Express Pharma (Vol.10, No.13) May 1-15, 2015 by Indian Express

VOL. 10 NO. 13 PAGES 86

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Cover Story Breathing jaan into Jan Aushadhi Management Possible effects of DE implementation in India 1-15 MAY 2015,` 40

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CONTENTS Vol.10 No.13 MAY 1-15, 2015 Chairman of the Board Viveck Goenka

PSU vaccine units: A ray of hope?

Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das Bangalore Neelam M Kachhap Pune Shalini Gupta DESIGN National Art Director Bivash Barua Deputy Art Director Surajit Patro Chief Designer Pravin Temble Senior Graphic Designer Rushikesh Konka Senior Artist Rakesh Sharma, Vivek Chitrakar Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Dr Raghu Pillai - South Sanghamitra Kumar - East Harit Mohanty - West Marketing Team Rajesh Bhatkal GM Khaja Ali Ambuj Kumar E Mujahid Arun J Ajanta Sengupta PRODUCTION General Manager B R Tipnis

P33: CLINICAL UPDATE Scientists develop new drug to reverse resistance to immunotherapy

CIRCULATION Circulation Team Mohan Varadkar

PHARMA ALLY

Drug, pharma and healthcare industry to come together at iPHEX 2015

MARKET

MSF TAKES TO SOCIAL MEDIA TO PRESSURISE GSK, PFIZER TO CUT PRICE OF FLU SHOT

JANSSEN INDIA LAUNCHES INVOKANA TO TREAT TYPE II DIABETES

PEL TO ACQUIRE MAJORITY EQUITY STAKE IN HEALTH SUPERHIWAY

PHARMA EM ISSUES NOT AS STRAIGHTFORWARD: EXPERTS

MANAGEMENT

P39: PRE EVENT

P40: INSIGHT Evaluation of Instacoat 4G high productivity coating system

‘WE ENSURE TO ACHIEVE THE HIGHEST STANDARDS IN REGULATORY, QUALITY AND SAFETY’

POSSIBLE EFFECTS OF DE IMPLEMENTATION IN INDIA

MELANOMA TREATMENT MARKET VALUE TO MORE THAN QUADRUPLE TO $5.64 BN BY 2023: GLOBALDATA

P45: VENDOR NEWS Leading pharma companies adopt Cirrius PharmaCRM platform

Manager Bhadresh Valia Scheduling & Coordination Mitesh Manjrekar

HLLBiotech launched two vaccines this year and is also working full throttle towards reviving three vaccinemanufacturing PSUs. Does it have the makings of a success story that will put the public sector back into action? | P26

P78: POST EVENT SAC-ACCP organises eighth annual international conference

‘OUR STRATEGY IS TO PROVIDE RELIABLE TECHNOLOGY BACKED WITH ADEQUATE SERVICES’

Express Pharma Reg. No.MH/MR/SOUTH-77/2013-15, RNI Regn. No.MAHENG/2005/21398. Printed for the proprietors, The Indian Express Limited by Ms. Vaidehi Thakar at The Indian Express Press, Plot No. EL-208, TTC Industrial Area, Mahape, Navi Mumbai - 400710 and Published from Express Towers, 2nd Floor, Nariman Point, Mumbai - 400021. (Editorial & Administrative Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021) *Responsible for selection of news under the PRB Act. Copyright @ 2011. The Indian Express Ltd. All rights reserved throughout the world. Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.

EDITOR’S NOTE

Rebooting Jan Aushadhi

s Prime Minister Modi completes a year in office this May, there will no doubt be many lists of this government’s achievements and comparison with the previous administration. As far as the healthcare and pharmaceutical sectors are concerned, there is a lot that remains to be done to achieve the oft stated goal of universal health coverage. One of the major disappointments is the Jan Aushadhi scheme, which was launched with much fanfare in 2008. Seven years down the line, the scheme had run out of steam but looks set for a revival this June. The revamped scheme is to be rolled out in six states initially, with a target of 5000 stores in three years. While the scheme aims to provide access to affordable medicines, the third A, availability, could remain a challenge. Our cover story in this issue analyses the various issues associated with the planned revamp and re-branding of this initiative. (Breathing jaan into Jan Aushadhi, pages 22- 25) The private sector seems far from convinced that the re-branding will work. Attempts to recruit a senior industry professional to spearhead Jan Aushadhi as its CEO have so far been unsuccessful. Wariness of the red tapism that shrouds any government-promoted initiative is reportedly the main deterrent. Many kinks in the Jan Aushadhi scheme still need to be worked out and these will reduce the chances of success. For instance, the tedious tender process lends itself to corruption and delays. Any prospective CEO would want a shot at success rather than a venture already mired in controversy and worse, lethargy.

Is the private sector objecting to these initiatives solely because they want policy tuned to their growth strategies? Or will they be proved right?

One of the major stumbling blocks to the smooth takeoff of Jan Aushadhi is that thanks to the hands-off stance of most established pharma manufacturers, the government will be forced to fall back on less established players from the MSME sector. With bigger pharma companies, including marquee names like Sun Pharma and Wockhardt themselves facing the ire of global regulators on the quality issue, MSME companies will have an even harder time negating this perception and standing up to public scrutiny. Public sector pharma units, many of which are defunct, are also not an option. Is the private sector objecting to these initiatives solely because they want policy tuned to their growth strategies? Or will they be proved right? While policy makers are right not to give up, they have to quickly implement the success strategies of states like Kerala and Tamil Nadu, where centralised sourcing of medicines has given good results. On the vaccine front too, the private sector seems dead against the government turning to PSUs. Keen to achieve some degree of vaccine security, the government is investing in PSU vaccine units but as another story in our cover section points out, here too policy makers could very well be on the wrong path. (PSU vaccine units:A ray of hope? pages 26-28) MSF recently launched a global social media campaign to pressurise vaccine majors to cut prices of their flu shots; maybe it is time for such a campaign in India as well. VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

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EXPRESS PHARMA

May 1-15, 2015

MARKET COMPANY WATCH

MSF takes to social media to pressurise GSK, Pfizer to cut price of flu shot lack of transparency in how companies set prices prevents governments from having a fair shot at protecting their children with an affordable vaccine. It’s led to the irrational situation where some middle-income countries pay more for the pneumococcal vaccine than wealthy ones, for example, Tunisia reportedly pays more than France and while South Africa pays almost three times more than Brazil. "It's absurd to see the pricing information of a lifesaving product kept secret, with countries and organisations left in the dark when trying to negotiate a fair price,” said Dr Manica Balasegaram, Executive Director, MSF’s Access Campaign. “The level of pharma’s secrecy is astonishing— we can’t get information from Pfizer and GSK on what they charge countries for the pneumococcal vaccine. The question we are asking today is, how any country can negotiate fair vaccine prices when critical information is missing?” MSF is now urging people everywhere to #AskPharma to disclose the price of the pneumococcal vaccine and to ask GSK and Pfizer to reduce the price of the vaccine to $5 or less per child ($1.66 per dose for three doses) in developing countries.

INDIA IS examining whether to take up with WTO the EU’s suspension order for sale of about 700 generic drugs which were approved based on clinical trials by pharma major GVK Biosciences. According to a PTI report, the European Medicines Agency (EMA) had in January suspended a number of medicines approved for sale in the EU which were based on clinical studies conducted by GVK Bio at its Hyderabad site. The action flowed from findings from an inspection that allegedly red-flagged how GVK conducted studies at the Hyderabad site on behalf of marketing authorisation holders. “The Commerce Ministry is internally analysing the issue. It is looking at the legal and WTO angle in it. Without gathering the complete information about the case, it will be difficult to discuss the matter even at a bilateral level with the EU,” a government source said. The source said it is not “easy” to file a complaint with the WTO without doing a complete due diligence. EMA’s Committee for Medicinal Products for Human Use had looked at over 1,000 pharma forms and strengths of medicines studied at the GVK site. Indian firms had faced similar issues in the past over generic drugs. In 2011, some of the EU Customs authorities, mainly from the Netherlands and France, had confiscated several Indian off-patent generic drug consignments headed for Brazil via European ports and airports over alleged infringement of EU intellectual property rights (IPR). After India voiced protest, the European Union members agreed not to seize Indian medicines passing through Europe.

EP News Bureau-Mumbai

Urges public to #AskPharma how developing countries can get ‘A FAIR SHOT’ when vaccine prices are being kept secret AHEAD OF World Immunization Week, Doctors Without Borders/Médecins Sans Frontières (MSF) launched a global campaign —‘A FAIR SHOT’— to call on pharmaceutical companies GlaxoSmithKline (GSK) and Pfizer to slash the price of the pneumococcal vaccine in developing countries to $5 per child, so more children can be protected from this childhood killer, and to disclose what they currently charge countries for the vaccine. To kickoff the campaign, MSF staff attended Pfizer’s shareholder meeting in New Jersey to ask a question from the floor, pushing the company’s board members to disclose the price of their pneumonia vaccine in all countries. MSF also handed out documents with key information blacked out to highlight the deadly secrecy surrounding vaccine pricing. MSF’s press release calling on the public to support its campaign on social media, also featured the same tactic, using a provocative censored text tactic that highlights the lack of information on vaccine prices, in order to increase pressure on the companies to be more transparent. In January, MSF released its vaccine pricing report, The Right Shot: Bringing Down Barriers to Affordable and Adapted Vaccines, which showed that in the

EXPRESS PHARMA

May 1-15, 2015

In January, MSF released its vaccine pricing report, The Right Shot: Bringing Down Barriers to Affordable and Adapted Vaccines, which showed that in the poorest countries, the price to vaccinate a child is now 68 times more expensive than in 2001 poorest countries, the price to vaccinate a child is now 68 times more expensive than in 2001, with many parts of the world unable to afford new high-priced vaccines like that against pneumococcal disease, which kills about one million children each year. “As doctors who have seen too many children die of pneumonia, struggling to breathe, we are asking anyone who cares about children’s lives to join our public call on Pfizer and GSK to make sure all developing countries can afford to protect all their babies against this killer disease,” said Dr Greg Elder, Director of Operations, MSF in Paris. “The sky-high prices Pfizer and GSK charge for the pneumococcal vaccine prevent many governments and humani-

tarian organisations from vaccinating children, and after seeing the price to vaccinate a child rise substantially over the past decade, we have no choice but to take action now.” An MSF points out that part of the reason vaccination has become so costly is that since very little information on vaccine pricing is available, many developing countries and humanitarian agencies have to negotiate with pharma companies from a very weak position, with no way to compare prices. Some countries have to sign confidentiality clauses that prevent them from disclosing the price they pay for their vaccines. In around 45 countries, there is no information about the price for the pneumococcal vaccine; this secrecy and

India maygo to WTO over EU’s drug suspension order of 700 generics

MARKET

Janssen India launches Invokana to treat type II diabetes Invokana belongs to a new class of medications called sodium glucose cotransporter 2 (SGLT2) inhibitors JANSSEN pharmaceuticals has launched Invokana, a highly differentiated treatment option for people suffering from diabetes in India. Taken orally once a day, Invokana belongs to a new class of medications called sodium glucose co-transporter 2 (SGLT2) inhibitors which work in a completely different way to other classes of type 2 diabetes medications. Invokana has been shown to reduce glucose levels in adults who have previously not been able to achieve adequate control through diet and lifestyle measures, or through treatment with other blood sugar lowering

Invokana can reduce glucose levels in adults who haven’t been able to achieve adequate control through and lifestyle measures, or other blood sugar lowering medicines medicines. Invokana and other SGLT2 inhibitors work differently from other classes type II diabetes treatments by blocking the re-absorption of glucose in the kidneys. The result is that more glucose is

excreted in the urine thereby reducing levels of blood glucose. The efficacy of Invokana has been studied in trials involving over 10000 patients, making it one of the largest development pro-

grammes for type II diabetes in the world. The trials, which involved significant number of subjects from India (1038), showed Invokana to increase the loss of glucose through urine, helping restore normo-glycemia with low hypoglycemia risk. Sanjiv Navangul, MD, Janssen India said, “Invokana has a very good safety profile, including a significant weight loss. India is among the earliest countries where this drug has been launched. At pricing level we will always have India specific drug pricing.”

nise children against fatal diseases.” While commending Government of India’s initiative, Mission Indradhanush, Hilleman Laboratories believes it can play a key role in supporting this programme through its robust heat stabilising technology that will help in distributing life-saving vaccines without the requirement of large bulk shipments, expensive warehousing and costly, difficult-to-maintain refrigerated shipping paths from the manufacturing plant to the patient. EP News Bureau-Mumbai

EP News Bureau-Mumbai

The company plans to support India’s aim of achieving 90 per cent coverage through its expanded programme by 2020

EXPRESS PHARMA

May 1-15, 2015

Last year, Hilleman Laboratories had initiated research and development of thermostable formulations of oral rotavirus vaccine, which offered longer stability of the vaccine even in varying temperature across diverse environment. The development of a combination of highly thermostable vaccine as well as cheap and easy-to-administer delivery has made the rotavirus programme an important initiative. Hilleman Laboratories now endeavours to replicate this achievement to other vaccine programmes for improved affordability as well as in-

creased access. On the occasion of World Immunization Week, Dr Davinder Gill, Chief Executive Officer, Hilleman Laboratories said, “India is the world’s largest manufacturer of vaccines, but it is really sad that the country has the largest number of unimmunised children at close to seven million. The current state of immunisation in the country is quite heterogeneous, with different states having achieved varying levels of protection through vaccination. The country needs a consistent access to technology which can help immu-

To develop a vaccine against visceral leishmaniasis

THE R&D subsidiary of Zydus, Etna Biotech will collaborate with US-based National Institute of Allergy and Infectious Diseases (NIAD) to develop a vaccine against visceral leishmaniasis (VL), known as Kala-Azar in India. According to a PTI report, Etna Biotech will also donate $2,40,000 for advancing research under the NIH leishmaniasis programme. In a BSE filing, Zydus said, “Etna Biotech announced a collaborative programme with the National Institute of Allergy and Infectious Diseases, part of the US National Institutes of Health (NIH) for advancing leishmaniasis research.” It further said, “Under a separate agreement, Etna Biotech also extended its support of the NIH leishmaniasis programme by donating $2,40,000 for research.” Commenting on the development, Pankaj R Patel, Chairman and Managing Director, Zydus Group said, “Zydus is proud to collaborate with US NIH to solve the increasing worldwide disease burden of visceral leishmaniasis and to move forward to put a basis for the successful development of a novel candidate vaccine for visceral leishmaniasis.”

