Express Pharma (Vol.11, No.22) September 16-30, 2016

VOL. 11 NO. 22 PAGES 64

www.expresspharmaonline.com

Market ‘Our united voice and effort could make the healthcare sector a better field for pharmacists in India’ 16-30 SEPTEMBER 2016,` 40

CONTENTS Vol.11 No.22 SEPTEMBER 16-30, 2016 Chairman of the Board Viveck Goenka

Countering the Chinese threat

Sr Vice President-BPD Neil Viegas

With the Indian government coming up with a slew of measures to counter the Chinese invasion in bulk drug manufacturing, can drug manufacturers in India make the most of it and become self sufficient | 22

Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das New Delhi Prathiba Raju DESIGN

National Design Editor Bivash Barua Asst. Art Director Pravin Temble Senior Designer Rekha Bisht Senior Artist Rakesh Sharma, Vivek Chitrakar Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Harit Mohanty - West Kailash Purohit – South Debnarayan Dutta - East Marketing Team Ajanta Sengupta Ambuj Kumar Arun J Debnarayan Dutta E Mujahid Mathen Mathew Nirav Mistry Rajesh Bhatkal PRODUCTION General Manager B R Tipnis

P10: PRE EVENT analytica Anacon India and India Lab Expo 2016 to be held in Hyderabad

CIRCULATION Circulation Team Mohan Varadkar

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‘OUR UNITED VOICE AND EFFORT COULD MAKE THE HEALTHCARE SECTOR A BETTER FIELD FOR PHARMACISTS IN INDIA’

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PHARMATECH EXPO 2016 WITNESSES HUGE TURNOUT

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UBM CONDUCTS WORKSHOP ON UNANNOUNCED AUDITS IN MUMBAI

MANAGEMENT

P11: POST EVENT Experts condemn blanket ban on combination drugs at second edition of Vantage Point

P29: UPDATES Research links eczema and hay fever to early antibiotic use

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IS HERBAL THE FUTURE OF EXCIPIENTS?

P32: VENDOR NEWS Werum IT Solutions wins Asian Manufacturing Award 2016

Manager Bhadresh Valia Scheduling & Coordination Ashish Anchan

MARKET

P59: RECOGNITION Kiran Mazumdar Shaw appointed ‘Knight of the Legion of Honour’ by the Government of France

PHARMA ALLY

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MERCK LAUNCHES NEW GENE EDITING TECHNOLOGY TO ENGINEER VIRUS RESISTANT CHO CELL LINES

Express Pharma® Regd. with RNI No. MAHENG/2005/21398,Postal Regd. No. MCS/164/2016 – 18. Printed for the proprietors, The Indian Express (P) Ltd. by Ms. Vaidehi Thakar at The Indian Express Press, Plot No. EL-208, TTC Industrial Area, Mahape, Navi Mumbai - 400710 and Published from Express Towers, 2nd Floor, Nariman Point, Mumbai - 400021. (Editorial & Administrative Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021) *Responsible for selection of news under the PRB Act. Copyright © 2016. The Indian Express (P) Ltd. All rights reserved throughout the world.

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

EDITOR’S NOTE

Reviving APIs

E

ven as Indian pharmaceutical companies pursue aggressive plans for global expansion, there are deep challenges in the domestic market.

Dr Reddy Laboratories, Cipla, Zydus Cadila, Aurobindo Pharma, Intas Pharma and Torrent Pharma have either bought or are bidding for Teva's brands as the Israeli firm readies for Allergan's acquisition. This expansion strategy into the EU market is in contrast to the travails of ingredient manufacturers in India, who are lobbying for policies to protect their turf. Countries like China have protected their local pharma manufacturers by imposing stricter laws for foreign companies as well as high tariffs on imports. But in India, the dumping of cheap APIs have squeezed many API manufacturing companies out of the market.

Today, India's dependence on China for key APIs is nothing short of a health security risk. As one of the stories in the September 16-30 Express Pharma issue analyses, the situation can be rectified but it needs both short and long term strategies. In the short term, API manufacturers need financial and technology inputs from the government as incentives to continue investing in API development.

This would revive their business outlook and prospects. For the long term, we need a bulk drug policy that will create an ecosystem to ensure the country's self sufficiency for key APIs and bulk drugs. Various ministries in the government were in discussions to put together the bulk drug policy, as it is in line with the Make in India theme of Prime Minister Modi. (See story, Countering the Chinese threat, pages 22-25, in September 16-30, 2016 issue of Express Pharma) But now there are reports that these plans for a bulk drug policy have been shelved or postponed.

According to Ananth Kumar, Minister for Chemicals and Fertilisers, instead of a bulk drug policy from the centre, the states will have to allocate land and resources for “bulk drug parks” to support bulk drugs manufacturing. In other words, central funds will not back this project; the onus will be on each state to create and nurture their own bulk drug ecosystem. This is even more obvious when you consider reports that from an initial promised investment of `5000 crores, the centre will now only invest `600 crores to set up common effluent treatment plants in three bulk drug parks. While this measure is welcome and will benefit the members of these parks, industry experts are disappointed at the seemingly stingy treatment. But, given that there are many SEZs which have not taken off and

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Today, India’s dependence on China for key APIs is nothing short of a health security risk.

The situation can be rectified but it needs both short and long term strategies

are laying vacant, with rumours that companies' used the SEZ scheme to simply acquire the land, maybe central authorities are playing the wait and watch game. Clearly, funds will be released only to deserving bulk drug parks, ones which seem to have the best chances of success. And this success will have to come from a major push by each state. When you consider this as a strategy, it seems logical to incentivise fund disbursement against demonstrated performance as well as create a competitive environment between state governments. Let’s hope the gambit pays off.

While the marque companies of the Indian pharma sector, straddle continents, there are players like Advanced Enzymes Technologies’ CL Rathi who are climbing the value chain. With a super successful IPO under his belt, Rathi's focus on an unglamourous segment like industrial enzymes has been slow and steady. There are many promoters like him who are the backbone of the Indian pharma sector and we hope his success will enthuse them to stick to their competencies rather than throw in the towel when faced with competition from cheaper imports. Rathi has proved that a sound strategy to focus on products with a high entry barrier and increasing this with more investment in R&D will put miles between him and his competitors. (See story, Breaking the mould, pages 16-21, in the Express Pharma September 16-30, 2016 issue) Looking ahead, the Indian pharma sector cannot expect the same growth rates of the past. A recent ICRA report predicts that the growth trajectory for the Indian pharma industry will be moderate on the back of slowing growth from the US given the relatively moderate proportion of large size drugs going off patent, increased competition, generic adoption reaching saturation levels, regulatory overhang along with base effect catching up.

Within the domestic market, the price regulator, the National Pharmaceutical Pricing Authority (NPPA) is scheduled to meet on September 14, to add more medicines to the National List of Essential Medicines (NLEM) 2015. With more medicines coming under price control, pharma companies in India would naturally look for greener pastures.

While pharma companies might feel betrayed by successive policy makers for cutting their margins, they would do well to bring the patient back in focus and look for ways to become more sustainable.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET I N T E R V I E W

‘Our united voice and effort could make the healthcare sector a better field for pharmacists in India’ Abhay Kumar, National President, Indian Pharmacist Association, recently met the Union Health Minister JP Nadda, to discuss various issues faced the pharmacists in India.

A memorandum was also presented to the health minister. Kumar in an interaction with Usha Sharma reveals more about the meeting

What were the highlights of the meeting?

I along with BP Ray, Member of Parliament, representing Andaman and Nicobar Islands, had an opportunity to meet the Union Health Minister, where we had a detailed discussion on the role of a pharmacist in healthcare sector. I presented him with a memorandum from IPA, the following points of which needed immediate intervention. The points are: ◗ Entry level pay scale of Grade Pay of Pharmacist at ` 5400 as recommended for staff nurse with same level of qualification ◗ Formation of directorate / cadre of pharmacists at the central and state government level ◗ Formation of food and drug administration in every state of India ◗ Pharmacist as prescriber in the absence of a doctor ◗ Non-Practising Allowance (NPA) @ 25 per cent at par with Medical Officer under Government of India (GoI) ◗ Additional increment/ upgradation for the higher techqualified pharmacist at par with staff nurse/ medical officer under GoI ◗ Creation of pharmacy cell / section under Ministry of Health and Family Welfare, New Delhi

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◗ B.Pharm as the minimum qualification for the post of pharmacist ◗ Inclusion of pharmacy subjects in civil services exam ◗ Proper implementation of Pharmacy Act 1948 and Drugs & Cosmetic Act

If IPA’s demands are met by the government, it will have a positive impact on the healthcare system in India, which will eventually lead to a lot of scope in the pharmacy field

What needs to be done to match the salary of pharmacists with other healthcare professionals?

One of the key points of discussion was on pay scale and promotional avenues for pharmacists. With no promotion and a grade pay (GP) of ` 2,800, the entire cadre was demoralised by VI Central Pay Commission (CPC). They were expecting better placement in the VII CPC. However, the VII CPC did not recommend any change in the pay scale for pharmacists.

The Union Health Minister was informed that a pharmacy graduate is a well trained professional having sound knowledge of pharmacology and has an equivalent curriculum as that of an MBBS graduate, except surgery. Even pharmacists, who are working at primary healthcare centres (PHC)/community healthcare centres (CHC), interact with various types of patients. They can be trained to practice

medicine in the absence of qualified doctors especially in rural areas.

Besides this, what other demands were put forth to the minister?

Another major point of discussion was the existence of very meek enforcement agency i.e, Drugs Control Department at the Centre as well as in every state. The Drugs Control Department, needs to be strengthened with the recruitment of drug control officers. This will cater to the demands of unemployed graduates and post graduate pharma candidates.

What was the minister’s reaction?

The Union Minister gave a patient hearing to all the matters related to pharmacists. He assured me that everything will be looked into with a serious note. I expect a concrete outcome soon.

Why do you feel a proper and effective healthcare system can be in place if pharmacists supervise it?

Pharmacists play an important role in treating patients.

Medicines are meant to be dispensed and handled by a registered pharmacist only as per various acts and rules

under the Indian constitution.

Basic information about any drug can be obtained from a pharmacist, let it be in a hospital or drug store/chemists shop, making the profession of a pharmacist most reliable in the healthcare system.

which can be filled by recruiting pharmacists.

Except a few, all states have no cadre of pharmacists, no designated promotional avenues and thus people are hesitant to choose pharmacy as a career option.

What are the challenges that exist in the Indian pharmacist profession?

Why do people hesitate to take this profession as a career option?

There is a dearth of job opportunities in government as well as the private sector for pharmacists. There are genuine vacancies in almost every states for the post of pharmacists, drug inspectors, and other technical posts in Drugs Control Department,

The government plans to impose guidelines for online pharmacies. Do you think it will reduce the prospects of pharmacists?

We, at IPA, have very strongly objected towards online pharmacies. Until and unless there is a strong enforcement agency to monitor and enforce Drugs and Cosmetic Act & Rules, online pharmacy must be totally stopped. In developed countries, where the enforcement agencies are

in full strength, online pharmacies are unable to have any type of unethical practices.

Many loopholes have evolved since the inception of Drugs and Cosmetic Act, which requires immediate revamp.

Medicines should not be treated as any other household goods and thus must be dispensed under the supervision of a registered pharmacist only.

What will make the profession an attractive and lucrative career option? Do you plan to modify or revamp the pharmacy curriculum?

We have spoken to the Pharmacy Council of India to support us and guide GoI with various soon to be launched health programmes, where

pharmacists can actively participate. If IPA’s demands are met by the government, it will have a positive impact on the healthcare system in India, which will eventually lead to a lot of scope in the pharmacy field. Creation of centralised and state level pharmacist register may rule out fake drug /chemist shops.

Even proper implementation of Pharmacy Act by PCI will weed out undesired players in pharma business. On different occasions, I wrote to the Prime Minister of India and also the health minister to delegate the prescription writing power to pharmacists.

As of now, pharmacists do prescribe / dispense medicines to patients in the absence of a doctor, but there

is no such standing order to do so. Some of the basic medicines for common ailments may be declassified from the existing Schedule –H and pharmacists should be allowed to prescribe the declassified drugs. This will help to better service needy patients.

