Express Pharma (Vol.10, No.14) May 16-31, 2015 by Indian Express

VOL. 10 NO. 14 PAGES 68

www.expresspharmaonline.com

Cover Story Mankindâ&#x20AC;&#x2122;s next force

Management Drug price rise: An efficacious move? 16-31 MAY 2015,` 40

CONTENTS

PIC/S

Vol.10 No.14 MAY 16-31, 2015

GETTING ACLEARER PICTURE

Chairman of the Board Viveck Goenka 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

MANAGEMENT

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 Manager Bhadresh Valia Scheduling & Coordination Mitesh Manjrekar CIRCULATION Circulation Team Mohan Varadkar

PHARMA ALLY

DRUG PRICE RISE AN EFFICACIOUS MOVE?

SCHEDULERS LOGISTICS HAS BEEN BUILT ON ETHOS OF PROVIDING VALUE TO CUSTOMERS

ABBOTT AND SEKISUI COLLABORATE

P16: POST EVENT Basic science research to be the thrust area of Modi Government

P28: RESEARCH UPDATES Measles vaccine thwarts other infectious diseases: Study

MARKET

‘WE HOPE BILATERAL PHARMA TRADE BETWEEN THE US AND INDIA WILL GROW AT OR ABOVE 10 PER CENT’

INDIA REMAINS ON USTR PRIORITY WATCH LIST

US FDA PUBLIC MEETING ON REAUTHORISATION OF GDUFA

US FDA NOD FOR GENERICS OF ABILIFY

RUSAN PHARMA LAUNCHES FIRST ‘MADE IN INDIA’ NRT PATCH 2BACONIL

IDMA ORGANISES WORKSHOP ON LABORATORY DATA INTEGRITY IN MUMBAI

BOOSTING APIS AND EXPORTS TAKE TOP PRIORITY AT 3RD IPHEX 2015

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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

When patience is not a virtue

ndia once again made it to the Priority Watch list of the 2015 USTR Special 301 Report, but this year, the reaction from India’s pharma industry was more measured. (See news story: ‘2015 USTR Special 301 Report: Reactions and the way forward; http://bit.ly/1F99jSA) While industry associations OPPI and IDMA reacted along expected lines, a more nuanced reaction came from Dr Gopakumar G Nair as Chairman of IDMA’s IPR Sub Committee. His opinion that ‘S. 3(d) has done its job’ is bound to raise at least a few eyebrows among industry observers. Nair’s point as IDMA’s IPR counsel is that as ‘the international community has taken note of its contribution and so the relevance of 3(d) in its present form may be opened for a debate and deliberation, even though it is India’s position that it is equally useful and adversely impacting incremental innovations of MNCs as well as research-based Indian companies.’ Even as IDMA Secretary Daara Patel’s comments follow the line of previous IDMA statements on IPR, Nair’s comments give glimpses of a moderation of tone and tenor, without ceding ground on key issues. IDMA’s new stance shows signs of self-confidence and movement away from a defensive position, and indeed the latter’s statement advises the country to follow suit as well. It is in this context that Nair’s statement concludes that there are common elements and threads between the PMO (one assumes he is referring to PM Modi’s controversial statement at the Commerce Ministry’s first Global Exhibition on Services (GES) Summit) and Commerce Ministry Nirmala Seetharaman’s comment that India’s IP policy is compliant with global norms. In a more recent discussion on the sidelines of another industry meet, Commerce Ministry officials explained that the apparent disconnect between the two comments was due to two reasons. One, the PM’s real message was ‘lost in translation’ as he made the statement in Hindi. Secondly, since the PM was speaking at the GES Summit, his comments should be taken in the context of that summit and audience. If I’m reading the tea leaves right, IDMA’s statements are only following the example of our Prime Minister, who has encouraged engagement and dialogue on the most contentious issues. India would do well to heed the warning of Professor Brook Baker, Northeastern U School of Law, and Senior Policy Analyst, Health GAP, also quoted in the news piece referred to above, who calls the annual USTR report a cat-and-mouse game, and

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India’s pharma industry has many more pain points beyond IPR.There are some signs (finally) that various ministries are working in tandem to fix some of these issues.But when will the talk translate into measurable, meaningful and sustainable results?

urges India to clarify its stance on various IPR issues as soon as possible. Equally important is a comment from Roger Bate, Economist, Resident Fellow of the American Enterprise Institute who warns that everyone is confused (about India’s IPR policy) and confusion prevents investment. India’s pharma industry has many more pain points beyond IPR. There are some signs (finally) that various ministries are working in tandem to fix some of these issues. But when will the talk translate into measurable, meaningful and sustainable results? For instance, the inauguration of the recent 2015 iPHEX exhibition saw key policy makers list out their plans to revive API manufacture and invigorate pharma exports. (See report: Boosting APIs and exports take top priority at 3rd iPhex 2015, http://bit.ly/1JJxvfi). The common refrain was that we would see the difference in the next few years, but will the various segments of India’s pharma industry be patient enough to wait till these efforts bear fruit? Faster policy implementation could make or break companies like Mankind Pharma, who are at a crucial crossroad. The man on the cover of this issue, Ramesh Juneja, Founder and Chairman & Managing Director, Mankind Pharma is counting on exports, affordable and safe indigenous APIs as well as forays into biologics and nutraceuticals to take his company to the next level. (See story: Mankind’s next force, pages 20-23 in the May 16-31, 2015 issue) Entrepreneurs like Juneja are not afraid to take risks, with aggressive marketing and rock-bottom pricing. In this volumes game, Juneja chose a category considered ‘taboo’ by serious pharma companies to build his company’s brand image: the OTC ‘sexual health’ category spanning products like emergency contraceptive pills, condoms and gels for erectile dysfunction. The company continues with this dual strategy, recently hiring porn star turned actor Sunny Leone as brand ambassador while Juneja and team build a global footprint, targeting a ` 5000-crore turnover by 2017. Juneja’s story is similar to many home grown pharma companies in India. It is up to our policy makers to enable many more Mankind Pharmas and RC Junejas to rise to the next level. Entrepreneur-promoters will agree that opportunity knocks but once. Very clearly, their patience has its limits. VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

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‘We hope bilateral pharmaceutical trade between the US and India will grow at or above 10 per cent’ The US-India Business Council (USIBC) led a Pharmaceutical & Biologics Executive Mission to Hyderabad and New Delhi late last month. Amy Hariani, Director, USIBC who manages the life sciences portfolio, reveals more in an interview with Shalini Gupta

What was the objective of the meeting? One year after the Modi government came to power, we wanted to better understand the government’s priorities and align pharmaceutical investments with some of the campaigns that the government has been pushing such as the “Make in India” and “Innovate in India”. Our purpose was how can we as a pharma industry partner with the government given our objectives and interest, invest more in India and in turn innovate more. What were the main points of discussion? We wanted to communicate to the government that we see a lot of positive signs coming from this new government, a positive momentum on intellectual property front with the new draft IP policy and a lot of willingness to understand the industry's concerns. We are optimistic and keen to partner with the government. Continued positive outcome and resolution around three areas that we consider important would help further attract more investment from the US in the future. Right now there is a lot of uncertainty on the pricing of pharmaceuticals.

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Intellectual property is the second area where we think things are moving in the right direction and we would want to work closely with the government. We understand that the IP taskforce has submitted its report to the government and we look forward to it. There's still a lot of uncertainty around clinical trials with a lot of court cases pending, but we think that if the government continues to tweak the regulations, it'll help bring in a lot of predictability on this front. What are your views on pricing? How’d the expansion of the essential medicine list under price control affect MNCs? We recognise the GoI’s efforts to make more medicines affordable to Indians. We believe it is a cause shared by all governments worldwide, an overarching desire to make medicines affordable. Even as the government is trying to develop the pricing policy with those objectives in mind, it is imperative that they keep in mind the investment climate as well. This balance would be a bit difficult. NLEM 2011 was a really great example where government, patient groups, NGOs and industry came together to

develop a model and pricing mechanism that was transparent, predictable and a win-win for everyone. There needs to be continued stakeholder consultation, opportunity to comment and engagement with the government . We need to develop pricing models with those factors in mind. India has been again placed on a priority watch list as per the latest USTR report. Would you still say that India's IP policy is on the right track?