Hilleman Laboratories to extend its thermostable formulations to other vaccines GLOBAL VACCINE research and development organisation, Hilleman Laboratories, announced the extension of its thermostable formulations to other vaccines, reaffirming its promise towards closing the immunisation gap in India. Hilleman Laboratories’ unique technology has shown remarkable advancement towards containing the life-threatening disease by creating safer and more effective vaccines. With this move, the company plans to support India’s aim of achieving 90 per cent coverage through its expanded programme by 2020.

Zydus to tie up with US-based research centre

MARKET

PEL to acquire majority equity stake in Health SuperHiway The investment will be made in two tranches PIRAMAL ENTERPRISES Ltd (PEL) will acquire a majority stake in Health SuperHiway (HealthHiway), a healthcare analytics company, over the next 12 months. This investment, which will come in two tranches, continues PEL’s development of a global healthcare information business. It began through the acquisition of Decision Resources Group in 2012, and its subsequent acquisitions of Abacus International and Relay Technology Manage-

ment. Ajay Piramal, Chairman, Piramal Enterprises said, “This investment continues our process of building a global healthcare information business and will enhance our ability to serve India-based customers in the healthcare industry.” PEL has invested ` 60 lakh in cash which will make it a minority shareholder in HealthHiway. It will be investing up to an additional ` 44.2 crores in

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PEL has invested ` 60 lakh in cash which will make it a minority shareholder in HealthHiway

the next 33 months, if HealthHiway achieves a set of specified growth milestones that are based on acquisition of hospital data partnerships. Upon the second tranche of investment, PEL will control a majority stake in the business, become the promoter, and assume operational control. The transaction is not subject to any regulatory approvals. No promoter/promoter group/ group companies of PEL has any interest in HealthHiway.

HealthHiway is well regarded for its strong competencies in providing data integration, analytics and solutions development to Indian healthcare providers. In conjunction with several leading Indian hospital groups, PEL plans to develop HealthHiway into the leading provider of information and insight about the Indian healthcare market. EP News Bureau-Mumbai

EXPRESS PHARMA

May 1-15, 2015

MARKET GROWTH TRACKER

IPM clocks ` 7389 crores in March 2015 Eight therapies have outgrown the IPM growth and all therapies have double digit growths

THE INDIAN pharma market (IPM) clocked ` 7389 crores in March 2015 and has grown at 20.9 per cent. Amongst the top 10, Lupin grew by 32.4 per cent followed by Macleods at 31.7 per cent and Mankind at 28.7 per cent. 22 corporates have crossed the growth of IPM amongst the top 50 corporates. Amongst the top 50 corporates, Akumentis has the highest growth of 74 per cent followed by Wockhardt at 44 per cent and Allergan at 39.3 per cent. 46 corporates showed growths more than 10 per cent amongst the top 50 corporates. Amongst the 11-20 ranked corporates, Aristo has the highest growth of 36.9 per cent followed by Sanofi at 30.8 per cent and Torrent at 30.5 per cent. Amongst the 40-50 ranked corporates, Allergan has the highest growth at 39.3 per cent followed by Apex at 19 per cent and Hetero at 18.2 per cent. Amongst the 51-60 ranked corporates, Eli Lilly grew at 40.3 per cent followed by Troikaa at 32.2 per cent and Systopic at 30.4 per cent. Amongst the 61-70 ranked corporates, Fresenius Kabi grew at 117.7 per cent followed by Boehringer which grew by 101 per cent followed by UCB at 36.1 per cent. GSK entered the ` 3000-crore club as on MAT 2015. Indian companies have grown at 21 per cent versus 20.9 per cent for MNCs in

EXPRESS PHARMA

May 1-15, 2015

With Bonus Units at Full Value Val in Crs

Rank

CORPORATE

MAT

MTH

MAT Mar -15

IPM Sun + Ranbaxy

Mar-15

Val (Cr)

MS%

GR%

Val (Cr)

MS%

GR%

86410 7695

100.00

12.9

7389

100.00

20.9

8.90

12.0

650

8.79

15.0

Abbott + Abbott HC + Novo

5378

6.22

10.5

477

6.46

23.9

Cipla

4337

5.02

15.5

378

5.11

24.9

Zydus + Biochem

3646

4.22

8.1

303

4.11

9.1

Mankind

3118

3.61

16.4

268

3.63

28.7

Alkem + Cachet + Indchemie

3084

3.57

13.7

255

3.46

19.8

Glaxo

3037

3.51

1.4

255

3.45

10.8

Lupin

2945

3.41

18.4

227

3.07

32.4

Pfizer

2598

3.01

16.4

221

3.00

17.9

Macleods

2566

2.97

29.8

220

2.98

31.7

Emcure + Zuventus

2313

2.68

12.2

192

2.60

13.0

Intas

2277

2.63

17.3

197

2.66

21.2

Sanofi India

2194

2.54

14.0

185

2.50

30.8

Aristo

2179

2.52

19.8

195

2.65

36.9

Torrent

1973

2.28

16.2

173

2.34

30.5

Glenmark

1921

2.22

17.4

168

2.28

28.1

Dr. Reddys

1824

2.11

12.2

160

2.16

24.1

USV

1691

1.96

19.7

145

1.96

24.8

Micro + Bal

1668

1.93

7.9

133

1.81

6.6

March 2015. Amongst the top 50 in MNCs, Allergan grew by 39.3 per cent followed by Sanofi at 30.8 per cent and Merck at 30.6 per cent. Under the non-NLEM category, Indian companies grew at 15.6 per cent whereas MNCs grew at 22.1 per cent. The DPCO containing molecules market grew at 1.6 per cent whereas the non-DPCO market grew by 21.7 per cent and non-Sch Para 19 Market at 15.6 per cent resulting in an overall growth of 20.9 per cent for March 2015. The NLEM and non - NLEM category showed unit growth at 9.5 per cent and 13 per cent respectively. The non-Sch Para 19 Market grew at 13.2 per cent from units perspective. The DPCO 2013 portfolio for Pfizer grew at 25.6 per cent, Ranbaxy 27.6 per cent, GSK at 12.2 per cent and Abbott 15.5 per cent.

Val in Crs Super Group IPM ANTI-INFECTIVES CARDIAC GASTRO INTESTINAL VITAMINS / MINERALS / NUTRIENTS RESPIRATORY ANTI DIABETIC PAIN / ANALGESICS NEURO / CNS DERMA GYNAECOLOGICAL VACCINES HORMONES ANTI-NEOPLASTICS OPHTHAL OTHERS BLOOD RELATED UROLOGY ANTI MALARIALS SEX STIMULANTS / REJUVENATORS STOMATOLOGICALS OPHTHAL / OTOLOGICALS OTOLOGICALS

MAT Mar 15 VAL IN CRS GR% 86410 12.9 13764 9.7 10708 13.0 9938 14.2 7798 12.2 6834 14.1 6692 25.0 6038 11.3 5204 9.3 4955 16.6 4347 8.2 1460 1.6 1438 6.9 1394 23.1 1257 16.2 971 17.8 964 5.9 919 24.0 552 6.6 473 5.9 375 13.7 224 6.8 105 9.7

Month Mar-15 VAL IN CRS GR% 7389 20.9 1150 22.0 921 19.1 842 23.4 637 14.9 637 27.8 597 32.9 495 16.5 444 12.5 411 19.2 376 15.3 134 21.2 122 12.5 119 20.3 111 22.3 99 48.4 82 15.3 78 29.5 37 19.1 41 14.0 31 18.1 18 10.4 7 13.7

MARKET From therapy perspective, eight therapies have outgrown the IPM growth and all therapies have double digit growths. The respiratory market grew at 27.8 per cent, gastrointestinal market grew at 23.4 per cent, pain and analgesics market grew at 16.5 per cent whereas the anti-infectives grew at 22 per cent. The anti-diabetic market grows at 32.9 per cent and cardiac at 19.1 per cent in chronic business. The derma market grows by 19.2 per cent and the urology market at 29.5 per cent. From regional perspective, 13 regions have outgrown the IPM growth. The UP East market grew the highest at 35.5 per cent followed by Tamil Nadu market at 29.7 per cent and North East Market at 28.9 per cent. No regions had negative growth in March 2015. Amoxycillin + Clavulanic acid market grew at 27.9 per cent whereas Glimepiride + Metformin grew at 21.9 per cent at number two. The markets of paracetamol grew at 26.7 per cent, Atorvastatin 17.5 per cent, Probiotic Microbes at 21.3 per cent, Cefixime 28.7 per cent, Pantoprazole 17.7 per cent, Montelukast + Levocetrizine at 35 per cent, Glimepiride + Metformin + Pioglitazone at 26.7 per cent, Vitamin-D at 36.7 per cent, Hydroquinone + Mometasone + Tretinoin at 15.4 per cent, Voglibose + Metformin + Glimepiride at 65.7 per cent, Rosuvastatin at 24.7 per cent, Protein Supplements at 26.5 per cent. Mixtard continues to lead the pack with ` 36 crores for March 2015. Monocef grew at 60.2 per cent, Augmentin at 42.5 per cent, Glycomet-GP grew at 33.3 per cent, Mixtard at 28.7 per cent and Becosules at 24.1 per cent amongst the top 10 brands. Few Brands who have gained ranks include Pentaxim (+454), Electral Powder (+158), Januvia (+68), Janumet (+59), Spasmoproxyvon Plus (+53), Panderm Plus (+51), Monocef – O (+44), Shelcal (+41), Jalra-M (+36), Tonact (+24), Dolo (+10), Taxim (+9), amongst top 100 Brands over

EXPRESS PHARMA

May 1-15, 2015

March 2014. A total of 185 brands and 313 SKUs launched in March 2015. Top new brands for March were Variped, Yondelis and Ozurdex.

About PharmaTrac PharmaTrac is a the secondary

sales data audit conducted by AIOCD Pharmasofttech AWACS, a pharmaceutical market research company formed by All Indian Origin Chemists & Distributors (AIOCD ) in a joint venture with Trikaal Mediinfotech. AWACS (Advanced Working, Action & Correction

System) reflects the underlying philosophy behind AIOCD AWACS’ research tools to reduce time to information by 50 per cent or more and to significantly improve on accuracy of information.

Terminologies used

MAT – Moving Annual Total MTH – Month Val (Cr) – Value in Crores MS per cent – Market Share in Percentage GR per cent – Growth in percentage. For more information, visit http://www.aiocd.net

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MARKET POST EVENT

Pharma EM issues not as straightforward: Experts Conference attended by regulatory affairs experts and pharma companies AS MORE pharmaceutical companies in India target emerging markets to fulfill their growth ambitions, they often stumble when it comes to navigating the regulatory landscape within these markets. Many of these issues and challenges were discussed at the recently concluded ‘International Conference on Regulatory In Emerging Markets’ organised by Alliance India in Mumbai. The meet was attended by global regulatory affairs consultants and regulatory affairs personnel from various pharma companies. The conference was inaugurated by Chairperson Hasumati Rahalkar, Founder and Managing Director, Metina PharmConsulting who stressed that accessing emerging markets (EMs) is not as straightforward and easy as it may first appear. Competition and business models will vary with product portfolios and regulatory frameworks and patent positions will give additional challenges across the regions. While day one focused on China, Brazil and Mexico, the following day looked at Russia, GCC and MENA, and South Africa. Besides the region specific sessions, experts also dissected issues related to country-specific requirements and trends. Nitin Gaikwad, General Manager, Regulatory, Lupin, gave a detailed information about the China market including China FDA regulations and technical requirements. Rahalkar spoke about latest international concept about super generics in emerging markets. Mature generic companies are looking for differentiation in products portfolio, better pricing and patient compliance, she said. Rahul Gupta, General Manager, Regulatory Affairs, Piramal Enterprises spoke on ‘Global regulatory requirement and process for NDDS formulation

20 EXPRESS PHARMA May 1-15, 2015

for smooth and speedy approval’ while Santosh Savarkar, Associate Vice President, Regulatory Affairs, Alembic, emphasised that GMP inspection remains GMP irrespective of the US, EU or any emerging market. On the following day, Santosh Kashyap, General Manager Regulatory Affairs, Dr Reddy’s Laboratories briefed the audience about the steps to be followed for the South Africa market. He gave information about the fee pattern, registration process and time line for the approval process in South Africa. Kashyap also intimated that many government policies are likely to come into effect by 2016. He said that 2016 seems a magical year for MCC as many things are in the pipeline and the government has planned to implement it from April 2016. Say for example, the Government of South Africa will make braille mandatory on medicine packaging. It is likely that the medical

The two-day conference, was organised by Alliance India and was attended by regulatory experts from various pharma companies device industry will get formal guidelines by 2017 which are in currently at draft stage. He also highlighted section 21 which is a special route to get an approval from MCC in a special approval category. Beena K Shah, General

Manager, Regulatory (International) Geltec discussed pharma business opportunities in GCC and the MENA market. She informed that most issues in the GCC and MENA markets are controlled by the government, resulting in ‘protectionism.’ She opined that regulation is always evolving and needs constant updation. She added that GCC regulatory approval comes much faster than developed countries. She also talked about the importance of halal and pork residue certifications for the approval process, as there are cultural and religious aspects attached to it. The MENA market is currently only two per cent of the global pharma market but is slated to increase, considering the requirements for medicines in different therapeutic areas. The conference also covered the possibilities and needs of developing pharma markets.

There is a need for skill-based medicinal products and Indian pharma companies should grab these opportunities. During the two-day long conference, speakers discussed how pharma companies in India can relate to the disease profile prevalent in GCC and MENA countries and are therefore in a position to read the market needs better. For example, Indian pharma companies can relate to disease profiles like malaria, as they are common to both regions, while simultaneously servicing other therapeutic sectors like diabetes, cardiovascular diseased and AIDS. The two-day conference, held in Mumbai and organised by Alliance India, was attended by regulatory experts from various pharma companies. (With inputs from Sachin Jagdale and Usha Sharma) EP News Bureau-Mumbai

EVENT BRIEF MAY - 2015 05

Respiratory Drug Delivery (RDD) Europe 2015

RESPIRATORY DRUG DELIVERY EUROPE 2015 Date: May 5-8, 2015 Venue: Antibes, France Summary: RDD Europe 2015 will welcome pulmonary and nasal drug delivery experts from around the world. The joint organisers of the event, RDD Online and Aptar Pharma, will celebrate RDD Europe’s 10th anniversary and announce the opening of registration at www.rddonline.com/ rddeurope2015.

Contact details: Elisa Eschylle, Events & Press Relations Manager Tel: + 33 (0)1 39 17 20 41 Email: elisa.eschylle @aptar.com

PHARMA PRO & PACK EXPO 2015 Date: May 13-15, 2015 Venue: Bombay Exhibition Centre, Mumbai Summary: PHARMA Pro & Pack Expo 2015 will be organised by IPMMA. 20,000

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PHARMA Pro & Pack Expo 2015

pharma trade professional/ decision makers and 250 industry majors will exhibit their technologies/ services. Visitors’ profile include biotechnology specialists, plant management, CEOs, engineers, technocrats and scientists, policy makers, diplomats and foreign commercial corp, compliance, process engineering, corporate management, procurement department, custom manufacturing/ marketing services and purchase officers.

