars enter the market.

However, the pipeline is promising for smaller indications such as acne vulgaris and epidermolysis bullosa, which could both see the approval of new first-in-class products.”

In terms of the market landscape, the dermatology therapy area is dominated by top the 20 pharma companies. In 2016 the most commercially successful companies in the therapy area were Johnson & Johnson, AbbVie, Amgen, Novartis and Pfizer.

Across the forecast period, these companies will continue to generate high revenue, although all will see their market shares change.

Wilkinson continues, “While several companies are expected to see a reduction in market share, some companies such as Sanofi, Novartis and Eli Lilly will see their market share increase.

In 2016 Sanofi had a market share of only 0.3 per cent, but following the approval of Dupixent in 2017 it is expected to become the fourth-largest company in the therapy area by the end of the forecast period, with a market share of 10.3 per cent.”

EP News Bureau

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RESEARCH UPDATES

Researchers identify visual system changes that may signal Parkinson’s disease Researchers used an MRI technique called diffusion weighted imaging to assess white matter changes and voxel-based morphometry to investigate concentration changes of brain’s gray and white matter

C

hanges in the visual systems of newly diagnosed Parkinson’s disease patients may provide important biomarkers for the early detection and monitoring of the disease, according to a new study published online in the journal Radiology.

“Just as the eye is a window into the body, the visual system is a window into brain disorders,” said lead researcher Dr Alessandro Arrigo, a resident in ophthalmology at the University Vita-Salute San Raffaele of Milan, Italy.

Parkinson’s disease is a neurodegenerative condition caused by neuronal loss in several brain structures. Parkinson’s disease is characterised by tremors, rigidity or stiffness throughout the body, and impaired balance and coordination.

“Although Parkinson’s disease is primarily considered a motor disorder, several studies

32

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July 16-31, 2017

have shown non-motor symptoms are common across all stages of the disease,” Dr Arrigo said. “However, these symptoms are often undiagnosed because patients are unaware of the link to the disease and, as a result, they may be under-treated.”

Non-motor symptoms experienced by patients with Parkinson’s disease include visual alterations such as an inability to perceive colours, a change in visual acuity, and a decrease in blinking which can lead to dry eye.

“These non-motor Parkinson’s symptoms may precede the appearance of motor signs by more than a decade,” Dr Arrigo said.

The study of 20 newly diagnosed and not yet treated patients (11 men, nine women) with Parkinson’s disease and 20 age- and gender-matched healthy controls involved a multi-disciplinary team of re-

The study of 20 newly diagnosed and not yet treated patients (11 men, nine women) with Parkinson’s disease and 20 ageand gender-matched healthy controls involved a multidisciplinary team of researchers in ophthalmology, neurology and neuroradiology of the University of Messina, Italy searchers in ophthalmology, neurology and neuroradiology of the University of Messina, Italy. MRI was performed on both the healthy controls and the patients, who underwent imaging within four weeks of their diagnosis. Researchers used an MRI technique called diffusion weighted imaging to

assess white matter changes and voxel-based morphometry (VBM) to investigate concentration changes of brain’s gray and white matter. All study participants also had ophthalmologic examinations.

The researchers found significant abnormalities within the visual system brain struc-

tures of Parkinson’s disease patients, including alterations of optic radiations, a reduction of white matter concentration and a reduction of optic chiasm volume. The optic chiasm is the part of the brain where the left and right optic nerves intersect.

“The study in depth of visual symptoms may provide sensitive markers of Parkinson’s disease,” Dr Arrigo said.

“Visual processing metrics may prove helpful in differentiating Parkinsonism disorders, following disease progression, and monitoring patient response to drug treatment.”

Dr Arrigo added that future studies are needed to better understand the timing of degeneration along visual pathways, as well as the specific changes.

“We’re excited by our findings,” he said. “However, this is just a starting point.”

EP News Bureau

FDAputs hold on Merck multiple myeloma trials According to Merck,the decision was taken after independent safety monitors observed more deaths in patients receiving the Keytruda combination than in the control groups in two of the studies MERCK & Co said that US Food and Drug Administration had placed a clinical hold on three multiple myeloma studies testing its Keytruda in combination with other medicines for the blood cancer after more deaths were reported in patients receiving the Merck immunotherapy.

Merck has been on a roll with the medicine, jumping to the front of the pack of companies with new immuno-oncology drugs, particularly after Keytruda extended survival as an initial treatment for advanced lung cancer, by far the largest oncology market. Bristol-Myers Squibb had been the perceived leader in the field until last year, when its Opdivo failed to match Keytruda's lung cancer success.

Merck last month said it had stopped enrolling patients in the trials testing Keytruda in combination with standard multiple myeloma regimens including Celgene Corp drugs.

The decision was taken after independent safety monitors observed more deaths in patients receiving the Keytruda combination than in the control groups in two of the studies.

The FDA said based on available data the risks of combining Keytruda with either of the Celgene medicines outweigh any potential benefit for patients with multiple myeloma.

The trials were testing Keytruda with either Revlimid or Pomalyst and dexamethasone against the regimens without Keytruda. All patients who were receiving Keytruda in combination with a Celgene drug will no longer take the Merck drug.

The clinical hold does not apply to other studies with Keytruda, Merck said. The drug, which helps the immune system fight cancer by blocking a protein tumours use to avoid detection, is currently being tested in hundreds of combination trials in a wide

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variety of cancers.

So far, Keytruda is only approved for one type of blood

cancer, classical Hodgkin lymphoma. But Merck has had a string of successes in solid tu-

mour cancers with approvals for advanced melanoma, advanced bladder cancer and a

type of head and neck cancer, in addition to lung.

Reuters

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THE RULES

RESEARCH

WHO warns of imminent spread of superbug gonorrhoea The WHO estimates 78 million people a year get gonorrhoea, an STD that can infect the genitals, rectum and throat AT LEAST three people worldwide are infected with totally untreatable ‘superbug’ strains of gonorrhoea which they are likely to be spreading to others through sex, the World Health Organization (WHO) said.

Giving details of studies showing a ‘very serious situa-

tion’ with regard to highly drug-resistant forms of the sexually-transmitted disease (STD), WHO experts said it was ‘only a matter of time’ before last-resort gonorrhoea antibiotics would be of no use.

"Gonorrhoea is a very smart bug," said Teodora Wi, a human reproduction spe-

cialist at the Geneva-based UN health agency.

"Every time you introduce a new type of antibiotic to treat it, this bug develops resistance to it."

The WHO estimates 78 million people a year get gonorrhoea, an STD that can infect the genitals, rectum and

throat.

The infection, which in many cases has no symptoms on its own, can lead to pelvic inflammatory disease, ectopic pregnancy and infertility, as well as increasing the risk of getting HIV. Wi, who gave details in a telephone briefing of two studies on gonorrhoea published in the journal PLOS Medicine, said one had documented three specific cases one each in Japan, France and Spain - of patients with strains of gonorrhoea against which no known antibiotic is effective.

“These are cases that can infect others. It can be transmitted,” she told reporters.

“And these cases may just be the tip of the iceberg, since systems to diagnose and re-

port untreatable infections are lacking in lower-income countries where gonorrhoea is actually more common.”

The WHO’s programme for monitoring trends in drugresistant gonorrhoea found in a study that from 2009 to 2014 there was widespread resistance to the first-line medicine ciprofloxacin, increasing resistance to another antibiotic drugs called azithromycin, and the emergence of resistance to last-resort treatments known as extended-spectrum cephalosporins (ESCs).

In most countries, it said, ESCs are now the only single antibiotics that remain effective for treating gonorrhoea.