We believe that having a clinical trial system is integral to an innovative ecosystem, so that one is able to strengthen R&D, which in turn impacts manufacturing

India’s stance on intellectual property has been evolving in a positive manner over the last several years. USIBC is working to not only promote a spirit of dialogue between businesses and governments in a goaloriented manner, but also making sure that the people of India can create and have access to innovative products. While USIBC member companies still have challenges with regard to intellectual property policies in India, we are encouraged that the current government is engaged and examining key IPR issues, as noted in the Special 301 Report.

What is your stance on clinical trials? We believe that having a clinical trial system is integral to an innovative ecosystem, so that one is able to strengthen R&D, which in turn impacts manufacturing. We are happy that the government continues to recognise that further changes need to be made to the clinical trial system. The Ranjit Roychowdhury report was a step in the right direction, but it will take some time to get back to the momentum in the industry that was before 2012. There's still some ambiguity on what is an adverse event, how it is defined and compensation as well. The government seems to want to get it right. Any discussions on the biosimilar front? We think biosimilar guidelines are a step in the right direction, however we are going to very carefully observe how they'd be implemented. We continue to urge the Department of Biotechnology to have discussions with other governments which are implementing these regulations so that there is some harmonisation. FDI in pharma has been in

the eye of a storm. Your comments. We had good discussions with the government on recognition in the brownfield where it should be 100 percent. There appeared to be a concern that acquisitions were leading to an increase in the prices of medicines , but empirical data reveals otherwise. There continues to be a sufficient amount of competition in the market which is being monitored by CCI. How much of the current business between the US and India is coming from the pharma sector?By how much do you hope this will increase to in the next few years?

We wanted to communicate to the government that we see a lot of positive signs coming from this new government, a positive momentum on intellectual property front with the new draft IP policy and a lot of willingness to understand industry's concerns The current US-India trade is heavily skewed towards the Indian pharma industry. Out of the total imports from India into the US at $41.8 billion in 2013, $4.5 billion, or roughly 10 percent was pharma imports from India. Conversely, total US exports to India was $21 billion and while exact numbers are

not available, I would expect that less than one per cent of this trade is US pharma imports to India. We hope the bilateral pharma trade between the US and India will grow at or above 10 per cent. How much investment has so far been made in the pharma sector in India?

It is difficult to say with certainty what the investment in the pharma sector has been, especially state-wise. If I had to take a very rough guess, I would say over the last five years, the US pharma sector would have invested about $500 million to $1 billion annually.

How much investment are you looking at in Telangana and Andhra Pradesh in the next few years? What policy and regulatory guidelines make it conducive for companies to invest here? Our companies are not looking at making a certain investment target in either Telangana or Andhra Pradesh. Instead, they are looking at states that are offering the best incentives, ease of doing business, and predicable and transparent policy environment. If any state, Telangana or AP included, offer those to the companies, it would naturally become more attractive for pharma investment. shalini.g@expressindia.com

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MARKET I N T E R V I E W

‘We are estimating revenue of ` 75 crores in 2016’ Indian clinical research organisations are witnessing a downshift and companies are learning from others. Though the market is not in favour of the CRO industry, Quest Life Sciences has chosen to expand its business in both domestic as well as international markets. It has already acquired an established CRO, FCRL. TS Jaishankar, Managing Director, Quest Life Sciences shares the company's corporate plans and details of the recent FCRL deal, in conversation with Usha Sharma

Why did you decide to acquire Fortis Clinical Research Ltd (FCRL), a division of Fortis Hospitals Group? Initially, Quest Life Sciences intended to acquire Fortis Clinical Research (FCRL) shares. The advantages would have been the following :- FCRL is an established CRO and well known for having done BA/BE studies for several regulatory markets such as US FDA, ANVISA, UK MHRA, MOH Malaysia and MOH Turkey, to name a few. Quest even thought that most of the regulatory approvals, except ANVISA and Turkey, have been ideally beneficial to straight away enter into these two markets. However, it decided against acquiring shares of FCRL but preferred to acquire the entire FCRL assets without the liabilities for financial reasons.

taking over regulatory services for and on behalf of FCRL for their existing clients. All the equipment of FCRL have current AMCs with IQ/OQ/PQ documents and validation. A few of the senior technical staff have also agreed to join us. It was beneficial to take up only the assets without the liabilities. Quest has funded the entire acquisition through internal fund generation and additional term loan from the banks viz, Central Bank of India, Chennai.

Can you give us financial details of FCRL and Quest Life Science deal? How did you arrange the funds? Quest Life Sciences is currently setting up a stateof-the-art facility in Gujarat with 40000 sq.ft area, which is nearing completion. So, it decided to acquire only the assets of FCRL besides

You have acquired FCRL at a time when the whole industry is facing regulatory issues. How are you going to tackle this challenge? The CRO industry is no doubt facing several challenges, particularly in reference to regulatory affairs. This certainly is a matter of concern. However,

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Presently, how many studies are in the pipeline and are at what stages? Presently, Quest has nearly 30 studies in the pipeline. Besides, over 50 studies are in the advanced stages of negotiations and will be scheduled based on approvals from the Drugs Controller General (India) (DCGI).

In spite of several impediments, India has the ability to provide high quality services with assured timelines

the industry as a whole, has enormous potential. India has a distinct advantage in the global pharma industry because of a vast pool of disease profile; large volunteer population and advanced information technology, highly experienced and skilled manpower and above all, extremely competitive compared to global CROs. The DCG(I) has made tremendous improvement in their systems and guidelines leading to faster approvals. In spite of several impediments, India has the ability to provide high quality services with assured timelines. The pharma industry in general, and particularly in the regulated markets, are seeing stiff competition in generics and thereby multinational pharma companies are presently keen to work with domestic as well as Indian CROs in view of the advantages mentioned above. What are your learnings from GVK Bio’s Data manipulation incident and what are the proactive steps taken by your country to avoid such an incidence? GVK Bio’s unfortunate

episode has in fact shaken the CROs and BA/BE centres in India. We, at Quest, have taken enormous steps in not only strictly adhering to Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) but have also strengthened our quality assurance (QA), data security and integrity. We have additionally added an external auditor to counter verify our systems and manpower training. Kandla project of Quest is almost nearing completion. We are expecting construction work of the facility to be completed by July, 2015. As we have already acquired the FCRL assets, the Kandla project will go but stream by September, 2015. The estimated project cost is ` 20 crores and is being funded by SIDBI and Quest, besides a private equity fund. Quest is setting up a BA/BE centre at Kandla, Gujarat in the Special Economic Zone. What kind of investment has been been on this project and by when it is likely to be commissioned? Also, what are the studies you plan to conduct and why? The reason for setting up a facility in Kandla is