Contact details Indian Pharma Machinery Manufacturers’ Association 52, 1st floor, Suyog Industrial Estate LBS Marg, Vikhroli (West) Mumbai – 400 083 Tel: +91 22 6561 9272

IPHEX 2015 Date: May 13-15, 2015 Venue: Bombay Exhibition Centre, Mumbai Summary: Pharmexcil with Ministry of Commerce and

iPHEX 2015

Industry, Department of Commerce, Government of India will organise iPHEX 2015. Over 400 overseas buyers from focus areas are being invited to participate in the exhibition. It will be co-located with PHARMA Pro&Pack Expo 2015. Contact details Pharmaceuticals Export Promotion Council of India TV Indl Estate, Unit No. 211, 2nd Floor, 248-ASK Ahire Marg, Worli Mumbai – 400030 Tel: 91 22 24938750

EXPRESS PHARMA

May 1-15, 2015

cover )

22 EXPRESS PHARMA May 1-15, 2015

(

he Jan Aushadhi scheme, launched in April 2008 by the then Union Minister of Chemicals & Fertilisers and Steel Ram Vilas Paswan, started with the objective of improving

out, “As a concept, it is a great initiative to ensure the accessibility of affordable medicines for the people of the country. These noble intentions have not lived up to the expectations of public in general for two

A fresh lease of life Heeding such industry feedback and going solely by the numbers, the new government at the centre looks keen to breathe new life into Jan Aushadhi. And intends to

THE MAIN FOCUS

start with a bang: Hansraj Gangaram Ahir, Minister of State for Chemicals and Fertilisers recently announced that the Union Government would open 1000 new Jan Aushadhi centres on a single

Aushadhi initiative, is to create an awareness among the population and also help in creating a better visibility of the programme. Commenting on re-branding the initiative, Anay Shukla, Member,

BREATHING JAAN INTO JANAUSHADHI The government plans to re-brand the Jan Aushadhi initiative by opening 1000 centres across India by this June. Will this breathe new life into the initiative? BY USHA SHARMA

access to affordable medicines. The idea was to set up special outlets known as Jan Aushadhi stores in each district where generic medicines would be available to the general public. But seven years down the line, the initiative was nowhere near achieving this objective with only 98 centres of the 178 centres functional. It is clear that implementation was not up to mark. As Dr Rajaram Samant, Chief Executive Officer and Chief Mentor, Akumentis Healthcare points

reasons; lack of quality standards prescribed to ensure that medicines available are of good quality and shortage of critical medicines all the time. This has lead to a huge trust deficit in the minds of practitioners and the public. There is an underlying nexus between chosen few manufacturing units and retail stores as well. Hence, there is a need to not only re-brand but also to address the above mentioned critical issues as well.”

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It is a big challenge to ensure a consistent supply of quality medicines, in well distributed outlets across the country Ranjana Smetacek Director General, OPPI

day in June as well as rebrand the initiative. Industry reaction to these announcements have been measured but optimistic. Welcoming the move, Ranjana Smetacek, Director General, Organisation of Pharmaceutical Producers of India (OPPI) says, “We welcome the Indian Government’s effort to breathe new life into the stagnant Jan Aushadhi initiative.” The government's move to rename the Jan

Pharma and Healthcare Practice, Nishith Desai Associates says, “Renaming the scheme is a prerogative step by the government. The objective of the scheme is positive for the benefit of patients at large. Re-branding the scheme is likely to give thrust and better acceptance by patients.”

Challenges ahead It is ironic that even though Indian pharma companies rank among the top performers in the global generics market, offering quality medicines

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May 1-15, 2015

cover ) at affordable prices to patients across the world, an initiative to do the same within the home market floundered for seven years. As Dr Ajit Dangi, President and CEO, Danssen Consulting informs, “The old scheme of Jan Aushadhi which was launched in 2008 is already struggling to survive. The new scheme is a fresh lease to infuse some life into the old. So far less than 200 shops are functional under the old scheme and study shows that mean availability of medicines was only about 33 per cent, largely because of dependence on public sector units for supply. The drugs are expected to be supplied by the Bureau of Pharma PSUs of India and will be co-ordinated by Indian Drugs and Pharmaceuticals Ltd (IDPL), Gurgaon.” Therefore the opening of 1000 new centres is a great idea but the key challenge lies in execution and ensuring that the end consumer does not end up with fake or spurious medicines. Expressing his concerns, Dr Gopakumar G Nair, Chief Executive Officer, Gopakumar Nair Associates suggests, “India needs to expand and deepen its reach for public distribution and available access for medicines especially to the rural masses. However, medicines without qualified pharmacists (for in-

Pharma and Healthcare Practice, Nishith Desai Associates says, “There is no doubt that the government has the capability to run the scheme and also to scale it up in the years to come. Jan Aushadhi scheme (stores) does not require significant infrastructure and resources to function. Since the Central and state governments have the infrastructure and resources to administer various other health schemes and hospitals, it can successfully implement Jan Aushadhi scheme and manage stores as well. However, it would definitely require commitment and dedication to make it successful.” Dangi informs that he has already put the proposal to the government to invite private players for the initiative. “The government is now mulling over the proposal to invite private sector for the scheme. To make the scheme more viable, it is also proposing to make it mandatory for the medical profession to prescribe only generic medicines. While this move is supported by Indian Medical Council, it is strongly opposed by Indian Medical Association and rightly so. Unless the issue of quality, safety and efficacy is resolved and a strong regulatory oversight is in place, the medical profession as well as the patient population are

unlikely to trust the generics,” adds Dangi. But given the inertia of the past seven years, sceptics abound. Nair feels that the as the ministry may not be able to manage this by themselves, they will need to set up an independent entity well-manned with trained or experienced professionals committed to the cause. Giving some options, BG Barve, Joint Managing Director, Blue Cross Laboratories says, “The model automatically has to be public-private-partnerships (PPPs), where the industry manufactures and provides generic drugs at heavily discounted rates and the government distributes these drugs through the shops and other centres. The government will again have to factor in retailers’ margins. It could be possible if they manage to rope in existing chemists/ retailers interested to join the scheme.” Antani too advocates the PPP model to improve accessibility of the programme. As he reasons, “The government has announced that it will seek participation of private players for supply and distribution of drugs in the scheme. In future, a partnership model (PPP) may be rolled out as well. We feel that proper implementation of PPP model would give necessary impetus to the

There is an underlying nexus between chosen few manufacturing units and retail stores. Hence, there is a need to not only re-brand but also to address the above issues

The objective of the scheme is positive for the benefit of patients at large. Re-branding the scheme is likely to give a thrust and better acceptance by patients

Dr Rajaram Samant

Anay Shukla

Chief Executive Officer and Chief Mentor, Akumentis Healthcare

Member, Pharma and Healthcare Practice, Nishith Desai Associates

24 EXPRESS PHARMA May 1-15, 2015

formed dispensing) and medical professionals (doctors, para-medicals) does not serve any purpose. Therefore, the proposal made by the ministry which seems to entrust one Jan Aushadhi outlet to one skilled pharma or medical professional to establish, manage and operate appears workable. Though it sounds ambitious to commence from June this year, a beginning can be made with qualified applicants/aspirants to join the project. This is a welcome initiative.” Smetacek too feels that opening up 1000 new Jan Aushadhi centres across India with a new name in a single day sounds interesting but presents challenges as well. She opines, “It is a big challenge to ensure a consistent supply of quality medicines, in well distributed outlets across the country. A professional approach is required and this would entail a motivated leader heading the initiative; appropriate focus on supply chain, logistics and warehousing; awareness building efforts to change existing perceptions, among other things. The industry will cooperate to support the government’s efforts in this area.” While agreeing that the implementation of the initiative in the past few years could have been better, Dr Milind Antani, Partner

The old scheme of Jan Aushadhi which was launched in 2008 is already struggling to survive. The new scheme is a fresh lease to infuse some life in to the old. So far less than 200 shops are functional under the old scheme and study shows that mean availability of medicines was only about 33 per cent Dr Ajit Dangi President and CEO, Danssen Consulting

The Ministry may not be able to manage this by themselves. They will need to set up an independent entity well-manned with trained or experiences professionals committed to the cause Dr Gopakumar G Nair Chief Executive Officer, Gopakumar Nair Associates

( scheme.” Realising the cost factor, which will play a key role in the initiative, providing affordable quality medicines will be not so easy and PPP model will not work that effectively. But the PPP model too will present certain challenges. As Samant points out, “It will be extremely difficult to manage the PPP model and provide quality medicines as it will require tremendous commitment and resources from government. The government needs to set up standards for all the medicines which are global in nature, and ensure a process by which these standards are monitored. The same will increase the cost of medicines many fold.” Besides the PPP model, the government needs to look at other options as well. Barve suggests that they could also consider expanding the scheme through post offices to promote generic drugs.

Drawbacks It is likely that even after its revamp, the Jan Aushadhi initiative will face various hurdles during its implementation process. Nair emphasises, “Drawbacks are plenty. Mismanagement, diversion, opportunistic substitution with spurious medicines at outlets, uninformed consumption are disadvantages. Above all, the conflict with Drugs & Cosmetics Act and other provisions, need to be resolved.” Pharma companies are already anticipating a new set of hurdles. Touching on one of the foremost of these, Barve says, “Quality in healthcare in India is best assured to public through brand names. Any attempt to abolish brand names and to push generic — generic products may not be the right solution and would be counterproductive and not in favour of the patient. To impose unbranded generics on patients will allow retail chemists to

The government needs to set up standards for all the medicines which are global in nature, and ensure a process by which these standards are monitored push products with better margins instead of the medical fraternity advising patients to purchase trusted and assured generic drugs from respected manufacturers with long standing reputation for quality products.” There are also those willing to give a fair chance to the government’s efforts, keeping in mind the intended benefits to the end consumer. Shukla explains, “The single and most important benefit of Jan Aushadhi scheme is its ability to ensure cheap and easy access of medicines to needy common people. There are no draw backs in particular, however, one issue that comes up off and on is quality and service. Availability of certain drugs which are required could be one of the factors that may reduce the pace of scheme. Some of the areas in which it could improve are the number of drugs which are presently covered, geographic reach of stores, ease of participation of private sector players, cost burden (though relatively miniscule) on the purchaser and services being offered and acceptance.”

Will quality be an issue? A more worrying stumbling block could be issues related to quality of the medicines sold under this scheme. Nair prefers to repose confidence in the government on this front, saying, “Department of Pharmaceuticals, Government of India will be able to source quality medicines and assure quality as well as build confidence on the quality of Jan Aushadhi medi-

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cines. These will, anyway, be subject to inspection, drawing of samples for quality testing, storage inspections etc. by drug inspectors under Drugs & Cosmetics Act. This will guarantee quality and instil confidence.” Global pharma regulators have pulled up pharma manufacturers in India for various GMP violations giving rise to drug recalls but Barve points out that to date, no product has been forced to be recalled due to any quality issues per se; it has been more of documentary negligency, issues of data integrity etc. “India manufactures and exports over ` two lakh crore worth of safe and efficacious generics. Many global NGOs such as MSF, UNICEF, IDA etc. have publicly recognised India’s quality generics and affordable prices and rated India as the best and largest supplier. India has earned international recognition for our commitment to safe, efficacious and quality affordable drug therapies both within our own domestic market and through exporting the same medicines to people in other countries.” But the perception created by recent drug recalls and similar regulatory actions will have an impact. As Dangi says, “Unless the issue of quality, safety and efficacy is resolved and a strong regulatory oversight is in place, the medical profession as well as the patient population are unlikely to trust the generics.” Along these lines, Antani avers that as all medicines supplied to Jan Aushadhi stores are supposed to be

THE MAIN FOCUS

tested at a government testing laboratory, the government may have to increase the number of recognised laboratories.

Outlook Inspite of the challenges, the Jan Aushadhi initiative remains an idea that needs to be implemented on a war footing. As Barve says, “The availability of medicines and health facilities in the hilly, tribal and inaccessible areas are either absent or inadequate. Therefore, such areas need to be given special treatment in a mission-mode approach, through which the health services and medicines are provided at affordable rates/prices. The Jan Aushadhi scheme needs to be expanded to cover these areas. There is also a need to ensure access of common man (poorer section) to medicines through public hospitals etc. Industry supports such objectives of easy accessibility of medicines to common man. To ensure that the common man is truly benefited, all formulations supplied to hospitals, serum vaccines and biologicals under public health programmes should be kept out of the purview of price control.” Giving another perspective, Dangi adds, “If improving access and providing poor patients affordable drugs are the key objectives, then priority should be given to expand the health insurance coverage, strengthening the regulatory system, focus on prevention rather than cure and exempt essential medicines from duties and taxes and unreasonable trade margins.” Finally, while the revamp of the Jan Aushadhi was necessary, will it enough to assure its success the second time around? Signing off, Samant cautions, “Unless radical changes are done, the same story will continue at a much larger scale and will drain resources from the government.” u.sharma@expressindia.com

Jan Aushadhi scheme (stores) does not require significant infrastructure and resources to function. Since the Central and state governments have the infrastructure and resources to administer various other health schemes and hospitals, it can successfully implement Jan Aushadhi scheme and manage stores as well Dr Milind Antani Partner Pharma and Healthcare Practice, Nishith Desai Associates

They could also consider expanding the scheme through post offices to promote the generic drugs. If these ideas work, then we could have more than 1000 distribution centres BG Barve Joint Managing Director, Blue Cross Laboratories

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cover )

HLL Biotech launched two vaccines this year and is also working full throttle towards reviving three vaccinemanufacturing PSUs. Does it have the makings of a success story that will put the public sector back into action? BY SHALINI GUPTA

26 EXPRESS PHARMA May 1-15, 2015

(

ebruary 2015 saw HLL Biotech, a subsidiary of HLL Lifecare, launch two new vaccines from its stable — Pentahil (Pentavalent vaccine) and Hivac-B (Hepatitis B), signalling the relaunch of the public sector into vaccine industry. According to the company, this has been a significant achievement of the 'Integrated Vaccines Complex' project that started in 2012 after the government issued a directive to upgrade three other vaccine-manufacturing PSUs — the Pasteur

Institute of India (PII), Coonoor, in Tamil Nadu, BCG Vaccine Laboratory (BCGVL) in Chennai and Central Research Institute (CRI), Kasauli and assigned HLL to the task.