Yet resistance to them has already been reported in 50 countries.

Reuters

Sleep apnea linked to worsening diabetic eye disease Sleep apnea, however, did not appear to be associated with faster progression of existing sightthreatening diabetic retinopathy or maculopathy PEOPLE WITH both sleep apnea and type II diabetes have more than double the risk of worsening retina disease compared to diabetics without the sleep breathing disorder, a UK study suggests.

Researchers followed adults with type II diabetes over about four years and found that for those with milder eye disease at the start, having sleep apnea was linked to higher odds that it would become more advanced.

At the outset of the study,

34 EXPRESS PHARMA July 16-31, 2017

they also found that advanced ‘sight-threatening diabetic retinopathy’ was already present in 43 per cent of people with sleep apnea, compared to just 24 per cent of those without apnea.

“Patients with type II diabetes and obstructive sleep apnea (OSA) are at increased risk of developing advanced retinopathy and also are at increased risk of greater decline in kidney function, as we found in a previous publication,” senior study author Dr Abd A.

Tahrani from University of Birmingham said.

“Hence, diagnosing OSA offers the opportunity to identify a high-risk group of patients which will allow doctors to apply preventative treatment strategy to slow the progression of these complications,” Tahrani said by email.

Diabetic eye disease, or retinopathy, affects as many as 50 per cent of people with diabetes, yet it remains unclear exactly what contributes to its development or what causes it

to get worse.

Past studies have found a link between sleep apnea and damage to tiny blood vessels that causes kidney and nerve problems in people with diabetes, the authors note.

Tahrani’s team looked at whether sleep apnea is associated with the progression of diabetic retinopathy in 230 patients with type II diabetes, none of whom had diagnosed respiratory conditions, including sleep apnea, at the start of the study.

After sleep monitoring was done, 63 per cent of the participants were found to have obstructive sleep apnea.

At the outset, the rates of sight-threatening diabetic retinopathy, advanced diabetic retinopathy and maculopathy (damage to the part of the eye responsible for central vision) were already higher in patients with sleep apnea than in those without sleep apnea.

As time went on, three times as many patients with sleep apnea, 18.4 per cent, progressed to more advanced stages of diabetic retinopathy compared to 6.1 per cent of

those without sleep apnea, according to the report in American Journal of Respiratory and Critical Care Medicine.

The worse the sleep apnea, the faster the progression of diabetic retinopathy, researchers found.

Sleep apnea, however, did not appear to be associated with faster progression of existing sight-threatening diabetic retinopathy or maculopathy.

On a positive note, sleep apnea treatment with CPAP (continuous positive airway pressure) slowed the progression to advanced diabetic retinopathy.

“While the impact of CPAP on retinopathy and other diabetes-related complications requires further study, CPAP treatment has several benefits, including lowering the blood pressure, improving sleepiness, improving quality of life, improving OSA-related symptoms and reducing the risk of road traffic accidents; hence CPAP treatment should be considered in patients with type II diabetes who have OSA,” Tahrani said.

Reuters

RESEARCH

Personalised vaccines hold cancer at bay in two early trials By adding a personalised cancer vaccine,scientists believe it should be possible to improve substantially the effectiveness of such immune-boosting medicines A NOVEL class of personalised cancer vaccines, tailored to the tumours of individual patients, kept disease in check in two early-stage clinical trials, pointing to a new way to help the immune system fight back.

Although so-called immunotherapy drugs from the likes of Merck and Co, BristolMyers Squibb and Roche are starting to revolutionise cancer care, they still only work for a limited number of patients.

By adding a personalised cancer vaccine, scientists believe it should be possible to improve substantially the effectiveness of such immune-boosting medicines.

12 skin cancer patients, out of a total of 19 across both the trials, avoided relapses for two years after receiving different vaccines developed by German and US teams, researchers reported in the journal Nature.

The small phase I trials now need to be followed by larger studies, but the impressive early results suggest the new shots work far better than firstgeneration cancer vaccines that typically targeted a single cancer characteristic.

The new treatments contain between 10 and 20 different mutated proteins, or "neoantigens," that are specific to an individual's tumor.

These proteins are not found on healthy cells and they look foreign to the immune system, prompting specialist T-cells to step up their attack on cancer cells.

One vaccine was developed at the US-based Dana-Farber Institute and Broad Institute and the other by privately owned German biotech firm BioNTech, which uses so-called messenger RNA to carry the code for making its therapeutic proteins.

Roche, the world's largest cancer drugmaker, is already betting on BioNTech's technology after signing a $310 million deal last September allowing it to test the German vaccine with its immunotherapy drug

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July 16-31, 2017

Tecentriq.

BioNTech's co-founder and CEO Ugur Sahin said that combination trials using Roche's

drug were due to start later this year against a number of different cancers.

Rival biotech firm Neon

Therapeutics, which was formed to exploit the US research, initiated tests of its personalized neoantigen vaccine in

combination with BristolMyer's Opdivo drug last year.

Reuters

RESEARCH

New Roche haemophilia drug prevents bleeds but questions remain Development of resistance, or inhibitors, in some patients can interfere with efforts to control bleeding, so Roche is hoping its drug, also known as ACE910, will offer a new avenue of treatment ROCHE’S investigational haemophilia drug emicizumab cut the bleed rate by 87 per cent in patients with resistance to standard therapy compared with those who received another treatment, the Swiss company said on Monday.

Roche is counting on emicizumab to wrest a share of the $11 billion-a-year haemophilia drug market now dominated by traditional treatments from Novo Nordisk and Shire.

Nearly 63 per cent of patients receiving emicizumab experienced zero treated bleeds, compared with 5.6 per cent of those getting so-called bypassing agents, according to data released ahead of the International Society on Thrombosis and Haemostasis (ISTH) industry meeting in Berlin in July.

Some analysts called the data release convincing, with Jefferies saying it underpinned its $5 billion peak sales estimate for the medicine.

"If full presentation of the data at the ISTH reassures on safety, our mid-term EPS estimates and valuation could increase by two per cent to four per cent," Jefferies' Jeffrey Holford wrote in a note to investors.

Haemophilia patients' blood does not clot properly, requiring life-saving infusions of clotting factors.

death came after a patient refused a blood transfusion for religious reasons, it has said -- analysts’ concerns linger.

Safety perspective

Development of resistance, or inhibitors, in some patients can interfere with efforts to control bleeding, so Roche is hoping its drug, also known as ACE910, will offer a new avenue of treatment.

Still, analysts continue to cite adverse events in Roche's studies including thrombotic microangiopathy -- damage to blood vessels in vital organs -- that accompanied repeated high doses of bypassing agents given to counter bleeds that occurred despite emicizumab treatment.

Although Roche has played down emicizumab's role in the complications -- one

“From a safety perspective, treatment with this drug will require physicians to carefully manage the use of bypassing agents,” Bank Vontobel's Stefan Schneider wrote. That "could limit uptake", he said.

Roche plans to file emicizumab with the US Food and Drug Administration this year for approval for patients with inhibitors, with follow-on submissions in 2018 including for patients without resistance.

Deutsche Bank analysts said Monday's data suggested it would be tough for emicizumab to make headway among those patients, however, since clotting factors appeared to be more effective for them.

"Current therapy in the non-inhibitor setting provides a very high hurdle to new entrants and we believe emicizumab's less than perfect efficacy and observed thrombotic events will temper enthusiasm for the drug," Deutsche Bank's Tim Race said.

Reuters

Researchers discover atomic structure of suspect Alzheimer proteins SCIENTISTS have for the first time revealed the atomic structure of the tau protein filaments that tangle in the brains of Alzheimer's patients and say it should point the way towards developing new treatments for the disease.