India has a distinct advantage in the global pharma industry because of a vast pool of disease profile; large volunteer population and advanced information technology, highly experienced and skilled manpower and above all, extremely competitive compared to global CROs. The DCG(I) has made tremendous improvement in their systems and guidelines leading to faster approvals

primarily because there is single window clearance by the Gujarat Government besides excellent infrastructure. More importantly, SEZ provides enormous benefits including 10 years income tax concession, exemption from sales tax, service tax, excise, and central excise. Beside this upcoming facility in Gujarat, the company is also planning to set up full-fledged BA and analytical research laboratory facility in Thailand. Will this facility tap the Asian market? The objective of setting up a BE centre in Thailand is primarily because the Thai government has made it compulsory for all clinical trials and BE studies to be conducted only in Thailand; for registration of drugs in the country. There are 150 pharma manufacturers in Thailand besides all global pharma companies including multinationals and large Indian pharma companies are forced to do their studies only in Thailand. One of our valued customers in Thailand has provided us adequate support and many Indian companies have already indicated their desire to offer us studies. There are only two centres in Thailand and as such we have distinct advantage of enormous back up support from Quest. Quest will be able to offer complete technology SOPs and

training besides deploying a minimum of three senior officials. Also, Quest will additionally offer the analytical services for the local pharma companies at extremely competitive rates. What is the company's current manpower strength and do you have plans to increase it in the near future? Quest Life Sciences, Chennai has a strength of 150 scientists. Quest has been audited six times by US FDA besides regulatory audits from UK MHRA, AEMPS Spain and WHO, MOH, Malaysia. Studies of Quest has been submitted for Europe, the US, the UK, Philippines, Malaysia, Korea and South Africa, Australia and the Middle East. How large is your international presence and do you have plans to expand it further? Our current international presence is very few. Keeping in mind our facilities in Chennai and Kandla and the upcoming one in Thailand. The company has expanded its operations with country managers based in New Jersey, Greece, Europe, Moscow and soon in Thailand. How much turnover you are expecting from 2015-16 We are estimating revenue of ` 75 crores in 2016. u.sharma@expressindia.com

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MARKET COMPANY WATCH

India remains on USTR PriorityWatch List But no OCR this year ... as yet INDIA REMAINS on the US Trade Representative's Priority Watch list of its annual Special 301 review. Unlike last year, the USTR is not announcing an Out of Cycle Review (OCR) at this time, but the Report mentions that it will monitor progress over the coming months, and will be prepared to take further action, if necessary. Other countries on the 2015 Priority Watch List are Algeria, Argentina, Chile, China, Ecuador, Indonesia, Kuwait, Pakistan, Russia, Thailand, Ukraine and Venezuela. Drawing attention to the increased bilateral engagement in 2015 between the US and

India on IPR concerns, following the 2014 OCR, the Report states that while India will remain on the Priority Watch List in 2015, there is expectation that the new channels for engagement created in the past year will bring about substantive and measurable improve-

Report lists access and trade barriers alleged practiced by India

ments in India’s IPR regime for the benefit of a broad range of innovative and creative industries. The Report reiterates the US' offer to work with India to achieve these goals. While the Report says that the US welcomes April 2015 statements made by Prime Minister Modi recommending that India align its patent laws with international standards and encourages India expeditiously undertake this initiative, the PM's statements have drawn protests here in India, with industry experts slamming the PM's apparent admission that India's IP laws are weak and need strengthening. Other pain points flagged off in the Report include Section 3(d) of India’s Patents Act, patent opposition procedures,

compulsory licensing law, regulatory data protection, trade secrets and localisation trends, where the US remains concerned about actions and policies in India that appear to favour local manufacturing or Indian IPR owners. Industry also points out that while the Report lists access and trade barriers alleged practiced by India, certain facts refute this allegation. For instance, between 2005 and 2014, India granted about 63,000 patents in 20 different fields, (including chemical, mechanical engineering, electronics, pharmaceuticals, etc.) with a majority of them, say 52,000 (82 per cent), granted to foreign companies. EP News Bureau-Mumbai

Pharmexcil organises series of initiatives during CPhI Japan Brand India Pharma was strongly represented by Indian pharma companies at various platforms PARTICIPATING UNDER the Brand India Pharma campaign from the Government of India, Pharmaceutical Export Promotion Council of India (Pharmexcil) led a powerful delegation to Japan and organised a series of initiatives on the sidelines of CPhI Japan. Starting with 5th IndiaJapan Pharmaceutical Seminar/Business Matching in Osaka recently, Brand India Pharma was represented by Indian pharma companies at various platforms. Suven Life Sciences, IndSwift Labs, Jubilant Life Sciences, Laurus Labs, Aurobindo Pharma, Vimta Labs and Simpex Pharma participated under the Brand India

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Pharma campaign. The seminar and B2B meetings in Osaka were organised in association with Osaka Prefectural Government, Osaka Industrial Promotion Organization, Indian Drug Manufacturers Association (IDMA) and Osaka Pharmaceutical Manufacturers Association (OPMA). Brand India Pharma also made an impacting presence at CPhI Japan which was held from April 22-24, 2015. CPhI Japan was inaugurated at the Big Sight Exhibition Centre in Tokyo, Japan. Amit Kumar, Deputy Chief of Mission, Embassy of India in Japan, co-inaugurated the event. Around 42 companies participated from

India at CPhI Japan. The IndiaJapan Pharma Summit organised on the sidelines of CPhI Japan in Tokyo attracted strong participation from the Japanese pharma industry. With about 280 registered visitors and panelists from the Department of Commerce, Government of India, Pharmexcil, Ministry of Health, Labour & Welfare, Government of Japan, Reva Pharmachem, Aurobindo Pharma, Mitsubishi Tanabe Pharma Corporation, PMDA, Meiji Seika Pharma, EISAI, Mitsubishi Tanabe Pharma Corporation and Meiji Seika Pharma, the India-Japan Pharma Summit was a successful forum.

Pharmexcil awarded Japanese companies like Eisai, Meiji Seika Pharma, Mitsubishi Tanabe, Shionogi & Co for their efforts in the Indian pharma industry. Pharmexcil also partnered with UBM, the organiser of CPhI Japan, for the CPhI Japan 2015 reception. “We are working with a three-pronged approach in Japan – to boost API exports from India, promote generics from India and position India as a contract manufacturing destination under direct supervision from Japanese companies,” said Dr PV Appaji, Director General, Pharmexcil. EP News Bureau-Mumbai

Wockhardt recalls 12 drugs in US made at two India units WOCKHARDT has decided to voluntarily recall all the remaining batches of 12-15 products that were manufactured in the Chikalthana and Waluj facilities prior to the import alert imposed by the US Food and Drug Administration (US FDA) recently. Wockhardt said this was a measure of preparedness and abundant precaution and there is no evidence of risk to patient safety from these products that are currently available in the US market. “Our main objective was to get back to normalcy faster,” said Habil Khorakiwala, Founder Chairman, Wockhardt. Khorakiwala had said during the last inspection the US FDA had inquired about products that were already in the US market, but had not directed the company to withdraw these products from the market. “We were looking at the work load involved to deal with this and the time it may take. After the last visit, we evaluated all this, and we thought it would be more prudent to just take a voluntary recall decision across all the products which were there (in the market) before the alert,” Khorakiwala added. He also said that Wockhardt did not expect a very significant financial impact arising out of the recall of these product batches from the US market. On March 18, Wockhardt had informed the BSE about US FDA’s follow-up inspection of the Chikalthana facility. Wockhardt had said the US FDA found the company’s quality and manufacturing system satisfactory, but had put forth certain observations on Form 483 pertaining to review of products manufactured before implementation of the GMP remediation programme. EP News Bureau-Mumbai