Progress on track HLL Biotech formally started functioning from TICEL park, Chennai in July and the IVC project began the same year in Chengalpattu with an estimated cost of ` 594 crores to research, manufacture

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I strongly recommend a review of vaccines in the UIP which is based on evidence Dr Y Madhavi Senior Principal Scientist, National Institute of Science, Technology and Development Studies

THE MAIN FOCUS

and supply vaccines to the government’s Universal Immunisation Programme. Talking about the progress made so far, M Ayyappan, Chairman and Managing Director, HLL Lifecare says, “The launch of both these vaccines was initially estimated in 2016, however, we have been able to launch them a year before in 2015 itself due to a loan licensing arrangement with Biological E, Hyderabad. We are in the market

now.” He hopes that the project which is halfway through, will be fully completed by September next year after completing the necessary regulatory requirements. The company is also working towards vaccines for Hib, measles, rabies, JE and BCG. Once the facility is complete it is expected to produce 40 million doses of rabies vaccine, 25 million of JE, 140 million of Hepatitis B and 100 million doses each for the rest. While the technology for rabies has been developed in house, it

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cover ) US and China have already burnt their fingers with this approach, and we are again going the same path Dr Krishna Ella Chairman and Managing Director, Bharat Biotech and President, Vaccine Manufacturers Association of India

The launch of both these vaccines was initially estimated in 2016, however, we have been able to launch them a year before in 2015 itself due to a loan licensing arrangement with Biological E, Hyderabad M Ayyappan Chairman and Managing Director, HLL Lifecare

has partnered with Biological E for Hepatitis B and BCGVL for BCG. “JE vaccine uses live attenuated vaccine imported from China, but manufacturing it poses a regulatory hurdle since it involves killing of hamsters. Hence, we are looking at killed vaccine, which we have proposed to the government,” pitches in Ayyappan. He is quite confident when he says that the facility will be a WHO approved one to cater to the export market. It will also be producing new vaccines towards the end of this year, apart from the ones it has been given a mandate for. Technical staff for the same has been recruited. Out of the three institutes, CRI, Kasauli is functional now and has been revived with an investment of ` 49.83 crores. Mechanical construction of BCGVL will be complete by this month end. However, validation of the facility and training is still left. The facility received GMP certification in December 2012 after NRAI inspection and production was started. Post CGMP certification, it is slated to produce 80 million doses annually. Pasteur Institute’s revival(` 144 crores) has been a bit delayed due to several factors, construction work is ongoing and it is expected to be completed by February 2016. Ayyappan notes that the real challenge will be capacity building of existing people to build the cGMP facility.

28 EXPRESS PHARMA May 1-15, 2015

Reinventing the wheel Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech and President, Vaccine Manufacturers Association of India, disagrees vehemently with what he terms as a 'backward approach' of the government of reviving PSUs. He cites the example of a developed country such as the US and a developing nation (China). In both these countries vaccines were being manufactured by the public sector; by state governments in the US during 1970-80 and 10-12 provinces in China from early 90s to 2000. However, given the technological challenges, governments realised that it was difficult to maintain the facilities since they need to be upgraded. While some companies were acquired, others shut down. Private companies now dominate the industry in these countries. He reiterates, “US and China have already burnt their fingers with this approach, and we are again going the same path. All three PSUs could have been upgraded

with lesser investment earlier since the facilities were already existing. What has been done is only going to open a Pandora’s box.” It is to be noted that the Government of India is buying ` 600-crores worth of vaccines annually from the private and public sector for the UIP out of which 75 per cent is currently coming from the private sector. This is just two per cent of the total budget earmarked for the health ministry (` 30,000 crores). And when asked about vaccine security, he is quick to add that the government can easily achieve that by signing an agreement with companies and fix a price to ensure that it is affordable to the masses. He also elaborates that vaccine manufacturing is a complex business, since all vaccines are treated as new drugs, requiring rigorous clinical trials as well as upgradation of facilities in every two years. “The price of vaccines supplied by the private sector in India is much cheaper. I think that the vaccines manufactured by the

public sector will be priced high,” he quips.

Vaccine rush? Even as we debate if the public sector introduction of vaccines will be a success, Dr Y Madhavi, Senior Principal Scientist, National Institute of Science, Technology and Development Studies (NISTADS), an institute under the Council of Scientific and Industrial Research (CSIR) offers a perspective. She feels that the Government of India is introducing new vaccines into the Universal Immunisation Programme (UIP) without taking cognisance of epidemiological data, disease burden and the safety and efficacy studies. She cites the example of Hib-containing pentavalent vaccine which is intended to replace two other pre-existing UIP vaccines-DPT (diphtheria, pertussis, tetanus) and Hep B (hepatitis B). “With a low incidence rate of 0.007 per cent, there is no need for the introduction of Hib. Also, several deaths have been reported following vaccination with

HLL Biotech is working towards vaccines for Hib, measles, rabies, JE and BCG. Once the facility is complete it is expected to produce 40 million doses of rabies vaccine, 25 million of JE, 140 million of Hepatitis B and 100 million doses each for the rest

pentavalent vaccine along with adverse reactions with a PIL that is now in Supreme Court,” she asserts. She also adds that the rotaviral disease burden in general population is low and most of the data has been extrapolated based on hospital studies which questions the introduction of the rotavirus vaccine as well. As we move from oral polio vaccines to Injectable polio vaccine, she quips that IPV was there even when OPV existed, it only now that we know OPV doesn't work in certain communities. “I strongly recommend a review of vaccines in the UIP which is based on evidence,” she adds. On affordability of vaccines she is quick to add that price is not everything, instead there needs to be a cost benefit analysis in view of public health while thinking of ways to complement it with preventive medicine. Meanwhile, as the world celebrates Immunisation week, Ayyappan hopes that the IVC along with the three revived PSUs will work in tandem to gear up India in a position to introduce new generation vaccines in the immunisation programme. Whether or not the public sector can raise its head will be revealed in time, once economies of scale have been achieved, the government though needs to ensure that adequate measures are taken to boost the industry while learning from hindsight as we move into the future. shalini.g@expressindia.com

MANAGEMENT INSIGHT

Possible effects of DE implementation in India

SANKAR SUNDARAM, Professor of Pharmaceutical Sciences, JSS University

Sankar Sundaram, Professor of Pharmaceutical Sciences, JSS University, talks about data exclusivity and if effective then how it will impact the Indian pharm industry DATA EXCLUSIVITY (DE) is the exclusion of data, generated by sponsors for supporting decision-making by regulatory authorities, for reaching the market-approval decisions, with regard to the product’s safety and efficacy, from its commercial exploitation by competitors. DE in the US with relevance to pharmaceuticals generally

concerns with the data generated from the four phases of clinical trials. In the first stage or the phase I stage of a clinical trial it is ascertained whether a treatment is safe for people to undergo, rather than to try to treat a disease condition, and to study the effect of the drugs in the human body and the effect of the human body on the drugs. Phase

I study involves typically around 20-80 people and is usually done in healthy volunteers or sometimes in patients. In the phase II stage of a clinical trial investigation, studies, for the safety and effectiveness of a potential therapy and for potential dose regimes are done. Phase II stage involves typically between 100 and 300 people and

is usually done in patients. Phase III stage of clinical trials involves a patient populatio n ranging from a few hundred to several thousand patients, and is spread between different hospitals and different states. Phase III studies are done to ascertain whether a drug is safe and effective over a wider range of population. Usually after the successful

completion of these three phases a sponsor can apply for a marketing authorisation. In the phase IV stage of clinical trials, post-marketing studies are done to gather additional information including the drug's risks, benefits and optimal use. These studies are designed to monitor effectiveness of the approved intervention in the

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MANAGEMENT general population and to collect information about any adverse effects associated with widespread use of the product. DE in the US with relevance to agrochemicals generally concerns with the data generated by suitable animal model studies carried out for the determination of the particular product’s oncogenicity, teratogenicity, neurotoxicity, effects on reproduction etc.

History of undisclosed information protection Article 39.3 of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement requires the World Trade Organization (WTO) member states to protect undisclosed test data which originates from new chemical entities and those which require considerable efforts to generate. It would be clear from a 2002 South Centre publication paper of Dr Carlos Maria Correa, of the University of Buenos Aires, Argentina - who had participated in the negotiations of TRIPS during the Uruguay Round - that TRIPS negotiators specifically considered and rejected language requiring grants of exclusive rights to test-data and hence the member countries are not obligated under Article 39.3 of TRIPs to confer exclusive rights on the originator of marketing approval data.

Surmounting the data exclusivity: Reinventing the wheel? As DE provisions implementation would prevent the disclosure of the test data, the generic approval seekers have to carry out their own trial studies. This would render the marketing approval seeking process a very costly and time consuming procedure. Perhaps by the time the study has been completed, the product in question would itself be out of the DE restrictions. Viewed from an end user’s perspective this repetition procedure would inflict unnecessary anxiety, would prove too costly and practically wouldn’t lend itself amenable for a treatment intervention. It is worth mentioning at this juncture that Indian health authorities are actively considering the waiver of phase III clinical trials, for those drugs

30 EXPRESS PHARMA May 1-15, 2015

for which the authorities in public interest could place reliance upon the clinical trial data available from other countries. DE is not an intellectual property, as it doesn’t involve the application of the intellect. It is a clause imposed for ensuring that the access to the trial’s data, gathered as above, is excluded from the competing commercial interests. If the competitor so wishes, he is free to repeat the same procedure and accumulate his own trial data. Now, the chances of a path breaking drug, being discovered, its safety and efficacy established and its launch be found patient-acceptable in India is somewhat unpredictable. But, we are ostensibly the world leaders for reverse engineering of an already proven medicine and to work out a more affordable process, so that any patient worldwide would accept this reverse engineered medicine as the first drug of choice, in terms of the bang for the buck. If DE is effected, then, till the exclusivity period is over, no Indian company can rely on the regulatorysubmission data of the big pharma. With the leeway proffered in the WTO legend, interpretation suits- similar to the Markman hearings - perhaps in the Dispute Settlement Board, are likely to become the preferential route to limit the regulatory authorities’ decisions. Alternatively, we have to transgress ethical practices and resort to a re-inventing process. A similar drama is likely to unfold in the agrochemicals sector too.

Making overkill? A preliminary comparison would show that, for those diseases affecting our Indian population, there has been very few treatment modalities made available by the US manufacturers. Once again, there are the small molecule drugs and the biopharma drugs. Currently, the biopharma drugs are very costly for an average Indian citizen. The trend in the US market is towards the marketing of biopharma drugs. Very few US companies currently show interest in small molecule drugs' launching. This is because the 1984 Hatch-Waxman act has almost delivered what it was in-

tended to deliver, in terms of bring an affordable pharma product quickly to the patients. This is a situation, where all the low-hanging fruits have already been plucked — in this case the small molecule drug segment. Borrowing a quote from Heather Behanna, analyst for Wedbush Securities of the US “Big Pharma is running low on innovation.” So, now, the big pharma lobbyists are actively considering the expansion of data exclusivity — for the drug products when they acquire marketing approval in India and elsewhere and apart from their patent protection — as a fortified means of protection for their markets. This over-protection is clearly perceptible from a 15th of March Bill introduced in the US House of Representatives calling for the Promoting Access for Treatments Ideal in Enhancing New Therapies (PATIENT) Act, 2015 invoking an extra two year protection extension for the already three-year DE protecting the newer version of a previously market approved drug. A similar situation is likely to be prevalent in the agrochemicals trial study data too.

Can DE provisions destroy the accessibility and affordability? DE provisions generally don’t compel an originator to launch the product immediately in Indian market. Hypothetically, a product could be launched towards the end of its patent term too. If Indian government was to confer DE protection, then, there is also a possibility that an attempt would be made to extend the product’s patent protection term until the completion of its DE period. This would further complicate a patient’s accessibility for medicines and a farmer’s accessibility for agrochemicals. Globally, there have been rare but real instances where, as in the case of an arthritis treatment drug, the only mainstay market command was based its clinical DE, without the support of even its extended patent term, which had expired due to regulatory delays in securing its market approval. Contrarily, if the originator doesn’t launch a product under the prevalent — non DE ? conditions, then, the originator’s product could automatically be launched by a generic

company in India, subjected to other compliance conditions. Another argument against DE is that even those products which are not new and inventive enough — in other words not deserving enough to be patent protected — could be extended commercial protection by the implementation of DE provisions and would create a barrier to generic entry. Unlike a patent protection which can be workedaround, a DE provision is airtight. Similarly, if a product is protected by DE provisions and that product is not worked-up by the innovator company for a time period of a few years, even then, a generic company can’t launch the product, as the generic-company has no compulsory-licensing clause to invoke for the launch of the product. This is because of the likely-nature of DE provision making a product, competitioneligible only after the expiry of its DE period. Likewise, as DE is automatically conferred on a product — as soon as it gets marketing approval — it now becomes the duty of the regulatory authorities to protect the private rights of the originator, a fiduciary responsibility. So, the innovator hardly incurs any litigation costs at all. Also the strain on the regulatory authority would be overstretched, as now the regulatory authority also has to divert its time and resources in policing every industrial application for commercial launch. Also, through a back door entry, nonpatentable subject matter also could be conferred DE protection. The scope of challenging the DE of a drug on the grounds of patient-care afforded in any court of law is very limited. Then again, a slew of data exclusivities, as for example, DE for a new-use of an already product, a DE for a product with a different mode of administration etc could be demanded. These also need special efforts from the regulatory authority’s side. Another danger of DE is that pending any incentivisation, there is a possibility that the generic manufacturer’s absence in the industry would create a monopolistic situation, when, even during a national emergency, there may be an acute shortage of a particular product.

MANAGEMENT The cultural influence on DE implementation There are many reasons cited for the non-recognition of the indigenous Indian drug discovery. One major reason is the indifferent attitude of Indian patients, for new chemical entities(NCEs) discovered indigenously. Indian patients need to appreciate that quality medicines discovered and produced from India, would essentially have to comply with official standards and specifications. The Indian mindset needs to undergo a sea-change and for the change there is the urgent need to revamp the setup, beginning from the work culture upward, to the infrastructure upward till the patient-care endpoint. In the absence of a renewed business-model, implementing the TRIPS-plus DE provisions is a surefire method of suffocating the Indian reverse engineering potential. If there is no DE, the current position of bioavailability and bioequivalence testing would maintain their status quo.

The role of clinical trial data in drug development A policy paper from the Health Action International which is an independent, global network, striving to increase access to essential medicines and improve their rational use through research excellence and evidencebased advocacy, has in 2013 citing a few examples had argued that “it is the withholding of clinical study reports that pose the greater risk to public health compared to non-disclosure.” There have been many instances

DE is not an intellectual property, as it doesn’t involve the application of the intellect. It is a clause imposed for ensuring that the access to the trial’s data, gathered as above, is excluded from the competing commercial interests even in the regulated-markets of the world where incorrect clinical trials reporting had led to an incomplete patient care. Eminent scholars have opined that the publicly generated clinical trial data need to be available for the drug discovery industry for its proactive use, in return of a consideration.