What is your message for Indian pharmacist community?

I would like to call upon the pharmacists across India to stand by IPA. Our united voice and effort could make the healthcare sector a better field for pharmacists in India.

Together we can achieve what alone we could only dream. u.sharma@expressindia.com

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September 16-30, 2016

MARKET PRE EVENTS

analytica Anacon India and India Lab Expo 2016 to be held in Hyderabad The conference will focus on analytical instrumentation, emerging trends in application, techniques and regulatory compliance ANALYTICA ANACON India and India Lab Expo 2016, the annual trade fairs for analysis, laboratory and biotechnology, will be held in Hyderabad from October 20 to 21, 2016 at the Hitex Exhibition Center. This year, the conference will focus on analytical instrumentation, emerging trends in application, techniques and regulatory compliance.

Discussions will be held on the following topics: They

are ‘Regulatory aspects of Pharmaceutical Laboratories’, ‘Biopharmaceuticals and Bioanalysis’, ‘Food Safety’ or ‘Clinical Diagnosis.’ Speakers, eminent scientists and industry representatives from India as well as from abroad will take part in the conference.

The following speakers are going to take part in the event are Dr Laxmikant Gandikota, Biological Evans, Dr Ashes Gan-

guly, Indian Analytical Instruments Association, Dr Myeong Hee Moon, Yonsei University, Dr Michael Hilderbrand, University of Jena, Dr Dietmar Knopp, Technical University of Munich, Dr Rainer Lehmann, University of Tuebingen, Dr Eike Reich, CAMAG, Dr Pia Rosendahl, ISAS, Dr Michael Rychlik, Technical University of Munich, Oliver Schmitz, University of Duisburg-Essen, Arjan Timmer-

man, Waters Corporation and Dr SP Vasireddi, Vimta Labs.

Bhupinder Singh, CEO, Messe München India says, “The conference will bring together leaders of this field to share a comprehensive overview of this rapidly expanding industry with the prime objective of knowledge transfer.

Over 250 delegates will participate at the conference who will have the opportunity to interact

with well-known scientists around the world.”

More than 350 exhibitors and 8,500 visitors will participate at analytica Anacon India and India Lab Expo. The two events will bring together companies with similar product lines and business interests, apart from bringing the buyer and seller community on one common platform.

EP News Bureau

Second edition of Pharmasafe India to be held in Mumbai The conference will have discussions on latest developments in drug anti-counterfeiting MESSED FRANKFURT Trade Fairs India, with its commitment to fight the menace of counterfeit and spurious drugs, will organise the second edition of Pharmasafe India in Mumbai from September 22 – 23, 2016.

High level representation from various government and regulatory stake holders are expected to transform the dis-

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cussion-points into actionpoints. Speakers including Dr Shailesh Ayyangar, Managing Director, India & Vice President, South Asia, Sanofi & President, Organization of Pharmaceutical Producers of India; Dr Rao VSV Vadlamudi, President, Indian Pharmaceutical Association; Samson Chiu, Director, Asia Pacific Region,

Pharmaceutical Security Institute; Edmond d’Arvieu, Vice President – Corporate Security, Sanofi, Bejon Misra, Founder, Partnership for Safe Medicines India and Prashant Tandon, Founder, 1 mg, will give insights into the latest trends in anti-counterfeit technologies, discussions on counterfeiting in parallel trade, as well as case

studies on a global and domestic level.

Apart from an eminent speakers, the conference has also drawn support from both pharmaceutical companies and industry associations such as OPPI, IDMA, IPA, IPEC, ASPA, Sanofi and HP. The scale and scope of the event will further be enhanced by a

line-up of expert speakers taking up the most pertinent and relevant topics to draw attention to the source of counterfeit medicines and effective initiatives, regulations, and policies of the $4.25 billion (` 65675.5 crores) fake drugs market, in order to safeguard public health.

EP News Bureau

MARKET POST EVENTS

Experts condemn blanket ban on combination drugs at second edition of Vantage Point Panelists highlight the need for proper guidelines and processes to weed out harmful FDCs from the market and ensure better safety and efficacy of medicines Lakshmipriya Nair Mumbai THE SECOND edition of Vantage Point, Express Pharma’s platform to discuss and deliberate on Indian Pharma’s most pressing and controversial topics, was recently held at SciTech Centre in Mumbai.

This time the debate was on ‘Combination Drugs: Is Banning the Real Answer?’ The event was presented by ACG Worldwide.

The eminent panel at the second Vantage Point, comprising Dr Jayesh Lele, President, IMA Maharashtra state; Dr Milind Antani, Head, Pharma and Life Sciences, Nishith Desai Associate; Dr Vasant V Joshi, General Manager- Clinical Research, USV; Susan Josi, Managing Partner, Sorento Healthcare; Ashish Babtiwale, Marketing Director, Virchow Pharma Group; and Ashish Prasad, Partner – Legal, Economic Laws Practice, discussed and shared their views on various aspects of this issue and their implications. It was moderated by industry veteran, Dr RK Sanghavi, Chairman – Medical Committee & Nutraceutical Committee, IDMA. Dr Lele said that FDCs should be both, compliant with the regulations and effective in treatment. Answering Dr Sanghavi’s query on the different criteria to judge an FDC, he answered that the foremost criteria is the need for it. The other aspects to be looked into are the compatibility of the combination drugs, the dosage of each drug and the effect the FDC seeks to achieve. He also pointed out that one issue with FDCs is that in case of adverse

drug effects, it becomes difficult to identify which of the combination drugs caused the problem. However, he also counterbalanced it by stating that some combination drugs have given very good results in treatment, in fact certain combinations have nullified the side effects of the individual drugs.

So, a blanket ban on FDCs was definitely not justified.

Antani, who practiced as an ENT surgeon for 14 years before becoming a lawyer, offered very valuable insights on this issue. He said that FDCs offer comfort and convenience to patients and healthcare practitioners, however, ensuring the safety and efficacy of these FDCs are equally important.

He highlighted how essential it was for the combination drugs to be rational. He also raised concerns over the judicial delays in settling this issue. He also felt that better documentation by the industry would help them prove that their FDCs is safe and effective and at the same time make their case stronger.

Babtiwale highlighted that India has the ability to offer rational combination drugs to

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the world and he was of the opinion that safety was not being compromised in their production. He also pointed out that the banned drugs were earlier given approvals by the government after studies about their side/ adverse effects were conducted and analysed. He also raised a query that when there were very elaborate steps to be taken before approval was granted to manufacture combination drugs why was the ban enforced without any process and research? He also mentioned that the role of a regulator was to regulate, however, an extreme stance has been taken by the regulator in this issue.

Prasad spoke on the existing regulations for drugs and their efficacy. He said that the current regime covers several points but also needs amendments and clarity in certain areas. He also emphasised that that there is a need to analyse and learn from the regulatory guidelines globally. He felt that the ban was very skewed. He opined that it was important to weed out the wrong doers, however, it is equally important

to ensure that ethical, effective, safe and efficacious FDCs get a chance to thrive.

Representing the pharma industry, Joshi elaborated on the process of formulating the combination drugs and steps taken to ensure their safety and efficacy. The panelists also pointed out that if there was sufficient evidence about the adverse effects of a drug then the doctors themselves would stop prescribing it.

Josi, speaking on behalf of the patients, said that the consumers remain woefully misinformed about the whole issue.

She also felt that the government’s move has caused panic among the public because many of these drugs have been in use for quite some time. The other panelists agreed with this view.

Dr Sanghavi also steered the panelists to discuss various points like, whether safety is really compromised in FDCs, loopholes in the current regulatory system for drugs, eligibility of the current regulatory committee which passed the ban to take this step, and so on.

He also drew parallels between the current issue and the case

of Pioglitazone, a popular diabetic drug which was banned by the government citing concerns over safety. Later, the ban was revoked due to lack of sufficient evidence.

Thus, the panelists were unanimous in their view that the sudden ban on 344 FDCs by the government was an irrational and hasty decision. They also pointed out that as many diseases today were multi-factorial, FDCs served a very pertinent need. They were of the opinion that the government had no conclusive evidence proving that all the banned FDCs are harmful to human health. However, there was a consensus over the need for proper guidelines and processes to weed out harmful FDCs from the market and ensure better safety and efficacy of medicines.

The panelists stressed on the need for regulatory authorities to put better processes in place so that what’s good stays while what’s bad gets taken out of the system. The experts also recommended some measures such as: ◗ Mandatory patient information leaflet about the drug, its usage and warnings about side effects ◗ Improved pharmacovigilance ◗ Better reporting of adverse drug effects ◗ Improved synergy between stakeholders to ensure safety, compliance, and efficacy of drugs ◗ Formation of an ethical committee with proper guidelines to judge and analyse these cases The event ended with a Q&A session between the panelists and the audience. lakshmipriya.nair@expressindia.com

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MARKET

PharmaTech Expo 2016 witnesses huge turnout More than 150 exhibitors from different states of the country participated in the event which was attended by more than 5000 trade visitors Sachin Jagdale Mumbai THE THREE-DAY PharmaTech Expo 2016 exhibition and conferences, a PharmaTechnologyIndex.com initiative (KNS Group of Company), recently took place at Gujarat University Convention Centre, Ahmedabad, Gujarat. The expo has been unanimously endorsed by industry experts as the largest in Gujarat. With each passing year the expo has witnessed a rise in the number of exhibitors and visitors, and the latest edition wasn’t an exception. Pack and Printech Expo 2016 was also held concurrently.

The expo was inaugurated

by Chief Guest, Parshottam Rupala, National BJP Vice President, Union Minister of The State-Agriculture, Farmers welfare and Panchayati Raj. Bipinbhai Patel, President of Gujarat Chamber of Commerce and Industry was the Special Guest. Gautam Shah, Mayor, Ahmedabad and Dr H G Koshia, Commissioner of Food and Drug Control, Administration (FDCA) Gujarat were the Guest of Honours at the event.

Rupala’s speech was full of optimism and he discussed the strengths of the pharma sector in Gujarat. He said that the pharma industry in Gujarat is globally known and the state’s industry-friendly policies are attracting great investments. Rupala expressed the need of making the optimum use of technology, which would later help to reduce the cost of the product.

Ramesh Shah, Chairman, PharmaTechnologyIndex.com informed the audience that this year’s expo’s focus was on ayurveda, herbal and cosmetics products, as well as GMP and Schedule M. A special pavilion on Track and Trace and Vision Inspection also

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offered great opportunities to suppliers, manufacturers, industrialists, buyers, consultants and academicians to assemble on a common platform.

Koshia pointed out that the Gujarat state FDA’s steps such as issuance of online licenses and implementing egovernance has made operations easier for the industry.

Koshia also mentioned that PharmaTech Expo 2016 will definitely help to update and grow the pharma industries and pharma technocrats of Gujarat.

A series of lectures on ‘Track and Trace: A need of industry, are we ready?’ was also held

On day-one, Pharmexcil was the conference partner for discussion on the subject, ‘GMP for SMEs-Schedule ‘M’ and beyond’. Kapil Bhargava, retired DDC, Government of India, provided detailed information on ‘Training and Self Inspection’. SM Mudda, Director, Global Strategy-Technical, Micro Labs spoke on the topic, ‘Introduction to Quality Management System’.

Day-two had an interesting discussion on the theme ‘Ayurveda: The Future of Healthcare’ which was organised by KNS Media. BV Patel

Pharmaceutical Education and Research Development (PERD) Centre was the Knowledge Partner.

Dr Vijay Singh Chauhan, Sun Wave Pharma, Romania gave the keynote address on the topic ‘Overview of Ayurveda for a better tomorrow : Blending Today’s Technology with Yesteryear’s wisdom’ followed by a very interesting lecture on ‘Cosmeceuticals: An emerging concept in Ayurveda’ by Dr K Mitra, Matxin Labs, Bangalore. Dr Vandana Patravale, Institute of Chemical Technology, Mumbai, spoke on ‘Nanotechnology in Ayurveda:New Perspective and Current Need’. Dr Narendra Bhatt, BVU College of Ayurved, Pune, informed the audience on ‘Regulatory Aspects and Accreditation of Ayurveda Products’.