MARKET

US FDApublic meeting on June 15 on reauthorisation of GDUFA FDA has invited public suggestions on the GDUFA programme and the features FDA should propose for the next programme FDA WILL hold a public meeting on June 15 to seek input on the reauthorisation of the Generic Drug User Fee Amendments of 2012 (GDUFA) as the legislative authority for GDUFA expires at the end of September 2017. At that time, new legislation will be required for FDA to continue to collect generic drug user fees for future fiscal years. A release from the FDA invites public comment on the GDUFA programme and to provide suggestions regarding the features FDA should propose for the next GDUFA programme, especially on the assessment of the overall performance of the GDUFA programme to date and aspects of GDUFA that should be retained, changed, or discontinued to further strengthen and improve the programme. FDA will consider written comments received to the public docket up to 30 days after the public meeting and will publish the comments on FDA’s website. The comment period to the public docket is currently open and will remain open until July 15, 2015. For registrations, information needs to be emailed to GenericDrugPolicy@fda.hhs.g ov by June 1, 2015. EP News Bureau-Mumbai

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NPPAthreatens action against companies yet to register in IPDMS More than half of top 100 pharma companies yet to register Usha Sharma Mumbai INDIA’S DRUG price watch dog National Pharmaceutical Pricing Authority (NPPA) has issued a notice to all pharma associations warning that it will be constrained to take ‘appropriate action’ against their member companies who have yet to register in the Integrated Pharmaceutical Database Management System (IPDMS). Since NPPA will be launching this system shortly, it has urged the associations to ‘impress upon their member companies to register themselves with the IPDMS immediately.’ According to the notice dated May 1, of the top 100 pharma companies, 59 companies have not yet registered with the system. NPPA has alerted to take appropriate actions against non-registered pharma companies under the provisions of DPCO 2013 read along with the Essential Commodities Act, 1955. NPPA in collaboration with

the National Informatics Centre, had developed the Ingredient Pharmaceutical Data Base Management System (IPDBMS), which aims at facilitating online submission of mandatory returns/reports under the DPCO, 2013 by manufacturers, including companies which make, import and market drugs for distribution or sale in the country. NPPA has requested all manufacturers to register themselves and complete registration formalities, which include company details, head office/corporate office address, contact person details, product source details and product details. According to the NPPA website, about 300 pharma companies have already registered with the IPDMS, covering more than 20, 000 formulation packs. The list of 59 pharma companies which have not registered includes Dr Reddy’s Laboratories, Cadila Pharma, Mankind Pharma, MSD Pharmaceutical, Ranbaxy Laboratories, Cipla, USV, Wockhardt among others.

Commenting on the recent notice issued by the NPPA, Daara Patel, Secretary General, Indian Drug Manufactures Association (IDMA) said, “After the recent notice issued by the NPPA, today, we will be writing a letter to all our members asking them to comply with the NPPA order and register their companies accordingly. ” SV Veerramani, President, IDMA expressed, “IDMA appreciates the overall move of NPPA to bring in uniformity and compliance of the data to be provided by the industry. But, there have been some concerns like absence of provision to make any modification or addition in the submitted data, submission of production capacity and duplication of data for the same products from the manufacturer as well as marketer (if they are different).” Patel elaborated, “There is also a concern regarding Loan License business, whether the contract manufacturer or the brand owner has to submit the data for the particular product.

Also if part of the data has been missed out there is no provision to include or make changes and the company has to resubmit the entire data, which should be relooked seriously by NPPA.” While raising concerns of the SSI players, Veerramani mentioned, “We also submitted that the SSI manufacturers without adequate technical manpower may find it difficult to provide the data online. We have also attended the meetings convened by NPPA regarding IPDMS.” Patel also informed that the IDMA had made two representations to the NPPA last year (on October 10 and December 30) concerning this issue. During the meetings, there were discussions on issues related to uploading of product details through Excel sheets and implementations of e-filing of data etc by pharma companies on IPDMS. Ranjana Smetacek, Director General, Organisation of Pharmaceutical Producers of India (OPPI) said, “We have also received the communication from

the NPPA and have forwarded it to all our members. We are hoping that they will handle it on their own, as we won’t be able to track individual companies’ adherence to it.” As per the IPDMS, pharma manufacturers have register online which has been initiated by the NPPA. The initial target date for implementation of the system was by October last year. Veerramani informed, “While NPPA have made the production capacity details optional, and also assured to make suitable modifications subsequently for changes if any, the operational problems need to be fully sorted out.” Despite the extension of the time limit by the NPPA, many pharma companies have not registered themselves with the IPDMS system. NPPA has already provided the user ID and password to the registered companies to make online submission of data as required under the provisions of DPCO, 2013. u.sharma@expressindia.com

US FDA nod for generics of Abilify To market generic aripiprazole in multiple strengths and dosage forms to treat mental disorders THE US Food and Drug Administration has approved the first generic versions of Abilify (aripiprazole). Generic aripiprazole is an atypical antipsychotic drug approved to treat schizophrenia and bipolar disorder. Alembic Pharmaceuticals, Hetero Labs, Teva Pharmaceuticals and Torrent Pharmaceuticals have received FDA approval to market generic aripiprazole

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in multiple strengths and dosage forms. “Having access to treatments is important for patients with long-term health conditions,” said John Peters, Acting Director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research. “Healthcare professionals and consumers can be assured that FDA-approved generic drugs

have met the same rigorous standards as the brand-name drug,” he added. Schizophrenia is a chronic, severe and disabling brain disorder. Symptoms of schizophrenia include hearing voices, believing other people are reading their minds or controlling thoughts and being suspicious or withdrawn. Bipolar disorder, also known

as manic-depressive illness, is another brain disorder that causes unusual shifts in mood, energy, activity levels and the ability to carry out day-to-day tasks. The symptoms of bipolar disorder include alternating periods of depression and irritable mood, increased activity and restlessness, racing thoughts, talking fast, impulsive behaviour and a decreased need for sleep.

All atypical antipsychotics contain a boxed warning alerting healthcare professionals about an increased risk of death associated with the off-label use of these drugs to treat behavioural problems in older people with dementia-related psychosis. No drug in this class is approved to treat patients with dementia-related psychosis. EP News Bureau-Mumbai

MARKET

Rusan Pharma launches first ‘Made in India’NRTpatch 2baconil Designed for humid climates; to co-partner with Brazilian govt in early May Usha Sharma Mumbai IN LINE with the ‘Make in India’ campaign, Mumbai-based pharmaceutical company, Rusan Pharma, has launched nicotine patch 2baconil in the Indian market and is looking for a public private partnership (PPP) with the Government of India. The promoters indicated that the company is already in discussion with government agencies from the US, Europe and Mauritius. The company is to partner with the Brazilian government

for 2baconil in early May and will transfer the technology to them five years down the line. Dr Navin Saxena, Chairman, Rusan Pharma said, “After the announcement of ‘Make in India’ campaign by Prime Minister Narendra Modi, we decided to manufacture nicotine patch 2baconil in India from our Uttarakhand facility and then export it. This is the first product which has been launched by an Indian company using its own technology.” The company’s newly

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launched product 2baconil patches is a new form of nicotine replacement therapy (NRT) which is now available in India for patients seeking treatment for tobacco de-addiction. Though available as an over-the counter (OTC) product, patients below 18 years will need to seek a doctor’s advice. Dr Kunal Saxena, Managing Director, Rusan Pharma said, “Patients using NRTproducts reported that the patch often fell off /got displaced due to the high humidity. 2baconil and has been manufactured keeping in mind

South Asian climatic conditions such as humidity.” The company has made various representations to the Ministry of Health and Family Welfare of India. Saxena revealed, “The National Tobacco Control Program (NTCP) formulated in 2008-11, in their treatment guidelines had included nicotine patches, but had also mentioned non-availability at the point of time. Available as an OTC product now, 2baconil solves this problem, even as the NTCP has stated that new guidelines are to be expected soon.”