Using a technique known as cryo-electron microscopy, a team from Britain’s Medical Research Council Laboratory of Molecular Biology mapped

36 EXPRESS PHARMA July 16-31, 2017

in fine detail the tau filaments extracted from the brain of a patient who had died with Alzheimer's.

The most common neurodegenerative disease, Alzheimer's is characterised by two types of abnormal protein which form lesions or clumps in the brain. Tau forms filaments inside nerve cells and amyloid-beta forms filaments outside.

In healthy brains tau pro-

tein normally helps brain cells to function but in the brains of people with Alzheimer's disease tau clumps up in tangles inside the cells.

“Knowing which parts of tau are important for filament formation is relevant for the development of drugs,” said Sjors Scheres, who co-led the research.

Since many pharmaceutical companies are using dif-

ferent parts of tau to test the effect of potential drugs on filament formation, this new knowledge “should significantly increase the accuracy of such tests,” he said.

Specialists not directly involved in the study, which was published in the journal Nature, said its findings would prove extremely important in future.

Reuters

Celgene to buy stake in BeiGene BIOPHARMACEUTICAL company Celgene Corp will buy a stake in BeiGene and help develop and commercialise BeiGene’s investigational treatment for tumour cancers, the companies said.

Celgene will acquire 32.7 million, or 5.9 per cent of BeiGene's ordinary shares, at $4.58 each, or $59.55 per BeiGene's American Depositary Shares (ADS), they said in a statement.

BeiGene will receive $263 million in upfront license fees and $150 million equity investment. The company will also be eligible to receive up to $980 million in development, regulatory and sales milestone payments.

BeiGene will acquire Celgene's operations in China and will also license and assume commercial responsibility for Celgene's approved therapies in China.

BeiGene’s advanced clinical-stage investigational tumour cancer treatment, BGB-A317, is a type of antibody that belongs to a class of immuno-oncology agents known as immune checkpoint inhibitors.

The treatment has been tested in over 500 patients, with initial clinical data suggesting that it is well tolerated and exhibits anti-tumour activity across a range of solid tumour types, the companies said.

BeiGene will retain exclusive global rights for the development and commercialisation of BGB-A317 for malignancies related to blood-forming tissues and for solid tumours in Asia, excluding Japan.

Reuters

RESEARCH

Merck heart drug surprises with positive result The company has yet to decide whether to seek approval MERCK & CO said its experimental cholesterol drug from a class with a history of consistent failure lowered deaths and heart attacks in a large trial, but the company has yet to decide whether to seek approval despite the surprise success.

The drugmaker reported only that the drug, anacetrapib, met the main goal in the four-year trial of about 30,000 high-risk heart patients already on cholesterollowering statins. It showed a statistically significant reduction in the combined risk of heart attacks, heart-related death and need for repeat artery-clearing procedures.

While announcing the positive result few had expected, given the checkered past of

similar medicines, Merck said it plans to review the data with external experts and consider whether to file applications seeking approval.

“When they make a statement that we haven't decided

whether to file a new drug application it sends a very strong message,” said Dr Steven Nissen, Chief of Cardiology, Cleveland Clinic, who has studied other drugs in the class known as CETP inhibitors. "The

fact that they're hedging their bets ... suggests that the treatment effect may have been relatively small."

Full details of the trial will be presented at a major European heart meeting on August 29.

"We believe it is more prudent to wait for the full data release before drawing broad conclusions on the product’s commercial potential," Credit Suisse analyst Vamil Divan said.

A little over a decade ago, CETP inhibitors were hailed as the next big heart drug due to their ability to dramatically raise HDL, the so-called good cholesterol.

Pfizer had been banking on its torcetrapib to replace lost revenue when Lipitor, then the

world's top-selling medicine, lost patent protection. Analysts had forecast more than $10 billion in eventual annual sales.

But it became the most expensive failure in pharmaceutical history in late 2006, when Pfizer had to pull the plug on its $800 million Phase III programme over an imbalance in deaths and other safety issues.

CETP inhibitors from Roche and Eli Lilly and Co subsequently failed due to lack of sufficient efficacy, and other drugs that raise HDL by other mechanisms also failed to show benefit.

Merck’s anacetrapib does also lower ‘bad’ LDL cholesterol, which has proven to cut heart attacks and deaths.

Reuters

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PACKAGING SPECIAL

C

PA KAGING MATTERS Smart packaging emerges as key to tackle the complexities and challenges facing the pharma industry

By Lakshmipriya Nair

‘S

mart’ is the buzzword in the fast transforming landscape of pharmaceutical packaging which has metamorphosed from an afterthought to a crucial differentiator. Going beyond the traditional functions of containment and protection, smart packaging solutions offer significant value-additions and tremendous impact as the life sciences sector moves towards sustainability, value-based care and patient-centric medicine.

They have also become a valuable tool as the industry grapples with growing complexities and mammoth challenges like cost reduction, regulatory compliance, altering demographics, varying treatment patterns, and threat of counterfeiting.

But, what does ‘smart packaging’ actually entail?

It is an umbrella term that involves the transformation of conventional packaging into intelligent systems that are multi-functional by nature. The market for smart packaging is broadly classified as: active and intelligent packaging. The former interacts with the product and improves it while the latter encompasses electronic devices and sensors to communicate data to users.

Growth drivers The market for smart packaging is growing at a rapid pace. Research and Markets, a global market intelligence firm, in its ‘Global Smart Packaging Market Analysis & Trends - Industry Forecast to 2025’ predicts that the global smart packaging market is poised to grow at a CAGR of around 5.4 per cent over the next decade to reach approximately $52 billion by 2025.

Debarati Sengupta, Senior Analyst, Transformational Health Practice, Tech Vision, Frost & Sullivan, explains, “Traditionally, the primary function of pharma packaging was to ensure protection to the drugs/biologics, ease the handling, and to provide relevant product information to the caregivers and patients. However, with the growing challenges of counterfeiting, prescription drug abuse, patient non-compliance, and requirements of an increasingly-sophisticated, digitally-connected

38 EXPRESS PHARMA July 16-31, 2017

supply chain, these packaging features have been proven to be insufficient. Smart packaging is being used to address these challenges.”

Let's examine some major applications of smart packaging in detail.

Regulatory compliance: Changing regulations in different markets have been instrumental in the pharma sector moving away from conventional packaging to more intelligent packaging. As Sengupta states, “There is a greater emphasis on supply chain streamlining, digital connectedness, and increased attention from regulatory agencies to ensure standard of drugs.”

To cite recent examples, the US FDA recently issued a draft guidance for industry, instructing the manufacturers and other supply chain stakeholders to include a product identifier on prescription drug packages and cases before November 2018, under the US Drug Supply Chain Security Act. The European Union has also released the Falsified Medicines Directive (FMD) Safety Features Delegated Regulation, which mandates serialisation of licensed drug products for companies operating in the EU from early 2019. Such measures have led to the rise of radio frequency identification (RFID) systems and innovations in serialisation technologies to aid compliance.

Countering counterfeiting: Counterfeiting is another major challenge in the pharma sector. As per World Health Organisation (WHO) estimates, around ten per cent of pharma products in the world are counterfeits, with far higher rates in developing countries. Thus, the need for more sophisticated packaging options in the war against counterfeit medicines has become evident.