A series of lectures on ‘Track and Trace: A need of industry, are we ready?’ was also held. The conference was organised by PharmaTechnologyIndex.com. Sanjay Patel, Director Software, Shubham Automation spoke on the challenges and opportunities in Track and Trace. Lokesh Patel, Vice President Track & Trace, Aseptic Technology shared his thoughts on a very important topic ‘Track and Trace: Need of the industry, are we ready? This was followed by a presentation on the topic ‘Tips and tricks of track and trace for SME’s’ by Suketu Shah, Soham ERP Solutions.

More than 150 exhibitors from different states of the country participated in the event and varied kinds of high tech pharma machinery, lab and packaging equipments were on display. With more than 5000 trade visitors, PharmaTech Expo 2016 put up a great show once again. sachin.jagdale@expressindia.com

MARKET

UBM conducts workshop on unannounced audits in Mumbai The event aimed to educate the pharma professionals about the do’s and dont’s during the auditing process Sachin Jagdale Mumbai MANAGING AUDITS in the pharma industry has always been a complex issue for the pharma operators. To educate the pharma professionals about the do’s and dont’s during the auditing process, UBM recently organised ‘Unannounced audits’ workshop 2016 in Mumbai. Representatives from various reputed

pharma companies attended the workshop. Throughout the workshop, the focus was on managing audits in challenging environment in order to meet regulatory expectations.

On day one, Bhavan Mehta, Independent Consultant, FDA expert gave the course introduction and objectives. By giving a few examples of Indian pharma companies who had received warning letters from the regulatory authorities,

Mehta spoke on inspection management and good documentation practices. Mehta’s lecture on data integrity and applicable guidance was well received by the audience with many attendees raising questions and Mehta solving them to their satisfaction.

Mohan Ponnudurai, Program Director, Sparta Systems and Anand Iyer, Account Director, UL India were also the speakers on day one. Pon-

nudurai taught the audience how to manage internal and external audits to reduce risk and ensure compliance. Iyer used few attendees as objects while explaining how to face the audits. He gave a few examples of how employees at the plant get anxious while facing the auditors and how to face the auditors without making spoken or behavioural mistakes.

Contamination control is

one of the most worrying issues for the drug manufacturers. Avinash Vhanakaware, Segment Marketing Manager, Kimberly Clark Hygiene Products, briefed the audience on the ways to control contamination. All the sessions during the day were very interactive and the participants got to know many new things about the auditing process. sachin.jagdale@expressindia.com

EVENT BRIEF SEPTEMBER TO NOVEMBER - 2016 19

cGMP Workshop

CGMP WORKSHOP Date: September 19 - 20, 2016 Venue: Mumbai Description: CPhI is announcing for the first time ever a ‘cGMP workshop’, a two-day practical training to be conducted by a former US FDA drug investigator. The workshop will guide companies prevent instances of contamination, mix-ups, deviations, failures and errors to successfully meet the desired quality standards.

Contact details: E: Purvai.gupta@ubm.com T: 91-22-61727077

HEALTHCARE SENATE Date: September 22-24, 2016 Venue: Hyderabad Summary: Healthcare Senate, the national private healthcare business summit will host the game changers, path finders and opinion leaders of the healthcare industry, to facilitate sharing of innovative ideas and experiences, and convert them into reality.

The event will see a largest

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Healthcare senate

gathering of India’s most influential healthcare practitioners; CEO/CFO/MDs of hospital chains, medical superintendents, hospitals owners and decision makers, owners of single specialty hospitals, owners of diagnostic and other healthcare centres, hospital administrators, HoD of medical and bio-medical departments, HoD of engineering and operations, medical directors, purchase managers, healthcare consultants, project heads, bio-medical engineers, dealers and distributors, thought leaders, industry stalwarts and domain experts Contact details: For delegate registrations Vinita Hassija Mobile: +91 9820590053 Email: vinita.hassija @expressindia.com Shilpa Chaurasia Mobile: +919892170209 Email: shilpa.chaurasia @expressindia.com For awards Raelene Kambli raelene.expressindia @gmail.com

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2nd Edition of Asia Labex

2ND EDITION OF ASIA LABEX Date: September 22-24, 2016 Venue: Gujarat University Convention & Exhibition Centre, Ahmedabad Summary: Asia Labex is a premiere exhibition and conference on laboratory, analytical, scientific, diagnostic, biotech, research and testing instruments and consumables. The exhibition will be organised by Fenza Exhibitons.

Contact Fenza Exhibitions Plot No 1, 2nd Floor, GT Karnal Road, Opposite PNB Bank, New Delhi – 110033

CSV WORKSHOP Date: October 6 - 7, 2016 Venue: Mumbai Description: A two-day in depth workshop designed to provide unique insights and authoritative debate into CSV models, validating data integrity, CSV metrics, network validation and cloud validation.

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CSV Workshop

Contact details: E: sean.palanna@ubm.com T: 91-22-61727072

BIOSIMILARS CONGRESS INDIA 2016 Date: October 13 – 14, 2016 Venue: Hyderabad Description: Biosimilars Congress India 2016 will aim to provide strategic solutions to key issues faced by the manufacturers around the regulatory guidelines of FDA, EMA, upstream, downstream processing, identifying critical quality attributes and statistical approaches to demonstrate biosimilarity.

Contact details: E: Drashti.shah@ubm.com T: 91-22-61727381

PHARMA DATA INTEGRITY, REGULATORYAND QUALITY CONFERENCE Date: October 18 - 19, 2016 Venue: Mumbai Date: October 20 - 21, 2016 Venue: Hyderabad

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Biosimilars Congress India 2016

Description: CPhI's 3rd Annual Data Integrity, Reliability and Quality Metrics a case study- led two-day workshop will cover the latest draft guideline on quality metrics and critical topics related to overcoming data integrity issues.

Contact details: E: Purvai.gupta@ubm.com T: 91-22-61727077

ANALYTICAANACON INDIA AND INDIALAB EXPO 2016 Date: October 20-22, 2016 Venue: HITEX Exhibition Centre, Hyderabad Summary: analytica Anacon India and India Lab Expo happens to be India's largest trade fair for the analysis, laboratory-technology and biotechnology sectors. As the industry's leading marketplace, it brings together scientists, entrepreneurs and users from around the subcontinent.

At the analytica Anacon India and India Lab Expo Conference,

MARKET scientists from around the world will present their innovative analysis solutions.

Contact Email: info@analyticaindia.com

recognition in the field of pharma. With two venues this year, Bombay Exhibition Centre and Bandra Kurla Complex in Mumbai, CPhI &

P-MEC 2016 will include exhibitor showcase, innovation gallery, speed meetings, live entertainment and much more.

Contact details UBM India TIMES SQUARE Unit No 1 and 2, B Wing, 5th Floor, Andheri

Kurla Road, Marol, Andheri (East) Mumbai - 400 059 Tel: +91 22 61727272 Fax: +91 22 61727273

PHARMA CONFERENCE SERIES Date: November 3-4, 2016 November, 2016 Venue: Mumbai Description: A strategic conference series that will address the most critical issues in pharmaceutical and biopharmaceutical manufacturing in India Contact details: E: sean.palanna@ubm.com T: 91-22-61727072

CPHI PRECONNECT- DAY ZERO Date: November 17, 2016 Venue: Mumbai Description: CPhI's Pre Connect Congress will bring together thought leaders under one roof to discuss on the latest trends and advancements in the Indian pharma industry. Discussions will be held on key topics such as M&A, regulatory challenges, drug discovery and other critical topics which are a burning issue in the pharma industry.

Contact details: E: sean.palanna@ubm.com T: 91-22-61727072

CPHI AND P-MEC INDIA Date: November 21 – 23, 2016 Venue: Bombay Exhibition Centre & MMRDA Grounds, BKC, Mumbai Summary: The event will be an ideal congregation for companies to pick up on the latest trends and innovations the market has to offer. CPhI India is also co-located with PMEC India, the pharma machinery show in Asia. This year, the expo has grown from a three-day exhibition to a show spanning a week, Pharma Week, (November 17 to 23, 2016). The Pharma Week will hold more than 12 events that will take place across the city of Mumbai focusing on business, knowledge, leadership, innovation and

To subscribe: bpd.subscription@expressindia.com

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cover )

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(

THE MAIN FOCUS

Advanced Enzymes Technologies’ stellar debut at the stock exchange, despite the niche nature of its business, demonstrates that there is no fixed formula for success

BY LAKSHMIPRIYA NAIR

T

reading the untrodden path is not new to Advanced Enzymes Technologies. Its Founder, Late LC Rathi pioneered the extraction of papain, an enzyme complex derived from papaya fruit and used for pharma and medical purposes. Reportedly, he also established India’s first enzyme manufacturing plant in 1958, though the company, Advanced Enzymes Technologies was incorporated only in 1989. The same pioneering spirit led the current generation leaders to go down the IPO route, an uncommon choice for a B2B company in India, to

further its progress. A risky venture with several pitfalls.

Let’s examine the factors which led to Advanced Enzyme Technologies’ phenomenal performance.

A spectacular debut....

Yet, the company’s IPO received an overwhelming response, with the issue seeing a demand 115 times more than the offered shares. Reportedly, the three-day IPO, from July 20-22, 2016, got applications for 374.80 million shares, compared with the issue size of 3.23 million shares. At ` 1178.10, the shares of Advanced Enzymes Technologies rose 31 per cent higher over its issue price of ` 896 each share and the company raised ` 411 crores through the IPO.

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A leadership position: The promoters of the company, Vasant Laxminarayan Rathi and Chandrakant Laxminarayan Rathi have over three decades of experience in the enzyme industry. Under their stewardship, the company has grown to become the largest domestic enzyme company engaged in research, development, manufacturing and marketing of over 400 proprietary products developed from 60 indigenous enzymes. With reportedly 20 per cent market share in India,

it is second to only Novozymes, the global market leader in this space.

Sound financial standing: The company’s record in terms of revenue and profitability has been notable since 2012, with a compounded annual growth rate (CAGR) of over 14 per cent in the last five years. The net profits of the company in FY12, FY13 and FY14 stood at ` 47.68 crores, ` 76.16 crores and ` 27.75 crores, respectively. The revenue of the company stood at ` 294.64 crores in FY16, registering a steady growth from ` 174.88 crores in 2012. Its net profit stood at ` 122.53 crores for the year

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cover ) ended March 31, 2016, as compared to ` 73.75 crores in the last year. Currently, the US offers 54.94 per cent of revenue, India accounts for 36.44 per cent, 3.84 per cent comes from Europe, 3.63 per cent from Rest of Asia, and other geographies account for 1.15 per cent.

(Source: http://www.financialexpress.com/markets/indian-markets/advanced-enzyme-technologies-shares-listing-bse-and-nse-on -august-1-2016/334520/)

We see huge potential to grow to $100 million in the US itself.

Combined with our growth in other markets, this company can easily grow to $200 million in a matter of three to four years

Growing overseas presence: With over 700 global customers in across 50 countries globally, the company has earmarked a place for itself among the top 15 enzyme manufacturing companies in the world.

Sanofi India, Cipla, Ipca Laboratories, Alkem Laboratories, and Emcure Pharmaceuticals are some of its clientele in the pharma segment. It has six manufacturing units, four in India and two in the US. Thus, it is poised to expand its footprints in the global arena as well.

Significant investments in R&D: The company has also fortified its own standing in the industry through noteworthy investments in R&D. It has four R&D units, three in India and one in the US; as well as a strong team of 55 members. Reportedly, its R&D expenditure is around 5-7 per cent standalone of revenues. The company owns 13 patents till date while another four are awaiting approval. The company has also launched its branded enzyme supplements in the US.