Kunal Saxena informs, “Since the NTCP is a national programme, we have initiated discussions with several states across the North East and Karnataka in the south.” Commenting on the company’s future plans, Navin Saxena says, “We will set up a centre of excellence research in Kandla, which will be known as Navin Saxena Research and Technology (NSRT). We will focus both on emerging as well as BRICS markets.” u.sharma@expressindia.com

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MARKET PRE EVENT

CPhI to conduct 3 Annual Pharma Project Management Conference rd

To focus on addressing challenges faced by project managers while handling projects in complex environments CPHI WILL conduct its 3rd Annual Pharma Project Management Conference, on June 29 and 30, 2015 in Mumbai. It will focus on addressing challenges faced by project managers while handling projects in complex environment and gaining practical insights on quality and timely de-

livery of projects. Topics which will be discussed during the conference are discovering various practical tools to manage the portfolio by efficient project prioritisation to explore the significance of portfolio management, determining risk management practices and

focusing on systematic approach in handling risks to avoid future contingencies, bridging cultural gaps in projects and showcasing issues that can be caused by misunderstandings of cultural differences, setting up of PMO as a means of providing strategic and tactical leadership for improving

consistency, transparency and effectiveness of project management process. The conference has had more than 150+ delegates from companies like Agila, Alkem Laboratories, Astra Zeneca, Aurobindo, Biocon, Biological E, Cipla, Dishman Pharmaceuti-

cals, Dr Reddys Labs, Emcure, Famy Care, Fresenius Kabi Oncology, Glatt, Glenmark, IPCA Laboratories, Jubilant Life Sciences, Kinapse, KPMG, Laila Nutraceuticals, MacChem Products, Merck, Mylan, Piramal Health Care, RPG Life Sciences, Sanofi, Shasun Pharmaceuticals, Sun Pharma, Teva, The Himalaya Drug Company, Torrent Pharma and many more. EP News Bureau-Mumbai

POST EVENTS

Basic science research to be the thrust area of Modi Government Vardhan asks scientists at IACS to accept new challenges DR HARSH Vardhan, Union Minister for Science and Technology, said that Narendra Modi government is firmly committed to improving the state of science research in India. According to a PIB release, addressing scientists and scholars at the Indian Association for the Cultivation of the Sciences (IACS) in Kolkata recently, Vardhan said, “Being a man of medicine and having toured most of the famous science institutions of the world over the past three decades, I am aware of the paucity of facilities and incentives for carrying out research in cutting-edge science.” Vardhan said that basic science research in the country will be a thrust area of this government. The founding

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vision of the country was the attainment of self-sufficiency and the capacity to chart its own course of development. Somehow we lost our way. Now, through ‘Make in India,’ Modi wishes to rejuvenate that search. He called for a paradigm shift, which gives more power and autonomy to young scientists. There are many good and sincere scientists in India whose interests are not motivated by awards and recognition. He said that scientific progress of the country is the result of the efforts of these people, though limited resources have strained their efforts. Remarking on IACS’s history, he pointed out that limited resources had not prevented

Calls for a paradigm shift, which gives more power and autonomy to young scientists Acharya Jagadish Chandra Bose, Dr CV Raman, Acharya Prafulla Chandra Ray, Dr SN Bose and others from carrying out pioneering research in this very city under colonial rule. “The Prime Minister and I consider it unacceptable that prior to independence we could produce great scientists in India, but after that only from the US. Therefore this government wants the centre of excellences in India to perform

better,” he said. Speaking on renewable energy, he noted with satisfaction that a lot of good work has been initiated in the Energy Research Unit of IACS. “The prime minister has set a target for generation of 100 gigawatt of solar power by 2022. As the Minister for Science and Technology, it is my responsibility to galvanise the entire scientific community to accept the challenge and prevent a ‘free’ source of power from becoming costly for the common man,” he said. He said that it was thanks to his friendship with a Kolkatabased scientist on renewable energy, Dr SP Gonchaudhury, that New Delhi’s prestigious All India Institute of Medical Sciences (AIIMS) would soon be generating solar power for its own needs. “I have also taken up a project to install solar-power fu-

elled lights, fans and intelligent flushes in all the public toilets in my constituency – Chandni Chowk. Thanks to the advice given by Gonchaudhury, this is working out cheaper than the thermal power option. I am sure that in the near future solar power will be free for the consumer,” said Vardhan. Speaking on genomics, Vardhan said that the importance of basic sciences, which is the thrust area of IACS, cannot be overestimated in the 21st century. He said, “Being a doctor I know the need for higher and higher achievements in anatomy, physiology, bacteriology, pathology and biochemistry as these are fundamental to the study of medicine.” He pointed out that cloud-based Genome Analysis Service, DNA editing and other developments has placed a tremendous pressure on society. EP News Bureau-Mumbai

MARKET

IDMAorganises FICCI-HADSA workshop on Laboratory nutraceuticals Data Integrityin Mumbai conference held in Mumbai More than 150 participants from different pharma companies participated Usha Sharma Mumbai INDIAN DRUG Manufacturers’ Association (IDMA) recently organised a day-long workshop on 'Laboratory Data Integrity' in Mumbai. The conference provided information on detailed quality parameters required in a laboratory data management system. Daara B Patel, Secretary – General, IDMA delivered the welcome address. He said, “Data Integrity is today one of the most crucial problems being faced by most pharmaceutical companies and it is well demonstrated by the number of registrations we have received.” Speaking about the urgency of such workshop, Patel continued, “Most of the warning letters issued to different pharma companies in the recent past were on laboratory data integrity. The main focus of data integrity is on the QC department where a huge amount of data is handled. A lot of electronic data is generated during analysis as evidence to compliance to product specifications.” Dr K Bangarurajan, Deputy Drugs Controller General (I), CDSCO was the chief guest of the event. He informed about the new Foreign Trade Policy 2015-2020 and the changes applicable to it. He also stressed on the importance of laboratory data integrity management and on why Indian pharma companies should make a habit to follow the required process. As per information provided by the organisers, there were more than 150 participants from different pharma

The conference provided information on detailed quality parameters required in a laboratory data management system companies. R Raghunandan, Pharma Consultant, Former Vice President – Quality South Asia, GSK, AV Jayakumar, Vice President, - Corporate Quality, Ajanta Pharma, Sathya Sekhar Surabhi, Chief Executive Officer and President, Caliber Infosolutions, Sudesh Shetty, Director, Ernst and Young and T Lakshman Murthy, Senior GMP Auditor, USP India delivered presentations on different topics and informed the participants on how to tackle issues related to laboratory data integrity issues in the pharma industry. Raghunandan emphasised that presented data to regulatory authorities should always be original. He pointed out that unless we report we are not going to improve and honesty is our most precious output. “Whatever you realise during a research work do report on that don’t make a mistake of fudging a falsify data,” he said. “Today the industry is facing one amongst the various challenges is that laboratory equipment are not updated,” he added. Jayakumar mentioned that most of the data integrity problem today happens in pharma companies because of minimised use of chromatography applications. He also talked about the importance of

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ultra pure water for buffer preparation as de-ionised water many contain some organic compounds that can affect companies’ HPLCs performance. “So, I ask all the participants to request your companies’ management to have an ultra pure water system in place for a better outcome,” added Jayakumar. Surabhi explained various parameters and procedures that need to be followed for better laboratory integration management within the laboratory and outside it. Shetty highlighted the steps that pharma companies' management need to follow. He briefed, “After receiving 483s or warning letters, most pharma companies have started firing the person responsible for it instead of training them. These people join another company with the same set of skills and knowledge and are bound to repeat the same mistake which they had done in their previous job. So companies are not resolving issues from the industry completely, in fact it is passed on to another. Management needs to train their staff efficiently instead of asking people to leave the organisation.” The workshop ended with a panel discussion. u.sharma@expressindia.com