To elaborate this point, Anand Khare, GM Innovations, ACG Pharmapack, gives the example of smart blister packaging and says, “To deter counterfeiters, pharma manufacturers are increasingly resorting to adding a feature in blister packaging that would be hard to copy. A variety of overt and covert solutions are incorporated directly into the barrier packaging film used for thermoforming, either as part of the film or at the time of thermoforming. These features, if incorporated at the time of manufacturing barrier films, becomes very

difficult for counterfeiters to copy the packaging. Various overt features such as holography are also available and are in use presently. ACG Pharmapack manufactures one such type of film where distinct and unique differentially-grated holographic images are embedded into the film. This technology has not only given pharma companies the ability to protect their products but also the opportunity to enhance their brand image and shelf presence. Since this is an overt feature, the end consumer can very well recognise the genuine brand just by looking at the blister pack.”

He also elaborates on some covert features that include taggants of various kinds. He says, “These taggants are embedded in the packaging material and are not visible to the naked eye.

Specialised detectors are required to find out whether the pack is genuine or fake. While these methods are more robust in nature, they are a little cumbersome too, as the end consumer cannot really find out whether the product is genuine unless he has these hand held detectors. This type of protection is usually used by field representatives to check whether the product is genuine in the supply chain before it reaches the patients' hands. The third and the most intricate level of anti-counterfeit packaging is where a forensic type of investigation needs to be done in designated labs to detect taggants built into the packs. Normally, the first two are used combinedly while the third is yet to gain favour with the pharma companies.”

Preserve and extend shelf life and quality of drugs: Another major advantage of smart pharma packaging is its ability to extend the shelf life of medicines, thereby providing more value to the patients and helping pharma companies reduce costs.

Sengupta elucidates, “It is possible for pharma manufacturers and the participants along the supply chain to monitor crucial parameters such as temperature and pressure. These data points can help the companies monitor the qual-

EXPRESS PHARMA

ity and integrity of their products during transportation. The importance of tracking these parameters becomes apparent when dealing with vaccines, and biologics, and when transporting drugs to places without appropriate storage facilities.”

Laxmikant Khaitan, GM,

Multisorb Technologies highlights, “With reducing product pipelines or promising pipelines that are in early clinical studies stage, pharma companies have returned to promising older drug products. Products that could not be stabilised with prior packaging systems have new

found potential with advances in smart packaging. Other products that have had limited success due to shelf life and distribution challenges can now reach new customers and new markets.” To elaborate this point, he highlights the foray of smart packaging technology into seg-

ments of the pharma industry such as parenteral drugs. He points out that whether administered in large dosage bags for infusion or in ready-to-administer pre-filled syringes, these drugs could be sensitive to oxygen degradation and can now be protected by a range of smart

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PACKAGING SPECIAL packaging approaches.

Similarly, Khare also refers to various types of specialised inks used in packaging that 'intelligently' change colours at certain temperature. For e.g. a pack can show whether the medicine has been preserved in refrigerated condition just by the colour of the ink which changes to a certain hue under cold conditions.

This, in turn, gives clear indications about the safety and efficacy of the product.

Sengupta informs, “Smart packaging may not be able to solve all the problems related to drug quality, but certainly issues relating to shelf-life and tampering can be monitored. In three to five years, we expect greater use of information and communication technology in pharma packaging.”

Patient adherence: This has always been one of the major factors in favour of smart packaging as it benefits the most significant stakeholder in the healthcare chain, the patient.

Sengupta explains various ways in which smart packaging can ensure patient adherence and points out, “Alarms and reminders in smart packaging ensure patients take their medication on time. This is particularly useful for patients suffering from neurological illness like Alzheimer's, which requires caregivers and family members to give timely medication to the patient. While this helps the patient considerably, the pharma company benefits in terms of better consumer acceptance and enhanced brand loyalty, significant advantages in the long run.

He gives the example of embedded sensors in packaging and explains, “At the patient’s end, added sensor features can further improve patient care.

For instance, sensors can be added to dispensing bottles to remind patients to take medications, and to prevent them from having them out-of-turn. In hospitals and clinical trials, smart packaging can ensure timely medications and avoid missing any dosage.”

Khare cites blisters with dates marked at the back of individual blister pockets with the amount of dosage built into a single pocket as a simple example of compliance packaging. So, for

40 EXPRESS PHARMA July 16-31, 2017

ATA GLANCE Global pharma packaging industry to reach

Pic 1: Braille packaging

Pic 2: Drug and disolving solution

Global smart packaging market to grow at a CAGR of around

$94.93 5.4% billion $52 billion $2.60 billion 45.5% in the next ten years to reach approximately

by 2021

Source:Markets and Markets

Pharmaceuticals packaging industry in India is expected to be worth

by 2020

Source: Research and Markets

Dispensing machine

instance, if the doctor has prescribed that the patient take two different types of medicines at the same time, these two medicines are then packed into the same pocket. Or, if the patient needs to consume the same on a particular date or time, the message can be printed on the back end. Usually when multiple dosages are packed together, deep draw blisters with adequate protection against moisture and oxygen are needed.”

Obstacles to growth Thus, the advantages offered by smart packaging are very crucial for the pharma industry.

Some technologies are finding rapid adoption, but many others with considerable potential haven't taken off as expected.

So, what is hindering the growth of smart packaging technologies? In Sengupta's opinion, “In India, there is greater use of RFID on pharma supply chain.

However, technology adoption is still in nascent stage, and hasn’t penetrated the supply chain completely.” This has been a major hurdle in the adoption of smart packaging.

Moreover, smart packaging material and production is expensive compared to conventional packaging which can hinder its widespread adoption.

With R&D costs already being quite high, and the time-to-market extending into decades, pharma companies may be loath to invest more in what may be viewed at this time as an extravagance.”

He further states, “Scaling up the smart packages is an-

other major challenge. Consumer education about the innovative packaging designs and functionality is essential for its proper usage.”

Khare believes that the biggest deterrent in adoption of smart packaging, especially for covert technology, is that the end consumer does not have direct access to its benefits and the cost of these technologies is still high for mass adoption. That said, he also believes that in the next few years prices would come down as demand increases. In the meanwhile, he feels that overt and easily executable technologies such as differentially grated images and track and trace will find traction with pharma companies.

Tsuyoshi (Zach) Yamazaki, Director, PharmaPackaging Division, Nipro Corporation, also asserts, “The problem isn't the lack of acceptance for the concept of smart packaging; it's bringing it to scale affordably.

Unless the figures add up concepts will stay as concepts.”

He also feels that scepticism about the return on investment and aversion to taking a huge risk is deterring adoption of smart electronic technologies for packaging. Yamazaki also has an alternative to this problem.

He says that companies should look at simpler and less technology-intensive, but effective and smart ways of packaging to be smart yet affordable. He gives the examples of a few products offered by his company. One of them is a new bag-type combination product combining powdered drug and dissolving solu-

by 2020

World electronic smart packaging market to grow at a CAGR of

Source: Novonous Report

GROWTH DRIVERS OF SMART PHARMA PACKAGING ◗ Evolving regulations, e.g. serialisation, tamper evidence requirements ◗ Changing demogaphics (geriatric, paediatric) ◗ Self medication ◗ Anti-counterfeiting ◗ Evolving therapeutic areas ◗ The growth of biological medicines ◗ Growing malpractice suits ◗ Growing deployment of intellingent technology ◗ Growing importance of data

tion. Its design and packaging prevents risks of medical malpractice by preventing administration before mixing medication. (See pic 2) Similarly, he explained how information printed in Braille, makes patient adherence easier in the case of blind patients. (See Pic 1) He also gave the example of how they have enabled a tamper-proof packaging solution which has a pink strip and is visible only if the packaging has been opened. Thus, he recommended that alongwith hightech solutions, smart packaging also means using effective means of packaging which need not be driven by electronic tech-

from 2016-2022 to touch an aggregate of

$1.700.8 million by 2020

Source: www.infoholicresearch.com

nology only.