Could a modified Adaptive Pathways Approach alleviate the problem? The European Medicines Agency(EMA) had launched a pilot project in 2014 called as the Adaptive Pathways Approach. Here, those medicines, addressing life-threatening conditions were to be given conditional approval. The authorisation of a medicine, was to be granted on the basis of the demonstration of a positive benefit/risk balance. From the patient registries and pharmacovigilance tools, postapproval data on the medicine’s use were to be collected and the marketing authorisation was to be extended to enable the access of this medicine to a broader patient population. On iterative evaluation of the post-approval data, the changes to the status of the product’s authorisation, was

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to be made. Whereas the EMA declared that data protection and other relevant legal provisions remained the same in the Adaptive Pathways Approach, relevant modifications, tailored to suit Indian situations could certainly make it more adaptable for regulatory purposes especially in the arena, where unmet medical need exists.

The other side of the coin India is a country with more mouths to feed. The same is true for treating diseases too. So, if and when the DE provisions are implemented, the clinical trials costs would directly have to be borne by the end users. Although in the long term, this would breed competency in new discovery, in the short-span these trials would likely cause a rush for unnecessary amassing of medicines/ agrochemicals among certain strata and would cause frustration among certain strata of the society. Indigenous discovery would flourish in the long run. The invention-based industry (in contrast to being a manufacturing hub) would be established and a lot of new regulations which are inconceivable now would be in promulgation.

Instead of being a mere manufacturing-hub, catering mainly to the export markets of the world, our industry would concentrate more on her own citizens. Our indigenous industry would be given a jump start.

Recent political moves The January 2015 US Trade Representative (USTR) Michael Froman’s statement at a US Congressional hearing assuring that the USTR has been able to "secure commitments from India in the 2014 Trade Policy Forum on a broad range of Intellectual Property (IP) issues of concerns to the US and its stakeholders" sounds an alarm in the minds of the generic manufacturers in India. Also, it has been recently cited in a SpicyIP article, by Swaraj Paul Barooah, about the Government of India’s intention to table the “Pesticides (Amendment) Bill” in the Parliament during the current session. The Bill purportedly includes DE provisions to be introduced in the area of agro-chemicals for a period of five years, based on the recommendations of the Standing Committee Report. It remains to be seen whether these DE provisions would

slowly be extended to include pharma products also.

Conclusion A recent statement of New York’s Attorney General, though pertaining to a different context, sums it up all: One commercial entity trying to "squeeze every last dollar out of its drug franchise with no concern about the effects on highly vulnerable patients," is a replete reminder of the situation, should India adopt the DE provisions, in the short term. Again, keeping in mind the welfare of Indian citizens above everything else and weighing the tangible and intangible give-andtakes of the dialogue involving India’s diplomacy, the Indian government is the best authority to implement the level of regulations in the pharma and agrochemical industry. From one side, the argument is for implementing the DE provision but from the opposite side it is a plea for freeing the access to data. Either way the government has to take cautious measures to safeguard its citizen’s interest in an efficacious, accessible and affordable way. As a recent Wall Street Journal article by Geeta Anand had opined, it is very important for the Indian government to reach the balance to stimulate innovation by rewarding it against the imperative of making life-saving inventions accessible to people, at this moment of time. India was never against intellectual property protections and never would be. But the data exclusivity provision is altogether a different ballgame.

EXPRESS PHARMA

May 1-15, 2015

MANAGEMENT

Melanoma treatment market value to more than quadruple to $5.64 bn by 2023: GlobalData THE GLOBAL treatment market for melanoma will expand more than fourfold in value from $1.34 billion in 2013 to reach an estimated $5.64 billion by 2023, representing a robust Compound Annual Growth Rate (CAGR) of 15.5 per cent, according to research and consulting firm GlobalData. The company’s latest report states that this impressive growth, which will occur across the eight major markets (8MM) of the US, France, Germany, Italy, Spain, the UK, Japan, and Australia, will be driven primarily by increasing sales of Bristol-Myers Squibb’s blockbuster immunotherapy Yervoy. Fenix Leung, DPhil, Global-

Data’s Analyst covering Oncology and Hematology, says: “While Yervoy’s sales will be negatively impacted by the first-line uptake of PD-1-targeting monoclonal antibodies (mAbs) Keytruda and Opdivo from 2015 to 2017, the approval of the Yervoy/Opdivo combination will recover the former’s market position in the second half of the forecast period. “Furthermore, Yervoy’s label expansion into the lucrative adjuvant setting will further enhance its sales from 2019 onwards.” GlobalData estimates sales of $889 million for Yervoy in the 8MM in 2013, and forecasts this to rise at a CAGR of 8.2 per cent

Impressive growth will occur across the eight major markets of the US, France, Germany, Italy, Spain, the UK, Japan, and Australia

to $1.96 billion by 2023. The analyst adds that the recent launch of premium-priced, PD-1-targeting mAbs and BRAF/MEK inhibitor combinations will play a central role in driving the melanoma market expansion by 2023. Leung explains, “The BRAF/MEK inhibitor combinations, in particular Novartis’ Tafinlar/Mekinist and Roche/Exelixis’ Zelboraf/cobimetinib, will replace standard BRAF inhibitor monotherapy of Zelboraf or Tafinlar. In addition, Keytruda and Opdivo will garner rapid growth in both BRAF mutated and wild-type settings.” “These novel agents and combinations will experience

large uptake globally, thanks to their improved overall response rate and overall survival, along with their manageable side effect profiles. Notably, the combination treatments will fetch a higher premium price than monotherapies, which, on top of raising company sales, will also result in greater pushback from payers.” GlobalData expects these new, more efficacious entrants to replace generic chemotherapy-only regimens in the firstand second-line settings, therefore driving the growth of the overall melanoma market and extending the lines of treatment available for patients. EP News Bureau-Mumbai

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RESEARCH CLINICAL UPDATE

Scientists develop new drug to reverse resistance to immunotherapy The new drug will now be tested in patients with chronic lymphocytic leukaemia and non-Hodgkin lymphoma in an early stage clinical trial A NEW drug with the potential to reverse resistance to immunotherapy has been developed by scientists at the University of Southampton. It has shown great promise in pre-clinical models and will be available to patients with certain leukaemias and non-Hodgkin lymphomas in clinical trials later this year. Targeted drugs made from engineered immune proteins — called monoclonal antibodies — have revolutionised treatment for several types of cancer in recent years. They work by sticking to specific proteins found on the surface of cancer cells, flagging them up to be killed by the immune system. Unfortunately, a number of patients do not respond or develop resistance to treatment. The findings, published in the journal Cancer Cell, show that resistance to many types of antibody drugs can be overcome by preventing cancer cells from ‘hiding’ from immune cells. The research was carried out by scientists at the University of Southampton and Swedish biotech company, BioInvent International. The researchers, who were funded by Leukaemia & Lymphoma Research and Cancer Research UK, have shown that some cancer cells are able to draw monoclonal antibodies inside themselves, making them invisible to immune cells. However, the researchers showed that a new antibody, called BI-1206, can effectively prevent this drug destruction process and enhance cancer killing by binding to a molecule called Fc?RIIB. BI-1206 showed remarkable suc-

cess in mice in overcoming resistance to monoclonal antibodies like rituximab, currently used to treat different types of lymphoma and leukaemia. The study, led by Dr Ali Roghanian and Professor Mark Cragg in Southampton and Dr Ingrid Teige and Professor Björn Frendéus in Sweden, represents a six year endeavour into how to improve antibody therapeutics for blood cancers. Professor Cragg, Professor of Experimental Cancer Research at the University of Southampton, said: “With more monoclonal antibody treatments being developed, there is an urgent need to understand how tumours become resistant to them and develop ways to overcome it. Not only

EXPRESS PHARMA

May 1-15, 2015

RESEARCH does BI-1206 appear to be able to reverse resistance to a range of monoclonal antibodies, it is also effective at directly killing cancer cells itself.” The new drug will now be tested in patients with chronic lymphocytic leukaemia and non-Hodgkin lymphoma in an early stage clinical trial. The trial will test safety in humans and if it has any anti-cancer effects when combined with rituximab. This is a new collaborative venture between Leukaemia & Lymphoma Research, Cancer Research UK and its development and commercialisation arm Cancer Research Technology, aimed at accelerating the delivery of promising new treatments into blood cancers. Professor Chris Bunce, Research Director at Leukaemia & Lymphoma Research, said, “Targeted drugs, like monoclonal antibodies, have shown great promise in recent years in effectively treating a patient’s disease while minimising side effects. BI-1206 could have a real impact on survival for a significant number of patients.” Björn Frendéus, Chief Scientific Officer, BioInvent, and honorary Professor at the University of Southampton, said, “BI-1206 binds very specifically to the inhibitory FcyRIIB, a receptor that acts as a brake to dampen critical anti-cancer immune cell’s function and to eliminate therapeutic antibody from the targeted tumour cell surface.” Emma Smith, senior science information officer at Cancer Research UK, said, “This exciting research has the potential to be a game-changer for people with white blood cell cancers that don’t respond, or have stopped responding, to treatments like rituximab. It could also make immunotherapy for other types of cancer more effective too. “The work was carried out in mice, so we’ll have to wait for the results from clinical trials to find out if the treatment is safe and effective in people, but it’s certainly a promising approach and could lead to more potent drug combinations that benefit patients.” EP News Bureau-Mumbai

34 EXPRESS PHARMA May 1-15, 2015

RESEARCH UPDATES

Duke University researchers finds new metric for antibiotic dosing A regimen based on a pathogen’s recovery time could eliminate an otherwise resistant strain of bacteria DUKE UNIVERSITY researchers have identified a single, simple metric to guide antibiotic dosing that could bring an entire arsenal of first-line antibiotics back into the fight against drug-resistant pathogens. A computer simulation created by Hannah Meredith, a biomedical engineering graduate fellow at Duke, revealed that a regimen based on a pathogen’s recovery time could eliminate an otherwise resistant strain of bacteria. In theory, a database of recovery times for bacterial and antibiotic combinations could allow firstline antibiotics to clear many resistant infections. Meredith has already begun lab work to create such a database, and early tests are confirming her model’s predictions. “Bacteria are forming resistance to antibiotics faster than we can make new ones, so there is a real need to use the antibiotics that are already on the market more efficiently,” said Meredith. “We hope this research will help hospitals improve patient outcomes while also making our antibiotics last as long as possible.” The computer simulation models the relationship between bacteria, antibiotics and a method of resistance called beta-lactamase — an enzyme that degrades betalactam antibiotics, one of the largest and most-used classes of antibiotics. Many beta-lactam antibiotics are currently disregarded out of concern for the infection being completely resistant to that type of antibiotic — even

if the antibiotic appeared to be effective in the lab. The new model, however, reveals that the bacteria might be temporarily sensitive to the antibiotic before the beta-lactamase degrades the drug and allows the infection to recover. “You can think of this as a race between the cells and the antibiotics,” said Lingchong You, the Paul Ruffin Scarborough Associate Professor of Biomedical Engineering at Duke and Meredith’s adviser. “Before their beta-lactamase degrades the antibiotics, the cells are still sensitive and can be killed. But the antibiotics degrade faster than the cell population declines, allowing some cells to survive and repopulate.”

When clinicians realise an infection is resistant, they often skip straight to some of the strongest antibiotics available. But the study indicates that if they instead changed the dosing frequency of first-line antibiotics so that each dose is delivered while the bacteria are weakened during their recovery period, some infections could be cleared without skipping to the last resort. Doctors also need to be careful, however, not to wreck native populations of bacteria vital to human health. A database detailing the responses of different strains to different antibiotics could allow Meredith’s computer model to determine the most efficient regimen to keep total

exposure to a minimum. It could also indicate if multiple doses would not work, letting clinicians know when it is time to call in the heavy artillery. “There’s already a lot of work being done to determine antibiotic dosing schedules,” said You. “But that typically involves building a model based on many complex biological mechanisms. This takes a lot of time, and there are thousands of constantly evolving bacterial strains, making it impossible for researchers to catch up. We’re trying to see if this one, easy-to-test metric of recovery time can make a good enough prediction without years of study.” EP News Bureau-Mumbai

RESEARCH

Tekmira ebola drug succeeds in curing small monkeys AN EXPERIMENTAL ebola drug from Tekmira Pharmaceuticals Corp cured all three monkeys intentionally infected with the virus, scientists reported, the first such success against the strain of ebola in West Africa's 2014-2015 outbreak. Although other experimental treatments appeared to help ebola patients last year, especially in the US, those one-time uses cannot prove efficacy against the ‘Makona’ strain, since patients' recovery might be due to other causes. Similarly, drugs, including Mapp Biopharmaceutical's ZMapp, cured monkeys in lab experiments, but in a strain of ebola different from that responsible for the current outbreak, the worst ever recorded. "We can't say for certain that

an experimental drug that works against one strain will work in another, even if they're almost identical genetically," said Thomas Geisbert of the University of Texas Medical Branch, senior author of the study published in the journal Nature. In the experiment, six rhesus monkeys were infected with huge doses of the Makona strain. Three days later, three received an infusion of the Tekmira product, a cocktail of ‘small-interfering RNAs’ (siRNAs) encapsulated in a fat droplet called a lipid nanoparticle. The siRNAs bind to two of the virus’s seven genes, silencing them and thereby preventing the virus from replicating. All three treated monkeys survived despite fevers and enormous blood levels of virus.

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Three untreated monkeys became so ill they were euthanised within nine days. The drug can be adapted to target any strain of ebola and produced in as little as eight weeks (compared with the months required for ZMapp),

Geisbert said, in what he called ‘plug and play’: sequence any ebola genome and custom-make a siRNA cocktail. "There is a need for treatments that can be quickly modified if the strain changes,” he said.