Delegates discuss India's potential in nutraceuticals at the event in Mumbai

FICCI-HADSA 6 th Annual Nutraceuticals Conference recently took place in Mumbai. Subhash Desai, Industry Minister, Maharashtra inaugurated the conference which was jointly organised by Federation of Indian Chambers of Commerce and Industry (FICCI) and Health Foods And Dietary Supplements Association (HADSA). Manoj Patodia, EC Member, FICCI-MSC and Vice Chairman and MD, Prime Urban Development, delivered the welcome address and Dr Vaibhav Kulkarni, Co-chair, FICCI-MSC Task Force on Nutraceutical and Treasurer, HADSA, proposed a vote of thanks. A knowledge paper on ‘Make in India – Nutraceutical Opportunities’, prepared by FICCI and its knowledge partner SynCore, was released at the inaugural function. A white paper on ‘Balancing Malnutrition Factors’ was also released on the occasion. Desai, spoke about the impact that the country’s ‘Make in India’ campaign is having on industries and investors all over the world. “The world is really interested to set up units in India. It is our duty to see that this does not remain a dream but transforms into reality,” he said. He added, “Indian phar-

maceuticals have created impact globally. We export generic medicines to different parts of the world. When the world is getting treated with Indian medicines, why cannot that happen with nutraceuticals?” He was of the opinion that the nutraceutical industry has great opportunities in Maharashtra, since there are pharma industries everywhere. Desai even talked about the necessity of the nutraceutical clusters in the state. Roopwant Singh, Managing Director, iNDEXTb (Gujarat), said, “Globally nutraceutical business is going to be worth $241 billion in the coming five years. As the number of senior citizens rises, the demand is likely to go up.” He disclosed that India corners just around two per cent of the global trade; hence there is huge potential in this sector in the country. Ric Hobby, President, HADSA, described India as a “strong and vibrant country.” He observed that today there is no part of the world that does not look at India. “What they see is a land of enormous opportunities and enormous challenges.” The conference included plenary sessions on various themes pertaining to the nutraceuticals industry. EP News Bureau-Mumbai

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MARKET

Boosting APIs and exports rd take top priority at 3 iPhex 2015 Govt officials promote India as ‘Healthcare provider to the world’ Policies in the pipeline

Viveka Roychowdhury & Usha Sharma THE THIRD edition of iPhex 2015, promoted by the Pharmaceutical Exports Promotion Council of India (Pharmexcil), Ministry of Commerce & Industry, Govt of India, kicked off successfully in Mumbai. The show has attracted global drug regulators, pharmaceutical as well as machinery manufacturers. Explaining the rationale and focus of the event, Rajeev Kher, Secretary, Department of Commerce said that this year there is a concerted effort to promote India, not just as the ‘Pharmacy of the world’ but as the ‘Healthcare provider to the world’. He revealed that ministry officials have visited various countries in the past few months to promote India’s capabilities in medical devices, healthcare services and pharma machineries, in addition to the country’s proven expertise in pharmaceuticals. He also mentioned that Indian pharma exports have improved in the last one year. India exports $15 billion worth medicines, of which more than 55 per cent were to regulated markets. The US with 28 per cent is the India’s largest pharma export destination followed by the European Union. He made the point that these figures indicate that Indian medicines have established themselves as affordable and reliable across the world.

Push for APIs Hansraj Gangaram Ahir, Minister of Chemicals and Fertiliser, Chief Guest inaugurated the three-day long event. Commenting on the performance of the Indian pharma industry and its sizeable contribution to GDP, he said that we export nearly 50 per cent

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Minister for Chemicals and Fertilizer, Hansraj Gangaram Ahir and Minister for Food, Civil Supplies & Consumer Protection Girish Bapat lighting the lamp at the inaugural function of iPHEX 2015 event

of production to over 200 countries and with the Prime Minister’s support, this can go up to even 75 per cent. Taking a dig at the coal mining industry and the recent travails facing that sector, he said, “While other industries take (natural resources) from India, the pharma industry has consistently made (medicines) for India,” earning a round of applause from the audience. Realising the urgency of need for the country to make sufficient quantities of active pharmaceutical ingredients (APIs), he requested bulk drug manufacturers to become self reliant and focus on API manufacture. He also disclosed that the Telangana government has helped create Bulk Drug Park with the intention to promote and scale up production of bulk drugs and APIs the industry. Kher later indicated that the ministry plans to set up at least four to five such mega bulk drug/API parks and is scouting for suitable locations across India.

He lamented that even though the industry has the skills and talent, 60-70 per cent alumni from reputed institutes like NIPER Mohali opt to go abroad. He also pointed out that the pharma industry in India always had the talent and capabilities, but had not been able to capitalise on it and retain skilled professionals in India. As a result, Indian pharma professionals are helping developed countries develop drugs for their needs, rather than for the country.

Pitch for Maharashtra Dr Harshdeep Kamble, Commissioner, FDA Maharashtra said, “In step with Prime Minister Narendra Modi’s ‘Make in India’ initiative, Chief Minister Devendra Fadnavis will soon be launching the ‘Make in Maharashtra’ programme. Since Maharashta has the maximum number of US FDA approved manufacturing facilities, we are planning to have two-day pharma conclave as part of this

launch programme.” Emphasising the state’s preeminent position in the pharma industry, Girish Bapat, Food, Civil Supplies and Consumer Protection made the point that Maharashtra accounts for 60 per cent of the domestic market and as much as 23 per cent of the country’s pharma exports. But he also cautioned that the state government is firm that the pharma sector should remember that it is not just another business and cannot ignore its social responsibilities. Pitching Maharashtra as a preferred business destination, he appealed to global pharma manufacturers to increase their business activities with the state. “Our approach is constructive. We have taken steps to increase ease of doing business. As a minister of Maharashtra state, I assure the industry of all support.” He also projected that the state is targeting to register a growth of 10-12 per cent from the domestic market in the current fiscal itself.

Dr GN Singh, DCG(I) said that his office has taken several steps towards increasing the ease of regulation to create a more conducive business environment. The results will be seen in a few years, when the regulatory mechanism will go completely paperless while still retaining the stringency levels required.” Sudhanshu Pandey, Joint Secretary, Dept of Commerce, Government of India made the point that the focus has been on the quality since the last two years. Referring to the challenges faced by the Indian pharma industry in the recent past, he said most of these cases were related to data integrity and faulty documentation procedures rather than actual to quality issues. He said that the ministry had organised several workshops with global regulators and quality consultants to make Indian pharma companies realise the importance of demonstrating and documenting evidence of quality in addition to making quality products. Ashutosh Gupta, Chairman, Pharmexcil said that the industry feels the new positivity, thanks to support from Kher and his ministry. They are confident of converting challenges into opportunities and opportunities into gain. Over the next three days, the organisers of the show are expecting to host over 20,000 potential buyers including 450 overseas buyers from 90 countries at the exhibition. Over 40 drug regulators will be attending the event from 15-20 countries. The event is co-located with PHARMA Pro&Pack Expo 2015, a show for pharma machinery manufacturers. viveka.r@expressindia.com u.sharma@expressindia.com

EVENT BRIEF SEPTEMBER - 2015 2

PharmaLytica 2015

Pharmac India 2015

common platform and contributed substantially towards the growth of the industry. Pharmac India 2015 is

jointly organised by Orbit Exhibitions and Indian Drug Manufacturersâ&#x20AC;&#x2122; Association (IDMA-GSB). The media partner for the event is

Express Pharma. Contact details Orbit Exhibitions Address: 103, Navyug Industrial Estate,

TJ Road, Sewri (W), Mumbai - 400 015 Tel:+91 (22) 2410 2801/2/3 +91 (22) 6728 2400 Email:info@pharmacindia.com