In times to come All said and done, the need and potential of smart packaging cannot be denied. However, pharma companies would need to make a major shift in their strategy and structure to integrate newer systems and processes. Though leading pharma companies have already embarked on this journey, it is time the rest of them to go down this route to address unmet needs, get a competitive advantage in industry, and leverage the growth opportunities in the market. lakshmipriya.nair@expressindia.com

PACKAGING SPECIAL I N T E R V I E W

Our key approach is to focus on quality Chris Henshall, Senior Director, Strategic Marketing – Biologics, West Pharmaceutical Services, in an interaction with Usha Sharma, talks about the latest trends of biologics drug delivery system and the company’s innovative products

Tell us about the latest global trends of biologics drug delivery system and how closely has this trend evolved in India?

First, I think it’s important to talk about a trend within the biopharmaceutical industry, which is an overall shift away from primary care toward speciality care, patient-centric and precision-based medicine.

With this as a driver, increased competition and the healthcare industry’s focus on costs and quality-based metrics are spurring drug companies to engineer better patient experiences into their treatments. This means companies are refining the design of the product in the earlier stage of the drug development process. The focus on the patient has helped increase the interest in biologics.

Five major trends include: ◗ From less expensive, one-sizefits-all drugs to higher-priced targeted medicines (driven by scientific advancements) ◗ From provider as decision maker to patient as decision maker (driven by better access to information, payer formulary, copay and benefit tiers) ◗ From point-in-time, nonintegrated medical/patient data to continuous and integrated medical/patient data (driven by payers/physicians/hospitals/ regulatory) ◗ From open patient access

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PACKAGING SPECIAL (US) to limited patient access (driven by healthcare cost control through payers) ◗ From limited patient access (developing nations) to increased patient access (driven by lower cost medicines and biosimilars) As more biologics and biosimilars come onto the market—including those used for the diseases such as rheumatoid arthritis, multiple sclerosis and psoriasis— patients in India and around the world are offered new hope in the management of their chronic conditions. However, despite the promise for patients, maintaining the safety and efficacy of these cuttingedge therapies can present unique challenges around packaging, containment and delivery for pharmaceutical manufacturers.

Pharma manufacturers are now making packaging and delivery systems an integral component of drug development and research.

Increasingly, pharma and biopharmaceutical companies are moving toward polymers, not glass, for containment.

Additionally, they are adopting innovative approaches to drug delivery that strike the needed balance between high-quality drug containment and userfriendly design.

The NovaPure brand addresses growing need for high-quality packaging solutions for pre-fillable syringe systems. Tell us more about the product and how relevant it is in today's time.

The market for pre-fillable systems is growing. In fact, twothirds of the world’s blockbuster drugs are now delivered via a pre-filled syringe system or auto-injector, and auto-injectors are one of the fastest growing delivery segments. To ensure effective delivery and patient safety, manufacturers need highquality components that are designed and manufactured to reduce particulates, ensure consistency of delivery and that fit the changing needs of higher-volume delivery systems.

West’s NovaPure plungers are manufactured using Quality

42 EXPRESS PHARMA July 16-31, 2017

by Design (QbD) principles to help ensure superior quality.

The QbD approach for NovaPure plungers has resulted in lower part-to-part variability, low particulate levels, and a more consistent injection rate when used as part of an injection system. The NovaPure brand is incredibly relevant in today’s global market, which continues to see an increased focus on quality.

One of the biggest challenges we hear from customers is meeting regulatory standards for quality. Driven by concerns for patient safety, regulatory agencies are asking drug and packaging manufacturers to build quality into their products from the start to ensure consistent quality throughout a drug product’s lifecycle.

Biosimilars are one of the fastest growing segments in India. What are the challenges and opportunities that exist in this segment?

Biosimilar manufacturers are looking for delivery system companies that incorporate innovative design features such as ease of use, versatility and adaptability to address emerging challenges and incorporate forward-thinking innovation. This presents significant opportunity for packaging and delivery system manufacturers to design innovative, integrated delivery systems that not only function effectively, but are also designed to be easy and intuitive for patients to use. As patents continue to expire on marketed biologics, there is a huge opportunity for biosimilar manufacturers to capitalise on market opportunities and bring more affordable medicines to the market. This means being ready to file first, and that requires having a plan to bring the biosimilar to the market, and to the patient, quickly and efficiently with high quality supporting data.

How will the latest trends in biosimilars impact pharma manufactures in strategising pharma packaging?

While biologic drug manufacturers may have the resources to collaborate with a drug delivery manufacturer to

design a custom-made device, biosimilar manufacturers—due to the rush to file first once the original patent expires and smaller budgets—are often not afforded that luxury. Instead, biosimilars must be delivered in ready-made delivery systems.

The good news for drug makers is that these offerings are being created based on previous designs and data utilised for original biologics drugs. The challenge biosimilar manufacturers face is knowing which delivery system is best for their drug and how quickly their partner can assist them in getting the offering to market.

To this end, biosimilar manufacturers will likely look for a trusted partner in the drug delivery device manufacturer space to guide them as they choose the appropriate system to deliver their drug.

Why are pharma companies demanding drug containment and delivery systems solutions? How can integrated containment and delivery solutions help improve patient outcomes?

Most patients are not trained medical practitioners; therefore, they need delivery systems to be intuitive.

Ensuring a self-injection system is easy to hold and deploy, as well as limiting the number of steps that a patient has to manage through administration, will greatly increase their satisfaction with the injection system and help promote greater adherence. To this end, collaborating with a delivery system manufacturer that is knowledgeable and focussed on providing quality solutions to ensure that all four key elements of an integrated design— the drug, the primary container, the delivery system and the end use—can be very beneficial to the drug manufacturer. Together, device and drug manufacturers can work seamlessly as partners to provide innovative solutions that help mitigate risk, encourage patient adherence and enhance value through unique integrated delivery combinations.

What key factors need to be

considered while selecting a containment and delivery system?

More and more, drugs are coming to market as combination products, meaning the drug is paired with a delivery device. This is especially true for chronic conditions such as rheumatoid arthritis and diabetes. As a result, pharma companies are paying closer attention to the design, function and efficacy of integrated delivery systems.

This, coupled with a broader trend in the market toward patient-centric design and increased home-based administration, means that it behoves drug manufacturers to care about the delivery device for their drug. Perhaps the biggest benefit is the delivery system’s impact on the likelihood of medication adherence. A drug can only truly have the desired patient benefit if it is taken as prescribed, delivered effectively and maintains performance over time.

However, it is hard for patients to alter their lifestyle and routines; making an easy-touse, integrated delivery system essential for improving patient outcomes.

How can West Pharmaceutical’s focus on quality and innovative drug packaging and delivery systems help biosimilars and generics makers to differentiate their products from others?

At West, we understand the biosimilars and generics boom intimately. We know the complexity of these drugs and their need to be delivered through an integrated system that is safe, reliable and patientcentric. We also know that generic and biosimilar manufacturers feel immense pressure to file first, and we have a comprehensive portfolio of offerings to help them to get their products to market quickly. A key part of our approach is a focus on quality.

Regulators and drug manufacturers alike place significant emphasis on quality standards. No longer just an innovative suggestion, QbD has become a non-negotiable

aspect of drug delivery technology development.

Applying a data-driven, design control process and QbD approach to the design and development of packaging components and delivery systems can help ensure a delivery system that consistently functions as expected. The use of clean, injectable systems with highquality injectable drug components can also lower the risk of particulates and leachables, helping to reduce patient risk and ensure the drug and its packaging meet strict standards for quality set by regulatory agencies.