A clinical trial of the new cocktail began last month in ebola patients in Sierra Leone. A study of an earlier version was partly halted after healthy volunteers developed side effects at high doses. The study continues a string of encouraging news in ebola research. Scientists reported that an improved version of a vaccine from NewLink Genetics Corp and Merck & Co Inc protected all eight lab monkeys injected with ebola. The improved version, from Profectus BioSciences, was altered to improve safety. In March, scientists reported that both the NewLink-Merck vaccine and one from GlaxoSmithKline appear safe and triggered an anti-ebola immune response in volunteers in Liberia. Reuters

EXPRESS PHARMA

May 1-15, 2015

RESEARCH

MMR vaccine not linked to autism, even in high-risk kids: Study The researchers used insurance claims data on 95,727 children followed from birth to at least age five between 2001 and 2012 THE MEASLES, mumps and rubella (MMR) vaccine is not linked to development of autism spectrum disorders, even among children considered to be at risk, a large new study finds. Among nearly 100,000 children, receipt of the MMR vaccine did not increase the risk for autism spectrum disorder (ASD), regardless of whether kids were at higher risk because an older sibling already had the condition, researchers write in JAMA. “Even for children who are high-risk, the vaccine does not play a role,” said lead author Dr Anjali Jain of healthcare consulting firm The Lewin Group in Falls Church, Virginia. “We don’t know what does unfortunately, but it’s not the MMR vaccine.” The results should be reassuring, she said. Autism spectrum disorder is a range of symptoms that often includes difficulties with communication and social interaction, according to the US National Institute of Mental Health. It’s may also include restricted and repetitive behaviors. The 1998 study that

claimed to find a connection between the MMR vaccine and ASD was later debunked. The Lancet, the medical journal that originally published it, withdrew it. Studies continue to vouch for the safety of the vaccine. Still, some people continue to believe that the vaccine is connected to ASD. Parents of children with ASD may also believe there is a genetic component, and so they decline to vaccinate their other children, Jain and colleagues noted in their report in the Journal of the American Medical Association.

For the new study, the researchers used insurance claims data on 95,727 children followed from birth to at least age five between 2001 and 2012. They also had data on the children's older siblings. Overall, about two per cent of the children had an older sibling with ASD. Those children were more likely to go on to develop ASD themselves whether they were vaccinated or not, according to the report. The vaccine didn't increase their risk, the researchers say. For example, among highrisk five year olds, ASD developed in 23 of 269 who weren't

vaccinated (8.6 per cent), compared to 30 of 796 (3.8 per cent) who received two doses of the MMR vaccine. Among kids not at high risk of ASD, 7,735 were unvaccinated at age five and 56 (0.7 per cent) were diagnosed with the condition. That compared to 244 of 45,568 children (0.5 per cent) who received two MMR doses. Furthermore, children with an older sibling with ASD were significantly less likely to have received the MMR vaccine in the first place. By age five, about 92 per cent of the children without ASD in the family had received at least one MMR dose. By comparison, only 86 per cent of children with an older sibling with ASD had been vaccinated by that age. “I think it’s important to show that the degree of undervaccination in the families with children with autism spectrum disorder was significant,” Jain said. Alongside the lack of association between the vaccine and ASD, the undervaccination rate deserves attention, she said. Reuters

compared to the left arm. “Given the nature of ALS and lack of effective therapies, a treatment that could even modestly slow progression would be welcomed by patients and physicians,” said Dimitrios Karussis of Hadassah University Medical Center, the principal investigator for the study.

ASTRAZENECA’S recently approved ovarian cancer drug Lynparza, or olaparib, can also help men with prostate cancer, according to new clinical trial results. The news is the latest boost to the British company’s cancer drug pipeline, which formed a central plank of its defense against a $118 billion takeover attempt by Pfizer last year. AstraZeneca has flagged olaparib as a potential $2-billion-a-year seller, based on ongoing phase III studies in ovarian, breast, gastric and pancreatic cancers. The latest phase II prostate findings would represent further upside. Olaparib works by blocking an enzyme involved in cell repair and is approved for women with ovarian cancer and hereditary BRCA gene mutations. The new research suggests it could also benefit men with genomic faults within their prostate tumours. “This opens up the exciting possibility of delivering precise treatment for advanced prostate cancer, guided by genomic testing and based on the particular molecular characteristics of patients’ tumors,” said Chief Investigator Johann de Bono of Britain’s Institute of Cancer Research. De Bono presented data to the American Association of Cancer Research conference showing that 16 out of 49 men with treatment-resistant, advanced prostate cancer responded to olaparib. Among the responders, 14 of the men had detectable DNA repair mutations.

Reuters

BrainStorm’s drug benefits ALS patients ISRAEL'S BRAINSTORM Cell Therapeutics said a midstage clinical trial of its adult stem cell treatment showed a ‘statistically significant’ effect in patients with amyotrophic lateral sclerosis (ALS). According to the ALS Association, 5,600 people in the US are diagnosed each year with the neurodegenerative disease, also known as Lou Gehrig’s Disease, which has se-

36 EXPRESS PHARMA May 1-15, 2015

verely disabled British physicist Stephen Hawking. New data presented at the American Academy of Neurology annual meeting show that six months after a single administration of the stem cell treatment called NurOwn there was a statistically significant improvement in the rate of decline in Forced Vital Capacity, which measures the amount of air a person can dis-

pense from the lungs. There was also improvement in the rate of decline in the ALS Functional Rating Score, which tests 12 different functions. In addition, patients who received NurOwn through an intramuscular injection showed an improvement in the rate of decline in muscle mass in the right arm, the site of NurOwn administration, as

AstraZeneca drug shows promise in prostate cancer trial

PHARMA ALLY I N T E R V I E W

‘We ensure to achieve the highest standards in regulatory, quality and safety’ Ideal Cures recently received EXCiPACT certification. Suresh Pareek, Managing Director, Ideal Cures talks to Usha Sharma about the recognition and how it will boost the company’s growth

Ideal Cures has recently received EXCiPACT certification for pharmaceutical excipients. What is the significance of this certification for Ideal Cures as well as for your customers? Ideal Cures is the first Indian company to receive the EXCiPACT certification for manufacture of film coating materials, neutral pellets, Ecocool Extended Cooling Booster, Methacrylic Co-polymers and dispersions and Ethyl Acrylate CoPolymers. This covers the full range of products manufactured by Ideal Cures. This certification is an ample evidence of the fact that Ideal Cures produces pharma excipients, while maintaining high quality GMP and GDP practices. According to the EXCiPACT, Ideal Cures has yet again shown that it is very sincere about the quality of its products and providing the best products to the customers. It is an international accreditation and it is going to be an important tool for the customers to repose the trust in the EXCIPACT certified company and eliminate elaborate audits and inspections to consider us a trustworthy vendor with consistent quality for the listed materials. With our products

38 EXPRESS PHARMA May 1-15, 2015

portfolio, we ensure to achieve the highest standards in regulatory, quality and safety. The EXCiPACT scheme can be made available when the regulators in the EU and the US require the holder of the marketing authorisation for medicines to ensure that appropriate GMP and GDP is applied to the manufacture and distribution of both APIs and excipients. The US Food and Drug Administration and the European Medicines Agency continue to require drug producers to qualify their excipient suppliers appropriately and as a result the suppliers must be prepared to receive increasing numbers of audits from their customers. EXCiPACT helps to avoid additional audits in a costeffective manner for all parties concerned because one single audit is all it takes to prove that an excipient complies with current GMP and GDP requirements. Which manufacturing sites have received the certification and for what? Ideal Cures has three manufacturing sites at Vasai (Maharashtra), Jammu and Khambhat (Gujarat) and we have already been awarded the certification for Khambhat and Jammu. For

the Vasai site, the audit is already done and the recommendations have been forwarded to the EXCiPACT headquarters by SGS and we hope to get the certificate by mid May 2015. We manufacture the tablet film coating materials (Instacoat, Instaspray, Instamodel), acrylic polymers (Ecopol) Cooling boosters (Ecocool), Neutral Spheres/Pellets (Espheres). We are the first Indian company to have achieved this distinction and it shows a symbol of quality.

We have plans for acquisition of manufacturing units outside India involving an outlay of ` 50 – 100 crores

So far, how many Indian as well as multinational excipient manufacturing companies have obtained this certification? How will this certification differentiate Ideal Cures from other domestic excipient manufacturers? So far no other Indian company has received this distinction/certification, Ideal Cures has become the first Indian company to receive this certification. A total of 15 multinational organisations have received this certification www.excipact.org/certification /certificates/. How will EXCiPACT certification impact your exports? We export our products to 42 countries spread across

five continents. This certification encompasses all the regulatory and GMP aspects what the pharma regulators look for. This accreditation will fulfil the basic requirements of the customers so the product evaluation becomes faster and based on the suitability of the material in the customer, products will accelerate the usage and supply. This will be beneficial to both the customers as well as Ideal Cures .Since EXCiPACT is going to be an acceptable certification for highly regulated markets, the acceptance of our materials for use in the products of international drug manufacturers will open up a lot of opportunities. What is EXCiPACT? EXCiPACT is a project of the IPEC Federation, a global organisation to promote quality in pharma excipients (see www.ipecfed.org ). EXCiPACT is a voluntary international scheme which provides independent third party certification to manufacturers, suppliers and distributors of pharma excipients worldwide. It ensures patient safety through supplier quality while minimising the overall costs for assessing the excipient supply chain.

It was launched in January 2012 since when there has been a considerable interest among pharma excipient suppliers, customers and regulators. Give us a review of the new products in the Ideal Cures pipeline? Will they be launched in the international markets? Our new product Instacoat 4G, which is for immediate release film coating, at 35 per cent reconstitution has been launched and is receiving an excellent response. The product reduces process time by more than 50 per cent for normal film coating operations. This saves cost in terms of time and power and

Our new product Instacoat 4G, which is for immediate release film coating, at 35 per cent reconstitution has been launched and is receiving an excellent response. The product reduces process time by more than 50 per cent for normal film coating operations. This saves cost in terms of time and power and machine utilisation can be enhanced machine utilisation can be enhanced. The product is very good for continuous coating and we have already taken successful trial with Thompson machines in

Chicago and the product has performed with excellence. So far, Instacoat 4G is the only product with 35 per cent reconstitution level and has excellent coating ability.

Apart from this, other products in the existing products range of Instacoat, Instamodel, Ecocool have already been launched. For Espheres, we are having the

commercial availability of SiO2 and tartaric acid. What are the corporate plans for the current financial year? In April 2015, we have completed the second phase of expansion at Khambhat and the Ecopol manufacturing capacity is enhanced to 400 MT per month. For 2015 – 16, we have plans to expand our Jammu facility for both Instacoat film coating materials and E Spheres (Neutral pellets). Apart from this, we have plans for acquisition of manufacturing units outside India involving an outlay of ` 50 – 100 crores. u.sharma@expressindia.com

PRE EVENT

Drug,pharma and healthcare industry to come together at iPHEX2015 Event to be held at Bombay Exhibition Centre from May 13 to 15, 2015 iPHEX 2015 will be held at Bombay Exhibition Centre from May 13 to 15, 2015. The exhibition will bring together the drugs, pharmaceutical and healthcare industry, all under one roof. Pharmaceuticals Export Promotion Council of India (Pharmexcil) will organise the exhibition and Ministry of Commerce and Industry, Department of Commerce, Government of India will support it. Over 400 overseas buyers from focus areas are being invited to participate in the exhibition. The event will be co-located with PHARMA Pro&Pack Expo 2015, a show for pharma machinery manufacturers. The three-day long international Buyers Seller Meet (BSM) at PHARMA Pro&Pack Expo 2015 is expected to host more than 150

international buyers towards promoting the exports of pharma engineering products. Jointly organised by IPMMA – Indian Pharma Machinery Manufacturer’s Association and GPE EXPO, PHARMA Pro&Pack Expo 2015 will be co-located with IPHEX 2015. The BSM at PHARMA Pro&Pack Expo 2015, Mumbai Exhibition is being initiated and organised in association with the EEPC India (formally known as Engineering Export Promotion Council of India, set up by Ministry of Industry andCommerce, Government of India). The third edition of PHARMA Pro&Pack Expo 2015 on total pharma manufacturing technologies will offer a common business platform for the pharma industry. PHARMA Pro&Pack Expo

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Over 400 overseas buyers from focus areas are being invited to participate in the exhibition 2015, along with the co-located exhibitions, PharmaLAB Expo 2015 will feature a complete range of analytical and biotech lab instruments. Various trade associations have extended their non-financial support to the exhibition which includes Indian Pharmaceutical Association (IPA), Indian Drug Manufac-

turer’s Association (IDMA), Indian Pharmacy Graduates’ Association (IPGA), Confederation of Indian Pharmaceutical Industry (CIPI), Indian Analytical Instruments Association (IAIA), Ambala Scientific Instruments Manufacturers Association (ASIMA), Federation of East African Pharmaceutical Manufacturers (FEAPM), Bangladesh Associaiton of Pharmaceutical Industries (BAPI), Hologram Manufacturer’s Association of India (HOMAI), Association of Pharmaceutical Producers of Nepal (APPON), Pharmaceutical Manufacturers Group of Manufacturers Association of Nigeria (PMG-MAN), Institute of Packaging Machinery Manufacturers of India (IPMMI), and Indo African Chamber of Commerce and Industries (IACCI).

At PHARMA Pro&Pack Expo 2015, PharmaLAB Expo 2015 and iPHEX 2015, more than 523 exhibiting companies from 18 countries are expected to participate to showcase their latest products /services. Above 20,000 potential buyers including 1,400 international buyers from 180 countries are anticipated, will reportedly mark their presence in these twin exhibitions (PHARMA Pro&Pack Expo 2015 and iPHEX 2015). Exhibitors’ profile range from pharma processing and packaging machineries and materials, analytical lab instruments, consumables and glasswear, environment control equipment and services, water management products and services and turnkey contractors. EP News Bureau-Mumbai

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May 1-15, 2015

PHARMA ALLY INSIGHT

Evaluation of Instacoat 4G high productivity coating system Suresh Pareek, Managing Director, Ideal Cures; Dario Luini, Area Manager EMEA & US, Ideal Cures and Sanjay Negi, DGM Film Coatings, Ideal Cures, share more details about Ideal Cures revolutionary product Instacoat 4G

THE PHARMACEUTICAL industry is witnessing a changeover from conventional batch to automated continuous processing in response to changing marketplace and productivity requirement. In view of this trend, the tablet coating industry has also seen the introduction of numerous types of coating equipment from early batch coating machines having 60 to 72” pan diameter to continuous coating machines, all claiming improved efficiency and productivity. The present study evaluates the coating uniformity and appearance of tablets coated with IDEAL CURES revolutionary product Instacoat 4G (patent pending), high solids coating system of 35 per cent in a continuous mode from start-up to shut-down in a fully perforated continuous coater. It is for the first time, that a coating material at a high solid content of 35 per cent is used for coating of tablets in a continuous coater. Continuous film coating processes are recognised for their high production rates, but have not gained wide acceptance for pharma products due to potential product losses during start-up and shut down. Advancements in continuous coater design over

40 EXPRESS PHARMA May 1-15, 2015

DARIO LUINI Area Manager, EMEA & US, Ideal Cures

SANJAY NEGI DGM Film Coatings, Ideal Cures

the years, not only allows processing in batch and continuous modes but also ensure uniform and consistent coating for tablets from start to finish.