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ADVANCED ENZYMES TECHNOLOGIES ATA GLANCE

THE LARGEST INDIAN PLAYER IN ENZYMES

400 700 60 50 PROPRIETARY PRODUCTS DEVELOPED FROM

GLOBAL CUSTOMERS IN ACROSS

INDIGENOUS ENZYMES

COUNTRIES

CAGR OF OVER

NET PROFIT FOR THE YEAR ENDED MARCH 31, 2016

IN THE LAST FIVE YEARS

`

14%

122.53

SIX MANUFACTURING UNITS FOUR IN INDIAAND TWO IN THE US

CRORES

High entry barrier: Factors like huge dependency on R&D, highly technical nature of the business, scarcity of qualified professionals in enzyme and biotechnology industry etc. have acted as entry barriers to new players. This, in turn, has proved beneficial for existing players like Advanced Enzymes Technologies as it has to deal with less competition. As one of the top players, it has managed to get a substantial slice of the market share.

CL Rathi MD, Advanced Enzymes Technologies

No listed peers: Domestically, Advanced Enzymes Technologies has no like to like listed peer and the shares of Novozymes, its international competitor trades at considerably higher prices. Moreover, Novozymes focuses more on the industrial enzymes segment while healthcare and nutrition is one the major focus areas for Advanced Enzymes Technologies. Catering enzymes to various major pharma and nutraceutical players, the healthcare and nutrition segment accounted for 88 per cent of the company's revenue in FY16.

As per reports in the media, including The Financial Express, renowned market analysts also gave a cautious thumbs up to investors interested in buying the company’s stocks.

Angel Broking predicted that the company could have a ‘robust growth’ in future, spurred by the strong standing of the company and its experience in this sphere. They believe that the cost advantage offered by India would also work in the company’s favour. “High return ratios, reasonable valuations and healthy earnings and EBITDA growth,” were the reasons stated by Reliance Securities to recommend the IPO. Bullish on the IPO, Hem Securities opined that the lack of listed peers in the domestic market would work in the company’s favour. (Read: http://www.financialexpress.com/ markets/indian-markets/advanced-enzyme-technologies-ltdipo-hit-bse-nse-on-july-20-shouldyou-invest/321319/) Speaking to Express Pharma, Mahesh Singhi, Managing Director, Singhi Advisors, airs similar views. He says, “At IPO price, Advanced Enzymes was available at PER of 20.3x FY17 earnings (market consensus). It was inexpensive as the company has no listed peer in India while global enzymes leader Novozymes trades at a PER of 35x. So, Advanced Enzymes was safe bet given reasonable valuations, strong return on equity (ROE) and solid cash flow generation.”

( He further elaborates, “For Advanced Enzymes, the healthcare and nutrition segment, which supplies enzymes to various major pharma and nutra players, accounts for over 85 per cent of revenue.

Major global players such as Novozymes and Dupont Danisco are more focused on serving the industrial enzymes segment as compared to the nutraceutical segment. Thus, limited competition in the nutraceutical segment in the core market, augurs well for Advanced Enzymes Technologies to capture market share and growth.”

…..but not without challenges Thus, Advanced Enzyme ticks most of the check boxes that investors look for and this has led to its stellar debut at the stock exchange. However, it’s been a hard earned victory. Various hurdles on different fronts could have derailed the company’s march to progress.

For instance, the company had to recall one of its products from the market due to contamination issues in 2014. The incident hurt the profit margins considerably, it helped the promoters to salvage the reputation of the company. However, the top management at Advanced Enzymes Technologies believe that the incident was a tough but learning experience which helped them emerge as a stronger entity.

This claim is validated by the fact that it posted a growth of almost 50 per cent in the subsequent year.

Similarly, its decision to go for an IPO was received with mixed reviews. While there were many points in its favour, the market experts had also highlighted that the company’s major share of revenue depends on a few products groups. Any decline or interruption in the demand of these product groups could have a substantial adverse effect on the company’s profit margins.

Moreover, it was also pointed out that only 35-36 per cent of its revenue comes from the

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Indian units and the rest is dependent on its foreign subsidiaries. This could pose a problem due to foreign currency fluctuations and/or if any of the subsidiaries encounter

operational difficulties.

In yet another instance, during the three days of the IPO, rumours surfaced that the company produced enzymes from animal sources which

THE MAIN FOCUS

made them ‘non-veg’. These rumours could have hurt the company as many investors belong to the Gujarati Jain community who practice vegetarianism as a part of their

religion. To lay these fears to rest, the management had to issue a statement clarifying that the company uses only microbial fermentation to produce enzymes.

cover )

CL Rathi, MD, Advanced Enzymes Technologies and Piyush Rathi, Director and CMO, with their team

Thus, time and again, the company tackled these trials and managed to create a favourable impression in the minds of the investors. The result - one of the most successful IPOs of this year.

Creating a win-win situation But for the company, it is merely a foothold, albeit a significant one, in its journey to the pinnacle of success. CL Rathi, MD, Advanced Enzymes Technologies puts it very quaintly. He informs that his company had reached a ‘marriageable age’ and goes on to explain that marriageable age for a company is its ability to sustain the share capital coming and offer more value than ever before. “Our company is ready for more growth and family capital can take a

20 EXPRESS PHARMA September 16-30, 2016

business only so far. There was a need for more capital to drive more growth and an IPO is the means to raise large amount of capital,” says Rathi, explaining why they chose to go for an IPO. He also feels that despite the risks, IPO is also an effective way to raise cheap capital.

He states, “A PE investor would have more expectations and would look at a return of 25 per cent but the common public would be very happy with 15 per cent because it is much more than what a bank offers.”

He attributes the phenomenal success of the IPO to the company’s philosophy of creating a win-win situation for all.

He believes that the IPO ensured that all those who were involved, be it those who were selling the shares or the investors who chose to buy the shares, benefitted from the ex-

ercise. Moreover, it has also become the first and, currently, the only public listed Indian company in this space. However, he is also aware that a public-listed company has renewed share of responsibilities and obligations. He says, “The company now has to be more transparent, ensure good governance and comply with all the regulations and operate in a completely ethical manner.”

Rathi also claims that being a public-listed company also accelerate the growth rate of Advanced Enzymes Technologies because now it would be able to offer more value to its stakeholders, customers and employees.

He says, “We are now in a better position to grow more financially, attract better talent, grow more customers etc. These in turn would further propel the growth of the company. We

would also grow our partner network. We have got renewed respect since the IPO.”

Dreaming big Thus, the company is now poised to grow exponentially in the coming years, states Rathi.

Outlining an ambitious blueprint, he informs that around ` 40 crores of the money raised would go towards settling the debts of Advanced Enzyme USA, the wholly-owned subsidiary of Advanced Enzymes Technologies. Becoming debtfree is one of the foremost goals for the company. Rathi informs that becoming debt-free, would enable them to pursue their expansion plans in full swing as the cash flow from the US company would spur their expansion plans on the Indian front as well as globally.

Expanding R&D is the first

priority. Expanding their footprint comes a close second.

“We would want to make our presence felt in new geographies and wherever we already present, we want to make our foothold stronger,” updates Rathi. The company foresees huge potential to grow in the US, a $2 billion market. The company’s been operating there for a couple of decades but their market share is not yet substantial. In 2011, they acquired Cal India, a specialty enzymes and biochemical company, to aid their growth plans.

Rathi claims, “The US is the largest market for nutraceuticals and it is a major focus area for us. Long experience, sound knowledge, complete entrenchment in the market etc. would help us in expanding our presence. We see huge potential to grow to $100 million in the US

( endeavours and live up to the expectations of its investors is something only time will tell.

But, it’s undeniable that the company has broken the mould and chosen to take a route untravelled by its peers in India.

At IPO price, Advanced Enzymes was available at PER of 20.3x FY17 earnings (market consensus). It was inexpensive as the company has no listed peer in India while global enzymes leader Novozymes trades at a PER of 35x. So, Advanced Enzymes was safe bet given reasonable valuations, strong ROE and solid cash flow generation Mahesh Singhi MD, Singhi Advisors

itself. Combined with our growth in other markets, this company can easily grow to $200 million in a matter of three to four years.”

“We are also planning to expand in the European markets. But Europe is a difficult market because of cultural and linguistic diversities, regulatory differences in each country etc. Thus, expanding in Europe is challenging but we will definitely continue to grow there as well,” explains the MD. The company plans to expand into Japan and Latin America as well.

Setting an example Consequently, the company is gung-ho on growth and raring to achieve new heights of glory. Will it succeed in its

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Will Advanced Enzyme Technologies' step inspire the rest of them follow suit? Singhi doesn't think so. He opines, “India is a small market in overall global market proposition. Overseas companies are much ahead of

THE MAIN FOCUS

Indian firms in terms of R&D and patents. In our view, Indian firms will take longer time to make this business model successful.” If he is correct in his surmise, then the company would have proved itself to be a

disruptor, rewriting the norms of the industry and creating its own formula for success.

Either way, the company seems to be creating history. lakshmipriya.nair@ expressindia.com

MANAGEMENT

COUNTERING THE CHINESE THREAT With the Indian government coming up with a slew of measures to counter the Chinese invasion in bulk drug manufacturing, can drug manufacturers in India make the most of it and become self sufficient

BY PRATHIBA RAJU

A

t a time when China is leveraging its bulk drugs or Active Pharmaceutical Ingredients (API) production, Indian pharma companies are lagging far behind. Indian generic drug manufacturers are unable to deliver the desired quantities and if prices are not favourable, supplies will be restricted. According to industry experts, this could have an impact on the country’s competitiveness and its objective to become a global generic pharma power hub would remain a distant dream.

“Dependence on China for APIs and advance intermediates is undoubtedly very high.

From less than one per cent in 1991, the percentage of API imported from China had reached almost 60 per cent in 2011. If one accounts for the import of advanced API intermediates, then this number would be even higher. This presents a significant risk to

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the industry,” said KV Subramaniam, President, Reliance Life Sciences.

A joint report by Boston Consulting Group (BCG) and Confederation of Indian Industry (CII), states that India depends heavily on imports.

Nearly 80 per cent of many key raw materials (mostly intermediates and some API) are imported from China, which are used to manufacture at least 12 essential drugs. Some of these are are paracetamol, ranitidine, ciprofloxacin, metformin, acetyl salicyclic acid, ofloxacin, metronidazole, ampicillin, amoxicillin and ascorbic acid.

“India is considerably dependent on Chinese imports for many APIs that are required to manufacture essential drugs listed in the National List of Essential Medicines (NLEM) 2015. Data analysis reveals that the value share of China in India’s import of a few key bulk drugs — such as

API is a very critical issue.

Gradually we have lost the contribution in API because more cheaper imports are coming in from other countries. We (the government) are conscious of the bulk drug manufacturers Nirmala Sitharaman Union Minister for Commerce and Industries

6-APA, DCDA, PAP and PenG— is between 98 and 100 per cent. Given the critical nature of the formulations derived from these APIs, any adverse circumstances between the two countries could potentially lead to a health security risk in India. For example, during Beijing Olympics in 2008, China closed down several API plants, leading to a 20 per cent rise in the price of bulk drugs that we were sourcing primarily from China. Therefore, India needs to build a viable ecosystem to support the growth of bulk drug industry and achieve self-sufficiency at least in the strategically important drugs,” said Utkarsh Palnitkar, Head – Lifesciences, KPMG India.

According to CRISIL research database on bulk drugs, the API market in India comprises bulk drugs for exports and bulk drugs for internal consumption. It was estimated at $14 billion in 2015-16

and is expected to reach $25.4 billion by 2020-21 with a CAGR of 16 per cent. In 2015-16, domestic consumption remained almost flat in dollar terms, while exports reduced by almost four per cent year-on-year.

But even though Chinese API manufacturers have captured the lion’s share of the API market, Subramaniam hints at a ray of hope saying, “The pharma industry in India is estimated to have revenues of $30 billion, including exports. API currently forms a very small part of this. Only complex APIs continue to be manufactured in India because of the complexity and quality involved in the drugs’ development and manufacturing. India has a competitive advantage of having broad and deep knowledge of science associated with API and formulations. This, coupled with recent thrust by the US and European regulators for quality and adherence to GMP

norms, gives India a significant advantage in competing with Chinese suppliers. The only area of concern is the scale and cost competitiveness.”

Displaying the same optimism, Ajit Kamath, CMD, Arch Pharmalabs, highlighted that two decades back, India was self-sufficient in bulk drug capabilities and capacities. He is confident that even today, India can outdo most other countries in API manufacturing and can easily wrest back a sizeable market share what was conceded to China in the last 20 years."