Tell us more about West’s Biopharma Week 2017.

From May 29 – June 2, 2017, we participated in educational seminars and activities focussed on trends and best practices in biologic drug delivery throughout India. One of the highlights of West’s Biopharma Week 2017 was a presentation on best practices for improving patient outcomes through integrated containment and delivery systems at the 6th Annual InnoPack Pharma Confex in Mumbai. Other activities included scientific seminars in Bengaluru and Hyderabad, and in-house educational workshops with pharmaceutical and biotechnology customers in Ahmedabad. Throughout the week, West experts in integrated containment and delivery systems shared market insights and discussed industry trends, challenges and solutions for the safe and effective containment and delivery of injectable biologics and biosimilars with local pharmaceutical and biotechnology professionals.

We also showcased several innovative drug delivery system and packaging component technologies. ◗ SmartDose platform ◗ SelfDose patient-controlled injector ◗ A range of administration systems ◗ NovaPure components ◗ Daikyo Crystal Zenith® cyclic olefin polymer u.sharma@expressindia.com

PACKAGING SPECIAL VENDOR NEWS

Honeywell solution helps customers overcome automation lifecycle and efficiency challenges LEAP for Operations will enable industrial plants to increase productivity and throughput HONEYWELL PROCESS Solutions (HPS) has introduced LEAP for Operations, a programme that utilises the innovative and proven LEAP project execution methodology to help customers optimise, simplify and run ongoing industrial operations more efficiently.

LEAP for Operations includes a variety of solutions with a flexible deployment strategy to get more value out of plant processes. HPS made the announcement at its annual Honeywell Users Group sympo-

sium. Honeywell services the lifesciences sector.

With companies in the process industries under increasing pressure to show return on investment earlier on automation projects, they are emphasising the efficiency of operating expenses (OPEX) and their longer-term impact.

Honeywell can resolve the complexities of today’s industrial operations with LEAP methodology that applies efficiency to ongoing operations through edge device integra-

To subscribe: bpd.subscription@expressindia.com

tion, cloud-enabled execution, and universal and connected assets.

“LEAP for Operations helps our customers take operational intelligence to the next level,” said John Rudolph, VP and GM, HPS Projects and Automation Solutions. “This programme enables plant engineers to continue to use the LEAP principles to run their facility more efficiently, squeeze more out of the assets they have, and avoid major capital expansions. It provides a

step change in productivity and throughput once an automation project is implemented.”

Honeywell is uniquely positioned to support customers throughout the entire lifecycle of an industrial facility. The company’s focussed new product development programmes have expanded its capability to address more project and operational challenges in both brownfield and greenfield applications.

Before evolving the LEAP methodology to include oper-

ations, LEAP for projects began with lean execution techniques to eliminate waste by removing repetition, rework, and redundant tasks. Honeywell revolutionised automation project execution by extending this approach through simplification with independent workflows, standardised design, and enabling engineering to be done from anywhere in the world. This keeps automation off the critical path.

EP News Bureau

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PACKAGING SPECIAL

Survey reveals importance of standardised label mgmt in pharma

Lonza completes acquisition of Capsugel

The survey mentioned the need for a single, centralised platform for label design, change control, printing, integration and management to overcome the challenges

LONZA ANNOUNCED that following the receipt of all required regulatory approvals, it has completed the acquisition of Capsugel from KKR for $5.5 billion in cash, including refinancing of existing Capsugel debt of approximately $2 billion. The acquisition of Capsugel, a world leader in advanced oral dosage delivery technologies with a leading position in hard capsules, is expected to be accretive to Lonza’s core earnings per share in the first full year post closing.

This acquisition is in line with Lonza’s stated strategy to accelerate growth and deliver value along the healthcare continuum by complementing its existing offerings and by opening up new market opportunities in the pharma and consumer healthcare and nutrition industries.

With the acquisition of Capsugel, Lonza adds a trusted brand with a large breadth of technologies that it believes will expand the market reach of both companies’ contract development and manufacturing organization (CDMO) and products businesses. It also supports Lonza’s strategic ambition of getting closer to the patient and end consumer.

Capsugel’s business will continue to operate in its existing structure until the full integration has been completed.

The acquisition was financed partially through the net proceeds of the successful placement of 5 million new shares at CHF 173.00 per share with total gross proceeds of CHF 865 million, which was completed in February 2017, as well as the issuance of 16,548,612 fully paid registered shares, with gross proceeds in the amount of CHF 2.26 billion, which was completed in May 2017. The balance of the acquisition price was financed through indebtedness.

A RECENT survey on the state of label management in the pharmaceutical industry was recently undertaken by Slovenia-based NiceLabel, a leading global developer of label and marking productivity, software solutions, in cooperation with pharma manufacturers. The survey revealed the challenges facing pharma manufacturers as they try to produce accurate, compliant labels, and highlights the increasing importance of a single, integrated label management system.

The survey of a hundred key decision makers involved in the selection and purchase of label management systems in the pharma and biopharma industries uncovered the key challenges facing pharm manufacturers. Document control, integrating label management systems with ERP/MES and other systems, web printing and scalability have been identified as the most common challenges in an increasingly complex and fragmented production environment that often involves managing multiple products, locations and markets.

One of the overarching themes emerging from the survey was the need for a single, centralised platform for label design, change control, printing, integration and management to overcome the challenges.

“Only 14 per cent of those surveyed have achieved 100 per cent integration with their MES/ERP system. Over 34 per cent are still using separate systems to manage their labelling and marking printers.

Having disconnected systems makes it extremely difficult to update and maintain label databases, and it means pharma manufacturers are

44 EXPRESS PHARMA July 16-31, 2017

missing out on the productivity and quality gains that can come from a fully-integrated label management solution. Ultimately it comes down to the safety of their customers, who can be adversely impacted by inaccurate label information.

This is just one of the major risks that a modern label man-

agement system can help mitigate,” states Ken Moir, Vice President of Marketing, NiceLabel.

The survey also revealed that compliance with upcoming regulations is top-of-mind for pharma manufacturers. 80 per cent of respondents listed compliance as the number one

driver when selecting a label management software. And over 60 per cent of those surveyed stated that familiarity with the pharma industry and its compliance requirements is the most important factor when selecting a new labelling system provider.

EP News Bureau

EP News Bureau

PACKAGING SPECIAL PRODUCTS

Gandhi Automations’ high speed doors ideal for medium and large entrances GANDHI AUTOMATIONS, an entrance automation and loading bay equipment company offers high speed doors, which are sturdy, dependable and are the ideal solution for medium and large entrances. The doors are manufactured with European collaboration and technology with innovative and creative engineering.

Fast moving functional and reliable doors are needed in industrial and commercial contexts. Gandhi designed and manufactured high speed doors are versatile and solid ensuring long-lasting reliability. The modular structure of the curtains, assembled and joined by anodised aluminium extrusions, provides for a wide range of polyester sections available in a variety of colours. Wide, full-width window panels ensure a safer traffic and allow more light in. Their fast and easy replacement, in case of accidental tearing, saves money and time. The alternating metal tubular structure there inserted ensures high wind-resistance.

Prime high speed doors are the ideal solution for internal and external entrances and effectively operate in any situation, even when strong winds are blowing and in rooms with high volume traffic. Sturdy and dependable, prime is

the intelligent door for medium and large entrances.

High speed doors for external entrance are equipped with spring steel wind lock in curtain pocket that ensures silent door travel, higher wind loads and curtain stability.