TABLE 1

PLACEBO TABLETS AND COATING FORMULATION DETAILS Placebo tablets details

Placebo tablets dimensions

SURESH PAREEK Managing Director, Ideal Cures

19.5 mm long with breadth 9.3 mm and thickness 5.5 mm oblong shaped tablets having monogram (INSTACOAT Logo) on both sides.

Coating formulation details Product name

INSTACOAT 4G

Colour

Red

Materials and methods Materials Oblong shaped tablets having ‘Instacoat’ embossing were used as a substrate. The coating system used was INSTACOAT 4G (patent pending), a high productivity film coating system by Ideal Cures, reconstituted in water at 35 per cent solids concentration and applied at a target weight gain of 2.5 per cent (see Table 1). This revolutionary coating product provides fast drying of tablets at high spray rates without causing gun blockages.

Equipment

Figure 1. Continuous Coating Pan (Thomas Engineering)

Trials were conducted in a 24 inch fully perforated drum (Drum Diameter) of Thomas Engineering based in Chicago, Illinois, US, continuous coater (Model: Thomas Flex CTC) (see Figure 1), equipped with 22 spray guns (Model: Schlick ABC Technology 940). 22 spray guns were divided into two separate Manifolds (11 Spray Guns per manifold)

PHARMA ALLY TABLE2.

TABLE 3.

COATING SUSPENSION CHARACTERISTICS

COATING PROCESS PARAMETERS

Parameters

Observations

Appearance

Free-flowing, lumps free coating suspension

Coating pan details

Pan diameter ( Inches) Colour

Red

pH (Two per cent w/w at room temperature)

Viscosity (cps)

210

Spray gun details

Gun type

Schlick

No. of guns

Nozzle diameter (mm)

1.0

Coating suspension details

Solids content (% w/w)

Solvent

Purified water

Stirring time (minutes)

Coating process parameters Figure 2. Interior of the continuous coating pan

Figure 3

controls. The discharge end of the unit contained a pneumatically controlled weir plate, which when lowered contained all the tablets and when raised, it served to control the flow of tablets in the discharge zone. This control mechanism is an enhancement over earlier continuous coater technology and allows for coating of tablets in both

batch and continuous modes. The individual gun sequencing system ensures less product loss and re-processing during start up and shut down. The absence of baffles in the pan interior is an additional feature that separates this machine from coating machines available earlier. (see Figure 2). Other than antislide bars, tablet movement

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through the pan is solely controlled via tablet in-feed rates and the height of the weir plate at the discharge end of the pan.

Trial-continuous mode process The batch was coated using Instacoat 4G, a revolutionary coating material which works efficiently at a high solids

Desired weight gain (%)

2.5

Batch size (Kg.)

1000

Inlet temp (?C)

59-64

Bed temp (?C)

43-45

Exhaust temp. (?C)

47-48

Airflow (cfm)

6700

Atomizing air pressure (Psi)

40-42

Pattern air pressure (Psi)

30-32

Pan speed (rpm)

10-12

Spray rate (g/min)

548-756

Weigh belt feed rate (kg/hr)

544-635

Environmental equivalence factor

7.265-11.256

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May 1-15, 2015

PHARMA ALLY content of 35 per cent and provides smooth and elegant coating without gun blockages. Thomas Engineeringâ&#x20AC;&#x2122;s tested coating parameters were used for carrying out continuous coating operation. The tablet container was loaded inside the continuous coater via weigh feed belt. Tablets loaded via bin onto the container of the coating machine feeding zone. Tablets were fed into pan via a tube from the hopper to a total fill of 150 kg. The batch tablets were moved into the waxing /cooling zone after achieving the desired weight gain. Once desired weight gain is achieved machine is tilted and all coated tablets were unloaded in suitable containers. The target process conditions are listed (see Table 3). In continuous mode of operation, colour development and colour uniformity was achieved in significantly less time than would be seen in a traditional batch coater. The fast attainment of colour uniformity was attributed to the shallow bed depth, resultant frequency of tablet presentations to the elongated spray zone and also the high solids (35 per cent w/w) capability of Instacoat 4G coating system. Instacoat 4G is a revolutionary product which at low viscosity provides easy coating of tablets at high spray rates even in continuous coating operation. The bed depth is significantly greater in a traditional batch coater than in the continuous coater. Consequently, in the shallower bed, the tablets are exposed much more frequently to the spray zone and the duration that the tablets are isolated from the spray is much less. The increased number of spray guns and elongated coating chamber may also play a role in improving coating uniformity by improving the consistency of spray distribution across the tablet bed.

Color development and uniformity testing Coated tablets samples were collected from the unloading point of the continuous coater once tablets achieved desired weight gain of 2.5 per cent.

42 EXPRESS PHARMA May 1-15, 2015

Tablets were visually tested for appearance, colour uniformity, colour difference, disintegration time and coating defects. Colour difference of the coated tablets was checked using premier colour matching instrument.

Results and discussion The coating trial of Instacoat 4G was successfully executed on a batch size of 1000 Kg using Thomas Engineering Continuous Coater. Coated tablets were evaluated for appearance, colour difference, coating defects and disintegration time at the end of coating process and all the results were found acceptable. The appearance of coated tablet was acceptable. The coated tablets had good colour uniformity and free of any coating defects. Instrumental colour testing of samples pulled throughout the trials confirmed the positive visual assessment of colour uniformity. Note: In a continuous coater, colour Uniformity was achieved for the lot in significantly less time (15 minutes) of coating than would be seen in Autocoater (60 Minutes) due to high solids capability of Instacoat 4G and Thomas Engg. Continuous coating technology.

Figure 4

TABLE 4.

COATING PROCESS EVALUATION Parameters

Observations

(A) Process feasibility Ease of operation

No gun choking observed during the coating process

Sprayability

Free-flowing, lumps free and grittiness free coating suspension

(B) Coating defects Sticking and picking Peel off Logo bridging

No coating defects observed

Roughness

Conclusion

Any other (C) Tablet appearance Smoothness

Smooth tablet surface

Logo clarity

Satisfactory logo clarity

TABLE 5.

COATED TABLETS CHARACTERISTICS

Sampling intervals (Min).

Actual coating weight gain (%)

Parameters

Observations

2.5

Appearance

Satisfactory

Colour difference (dE)

1.0

Disintegration time (Sec.)

Coating Defects

Nil

The Instacoat 4G coating formulation is well suited for continuous coating technology due to its low viscosity and high solids capability (35 per cent w/w). As a result target 2.5 per cent coating weight gain could be achieved at a high tablet throughput rates (Feed Rate: 650 Kg/hr) during the continuous mode of operation. Further optimisation of the coating parameters for Instacoat 4G will enable an even higher throughput rate without compromising the quality of the finished product. Instacoat 4G is a highly advanced coating system from Ideal Cures is well suited for all the coating technologies from a conventional to most advanced continuous coaters being used in the pharma industry worldwide.

PHARMA ALLY I N T E R V I E W

â&#x20AC;&#x2DC;Our strategy is to provide reliable technology backed with adequate servicesâ&#x20AC;&#x2122; Pune-based HRS Process system offers innovative and cost effective heat transfer solutions offers its solution to various sectors. Its 25 per cent of the business comes from pharma sector, which is seeing a healthy growth. V Gokuldas, Managing Director, HRS Process Systems in an interaction with Usha Sharma, discusses the company's business strategies and future plans

What trend do you see in the heat transfer solutions market and how rapidly it is growing in India and abroad? Heat exchangers are one of the basic process equipment in any industry ranging from pharmaceutical, chemical, petrochemical, fertilisers, oil and gas, power, cement, refrigeration, food & beverage processing and many more. Innovation in heat exchanger design has been necessitated by the rapid growing technology demands in process industry. Heat exchanger design today needs to be energy efficient, withstand a range of process materials taking impact of factors such as varying temperature, pressure, corrosion, fouling, metal combination, etc. New heat exchanger types are developed for specific process application depending on the need for energy conservation. Globally, there has been a marked increase in demand for heat exchangers in chemical process industry for various processes to enhance energy efficiency. Hygienic and sensitive

processes like pharma, healthcare and food processing are moving much faster to adapt emerging advancements in heat transfer technology for a diverse range of applications. Heat exchanger market is growing faster in many emerging markets and in the Asian region including South East Asia and Asia Pacific. Heat exchanger market in these regions is foreseen to continue to have a CAGR of 10 to 15 per cent. How big is the market for the pharma industry? The pharma industry has witnessed a decent growth of over 25 per cent in the past years and we expect the industry to maintain and have much a higher growth. There is a growing demand for healthcare products like nutraceuticals, probiotic healthcare supplements, apart from fortified products and generic drugs. The improvement in healthcare infrastructure has also given a boost to the pharma sector. Which services/products do you offer to the pharma sector and how much business is generated?

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We have a flexible group policy whereby the company has direct access to different markets

We have a vast range of heat transfer products mainly; ecoflux corrugated tube heat exchanger, shell and tube heat exchanger, plate heat exchanger and heat exchanger based systems for various applications like heating cooling, heat recovery, condensation, sub cooling, reboiler, etc. Our products offer various advantages to the customers in terms of higher efficiency, better product recovery, flexibility in various processes apart from being economical. Our hot water systems for the pharma industry enable better control on the product processing, thus help to enhance productivity and lower cost. We offer heat exchangers in stainless steel and higher grades of metals like hastelloy, duplex, alloy 20, titanium, tantalum, etc., depending on the property of fluid and process requirement. Over 25 per cent of our business comes from the pharma sector and have been having a healthy growth in this sector. What cost effective solutions do the company offer to its clients?

We offer all heat transfer solutions for the pharma sector under one roof. Different applications require different heat transfer equipment. HRS is able to offer customer solutions based on any of these or a combination of these to suit the processes requirements. Thus, we offer right technical solution for the applications rather than select a product because we have. This is appreciated by customers who can evaluate the three key heat transfer equipment and make a cost effective selection. How competitive is the business market and whom do you consider as a competitor? The business market is very competitive with local fabricators and established companies, some of whom are multinationals. We have been able to create a niche for ourselves based on our innovative technology product 'ECOFLUX Corrugated Tube Heat Exchanger' and providing heat exchangers with different material of construction as required by the industry. We have been

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PHARMA ALLY able to demonstrate the advantage of our product and in the past decade have sold over 6000 heat exchangers to the sector with over 50 per cent repeat business. Who are your clients in the pharma industry. Our customers in the pharma industry are top notch blue-chip companies like Dr Reddy, Pfizer, Ranbaxy, Cipla, Sun Pharma, Glaxo SmithKline, Nicholas Piramal, Wockhardt, Glenmark, Hetero Drugs, Matrix Labs, Aurobindo Pharma, Torrent Pharma, Aventis Pharma, Lupin, Cadila Healthcare, Novartis, Alembic and many more, who always prefer us as their trusted process partners for heat exchange technology.

Our company is working on heat transfer solutions for heat sensitive and viscous products. These will be for the pharma, nutraceutical and probiotic product categories. We believe our product performance and customer satisfaction are the drivers for our business and to achieve it we have ensured a very high level of product quality and reliability

What are the marketing strategies? Our strategy for the sector is to provide reliable technology backed with adequate services. Customers value our solution, which is backed by equipment design and manufacturing facility which is ISO 9001 and ASME, U Stamp certified. Thus we offer quality product at reasonable price.

team is working on existing and future processing techniques for heat exchange solutions. Elaborate on it. What research works are being carried on by the company? Our company is working on heat transfer solutions for heat sensitive and viscous products. These will be for the pharma, nutraceutical and probiotic product categories. We are designing heat exchangers which can be suit well with heat sensitive products without causing degradation. Our other area of focus is effluent heat recovery applications.

The company's research

How many manufacturing

facilities do you have and where are they located? Do you plan to expand/set up new any facilities? Our manufacturing facility is located in Pune. This facility is ISO 9001:2008 and ASME ‘U’ Stamp certified spread over an area of four acre with about 40,000 sq ft built up area for various fabrication activities. We do not have any present expansion requirements. The facility is capable of manufacturing 300+ heat exchangers every month and can go upto 500 heat exchangers per month. Our state-of-the-art facility is built according to international standards and

has energy saving mechanism for light and ventilation. The company has a mission to establish a strong heat exchanger brand which will have both innovative and solution driven, meeting customer needs in the heat exchanger market. What strategies have you chalked out to accomplish? We believe our product performance and customer satisfaction are the drivers for our business and to achieve it we have ensured a very high level of product quality and reliability. Our mission slogan is “Once a customer, customer for life”.

Therefore, our product needs to perform to the satisfaction of our customer. In the sector we feel we have been able to establish a brand value for 'HRS' and our products. Tell us about your international business presence? We work as a group and have company or associates in different geographies apart from India; we are directly responsible for Asian, South East Asia and Asia Pacific rim countries. We have a group company in Malaysia which helps us in marketing our products and services to this part of the world. We have a flexible group policy whereby the company has direct access to different markets. Thus we are able to provide customers with the latest products and services at the shortest time. What will be the company’s road map for 2015-16. For the year 2015-16, we anticipate a big growth in pharma sector and as a company we are looking at a 25 per cent growth over the past year. We are also looking at making inroads in to the pharma industry in areas we have not yet been able to establish customer connect. u.sharma@expressindia.com

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.

44 EXPRESS PHARMA May 1-15, 2015

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

The Indian Express Limited, 1st Floor, Express Towers, Nariman Point, Mumbai - 400 021. Tel: 91-22-2202 2627 / 2285 1964/ 6744 0000 Fax: 91-22-2288 5831 editorial.ep@expressindia.com

PHARMA ALLY VENDOR NEWS

Leading pharma companies adopt Cirrius PharmaCRM platform The platform uses real-time mobility to reach physicians, improve coverage and performance leading to higher productivity and efficiency CIRRIUS PHARMACRM Digital Platform on Microsoft Azure has been adopted by leading pharmaceutical companies such as Cipla, Ranbaxy and Biocon for enabling multichannel digitisation of medical engagements. The platform rides on three components, the base CRM platform, closed loop marketing and the Phyzii engagement platform that fuels effective interactions between pharma companies and their network of medical reps, physicians, patients and the supply chain. The Cirrius PharmaCRM that digitally enables the pharma and life sciences companies, runs on Azure in the Microsoft cloud and is available on Windows, iOS and Android mobile platforms. More

The Cirrius PharmaCRM that digitally enables the pharma and life sciences companies, runs on Azure in the Microsoft cloud and is available on Windows, iOS and Android mobile platforms than 50 per cent of the large pharma and life sciences enterprises have created their digital lounges to engage, transact and service over 1,00,000 users consisting of medical reps, physicians and other elements of their ecosystem on the Cirrius Platform across 20 countries. Cirrius now features in the Gartner 2015 CRM Vendor List.