“India’s strength in API manufacturing can be gauged from the fact that India has the largest number of API sites that are approved as compliant by global regulatory agencies like USFDA, EDQM, PMDA Japan, TGA Australia, UK MHRA, Korean FDA. A proper financial and policy support to existing Indian API players itself would neutralise much of China’s strength today,” Kamath added.

View from the top Talking to Express Pharma at Idea Exchange, organised by Indian Express, Union Commerce and Industries Minister, Nirmala Sitharaman, said, “API is a very critical issue.

Gradually, we have lost contribution in API because cheaper imports are coming in from other countries. Now, this has a very big message, not just for pharma but to all the raw material-dependent industries, that manufacturing is crucial.

We (the government) are conscious of their problems and realise that lack of API base in India is very concerning and we would like to do something,” said Sitharaman.

Though India has a significant advantage to become a preferred source of API for customers worldwide, it needs stringent trade barriers to thwart China's dominance in the bulk drug market, observed experts.

Combating the bulk drug dragon In a way, India has helped

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China grow and become more competitive in API industry, as the country’s policies for registering APIs have been import-friendly. This has allowed Chinese manufacturers to dump their APIs in India at cheap rates, forcing Indian API manufacturers to shut

shop. Moreover, anti-dumping duties in India is a long drawn out procedure and Indian formulation companies themselves don't support it. Incentive schemes by China to promote exports and in some cases additional incentives for certain families of drugs (like

HIV, oncology, statins etc) make the Chinese manufacturers more competitive.

“Currently, import regulations of bulk actives in India are not as stringent as what the Chinese government have set for their own industry.

Recently, Pharmaceuticals

Export Promotion Council of India approached Union Ministry of Commerce and Industry to bring in stringency in order to encourage domestic manufacturers and also to curb indiscriminate dumping especially from other APAC nations. It is a well

MANAGEMENT

One of the core issues that the bulk drug industry faces is constantly changing environment policies adopted by the states.

A fixed long-term environmental norms and common effluent treatment plants will help the industry in many ways

India is considerably dependent on Chinese imports for many APIs. Given the critical nature of the formulations derived from these APIs, any adverse circumstances between the two countries could potentially lead to a health security risk in India

Ajay Saxena

Utkarsh Palnitkar

Director, Bulk Drug Operation, Rusan Pharma

Head – Lifesciences, KPMG India

known fact that India has better infrastructure and quality complaint bulk drug manufacturing facilities in the country in comparison to those in China. However, India is yet to match its productivity with that of China. There is no reason why India cannot move past China and Italy to garner a top position in the world’s bulk drug market with its additional quality of excellent communication skills in English. Hope, the latest FDI policies would trigger huge investments into the country bringing in financial, technological, R&D initiatives,” said SV Krishna Prasad, CEO, CITO Healthcare.

The Chinese have excelled in bulk drug manufacturing as they have huge trade barriers for export of medicines and APIs. Over the past few months, China’s Food and Drug Administration (CFDA) has brought out reams of new regulations on far-flung corners of its pharma sector: multi-regional clinical trials, biosimilars, drug evaluation and approval, and most recently, stem cell research.

24 EXPRESS PHARMA September 16-30, 2016

The dependence on China for APIs and advance intermediates is undoubtedly very high. From less than one per cent in 1991, the percentage of API imported from China had reached almost 60 per cent in 2011 KV Subramaniam President, Reliance Life Sciences

Our committee has recommended selfreliance in respect of antibiotics, pain killers, anti-cancer drugs, anti-hypertensive drugs, anti-diabetic drugs and vaccines that may be considered to be of public health priority and emergency life saving drugs VM Katoch Former Health Secretary

The increased bureaucracy around marketing approval applies mainly to foreign companies.

According to industry experts, if India doesn’t put in place similar stringent policy and trade barriers, despite having world-class assets and conceded market share, Chinese suppliers would dictate price in the future, which will pose a threat to Indian players.

Pharma companies in India were forced to evolve business strategies to cope with skewed policies. Relating the sequence of evolution, Palnitkar said, “Over the last few decades, many Indian manufacturers have moved up the value chain to focus on commercially attractive segments such as finished formulations and complex-to-manufacture APIs. Local players thus started sourcing raw materials and simple APIs from costcompetitive locations, especially China. China, with its large manufacturing base of pharma intermediates and APIs, has been able to supply at a much lower cost than lo-

cal companies. Over a period of time, our dependence on China resulted in a further increase of imports and unfortunately in shutdown of many manufacturing units in India, which simply could not compete with the Chinese firms.

This spiral, has over a period of time, led to a complete dependence on China for some bulk drugs.”

According to industry experts, factors which adversely affect India's API industry are high working capital costs, rising capital costs for setting up and expansion, restriction of foreign investment in the sector, unfavourable excise duty structure, power and utility costs, which are much higher than in China and lack of sufficient common effluent treatment plants.

“One of the core issues that the bulk drug industry face is constantly changing environmental policies adopted by states. A fixed long-term environmental norm and common effluent treatment plants will help the industry in many ways,” said Ajay Saxena, Director, Bulk Drug Operation,

Rusan Pharma.

“The Central Government is supporting bulk drug manufacturing by encouraging to come out with common effluent treatment plants, which is crucial in APIs,” informed Sitharaman.

The minister informed that she had taken the initiative and organised a meeting with Ananth Kumar, Minister of Chemicals and Fertilizers, and Prakash Javadekar, who was then the Minister of State (Independent Charge) Environment, Forest and Climate Change, where problems of bulk drugs manufacturers were discussed.

“Many bulk drug manufactures voiced their concern on how each one had to create an effluent treatment capacity and how a connected facility would help if provided. So the government agreed to set up common effluent treatment plants where small and big companies would be charged differently. . The government will spend around ` 300 crores to set up common effluent treating plants,” informed Sitharaman.

According to bulk drug manufacturers, to make India less dependent on China, a few trade barriers should be implemented on imports. For instance, the process of registration of drugs in India should be as tough as it is to register drugs in China. API manufacturers from China should furnish proof that drugs supplied to India are approved by China FDA for both supplies to Chinese formulation or finished dosage from companies. Anti-dumping duties need to be invoked to protect Indian manufacturers. Tax incentives and realigning excise duty structure on local bulk drug manufacturers will ensure competitiveness to both API and formulation companies and incentives should be given to Indian formulation companies, rather than from Chinese importers.

Stringent trade barrierscan be adopted only with a robust policy. Thus, a specific policy focused on bulk drug manufacturing needs to be implemented immediately, urge industry veterans.

MANAGEMENT Robust policy need of the hour In order to battle the Chinese bulk drug dragon, the Indian government is working on a new indigenous bulk drug policy, which is expected to enhance growth in the API market.

A senior official from the Department of Pharmaceuticals, Government of India, while speaking to Express Pharma, on condition of anonymity, said “The pharma sector offers huge opportunities for growth. The Central Government is working in that direction and are in consultation with all the stakeholders, including state governments.

A Cabinet note on bulk drugs has been moved, which is based on the recommendations by the Katoch Committee.�

Talking about the recommendations, VM Katoch, who headed the committee says, “The committee report aims to make the API industry viable, self reliant and growing, which will successfully overcome the competition from other countries. As a result, India will maintain leadership in pharma sector which is critical for the health of our people. Our committee recommended self-reliance in respect to antibiotics, pain killers, anti-cancer drugs, anti-hypertensive drugs, antidiabetic drugs and vaccines that may be considered to be of public health priority and emergency life saving drugs.� “In the API market, India stands third in the Asia-Pacific region. The main competition is from China. India’s API market share has been

witnessing a gradual growth over the years. The market share in 2005 was 6.5 per cent and was given a projected growth rate of 33.3 per cent by 2015. Exports of generic APIs have also seen an increase with 18.9 per cent between 2005-2010,� said Prasad. “Looking at the government's vision to accelerate growth in this sector, the policy is expected to address most of the challenges faced by the sector, and is certainly a step in the right direction,�

Subramaniam said.

Many Indian firms dealing with APIs have made consistent efforts to gain credibility in the regulated markets by improving their standards and seek approval for manufacturing facilities, therapeutic applications and products.

Government support is need

of the hour, stressed industry experts. “The proposed bulk drug manufacturing policy which is expected to relax environmental clearance norms and enable easier financing regulations for bulk drug manufacturers will provide a conducive ecosystem to enable growth of this vital industry. The proposed policy is also expected to facilitate clusterbased growth with key announcements such as establishment of bulk drug mega parks, availability of land at concessional rates, access to continuous power supply at reduced rates, tax concessions and income tax benefits to manufacturers, provision of soft loans, and establishment of common infrastructure.

Upon implementation, these provisions would collectively

trigger investments in the API segment. Revived government focus may also lead to steady inflow of investments in the sector boosting India’s bulk drug output,� opined Palnitkar.

Constant upgrades in the quality of products and cost effectiveness have catapulted the growth of Indian API market globally. But, a robust policy, which improves the manufacturing standards, would go a long way to revive the manufacturing industry and put in a different phase of growth. “We would like to see development in clearing policy guidelines, faster decision making, government’s role as a facilitator, common effluent treatment plants so that industry can concentrate on manufacturing, research and development and new

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EXPRESS PHARMA

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MANAGEMENT

Currently, the import regulations of bulk actives in India are not as stringent as what Chinese government have set for their own industry.

India is yet to match the productivity of China.

Hope, the latest FDI policies would trigger huge investments into the country bringing in financial, technological, R&D initiatives as a shot in the arm for the bulk drug industry SV Krishna Prasad CEO, CITO Healthcare

markets,” said Saxena.

Stating that the national policy on bulk drugs is quite ambitious, Prasad said that major investments are involved in land acquisition, facility design and construction, equipment plan, procurement installation. He also indicated that the operations part also need huge capital investments.

Experts said that the new policy should bring in reforms by providing both infrastructural and financial support to the industry.

“We expect concrete steps that will help the sector increase its scale of operations and reduce operating costs to become competitive in the domestic and international markets. Relaxation in clearance norms, stringent guidelines for good manufacturing practices, a single-window clearance system that removes duplicity and ensures faster approvals would be welcome changes,” Palnitkar added.

“The new bulk drug policy can help in giving the right messages and right support to those sectors which need them, and in this case to get into the specifics, which is getting APIs within India, I think there should be a concerted effort over and above the policy,” Sitharaman stated.

The Centre’s ‘Make In India’ policy has given a major boost to API manufacturers, which will help to boost the morale of the industry and that of the investors, informed experts.

Make in India to propel bulk drug sector

Even today, India can out do most other countries in API manufacturing and can easily wrest back a sizeable market share what was conceded to China in the last 20 years Ajit Kamath CMD, Arch Pharmalabs

26 EXPRESS PHARMA September 16-30, 2016

The imminent manufacturing policy supported by the ‘Make in India’ initiative is expected to trigger manufacturing activity in the bulk drug industry. Prime Minister Narendra Modi’s pet initiative will create a comprehensive environment for bulk drug manufacturing industry.

“Bulk drug manufacturing is indeed in line with the ‘Make in India’ initiative as it not only makes India self-reliant in bulk drugs, but also helps to increase exports to commercially attractive regulated markets. The

government has taken tangible measures in this regard by withdrawing exemption of customs duties given earlier to certain categories of drugs and bulk drugs. The government had earlier declared ‘2015 – Year of Active Pharmaceutical Ingredients’ to build confidence in the industry and the policy is expected to be a significant push in this direction,” said Palnitkar.

The new bulk drug policy with the ‘Make In India’ policy needs to be adopted with a cluster approach to further enhance it, urged industry experts.

“A cluster approach with common facilities will definitely bring down costs at levels lower than China. It will be appropriate for attaining progressive self-reliance and also for optimal utilisation of resources. For economising production, establishment of Large Manufacturing Zones (LMZs)/ mega parks for APIs with common facilities maintained by a separate Special Purpose Vehicles (SPV) will be most effective approach,” said Katoch.

Giving an estimate, Katoch indicated that an average cluster will require about 1000 to 2000 hectares of land, which will require a minimum of ` 1000 crores. He added that larger the cluster, bigger will be the returns and scope for larger number of players.