Contact details Gandhi Automations Chawda Commercial Centre Link Road, Malad (W) Mumbai – 400064 Off: +91 22 66720200 / 66720300(200 Lines)Fax: +91 22 66720201 Email:sales@geapl.co.in Website : www.geapl.co.inhttp://geapl.co.in/highspeed-doors.html

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EXPRESS PHARMA

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PACKAGING SPECIAL

Cole-Parmer launches ThinTouchPROtect nitrile gloves COLE-PARMER, a leading global source of laboratory and industrial products, equipment and supplies since 1955, recently launched ThinTouchPROtect Nitrile Gloves – a line extension of company’s ThinTouch range of gloves. Specially formulated, designed and tested to stringent standards, the gloves provide user with maximum assurance, superior comfort and enhanced tactility.

These gloves offer highest protection against many risks than any other glove in the category. They are tested against 29 chemotherapeutic drugs as per ASTM D 6978-05. They have exceptional breakthrough time even for Carmustine (3.3 mg/ml) – 127.5 mins and ThioTepa (10.0 mg/ml) – 240 mins where other gloves have failed.

Manufactured using a unique formulation - they undergo series of exhaustive tests to ensure these are the best in the category. The gloves are highly chemical resistant and are qualified for oncology production and research applications. The anti-static property with resistivity of 1X107 Ohms

The glove has a great tactile feel for wearer comfort over extended period of use at humidity 51 per cent - makes these gloves an ideal choice in processes demanding low electrostatic discharge.

The glove has a great tactile feel for wearer comfort over extended period of use. Its unique colour provides visual

differentiation from other natural rubber latex and synthetic gloves. ThinTouchPRotect Nitrile Gloves are available in 9.5” and 12” length and S to XL sizes. These are ambidextrous with beaded cuffs ensuring ease of donning and have textured fingertips for enhanced wet or dry grip.

The gloves have low-particulates to prevent glove-related work contamination.

Contact details Vinita Singh Marketing Manager Cole-Parmer India403, A-Wing, Delphi Hiranandani Business Park, Powai, Mumbai 400 076, India Tel: +91-22-61394410 (Direct) +91-22-61394444 (Board) +91-8828126093 (Mobile)Fax: +91-22-61394422 vinita.singh@coleparmer.in www.coleparmer.in

APPLintroduces silicone extruded gaskets AMI POLYMER Pvt Ltd (APPL) offers a wide range of silicone extruded gaskets in more than 1000 different shapes and designs (In round and square types). APPL’s extruded gaskets (Autoclave) are made from Food-Pharma Grade pure silicone rubber which can easily withstands a temperature range of -80°C to +250°C. Extruded gaskets are available in square cross sections like 6mm x 6 mm, 8mm x 8mm, 10mm x 10mm, 20mm x 20mm, 25mm x 25mm etc. with OR without hollow. These extruded gaskets are available in red, white, orange or any colour as per customer's requirement. These extruded gaskets are manufactured from fully automatic mi-

46 EXPRESS PHARMA July 16-31, 2017

crowave continuous curing system which ensures accurate dimensional properties, glossy surface finishes and aesthetically beautiful colours.

Extruded gaskets can be used in clean room doors, telecom shelters, air tight door seal application, bakery ovens, freeze doors, pharmaceuticals processing machine’s doors, autoclaves, isolators, dry heat sterilizers, etc.

Contact details 319, Mahesh Industrial Estate, Opp. Silver Park, Mira-Bhayander Road, Mira Road (E), Thane – 401104, Maharashtra Board: 91-22-28555107 / 631 / 914

PACKAGING SPECIAL

Domino Printech India to launch Ax-Series

DOMINO PRINTECH India will launch the Ax-Series, a new range of continuous ink jet (CIJ) printers optimised for the demanding industrial packaging environments and more suitably designed for Indian market conditions. In developing the new series, Domino has rewritten the rules of coding and marking by revisiting the underlying science behind CIJ and introducing innovations in three key areas. This has resulted in a comprehensive re-engineering of the technology that will reset customer expectations of productivity, quality and cost of ownership.

Domino’s three ‘pillars’ of innovation across the Ax-Series are the new i-Pulse print head and inks, the i-Techx electronics and software platform, and Domino Design, a fresh approach to the total product design to maximise productivity and ease of operation.

Contact details Rohanjoy Purkayastha Manager Marketing Handheld: +91-9818600319 Phone : 0124-4886100

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PACKAGING SPECIAL VALUE ADD

Mechanistic absorption modelling for extending biowaivers to BCS Class IVCompounds John DiBella, Vice President, Marketing & Sales, Simulations Plus, Viera Lukacova, Team Leader – Simulation Technologies and Dr Neelam Sayed, Application Scientist, Electrolab, give an insight about one of the first biowaivers granted by the US FDA for Class IV drugs through the use of mechanistic modelling THE USE of in silico modelling to support drug discovery research has been around for over 25 years. Only recently, however, has mechanistic absorption modelling (MAM), coupled with physiologicallybased pharmacokinetic (PBPK) modelling, gained widespread attention in the preclinical and clinical development stages. In 2016, the European Medicines Agency (EMA) and US Food and Drug Administration (US FDA) issued the first draft guidance documents focussed on the use of mechanistic modelling methods, where clear directives were given to sponsors planning to include these approaches in submissions. The use of this technology has been encouraged by regulatory agencies by waiving certain clinical studies (e.g., drug-drug interactions) based on modelling results.

Studies have shown how GastroPlus, the top-ranked MAM/PBPK modelling platform, has been used to justify biowaivers for BCS Class I, II, and III compounds.1,2,3,4 Simulations Plus, a leading provider of modelling and simulation (M&S) solutions for the pharmaceutical, biotech, and chemicals industries, worked closely with the sponsor to build models using GastroPlus software and prepared biowaiver reports that were ultimately approved.

John DiBella, Vice President, Marketing & Sales, Simulations Plus

Viera Lukacova, Team Leader, Simulation Technologies

Introduction Changes in a compound’s manufacturing process can affect the particle size distribution of the active pharmaceutical ingredient (API). In these cases, the US

48 EXPRESS PHARMA July 16-31, 2017

Dr Neelam Sayed, Application Scientist, Electrolab

Simulations Plus, a leading provider of modelling and simulation solutions for the pharmaceutical, biotech, and chemicals industries, worked closely with the sponsor to build models using GastroPlus software and prepared biowaiver reports that were ultimately approved FDA requires proof that the API’s oral bioavailability (F per cent) and bioequivalence are not adversely impacted by these changes. In the case presented here, the granulation process was changed from high shear to fluid bed granulation, and an in-line milling step was added to the crystallisation process as part of the overall process improvement. This was introduced to reduce the fines in the crystallisation step and narrow the particle size distribution (particle engineered, PE). The API from the original crystallisation process (non-particle engineered, NPE) was used to manufacture several Phase 1 and 2 clinical supply lots. Examination of these different API lots showed that two early batches of the NPE API had a broader particle size distribution than those of the PE API lot. Evidence needed to be supplied to show that this change did not adversely impact either its F per cent or

bio-equivalence.

Initially, the US FDA requested the sponsor to design an expensive relative bioavailability study for this BCS Class IV drug, delaying the approval of the product by many months. However, the sponsor was able to present a M &S plan for a biowaiver extension, utilising GastroPlus modelling with in vitro physicochemical API characterisation studies, that the US FDA reviewed and approved.

The modelling objectives ◗ Build the baseline mechanistic model for the API using clinical data from prior studies. ◗ Assess sensitivity of API particle size distribution on drug exposure. ◗ Compare predicted bioequivalence of the tablets from the NPE and PE API lots.