PHARMALYTICA 2015 Date: September 2 and 3, 2015 Venue: HITEX Exhibition Centre, Hyderabad Summary: PharmaLytica conference is a knowledge forum and important industry gathering where an entire range of topics in analytical, outsourcing, laboratory, scientific and biotechnology sector will be discussed. Decision makers and professionals from analytical / contract services, analytical development heads, outsourcing department heads, R&D heads, clinical trials and research associates, laboratory heads / technicians, quality control and quality assurance heads, formulations development, business development heads and production and purchase heads are likely to attend the event. Contact details Jayesh Kanaskar Project Head E: jayesh.kanaskar@ubm.com T: +91 22 61727162 M: +91 9819586780

PHARMAC INDIA 2015 Date: September 2 and 3, 2015 Venue: Gujarat University Exhibition Hall, Ahmedabad Summary: Pharmac India is fifth international pharma machinery, equipment, bulk drugs, api, pharma lab, pharma pack and material exhibition in India. It has successfully brought together manufacturers and buyers on a

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www.merckmillipore.com

cover )

MANKIND'S

NEXT FORCE RC Juneja's Mankind Pharma ranks fifth in India's pharma market but can he take it beyond flagship brand Manforce? BY SHALINI GUPTA

20 EXPRESS PHARMA May 16-31, 2015

(

THE MAIN FOCUS

There are certain patented molecules that we cannot launch in India without the consent of MNCs, so we are seeking tie-ups to facilitate that process RC JUNEJA

ankind Pharma began almost 20 years ago with marketing at its core, sourcing medicines and selling them primarily in tier II and III cities. Though this model was not practised then, its success story was reason enough for its competitors who had not looked at the immense potential of rural and semi-urban areas, to follow suit years later. The company known for its OTC sexual wellness products, particularly 'Manforce' which is a ` 350 crore brand today, has exhibited phenomenal growth with revenues to the tune of ` 3000 plus crore in FY2014-15, up from ` 3.7 crore in FY1995-96. For the month ending March 2015, the company ranked fourth by value and fifth by revenue as per IMS Health Market reflection report. The coming years will see it getting even bigger, if trends are to be believed.

Not just OTC According to IMS Health, top 30 pharmaceutical companies in India are looking at nutraceuticals as an avenue for future growth. Not only is this is a reflection of an increased awareness of health and well being among Indians, it also a result of higher disposable incomes and the willingness to spend on dietary supplements as is evident by sites such as healthkart.com. Mankind Pharma too does not want to remain far behind. It aims to increase its revenues from nutraceuticals to ` 500 crore (from ` 300 crore) by end 2015

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adding them to the pipeline of chronic cardiovascular diseases and diabetic management drugs. Pitches in Sheetal Arora, Managing Director, Mankind Pharma, “In the the last few years, the acute segment, including antibiotics has done well, but now the focus is shifting to lifestyle diseases, and this segment has been a major contributor to our revenues in the last five years. The future is nutraceuticals.” The chronic segment contributed just 0.5 per cent of the revenues before the company shifted base to Delhi in 2002 when the first drug for high blood pressure was launched. This was followed with drugs for diabetes, asthma, neurology and psychiatry disorders. 80 per cent of the products launched in the last two years have been in this category and he believes growth will come in the next two years. The segment grew in the range of 80-100 per cent over the last year and currently contributes approximately nine per cent to the revenues. His enthusiasm is matched by Arjun Juneja, Director of Operations, Mankind Pharma, who believes that with India home to a huge diabetic population that is growing exponentially every year, the market for nutritional supplements for pre-diabetics is also set to increase and presents a tremendous scope. “We launched multivitamin supplement HealthOk in the market last year which is almost a ` 75 crore brand by this year. I count it as our breakthrough in nutraceuticals,” he reaffirms. He is of the opinion that the Indian nutraceuticals

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cover ) We entered SriLanka three years back and have been aggressively entering foreign markets since the past two years Sheetal Arora, Managing Director, Mankind Pharma

The basic idea when we started our R&D centre was to develop complex molecules such as new chemical entities, (NCEs) Arjun Arora Director of Operations, Mankind Pharma

market is evolving, guidelines and regulatory framework will be critical to its growth. “I don't see the industry going down anytime in the future,” he stresses. Even as regulations in India are evolving, Arora believes that emerging countries including India have immense potential that needs to be tapped. He particularly cites the example of Myanmar and Kenya. OTC currently constitutes 10 per cent of the company’s revenues with seven to eight products in the market, with plans to introduce one to two products every year. Arora adds that most of the products in the acute segment antibiotics, antifungals etc are in demand with me-too brands launched by the company as well. Cardio and diabetes management together contribute 15-18 per cent of their revenues and they hope to gain another two per cent on this in the coming years. However, for the the future, he sees growth coming from niche brands in the gynaecology, cosmetics and OTC segment. There'll be a renewed focus on healthcare oriented OTC products such as Prega News, Manforce and Unwanted 72, well known brands from the company which together make eight per cent of the revenue. Adds Arjun Juneja, “Immediate expansion would be in the infertility segment which is catching up with the increase in the number of IVF clinics. The drugs are in the development phase and should hit the market in another three months.”

Multi-pronged approach

We expect ` 75-100 crores of our revenues in 2016-17 to come from APIs RC Juneja Founder and Chairman and Managing Director, Mankind Pharma

22 EXPRESS PHARMA May 16-31, 2015

Mankind Pharma has traditionally been a domestic company with more than 90 per cent of the revenues coming from domestic sales. Exports comprise a measly one per cent of the company revenues. “We entered Sri Lanka three years back and have been aggressively entering foreign markets since the past two years. We hope to generate revenues of ` 150 - 200 crores from exports in the

next three years,” Arora says emphatically. However, today it has established its presence in 15 countries including Africa, CIS and South-East Asia. Most of these markets are non regulated or semiregulated markets. The company is aggressively looking at increasing its share of exports in the coming few years. Exports to African countries started last year and it is now selling drugs in Tanzania, Kenya, Zambia, Uganda and Ethiopia. Regulated markets are also on the radar in the next two to three years. Expanding its domestic footprint is not far on the agenda. With close to a 1000 products across 14 segments and a strong hold on marketing, the company is well positioned as a potential partner for MNCs looking at launching their products in the Indian market. Thus it is only a matter of time when the right opportunity arrives. “There are certain patented molecules that we cannot launch in India without the consent of MNCs, so we are seeking tie-ups to facil-

itate that process,” clarifies Founder and Chairman and Managing Director, RC Juneja. It has also been reported that local companies with niche focus are much sought after with a view to further increase its reach, with upto ` 500 crore earmarked for the same. There were also reports of private equity fund ChrysCapital Investment Advisors India looking to sell its stake in the company. While there haven’t been plausible developments to this effect, Mankind Pharma has definitely created a buzz both among investors and local pharma companies alike. While it explores newer markets as well as expands its domestic reach, efforts are on on the R&D front too. The company invests five per cent of its revenues in R&D and has invested ` 150 crores this year. Elaborates Arjun Juneja, “The basic idea when we started our R&D centre was to develop complex molecules such as new chemical entities, (NCEs). In the last two-three

years, we have made considerable progress. Dydrogesterone, is a hormonal steroid that is only made by Abbott in the entire world. There has been no generic company that has been able to make this so far, however we have been able to crack it about a year back and are still in the process of doing the clinical studies etc We hope to launch it in the market by the end of this year, this would be one major breakthrough.” The R&D division involves formulation development, product development, new entities development and a biotechnology R&D centre set up 30 kms away from Manesar. He informs that the scientific team is also working on new drug delivery systems (NDDS), as well as NCEs especially in the field of diabetes. “There are a lot of gliptins (DPP4 inhibitors) that have come in the market for diabetes treatment, we are working on another concept which is similar to this, but is a novel molecule,” he adds. Work on biosimilars is also underway. “Biosimilars is an $80 billion dollar market poised to grow further. Biotechnology and biosimilars is where the the future of pharmaceutical research is. We have started our research on biosimilars and maybe in the next three to four years, we'll be able to launch two to three biosimilars,” he says confidently.