“I'm not against mega parks as long as they comply with the existing environment regulations. Now regulations have become even more stringent,” said Sitharaman.

According to KPMG, bulk drug manufacturing companies need large scale operations to achieve economies of scale and provide cost-effective raw materials.

“Investments for cluster development are required in the form of shared infrastructure, such as captive power plant, effluent treatment plant, testing and R&D labs, etc. Common facilities would help reduce manufacturing cost, making API-manufacturing companies competitive in the global market. Larger parks would entail higher investment outlay and would be best suited to compete with China’s mega cluster sized parks. With cluster approach formulations, manufacturers can also easily access fermentation and chemical synthesis–based products. A closer integration between API and formulations manufacturers would help companies become cost competitive,” Palnitkar added.

But the cluster approach would be a long-term objective, informs Kamath. He said, “The time taken to build such parks would be anywhere between 18-24 months, and securing regulatory approvals for manufacturing

units, starting from the local FDA to say, global regulatory agencies, takes anywhere between a year and even as long as five years, depending upon the agency. Also, inspection of global regulatory agency and customer’s quality analysis audits also takes time.”

As increasing dependence on China for API is posing a major threat. A long-term strategy to build bulk drugs parks might not immediately mitigate the present day risk.

Thus, manufacturers emphasised that in the short term, the focus should be to improve competitiveness in domestic manufacturers and revive existing financially stressed bulk drug manufacturers. This will help save thousands of crores of fresh capital investments later down the line. A new bulk drug policy with stringent trade barriers is sought by the existing Indian API players to neutralise the Chinese bulk drug strength.

Thus the need is for both short term measures to ease the immediate pain, while preparing a long-term policy.

But just as Band-Aid do not fix a long festering wound, different ministries and industry will have to get ready for a major overhaul for the API to survive and thrive against the competitors like China and Italy. prathiba.raju@expressindia.com

MANAGEMENT

IS HERBAL THE FUTURE OF EXCIPIENTS? Advantages such as low cost and less toxicity, which give them an edge over their synthetic counterparts, are spurring the use of herbal excipients in the pharma industry

By Sachin Jagdale

N

ot many patients know that the drug they consume contains very less amount of actual active molecule, the rest is made up of excipients. They are defined as “a natural or synthetic substance formulated alongside the active ingredient of a medication, used for the purpose of long-term stabilisation, bulking up solid formulations that contain potent active ingredients, or to confer a therapeutic enhancement on the active ingredient in the final dosage form, such as facilitating drug absorption, reducing viscosity, or enhancing solubility.” These ingredients

are present in all marketed drugs.

Though inert by nature they are as important as the active molecules as it is the excipent's role to keep a drug stable and help perform its duties. Synthetic excipients have ruled the market for a long time, but lately, herbal excipients have been giving them serious competition.

Growth drivers of herbal excipients “Need for safe and natural products for health and for specific areas like skin or hair care are some of the major drivers,” says Dr Narendra Bhatt, Con-

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September 16-30, 2016

MANAGEMENT sultant Ayurveda-Research and Industry. The belief that what's natural is usually safe, is also promoting the use of herbal excipients. Hence, instead of using synthetic excipients which would further add to the toxicity of drugs, several pharma companies are gradually shifting to herbal excipients.

Dr Dilip Ghosh, Regulatory and Projects, SOHO-Flordis International, International Speaker, Facilitator and Author, also lists some of the drivers of herbal excipients market. He says, “The growth of the global market of natural excipients is driven by the factors such as growing demand of functional natural excipients, increasing demand of generics, and emergence of new excipients in the market.

The availability of cheap labour, skills in abundance and comparatively lower cost of the raw materials will drive this industry. Industry is looking for natural alternatives, particularly to reduce drug-induced toxicity. Herbal excipients like cyclodextrin have natural, complex structure which are their unique selling points.”

Excipients’ have multiple roles to play as diluents, binders, disintegrants, adhesives, glidants and sweeteners in tablets and capsules. According to industry experts, herbal excipients can definitely equipped to take over these functions from synthetic excipients. Besides being low on toxicity, herbal excipients also provide cost advantages, thereby making their position stronger in the market. Ghosh sheds more light on this issue. He says, “A number of natural gums and mucilages have been investigated for inclusion in pharma formulations in novel drug delivery systems (NDDS) such as modified release dosage forms and delivery systems that target specific sites of delivery. NDDS is one of the innovative technologies under development for targeted delivery to specific organ/s. Several natural products such as Cyclodextrin, Carrageenan, Chitosan and Shellac are used in different encapsulated de-

28 EXPRESS PHARMA September 16-30, 2016

The growth of the global market of natural excipients is driven by the factors such as growing demand of functional natural excipients, increasing demand of generics, and emergence of new excipients in the market Dr Dilip Ghosh Regulatory and Projects, SOHO-Flordis International, International Speaker, Facilitator and Author

With increasing demands and use, I wonder what situation will develop soon if efforts are not made to cultivate and develop natural resources Dr Narendra Bhatt Consultant Ayurveda-Research and Industry

livery systems.”

Thus, spurred by the need for safer medicines, the herbal industry is registering steady growth. But, there are many hurdles to overcome too.

Challenges to tackle Though being natural is the biggest plus point of herbal excipients, their adoption has not been widespread. There is a need for more awareness, research and verifications to pave the way for their more effective use.

Dr Vijay Singh Chauhan, Consultant to Ayurvedic pharma industry, and Scientific Advisor, Sunwave Pharma, Romania, says, “As far as ayurvedic/herbal/dietary supplement markets are concerned, till now, universally accepted pharmacopoeial excipients are used. Herbal excipients are still under testing in various research labs.”

“The biggest challenge is availability,” asserts Bhatt. He adds, “With increasing demands and use, I wonder what situation will develop soon if efforts are not made to cultivate and develop natural resources.”

One view is that herbal excipients do offer more benefits than synthetic excipients, but, it is of no use till such excipients are accepted by the

Excipients’ have multiple roles to play as diluents, binders, disintegrants, adhesives, glidants and sweeteners in tablets and capsules authorities of various pharmacopoeias for ayurvedic proprietary products. This global acceptance will happen only if these excipients fulfill the scientific requirements laid down by various pharmacopeia.

Ghosh says, “There is no extensive research on herbal excipients, particularly in nano-technology area. There is also no big industry funding as well as government initiatives. Very limited cGMP (pharma-grade) manufacturing facility and contamination is also an issue.”

In the past, on numerous

occasions herbal products have come under fire due to presence of contaminants like heavy metals. Will the use of herbal excipients in medicines exacerbate this issue and pose regulatory problems for the drug manufacturers, especially during the exports? If yes, then it is yet another challenge to be tackled.

The industry seems to be divided on this issue Ghosh says, “Increasing soil and air pollution and higher level of heavy metals/pesticides/residues are major hurdles of India herbal excipients for export market.”

However, Chauhan says, “This question has no relevance till metal-based excipients come into use, which is not the case as of now! Heavy metals, viz. lead, mercury, arsenic and cadmium have been tested and found toxic by the scientists world over, hence their maximum permissible limits have been worked out and norms laid down!”

It’s a fact that regulatory issues are mainly debated when it comes to the export part of the business. If the industry shows a similar approach when drugs are distributed within the country then it will definitely raise its own standards.

Bhatt believes that the use

of herbal excipients might actually help to raise the standards of the industry. He says, “Rather it will help. One question I have is why do we think of only exports when it comes to safety. The fact is we should address these issues in a more logical and rational manner rather than only for trade gains. It will help us evolve our own parameters, take on challenges and provide sustainable growth, and not only opportunistic growth.”

He adds, “Nobody predicted that the herbal extracts market would grow so fast in a decade. But we must understand and accept that it was at the cost of value added formulations. We failed to get into value added formulations due to lack of scientific and technical efforts. I am afraid, it might happen again in excipients if proper care is not taken.”

Amidst the debate over possible contamination in the herbal excipients and regulatory hurdles arising due to it there is a promising development as well.

Dr Vandana Patravale, Professor of Pharmaceutics, Department of Pharmaceutical Sciences and Technology, Institute of Chemical Technology, Mumbai, informs, “The newer versions of herbal pharmacopoeia however in their monographs include limits for the heavy metal content etc. Adhering to the said limits can function as a reliable measure to use and control herbal excipients.”

Sustaining the growth momentum The global excipient market is growing consistently and is predicted to maintain the upward trajectory, however, on the other hand, the herbal excipient segment is yet at a very nascent stage of growth.

The pharma industry is well aware and optimistic about the potential that this segment holds but as scientifically proven theories constitute the core of the pharma business, herbal excipients will have to prove themselves on the same parameters. sachin.jagdale@expressindia.com

RESEARCH UPDATES

Research links eczema and hay fever to early antibiotic use The association with allergies was stronger if patients received more than one course of antibiotics early in life BABIES GIVEN antibiotics in the first two years of life are more likely to develop allergies as adults, according to an extensive analysis of past clinical studies involving nearly 400,000 people. The findings, to be presented at the European Respiratory Society

The latest research involved trawling back through 22 studies conducted between 1966 and 2015. After pooling the results, Ahmadizar and colleagues found an increased risk of eczema due to early life use of antibiotics of 15 to 41 per cent, while hay fever risk in-

annual meeting in London, point to a clear association with the risk of eczema or hay fever later in life.

Some previous research has suggested a link between early antibiotic use and allergies, but the results have been inconsistent. Lead researcher Fariba Ahmadizar of Utrecht University said antibiotics most likely disrupted the body's immune system by impacting microbes in the gut, which can negatively affect immune responses. Scientists have long puzzled over soaring allergy rates in developed countries, with many speculating that changing exposure to germs in childhood may be to blame, although the precise mechanism for this remains unclear.

creased by 14 to 56 per cent. The association with allergies was stronger if patients received more than one course of antibiotics early in life.

Adam Finn, a professor of paediatrics, University of Bristol, who was not involved in the research, said the findings added weight to evidence of long-term downside from antibiotic use. Medics are already worried about the emergence of antibiotic resistance due to drug over-use. Still, Finn and other experts said doctors needed to balance out the risks and benefits, since antibiotics remain essential weapons in fighting bacterial infections, saving millions of lives.

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Reuters

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September 16-30, 2016

RESEARCH

Vitamin D tablets may help reduce asthma attacks,review finds The trials were conducted in the US, Canada, India,Japan, Poland and Britain THE WORLD'S 300 million asthma sufferers could help reduce their risk of severe asthma attacks by taking Vitamin D supplements as well as their standard asthma medicines, according to the findings of a review of international trial evidence. The analysis, which covered trials in the US, Canada, India, Japan, Poland and Britain, found that taking Vitamin D tablets cut the risk of severe asthma attacks needing hospital treatment to around three per cent from six per cent. Adrian Martineau, a professor of respiratory infection and immunity at Queen Mary University of London who led the work, said the results were exciting, though also advised caution.

"The findings relating to severe asthma attacks come from just three trials in which the patients were mostly adults with mild or moderate asthma," he said. More trials are needed in children and in adults with severe asthma, he

said, to find out if Vitamin D could also benefit these patients.

Martineau further said it was not yet clear whether the effect of Vitamin D tablets was across all patients, or only in those who had low Vitamin D

levels to start with. "Further analyses to investigate this are ongoing and results should be available in the next few months."

Erika Kennington, Head of research for the charity Asthma UK, said the findings showed promise, but more evidence was needed for them to be conclusive.

"With so many different types of asthma, it could be that Vitamin D may benefit some people with the condition but not others," she said.

Asthma is a chronic disease that affects around 300 million people around the world, often giving symptoms of wheezing, coughing, chest tightness and shortness of breath.

Reuters

determined that local mosquitoes were transmitting Zika in an area of south Florida, while the US territory of Puerto Rico has experienced a widespread outbreak.

More recently, Singapore identified a local outbreak. Officials in Florida said they had trapped in the Miami area the first mosquitoes that tested positive for Zika in the continental US. There is an urgent need to develop a vaccine for the virus, which in pregnant women can cause the rare birth defect microcephaly. This can lead to serious developmental problems, and has been linked to severe fetal brain abnormalities.