All simulations were carried out with GastroPlus v7. The physicochemical and pharmacokinetic parameters values

used as inputs into the model are defined in Table 1. The drug’s sponsor provided complete and/or cumulative particle size distribution (PSD) data for all lots, along with pharmacokinetic data across three dose levels (50, 100, and 300 mg) in a patient population with four different NPE API lots.

The first step was to build the mechanistic model in GastroPlus and validate it against available clinical data. Figure 1 illustrates the validation of this model for 50, 100 and 300 mg doses of a particular NPE API lot. The graphs demonstrate that the same model does a reasonable job of predicting the observed plasma concentration-time data across three different doses of the NPE API lots.

Assessment of particle size changes The PSA mode was used to establish particle size specifications, which is the allowed variability in mean particle size and standard deviation before any significant changes in predicted outcomes are observed.

Since the drug is a Class IV compound with known dissolution limitations, simulations were run changing both the particle size and dose together to determine if an increase in dose would result in a higher or lower sensitivity to the change in particle size. Figure 2 illustrates the results of these simulations on absorption, which indicated that there would be very small changes, if any, in the fraction absorbed until the largest mean particle sizes of the NPE API lots (> 30 - 40 µm) were reached and the

PACKAGING SPECIAL TABLE 1

TABLE 2

dose exceeded 100 mg.

Virtual bioequivalence trials The Population Simulator in GastroPlus predicts likely population distributions of results across subjects.

This feature is commonly used to simulate crossover studies and evaluate whether two formulations are likely to be bioequivalent. Here, the Population Simulator was used to carry out simulations for 10 different populations, each with 25 virtual subjects. A combination of default and observed variability from the analysis of individual subject data from the clinical studies was used to define inputs for the population runs. To account for intra-subject and inter-occasion variability, a random multiplicative error term with CV=15 per cent was added to each of the simulated profiles.

Simulated AUC and Cmax values for the tablets manufactured from the NPE and PE API lots were compared, with sample results seen in Table 2.

These bioequivalence calculations, as defined by the FDA’s guidance on Bioequivalence Studies, were implemented to show the similarities between AUC and Cmax for the NPE API lots (up to 30 - 40 ¾m) versus the PE API lot.

Conclusion The BCS system currently allows for biowaivers for rapidly dissolving immediate-release (IR) products of Class I drugs. Here, we show one of the first cases where mechanistic modelling with GastroPlus was used to extend biowaivers to IR products of Class IV compounds, which is a breakthrough in formulation development. By eliminating bioequivalence studies, where ap-

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PACKAGING SPECIAL FIGURE 1 RESULTS

FIGURE 2

propriate, significant reductions in both costs and time to market reformulated drug products can be realised while ensuring good drug product performance.

Moreover, while the case study described here focuses on post-approval changes, the principle can be applied to generics when filing for ANDAs. References 1. Application of gastrointestinal simulation for extensions for biowaivers of highly permeable compounds.

Tubic-Grozdanis M, Bolger MB, and Langguth P. (2008) AAPS J. 10(1): 213-26.

2. An investigation into the importance of "very rapid dissolution" criteria for drug bioequivalence demonstration using gastrointestinal simulation technology. Kovacevi I, Parojci J, Tubi-Grozda-

50 EXPRESS PHARMA July 16-31, 2017

nis M, Langguth P. (2009) AAPS J. 11(2):381-4.

3. The biowaivers extension for BCS Class III drugs: the effect of dissolution rate on the bioequivalence of BCS Class III IR drugs predicted by computer simulation. Tsume Y, Amidon GL. (2010) Mol Pharm. 7(4):1235-43.

4. The role of predictive biopharmaceutical modeling and simulation in drug development and regulatory evaluation.

Jiang W, Kim S, Zhang X, Lionberger RA, Davit BM, Conner DP, Yu LX. (2011) Int J Pharm. 418(2):151-60.

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PHARMA LIFE RECOGNITION

Panjab University research scholar conferred with Young Scientist Award The award was conferred upon him by JP Nadda, Union Health Minister, Government of India, and

by Dilip Shanghvi, MD, Sun Pharmaceutical Industries

S

arwar Beg, a UGC Senior Research Fellow at University Institute of Pharmaceutical Sciences (UIPS), Panjab University, Chandigarh, has recently been bestowed with 'Sun Pharma Science Scholar Award' by Sun Pharma Science Foundation, Gurgaon. The award was conferred upon him by JP Nadda, Union Health Minister, Government of India, and by Dilip Shanghvi, MD, Sun Pharmaceutical Industries, India, at a recently held function at India Habitat Center, New Delhi.

The award included an engraved plaque and a cash prize

of ` 50,000. The award was bestowed on the candidate for his doctoral research work entitled, 'Systematic Development of Optimized Oral Nanostructured Delivery Systems of Cardiovascular Drugs employing

Quality by Design (QbD) Paradigms,' conducted by him while at UIPS under the guidance of Professor Bhupinder Singh Bhoop, Coordinator, UGC Centre of Advanced Studies in Pharmaceutical Sciences, and

Professor OP Katare, Director, Research Promotion Cell, PU. A three-tier selection process was employed for final selection of the candidate among scores of applicants across the country by a seven-

member expert panel on the basis of the novelty, and QbDoriented systematic patientcentric approach of his research work. The said research work entails multi-fold improvement in the efficacy of cardiovascular drugs when delivered through nano-pharmaceutical formulations, the successful outcomes of the same published in several high impact journals of international repute. Sarwar has recently been employed as a Research Scientist at Jubilant Generics, Noida.

EP News Bureau

TWO UIPS SCHOLARS GRANTED COMMONWEALTH SCHOLARSHIP FOR UK K

anika Thakur and Ranjot Kaur, two research fellows, both currently working at University Institute of Pharmaceutical Sciences (UIPS), Panjab university, have been selected for the highly prestigious 'Commonwealth SplitSite Scholarship-2017', fully funded to carry out Indo-British collaborative research. Selection of award was conveyed to each of the scholars through an official communiquĂŠ from the Commonwealth Scholarship Commission, UK. Ranjot Kaur, a UGC-Meritorious Research Fellow at UIPS, has been pursuing her doctoral research work on a topic entitled 'Systematic Development of Novel Inhalational Drug Delivery Systems of Antimicrobials for Efficient Treatment of Pulmonary Infections,' under the direct supervision of Professor Bhupinder Singh Bhoop, Coordinator UGC Centre of Advanced studies in Pharmaceutical

68 EXPRESS PHARMA July 16-31, 2017

Kanika Thakur

Ranjot Kaur

Sciences, UIPS and Professor OP Katare.

She has been selected to extend his work on inhalational drug delivery in pulmonary aspergillosis under the supervision of Professor Kamalinder K Singh at the

School of Pharmacy and Biomedical Sciences, University of Central Lancashire, Preston, UK. Kanika Thakur, a DST-INSPIRE Research Scholar at UIPS, has been

pursuing her doctoral research work on a topic entitled 'QbD-Oriented Design and Development of Lipid-Based Novel Drug Carriers of Anti-Infective Agents for Topical Delivery' primarily under the supervision of Katare, Director Research Promotion Cell, PU and Professor Bhupinder Singh Bhoop of UIPS. She will extend her research project to the development and evaluation of scaffolds for the treatment of acute and chronic wounds under the supervision of Dr Felicity Rose, Division of Regenerative Medicine and Cellular Therapies at the School of Pharmacy, University of Nottingham, UK. The highly prestigious award includes to-and-fro international travel expenditure to UK, tuition fees at the Universities, living allowance for one year, study travel grant within UK or overseas, all roughly accounting for approx. ÂŁ 40,000 each.

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