“The platform agnostic and open capabilities of Azure allow us to focus on strengthening the content and quality of stakeholder engagement while rendering across devices and platforms is facilitated by Azure. The analytics capabilities in Azure further help us derive meaningful insights,” said Kapil Kuwelker, Founder and CEO, Cirrius

Technologies. Subscribers of the Cirrius PharmaCRM Digital Platform see a digital transformation in their engagements. Medical reps are now more productive and effective. Coverage of physicians goes up to more than 90 per cent. In clinic effectiveness is significantly higher with rich interactive content being detailed to the

physician. Physician engagements are at an all-time high with 60 per cent physicians engaging on Phyzii. Finally, the decision making capability based on analytics coming from various products on the platform lead to quick and informed decisions. Srikanth Karnakota, Director – Server and Cloud Business, Microsoft India said, “The Cirrius platform leverages Microsoft Azure to empower the pharma sales force and make their lives simpler. The platform underscores Microsoft’s commitment to consistently evolve and deliver quality solutions using technology to our customers.” EP News Bureau-Mumbai

Bosch machine bags Red Dot Award Bosch receives the first design prize of this kind for packaging technology

BOSCH PACKAGING Technology has received the internationally renowned 'Red Dot Award' from the Design Zentrum Nordrhein-Westfalen in the category product design. The independent 38-member jury recently announced the award with an 'Honourable

Mention' and acknowledges the well-executed design achievement of the FXS Combi. The filling and closing machine for pre-sterilised nested syringes, vials and cartridges (small glass containers), developed at the site in Crailsheim, is the first machine from the Packaging Technology division to receive this important design award. “We are happy about the Red Dot Award, which underlines our expertise in the development of innovative solutions for the pharmaceutical industry. The award shows that our products are not only convincing in terms of quality. They also stand out interna-

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tionally because of their design,” says Klaus Ullherr, Product Manager, Bosch in Crailsheim. The international experts assessed a total of 4

928 entries from 56 countries. The FXS Combi, which was launched at Interpack 2014, offers particular flexibility and safety. The machine is

suited for three different presterilised packaging types, as well as all common filling technologies. As the first filling and closing machine of this kind, the FXS Combi features an integrated capping station for vials and cartridges. Here, the containers are immediately closed after filling to ensure the highest pharma safety. By combining the machine with proven tub and bag openers, as well as different barrier systems, the FXS Combi can be flexibly integrated into complete line concepts, while allowing for significant space savings. EP News Bureau-Mumbai

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Skytech System (I) launches Offline TOC analyser QbD 1200 SKYTECH SYSTEM (I) announced its association with Anatel Hach and launched the state-of-the-art Offline TOC analyser QbD 1200. With an upper limit of detection up to 100 ppm it fulfills the requirement of analysis of PW, WFI, CV samples. As the name stands for Quality by Design, it ensures the accuracy result by controlling the entire process of TOC analysis individually ie sample introduction, oxidation and detection.

with NDIR detector. ◗ Integrated windows platform eliminates the requirement of PC. ◗ Autosampler for 64 vials is available ◗ Stable Calibration for a year. ◗ Very less Consumable required for run the unit. The analysis of TOC is always critical for a pharma manufacturing unit so this has been designed to eliminate the hassles of buying reagents frequently, use expensive accessories like resin beds, catalysts etc. less dependency on peripherals so more robust process of analysis.

Quality by design approach ◗ Self-health check runs each time QbD1200 is powered on and available upon demand ◗ Seven sensor types at 10 different monitoring sites continuously check pressure, liquid flow, gas flow, UV lamp inten-

sity, temperature and NDIR detector ◗ Easily provides confidence

that all sub-systems are functioning properly to ensure a reliable measurement

The analyser has the salient features like ◗ UV per sulphate oxidation

Contact details Ramesh Sahu Product Manager rsahu@skytechindia.com or marketing@skytechindia.com

Hand flow regulator by Industrial Equipwash HAND FLOW regulator (dispenser) is used wherever controlled flow is desired. The dispenser is triggered operated. Whenever the trigger is compressed, the desired quantity of viscous/ semi solids/ clear liquids can be dispensed through the nozzle. The dispenser is useful when remote valve is in position and operator need not exert to put it off after every usage or filling of container. On releasing the trigger, the dispenser shuts down 100 per cent and there is no leakage. It is suitable for hot and cold temperature products. It comes with suitable jacket. The inlet connection

46 EXPRESS PHARMA May 1-15, 2015

has sanitary fittings triclover, sms,etc. The is ss 316/304 quality. sizes available are ½”, and 1”.

like moc The 3/4”

Contact details Industrial Equipwash 8/B, Surat Singh Industrial Estate,Near Agarwal Industrial Estate, SV Road, Jogeshwari (W), Mumbai - 4000 102 Mbl. 09869231815 Tel No.022-26797941 Telfax No.022-26798066. Email Us on : iewi@mtnl.net.in ; iewi@vsnl.net Website : www.iewi.net

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OSMOMETER 3250

Milk Cryoscopes Available

127, Bussa Udyog Bhavan, Tokershi Jivraj Road,Sewri, Mumbai - 400015. India

Tel: +91-22-24166630 Fax: +91-22-2662776 E-mail: support@rosalina.in Web: www.rosalina.in

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Innovation is our culture… Preclinical Toxicology Services: Single dose (Acute ) toxicity studies Repeated dose (14, 28, 90 & 180 Days) toxicity studies • Skin, Eye Irritation / corrosion • Skin Sensitization • Pharmacokinetic studies on Beagle dogs • LD50 and maximum tolerated dose • Immunotoxicity • Genotoxicity Studies • •

Test Systems: • Mouse (Balb-C, Swiss-Albino, C57, Diabetic) • Rat (Sprague Dawley, Wistar) • Rabbit (New Zealand White, Non albino) • Guinea Pig (Hartley) • Canine (Beagle Dogs)

SERVICES Formulation Development. Microbiological Studies. Biological Studies. Pre Clinical Studies. Analytical Research. Bio-equivalence Studies. Clinical Trials. Dossier Preparation. Preclinical Pharmacopoeial Services.

Quality in our genes… Pharmacopoeial Services: (Accredited by NABL for ISO/IEC 17025:2005)

• • • • • • • •

Pyrogen Testing Abnormal Toxicity Undue Toxicity Bioassays Systemic Injection Test Intracutaneous Test Implantation Test Eye Irritation Test

Facility Infrastructure: Individually Ventilated Cages Designed as per GLP/ AAALAC Independent facility for Rats, Mice Rabbits and Beagle Dogs • Ultra modern Histopathology lab • Safety alarms/call to scientists • Online Recording of Observations • • •

ACCREDITATIONS USFDA registered cGMP control testing laboratory. DSIR approved R & D Centre. Drugs Controller General of India (DCGI). NABL accreditation for Chemical, Biological Medical Testing, Bioanalytical & Mechanical. Recognized by Bureau of Indian Standards. Drugs Control Administration (A.P). Department of Biotechnology approved Institutional Bio-Safety Committee (IBSC). NABL for ISO/IEC 17025:2005.

!"! $!%!&'('%" )*!+",+'- ,% ./012 324. !*' 5'-,&%'5 "6 '%-7*' "6"!8 ,%"'&*,"9: -'+7*,"9 !%5 ;!-"'-" *'"*,'<!8=

ONE STOP SOLUTION FOR PHARMACEUTICAL RESEARCH

SIPRA LABS LIMITED Industrial Estate, Sanathnagar, Hyderabad – 500 018. Industrial Estate, Sanathnagar, Hyderabad – 500 018. Tel: 040-23802000, Fax: 040-23802005 Email:sipra@sipralabs.com web: www.sipralabs.com EXPRESS PHARMA

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Two great brands come together under Charles River to provide an even stronger testing solution for our customers.

Microbial Detection & Identification

Charles River Laboratories India Private Limited Bangalore (Regd. Office): Phone: 080 25588175 / 76 / 77. Email: blroffice@crl.com Ahmedabad: Phone: 079 40194730. Email: ahdoffice@crl.com Hyderabad: Phone: 040 27179998. Email: hydoffice@crl.com Mumbai: Phone: 022 27810061. Email: bbyoffice@crl.com Mumbai - Accugenix Facility: Phone: 022 41270504 / 05 / 08. Email: CRLIaccugenix@crl.com

www.criverindia.com

May 1-15, 2015

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PharmaTainersTM-Clean containers

Single-Use Containers for Storage & Transportation of Vaccines, Biopharmaceuticals, Culture Media and other Biotech Materials (Polyethylene terephthalate (PET) & Polycarbonate (PC), with High Density Polyethylene (HDPE) closures) Details • • • • • •

Clean, sterile & ready-to-use Medically approved resins Molded and capped in an ISO Class 5 (class 100) environment, Precision, injection molded, flash and burr-free neck finish eliminate the primary cause of seal failure Unlined, double seal closure system PET PharmaTainersTM have excellent gas barrier properties; PC Pharmatainers are ideal for freezing applications Each container is printed with a unique serial number, batch number, expiration date and machine readable data matrix for unrivalled traceability troughout production and during use

•

Compliance 3

Certified to meet USP788, EP, JP compendia standards

Endotoxins tested

Packed in an ISO Class 7 (Class 10,000) cleanroom

Traceability

Double Seal Closure System

ULTRA LOW PARTICULATES USP788 EP2.9.19 JP 14 ed. part 1 sect 24. th

Raw Material

Sterility

Manufactured from 100% virgin ADCF resins that are approved for medical applications

Precision molded closures and necks have robust threads that provide secure engagement between cap and bottle. Closures seal at two points - inside the neck and on the rim of the neck to provide a leak proof seal.

Each container is printed with a unique serial number, lot number, expiration date and machine readable data matrix to provide unrivalled traceability through the production process.

PET

HDPE

medical use

Yes

USP Class VI

Yes

In-vitro cytotoxicity Test

Yes

DMF15205

DMF1562

DMF1646

Approved for

Drug master file ADCF*

Yes

Yes Yes Yes *Animal derived component-free

PharmaTainerTM Polycarbonate Bottles & Carboys

PharmaTainerTM PET Bottles & Carboys

Polycarbonate has a wide

PET provides excellent gas

temperature range of use.

barrier properties. Phar-

PharmaTainers

PC bottles

Pharma TainerTM product families sterility certification is based on a VDmax 25 sterilisation study performed according to “ISO11137-2:2007, VDmax 25 sterilisation of healthcare products radiation-part 2”, which demonstrates that a 25kGy irradiation dose achieves a sterility assurance level (SAL) of 10-6. Ongoing sterility assurance is maintained by bioburden assessments on every product batch and quarterly VDmax 25 dose audit studies.

maTainerTM PET bottles and

& carboys are ideal for frozen

carboys are ideal for long

storage.

storage of materials like culture media.

Volume : 125 ml, 500 ml, 1, 2, 5, 10 & 20 liters

Temperature range of use : -130°C to +120°C

Temperature range of use : -40°C to +60°C

Clear and easy-to-read graduations with an accurancy of +/- 2 %

Certified sterile and endotoxins tested

Genetix Biotech Asia Pvt. Ltd. 71/1, First Floor, Shivaji Marg, Najafgarh Road, New Delhi-110015 E-mail : info@genetixbiotech.com, Web : www.genetixbiotech.com

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PHARMA LIFE POST EVENT

SAC-ACCP organises eighth annual international conference Felicitates six industry stakeholders and institutions Usha Sharma Mumbai SOUTH ASIAN Chapter of American College of Clinical Pharmacology (SAC-ACCP) recently organised its eighth annual international conference on 'Translational Clinical Pharmacology Research in Drug Development' at Nehru Centre in Mumbai. It also felicitated six industry stakeholders and institutions for their valuable contribution to the Indian pharmaceutical industry. The theme for the this year's conference was 'Translational Clinical Pharmacology for Drug Development'. The chief guest for the event was Dr GB Parulkar, senior cardiologist from Mumbai. Pankaj Patel, Chairman and Managing Director, Zydus Cadila, Dilip Shanghvi, Founder and Managing Director, Sun Pharma, Glenn Saldanha, Chairman and Managing Director, Glenmark, Dr Ram Vishwakarma, Director, CDRI Luc-

know, Dr Vishwa Mohan Katoch, Former Secretary to the Government of India (Department of Health Research Ministry of Health and Family Welfare) and Director General Indian Council of Medical Research and Dr Maharaj Kishan Bhan, National Science Professor, Indian Institute of Technology, Delhi were honoured by SAC-ACCP for 'Leadership in Drug Discovery and Development', 'Visionary in Drug Discovery Development', 'Innovator Entrepreneur', 'Outstanding Translational Research Institute' and 'Leadership in Health Research' respectively. Dr Nil-

ima Kshirsagar, President SACACCP, welcomed the dignitaries. She informed that the American College of Clinical Pharmacology started its South Asian Chapter in Mumbai in 2006. She added, “Out of 10 drugs which go for clinical trials, only one may reach the market. According to World Health Organization's (WHO) priority medicine report, there are 16 important disease conditions prevalent for which drug therapies are lacking or inadequate. On the other hand, cost and complexity of developing new pharma and diagnostics have escalated. As per WHO esti-

mates, half of the available drugs are not used correctly and even in the US, 15-20 per cent cannot afford medicines due to cost factor.” Patel said, “There are ample opportunities in the industry and we need to work on time. India completely relies on medicines from the developed western countries and now the time has come to show the world that even India can discover a drug. Indian researchers and industry stakeholders should work together and discover new drugs which can be used by western countries also.” Bhan, National Science Pro-

fessor, Indian Institute of Technology, Delhi and former Secretary, Department of Biotechnology Government of India, informed about the challenges which he and his team members faced during the development of rota virus vaccine. He continued, “When the central government is reducing healthcare budget almost 20 per cent every year we need to work together and develop new drugs to make them understand that the work is being carried and can divert their attention in the long run.” u.sharma@expressindia.com

CAMPUS BEAT

SIES Institute of Chromatography and Spectroscopy to organise certificate course SIES INSTITUTE of Chromatography and Spectroscopy will organise a one week certificate course on chromatography and spectroscopy from June 1-16, 2015. This year the workshop is fi-

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nancially supported by Association of Chemistry Teachers (ACT) and Chromatographic Society of India (CSI), which will be held in SIES Institute of Chromatography and Spectroscopy, Nerul, Navi

Mumbai. College teachers engaged in teaching the chromatography and spectroscopy techniques or those pursuing research and postgraduate research students or doctor-

ates, who intend to take up a teaching career are likely to attend. 24 participants only will be enrolled for this certificate course. Indian Women Scientists Association (ISWA) in Vashi

and KBP College in Vashi have agreed to allot a few rooms in their women’s hostel for the entire duration of the training. EP News Bureau - Mumbai

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