THE US Food and Drug Administration approved Novartis' biosimilar version of Amgen's arthritis drug Enbrel. The FDA approved the drug, Erelzi, known also as etanercept-szzs, for multiple inflammatory conditions including rheumatoid arthritis and plaque psoriasis, a skin condition.

The agency approved the drug as a biosimilar, meaning there are no clinically meaningful differences between Erelzi and Enbrel. But the two drugs are not considered interchangeable and are therefore not called generics. Enbrel is a biologic drug made from living cells. Biologics are more difficult to imitate.

The FDA's ruling followed a unanimous vote by the agency's advisory panel in July in favor of approval. "We are committed to bringing Erelzi to the US market as soon as possible," said Carol Lynch, Global Head of Biopharmaceuticals, Novartis' Sandoz unit in Germany.

Enbrel was approved in 1998 and generated more than $5 billion in US sales last year. It works by blocking a protein known as tumor necrosis factor, or TNF, that plays a role in inflammatory conditions. Amgen believes Enbrel has US patent protection until 2029 and is fighting in court to keep Novartis' drug off the market.

The FDA is also weighing approval of Amgen's biosimilar version of AbbVie's arthritis drug Humira, a TNF inhibitor that last year generated US sales of more than $8 billion.

AbbVie is in turn trying to block Amgen's drug from reaching the market, saying it has patents in place to protect Humira in the US until at least 2022.

Reuters

Reuters

Takeda joins effort to develop Zika vaccine with US funding Takeda will receive nearly $20 million over the next 18 months to fund preclinical research and manufacturing in preparation for early human trials JAPANESE DRUGMAKER Takeda Pharmaceutical Co said it is developing a vaccine to prevent the Zika virus, which has been linked to severe birth defects, and has secured funding from a US government agency.

Takeda, which is also working on vaccines for other mosquito-borne viruses such as dengue, said it would initially receive nearly $20 million over the next 18 months to fund pre-clinical research and manufacturing in preparation for early human trials. The contract is with BARDA, the US Biomedical Advanced Research and Development Authority, a unit within the US Department of Health and Human Services. It calls for funding of up to $312 million if

30 EXPRESS PHARMA September 16-30, 2016

the agency deems the vaccine worthy of moving through late stage testing and filing for approval, the company said.

Takeda has been conducting pre-clinical testing for several months and hopes to begin Phase I trials in healthy volunteers in the second half of 2017, Rajeev Venkayya, Head of Global Vaccines, Takeda, said.

The company said it was also in discussions with the Japanese government on its possible participation in the Zika collaboration. The Takeda vaccine will utilise inactivated, or killed, whole Zika virus to promote an immune response, Venkayya said. The vaccines now in early human testing are DNA-based and contain no actual virus.

"To help protect people from Zika in the US and abroad, we are aggressively pursuing the development of promising vaccine candidates around the world," Richard Hatchett, Acting Director, BARDA said in a statement. BARDA said that including the Takeda funding, it has so far committed $76 million to help develop Zika vaccines, diagnostics, blood screening tests and other technologies to fight the virus.

Takeda joins several companies and government agencies in efforts to develop a vaccine against the virus that has spread across the Americas since the current outbreak was first detected last year in Brazil.

In recent weeks, US authorities

FDAapproves Novartis biosimilar to Amgen's Enbrel

RESEARCH

Psoriasis may carry clogged-arteries risk similar to that with diabetes People with psoriasis tended to have fewer other heart disease risk factors like obesity, compared to those with diabetes PEOPLE WITH psoriasis may be at increased risk of calcium buildup in the arteries – an indicator of heart disease risk – comparable to that of people with diabetes, according to a new study.

Comparing people in their 50s with psoriasis, diabetes or neither disease, researchers found that moderate to severe calcium buildup, or atherosclerosis, was about five times as common in people with diabetes or psoriasis as it was in the others.

“We know that psoriasis accelerates vascular disease, but we’re not sure how or why,” said senior author Dr Nehal N Mehta of the US National Heart, Lung, and Blood Institute in Bethesda, Maryland. The fact that people with psoriasis have calcium buildups similar to those in diabetes may be a piece of the puzzle, Mehta said. People with type II diabetes are regularly screened for heart disease, which may also be advisable for psoriasis patients, he said. Psoriasis, characterised by itchy red and silvery patches on the skin, is an autoimmune disease that affects about two per cent of North Americans and Europeans.

Diabetes is much more common, affecting about nine per cent of the US population, according to the Centers for Disease Control and Prevention (CDC).

People with diabetes are twice as likely to have heart disease or a stroke as people without diabetes, and to experience these at an earlier age, according to CDC. One risk factor common to both psoriasis and diabetes and thought to play a role in elevated heart disease risk is chronic inflammation, which is known to promote arterial buildup.

The researchers studied 387 people who were in their early 50s, on average, and were recruited from outpatient clinics between 2013 and 2015.

The participants either had moderate to severe psoriasis but no diabetes or other inflammatory health conditions, or they had type II diabetes but no

psoriasis or other inflammatory conditions or they had neither psoriasis, diabetes nor any other inflammatory conditions. At least half of each group had no apparent coronary artery calcium build-up, but 19 people with psoriasis had high levels of build-up, as did 20 people with diabetes and just four people with neither disease, according to the results in JAMA Dermatology.

People with psoriasis tended to have fewer other heart disease risk factors like obesity, compared to those with diabetes. And when researchers adjusted for those kinds of factors, especially body mass, the link between diabetes and coronary calcium buildup was no longer significant, but the link to psoriasis remained. “The results are important confirmation of prior work which has suggested that patients with more severe psoriasis have a similar increased risk of major adverse cardiovascular events compared to diabetes,” said Dr Joel M Gelfand, Director of the Psoriasis and Phototherapy Treatment Center at the University of Pennsylvania Perelman School of Medicine in Philadelphia.

“The precise mechanism explaining the association of psoriasis and cardiovascular diseases is not known but it is thought that chronic inflammation, common to both disorders, is the primary culprit,” Gelfand, who was not involved in the study, said. In the short term, coronary artery calcium only presents a low risk to the heart, but becomes more dangerous as it builds up over time, he said.

“Get screened for cardiovascular risk factors at least once if you have psoriasis, and after the age of 40 they should get screened annually,” including measures of blood pressure, body mass index and cholesterol levels, Mehta said. It also makes sense to try to exercise three to four times per week and adhere to a low fat, low salt diet, he said.

Reuters

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PHARMA ALLY VENDOR NEWS

Werum ITSolutions wins Asian Manufacturing Award 2016 Its specialised solutions help pharma manufacturers in Asia increase efficiency, improve productivity and meet regulatory requirements

W

erum IT Solutions has been named 'Best Pharma Solutions Provider' at this year’s Asian Manufacturing Award ceremony. With this, the deciding jury of industry experts acknowledged Werum’s innovations and continuous advancement of its PAS-X Manufacturing Execution System.

Its specialised solutions help pharma manufacturers in Asia increase efficiency, improve productivity and meet regulatory requirements.

“A special thank you to our customers, because they are the foundation for this recogni-

David Margetts (right), Managing Director, Werum IT Solutions Thailand, receiving the Asian Manufacturing Award

tion,” says Rüdiger Schlierenkämper, CEO, Werum IT Solutions. “We are proud to be recognised as ‘Best Pharma Solutions Provider’ for our PAS-X manufacturing IT product and services offering. The award motivates us to continue developing innovative, high quality software products that address the challenges of the pharma industry – such as Manufacturing Intelligence and Industry 4.0 (Internet of Things) – together with our customers.”

David Margetts, MD, Werum IT Solutions, Thailand, who received the Asian Manu-

facturing Award in Singapore, adds, “Earning the Asian Manufacturing Award is a remarkable achievement we want to share with our customers, partners and employees. We would like to thank all of our customers for their trust and commitment.”

The Asian Manufacturing Award honours control, instrumentation, and automation product manufacturers and service providers who have delivered the best solutions to address today’s engineering and manufacturing challenges.

EP News Bureau

Kenzai offers robust business solutions to pharma companies Will help pharma companies move ahead with confidence KENZAI, A vertically integrated healthcare solution provider, based in Ahmedabad, is a provider of robust healthcare business solutions. The company has identified certain key areas and has set out to offer robust solutions to pharma companies by bridging the gap that exists due to lack of adequate knowledge and experience.

Pharma companies in order to have a competitive advantage over others and grab greater share or role in global scene, ensure that processes are world class, quality of output matches global standards, and products comply with all

32

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September 16-30, 2016

regulatory / statutory norms.

In the process, a lot of gaps exist, as companies in its pursuit to cater to market demands misses things on certain areas.

These may not be intentional but possibly due to lack of knowledge and absence of adequate experience.

Kenzai’s objective is to handhold clients and help them comply and improve their capability across the pharma value chain which could be at organisation level, marketing, human resource, operations, strategic or to adopt to new way of marketing ie digital.

Kenzai's partners are

Kenzai’s objective is to handhold clients and help them comply and improve their capability across the pharma value chain

pharma professionals having five decades of executive experience in leading MNC’s / Indian companies located in Mumbai and Ahmedabad.

Both the partners, P Pradeep Kumar and Dr Dipankar Dutta, have handled multiple therapies during their journey.

The partners intend to bring in the change in Gujarat Pharma Space and help their partners / associates to scale new heights in business by making them compliant, competitive and future global ready.

P Pradeep Kumar, one of the Managing Partner, says, “Adopting to processes and

binding the business through knowledge and experience is the key element to differentiate in the marketplace today.”

Kumar says, “Kenzai’s strong value added offerings will certainly help pharma companies move ahead with confidence. It will also influence the lives of manpower employed by equipping them with better work practises and skills.”

“Kenzai thus stands committed to robust healthcare solutions to healthcare,” says Dr Dipankar Dutta, Director and Co-Founder, Kenzai.

EP News Bureau

Merck launches new gene editing technology to engineer virus resistant CHO cell lines Enhances viral safety while maintaining cell line productivity, protein quality MERCK HAS launched a first-of-its-kind gene editing technology to modify CHO cell lines to be resistant to minute virus of mice (MVM), a common contamination threat that remains despite the shift to chemically defined, animal component-free manufacturing processes.

utive Board and CEO, Life Science.

“We are also leveraging this unique combination of experience and technologies to address some of the industry’s most complex challenges and exciting applications, including cell therapy.”

Under the Centinel programme,

CHO cells are commonly used in the manufacture of biologics. Merck’s new Centinel technology targets genes which play a role in MVM susceptibility. Viral contaminations like MVM can have major consequences for biopharmaceutical manufacturers, costing hundreds of millions of dollars, according to industry reports. The greatest impact of such contamination is on patients, as access to therapies can be put in jeopardy. Centinel technology provides manufacturers with an additional path for mitigating the risk of MVM contamination, while maintaining an equivalent level of protein quality and cell line productivity.

“The Centinel programme is just one example of how we are combining years of expertise and credibility in process development, biologics manufacturing and gene editing tools to increase safety for our customers and their patients,” said Udit Batra, member of the Merck Exec-

Merck can modify customers’ CHO cell lines to provide viral resistance to MVM. A patent application has been submitted for the technology used in the gene editing approach to viral resistance. The company’s BioReliance testing services can validate MVM resistance and demonstrate the virus is not propagated in the cell line.

Alternatively, customers can purchase the zinc finger nuclease pairs to engineer cell lines directly. Merck’s new Centinel technology builds on the company’s expertise in gene editing and biomanufacturing processes, as well as its in-depth understanding of the regulatory environment. In addition to enhancing the safety of biomanufacturing, Merck is also applying this expertise and approach to develop other technologies and services, including those supporting the cell therapy industry.

EP News Bureau

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PHARMA ALLY PRODUCTS

Particle Works launches range of high quality magnetic nanoparticles PARTICLE WORKS, the nano and microstructured material specialist, has developed magnetic nanoparticles offering superior performance and physical characteristics. The particles consist of cobalt protected by a thin shell of iron oxide, offering up to five times the performance of other commercially available products. Supplied with a choice of functional coatings, they are suitable for organic and aqueous solvents, as well as for functionalisation with, for example, antibodies.

Drawing on the Blacktrace group’s expertise in microfluidics, Particle Works magnetic nanoparticles are precision manufactured using continuous flow techniques to offer very narrow size

distributions and low batch-to-batch variation. Each product is supplied with full characterisation data, simplifying data analysis and offering enhanced process security for applications in the diagnostic imaging, pharmaceutical, biomedical and industrial sectors. Backed

by Particle Works’ quality guarantee and expertise in nanomaterials, the company’s magnetic nanoparticles are ideally suited to proof of principle, materials optimisation and scale-up studies.

Contact details Particle Works - India 420/421, Corporate Ave, Sonawala Road, Goregaon, Mumbai, 400063 Telephone: +91 22 2686 4410

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PHARMA ALLY

Dock shelters from Gandhi Automations GANDHI AUTOMATIONS, a known entrance automation and loading bay equipment company, offers a complete range of dock shelters available for every requirement and environment.

Dock shelters are installed mainly to seal the gap between the building and the vehicle in such a way that when the sectional overhead door is opened goods and personnel are protected against the harsh weather conditions outside. Dock shelters provide a seal between the internal and external environments, thus assisting in the reduction of energy consumption. The savings in energy costs are considerable.

Retractable dock shelters: The retractable PVC front panels dock shelter is commonly used. With its simplicity and efficiency, it grants for a constant payback of the investment.

These are available for dock level installation or for ground level installation for the protection of doors without dock. The front panels are made of high resistance black PVC reinforced with a double weaving of polyester that works like a spring in order to seal the vehicles of different shapes. The flaps are flexible and have very high wear and tear resistance. It has been designed to retract under the shock of any possible wrong manoeuvres of the docking vehicles and extend

when the vehicle drives away.

Cushion dock shelters: Due to its high insulation factor, the cushion dock shelter is the ideal solution for controlled temperatures. The three cushions are made of elastic polyurethane foam, covered with PVC coated polyester fabric, supporting the vehicle pressures and perfectly sealing the three sides, including the space between opened rear doors and sides of the vehicle.

The two vertical cushions have

continuous overlapped anti-friction limpets allowing for the up and down heavy friction of the vehicle on its suspensions, during the loading. It is available with fixed or adjustable horizontal top cushion, adjustable to the different vehicle heights.

Inflatable dock shelters: The inflatable dock shelter is the best solution for insulating and improving the working environment. It can be rapidly inflated with a fan and it creates a perfect

insulation between the vehicle and the loading bay, sheltering from cold, rain, wind also dust and humidity. The inflatable dock shelter is made of polyester fabric, PVC covered, a material resisting to hot temperatures and bad weather conditions. Inflatable dock shelters provide the most versatile seal available to service the widest variety of truck and trailer configurations.

Contrary to other types of dock shelters the vehicle does not

push towards the shelter instead the shelter is inflated around the vehicle.

Contact details Gandhi Automations Chawda Commercial Centre, Link Road, Malad (W), Mumbai â&#x20AC;&#x201C; 400064 Tel: +91 22 66720200 / 66720300 (200 lines) Fax: +91 22 66720201 Email : sales@geapl.co.in Website: www.geapl.co.in

ThermoFisher Scientific launches cell culture system with increased capacity A NEW high-capacity cell culture system has been designed

by ThermoFisher Scientific to provide efficient and economical large-scale production of cells by increasing productivity within the same manufacturing space.

The Thermo Scientific Nunc High Density Cell Fac-

36 EXPRESS PHARMA September 16-30, 2016

tory system incorporates additional layers compared with the standard Nunc Cell Factory systems, increasing surface area and yield up to 30 per cent. The incremental surface area allows greater output from a single run within the same footprint as the standard Nunc Cell Factory systems,

thus increasing manufacturing capacity without capital investment.

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Shah Brothers introducing

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PHARMA LIFE RECOGNITION

Kiran Mazumdar Shaw appointed ‘Knight of the Legion of Honour’ by the Government of France She has been appointed for her outstanding contribution and dedication to the bio sciences and research field globally

K

iran Mazumdar Shaw, CMD, Biocon has been appointed ‘Chevalier de l’Ordre National de la Légion d'Honneur’ (Knight of the National Order of the French Legion of Honour) for her outstanding contribution and dedication to the bio sciences and research field globally. The award will be conferred on behalf of the President of the French Republic at a special ceremony later this year.

“It is an absolute privilege for me to be appointed ‘Cheva-

lier l’Ordre National de la Légion d'Honneur’ and I am deeply grateful to the French Government for this great honour. I owe this recognition to my wonderful team at Biocon who have joined me in my mission to harness the power of biotechnology to provide affordable access to life saving biopharmaceuticals for cancer and diabetes,” Mazumdar Shaw said.

Chevalier l'Ordre National de la Légion d'Honneur, created in 1802, by Napoleon

Bonaparte, is the highest civilian award of the French Republic for outstanding contribution in diverse fields bestowed on citizens of the world. The award is conferred by the President of the French Republic.

Other Indians to have received this honour in the past are Yashwant Sinha, Narayana Murthy, Amitabh Bachchan, Aishwarya Rai, Nandita Das, Shah Rukh Khan, veteran musician Balamuralikrishna, Sivaji Ganesan amongst others.

EP News Bureau

TO ADVERTISE IN EXPRESS PHARMA, CONTACT:

HEAD OFFICE MUMBAI Rajesh Bhatkal The Indian Express (P) Ltd. Business Publication Division 2nd Floor, Express Tower, Nariman Point, Mumbai- 400 021 Board line: 022- 67440000 Ext. 527 Mobile: +91 9821313017 Email id: rajesh.bhatkal@expressindia.com BRANCH OFFICES NEW DELHI Ambuj Kumar The Indian Express (P) Ltd.

Business Publication Division Express Building, B-1/B Sector 10 Noida 201 301 Dist.Gautam Budh nagar (U.P.) India.

Board line: 0120-6651500.

Mobile: +91 9999070900 Fax: 0120-4367933 Email id: ambuj.kumar@expressindia.com Our Associate: Dinesh Sharma Mobile: 09810264368 E-mail: 4pdesigno@gmail.com CHENNAI Arun J The Indian Express (P) Ltd. Business Publication Division New No. 37/C (Old No. 16/C) 2nd Floor, Whites Road, Royapettah, Chennai- 600 014 Board Line: 044- 28543031/2/3 044- 42285522 Mobile: +91 91 9940058412

Fax: 044- 28543035 Email id: arun.j@expressindia.com BANGALORE Mathen Mathew The Indian Express (P) Ltd. Business Publication Division 502, 5th Floor, Devatha Plaza, Residency road, Bangalore- 560025 Board line: 080- 49681100 Mobile: +91 9840826366 Fax: 080- 22231925 Email id: mathen.mathew@expressindia.com HYDERABAD E.Mujahid The Indian Express (P) Ltd. Business Publication Division 6-3-885/7/B, Ground Floor, VV Mansion, Somaji Guda, Hyderabad – 500 082 Board line- 040- 66631457/ 23418673 Mobile: +91 9849039936, Fax: 040 23418675

Email Id: e.mujahid@expressindia.com KOLKATA Ajanta Sengupta The Indian Express (P) Ltd. Business Publication Division JL No. 29&30, NH-6, Mouza- Prasastha & Ankurhati, Vill & PO- Ankurhati P.S.- Domjur (Nr. Ankurhati Check Bus Stop) Dist. Howrah- 711 409 Mobile: +91 9831182580 Email id: ajanta.sengupta@expressindia.com AHMEDABAD Nirav Mistry The Indian Express (P) Ltd. 3rd Floor, Sambhav House, Near Judges Bunglows, Bodakdev, Ahmedabad - 380 015, Mobile: +91 9586424033 Email Id: nirav.mistry@expressindia.com

IMPORTANT Whilst care is taken prior to acceptance of advertising copy, it is not possible to verify its contents. The Indian Express (P) Ltd. cannot be held responsible for such contents, nor for any loss or damages incurred as a result of transactions with companies, associations or individuals advertising in its newspapers or publications. We therefore recommend that readers make necessary inquiries before sending any monies or entering into any agreements with advertisers or otherwise acting on an advertisement in any manner whatsoever.

To subscribe: bpd.subscription@expressindia.com

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59

September 16-30, 2016

PHARMA LIFE APPOINTMENT

AWARD

GSK Consumer Healthcare appoints Anup Dhingra as Supply Chain Lead,ISC Dhingra joins GSK from Reckitt Benckiser where he was Supply Director Poland GSK CONSUMER Healthcare has appointed Anup Dhingra as the Supply Chain Lead, ISC. Anup will be a member of the India leadership team and will be based in Gurgaon. He succeeds Jaiboy Phillips, who has retired after four years with the company.

Dhingra joins GSK from Reckitt Benckiser where he was Supply Director Poland and was responsible for the company’s largest operations globally.

Announcing the changes, Manoj Kumar, MD, GSK Consumer Healthcare said, “Anup brings in 27 years of experience with in-depth ex-

perience and exceptional knowledge of the industry. I am delighted to welcome him and confident that under his leadership we will continue to deliver the best for our customers.”

On his appointment, Dhingra said, “I am delighted to be back in India with such an exciting assignment. GSK has powerful consumer centric brands based on high- science. I look forward to being a part of the journey of the organisation as it establishes itself as a fast moving consumer healthcare company.

EP News Bureau

Global pharmacy awards go to pharmacists in seven countries Manjiri Gharat from India receives the FIP Fellowship TEN PHARMACISTS and pharmaceutical scientists from seven countries were recognised for their services to pharmacy at the 76th World Congress of Pharmacy and Pharmaceutical Sciences in Buenos Aires, Argentina.

Manjiri Gharat, VP, Indian Pharmaceutical Association and Chairperson of Commmunity Pharmacy Division of IPA and Vice Principal, KM Kundnani Pharmacy Polytechnic Ulhasnagar received the FIP Fellowship. Others who received the fellowship awards are Ralph Altiere and Michael Anisfeld from the US, Parisa Aslani from Australia, Thony Björk from Sweden, Timothy Chen from Aus-

tralia, Michiho Ito from Japan and Lindsay McClure from the UK.

Distinguished Science Award went to Shinji Yamashita from Japan and Joseph A Oddis Award for Exceptional Service to FIP to Dr Dieter Steinbach from Germany.

EP News Bureau

CONTRIBUTOR’S CHECKLIST ❒ Express Pharma accepts editorial material for

❒ We welcome information on new products and

regular columns and from pre-approved contributors / columnists. ❒ Express Pharma has a strict non-tolerance policy of plagiarism and will blacklist all authors found to have used/refered to previously published material in any form, without giving due credit in the industryaccepted format. All authors have to declare that the article/column is an original piece of work and if not, they will bear the onus of taking permission for re-publishing in Express Pharma. ❒ Express Pharma's prime audience is senior management and pharma professionals in the industry. Editorial material addressing this audience would be given preference. ❒ The articles should cover technology and policy trends and business related discussions. ❒ Articles for columns should talk about concepts or trends without being too company or product specific. ❒ Article length for regular columns: Between 1200 1500 words. These should be accompanied by diagrams, illustrations, tables and photographs, wherever relevant.

services introduced by your organisation for our various sections: Pharma Ally (News, Products, Value Add), Pharma Packaging and Pharma Technology Review sections. Related photographs and brochures must accompany the information. ❒ Besides the regular columns, each issue will have a special focus on a specific topic of relevance to the Indian market. ❒ In e-mail communications, avoid large document attachments (above 1MB) as far as possible. ❒ Articles may be edited for brevity, style, and relevance. ❒ Do specify name, designation, company name, department and e-mail address for feedback, in the article. ❒ We encourage authors to send their photograph.

Preferably in colour, postcard size and with a good contrast.

60 EXPRESS PHARMA September 16-30, 2016

Email your contribution to: The Editor, Express Pharma, Business Publications Division,

The Indian Express (P) Ltd, 1st Floor, Express Towers, Nariman Point, Mumbai - 400 021.

Tel: 91-22-2202 2627 / 2285 1964/ 6744 0000 Fax: 91-22-2288 5831 viveka.r@expressindia.com

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