The road ahead The company which started with 40 medical representatives, is gearing up towards an ambitious future by adding to its field strength which is close to 11,000 now. Of this, 1000 were added in 2014-15 and this number would be increased further on. Pitches in founder Juneja, “We have increased our field strength dramatically, we need to do that to increase coverage.” Known for its reverse approach, stationing its medical representatives in the areas surrounding Delhi in its formative years, Mankind Pharma

( now is looking at greater reach in the metros. 60 per cent of its revenues still come from tier-II, tier-III cities, but the management hopes that in the near future it'll come more from metros, with tier-I cities becoming metros and tier-II becoming tier-I. Two new API manufacturing facilities are also coming up in Rajasthan, one in Udaipur and the other in Sotanala, near Jaipur which will be established in another one and a half years. “In a small two-acre plant, we are putting up Rs 50 crores and we'll start production in September this year. We expect ` 75-100 crores of our revenues in 2016-17 to come from APIs. We will try to manufacture all those molecules that we import from China and other countries at lower prices here,” elaborates Juneja senior. This puts the number of manufacturing facilities to 15 including three facilities in Paonta Sahib, of which one is under expansion. Arjun Juneja says that the products manufactured in API units will be developed at the R&D centre. Majority of them would be used inhouse, as well as reduce the cost of APIs to reduce cost of formulations. The founder that he is looking at revenues of ` 4200 crores in the coming year. So can companies today afford to be in a niche segment and survive or do they need to expand their product basket? Juneja senior’s answers this with foresight. “It is a double edged sword. We have to expand our product basket in view of the increasing competition, to ensure our existence in the market and consistent growth. The market is much more dynamic today,” he says. He rules out the thought of the company coming up with an IPO anytime in the future. Affordability has been at the centre of Mankind Pharma's strategy with most of their brands being 35-40 per cent less than the competitors. Branded generics are coming up, although Mankind Pharma is not into it. The future looks promising for the company which seems

EXPRESS PHARMA

May 16-31, 2015

to be sharpening its claws to face the future in a dynamic industry such as pharma. There is no one approach, it realises, even as it hangs onto its traditional practices while keeping a

close eye on the future. So while brands like Manforce, PregaNews and Unwanted72 will continue to fetch revenues, investments in R&D will ensure that it is able to leverage the

THE MAIN FOCUS

next frontiers in biotechnology to meet the demands of the future. Marketing has been its forte from the beginning, however, the plunge into novel products reveals a desire to

much more than just a marketing company, it is heading towards innovation. This would be interesting to watch as it unfolds in the future. shalini.g@expessindia.com

MANAGEMENT

DRUG PRICE RISE

AN EFFICACIOUS MOVE? National Pharmaceutical Pricing Authority (NPPA) has allowed pharma companies to increase the prices of 509 essential medicines in tune with an increase in the wholesale price index (WPI). Industry stakeholders are optimistic about the move though some still feel it is not enough BY USHA SHARMA

24 EXPRESS PHARMA May 16-31, 2015

Government on their part, can help the patients by abolishing VAT and excise duty on essential medicines. A stronger drug procurement system in public health delivery would also go a long way Shobha Mishra Ghosh Senior Director, FICCI-Industry’s Voice for Policy Change

ince the establishment of the concept of 'essential medicines' by the World Health Organization (WHO), it has evolved and matured into a critically important element of national health system policies and practices. Essential medicines are those that satisfy the priority healthcare needs of the population, according to International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). They are selected with due regard to public health relevance, evidence of efficacy and safety, and comparative cost-effectiveness. IFPMA states that ‘As the WHO moves toward a revision of the model Essential Medicines List (EML), it is timely to revisit the evolution of the list since 1977 and its use across a range of countries.’ According to a PTI report, recently, the Indian government also allowed pharmaceutical companies to increase prices of 509 essential medicines by 3.84 per cent with effect from April 2015. These medicines are used for treating various ailments like diabetes, hepatitis and cancer. Shobha Mishra Ghosh, Senior Director, FICCI (Industry’s Voice for Policy Change) says, “As per National Pharmaceutical Pricing Policy 2011 duly discussed with Group of Ministers (GoMs) and approved by the Cab-

inet, there is a clear cut provision of an annual increase of National List of Essential Medicines (NLEM) drugs as per the Wholesale Price Index (WPI) as notified by the Department of Industrial Policy and Promotion (DIPP): Government of India. It is proposed that companies shall be allowed to revise the NLEM drug prices up to the limit of the increase in the WPI for the previous year.” Ranjana Smetacek, Director General, Organisation of Pharmaceutical Producers of India (OPPI) too agrees and says, “DPCO 2013 categorically lays down the guidelines for price revision, saying manufacturers can increase maximum retail price (MRP) of scheduled formulations once a year, in April, on the basis of the WPI of the preceding calendar year. Accordingly, the National Pharmaceutical Pricing Authority (NPPA) list has revised ceiling prices, taking into account the WPI for the preceding calendar year.” Recently, IMS Institute for Healthcare Informatics has released a report titled, ‘Understanding the role and use of Essential Medicines Lists,’ which mentions that as the movement toward universal health coverage strengthens, so does the role of essential medicines as a key part of bringing to all people the health services they need without suffering financial hardship when paying for them.

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May 16-31, 2015

MANAGEMENT

DPCO 2013 categorically lays down the guidelines for price revision, saying manuf acturers can increase MRP of scheduled formulations once a year, in April Ranjana Smetacek Director General, OPPI

Many people who are below poverty line cannot even afford low price medicines and they will require free medicines. The increase in price is an option, given to the manufacturers SV Veerramani President, IDMA

It is fair to increase the ceiling price of essential drugs by annual increase in WPI Anay Shukla Member, Pharma and Healthcare Practice, Nishith Desai Associates

26 EXPRESS PHARMA May 16-31, 2015

The National Pharmaceutical Pricing Authority (NPPA) has recently issued a memo on the WPI increase for the preceding year 2014. The memorandum mentions that as confirmed by the Economic Adviser (Ministry of Commerce and Industry) the annual increase in the WPI works out to 3.84 per cent during the calender year 2014 over the corresponding period in 2013. Ever since the announcement became public, there has been a debate on, how the government will make drugs affordable and reachable to end consumers? Dr Milind Antani, Legal and Tax Counselling Worldwide, Nishith Desai Associates replies cautiously, “We believe that the increase in the ceiling price of essential drugs as per annual increase in WPI is fair. This move by the government should not affect the government’s push for affordable healthcare as the increase in WPI usually also corresponds to the increase in purchasing power of the consumers.” SV Veerramani, President, IDMA justifies the medicine price hike and says, “This increase is given to the manufacturers for taking care of the inflatory cost and increase in the cost of operations, overheads, manpower, etc. Hence, it is fully justified. While manufacturing drugs, the inflatory cost need to be taken into consideration, otherwise, manufacturing will become non-viable. This small increase of 3.84 per cent is not going to impact government’s push for affordable healthcare.” Anay Shukla, Member, Pharma and Healthcare Practice, Nishith Desai Associates, agrees with the pattern of increasing medicines price based on WPI, “The annual increase in WPI indicates the increase in price of a basket of commodities over the span of one year. It is, therefore, a reliable estimate of the year-on-year increase in cost of raw materials required to manufacture essential drugs. A pharma manufacturer must be allowed to

The prices of 509 medicines which have increased from its existing range includes alpha interferon injection which is used to treat hepatitis B and C as well as certain types of cancer, carboplatin injection used for cancer treatment and fluconazole capsules indicated for fungal infections, among others pass-on the increase in cost of raw materials required to manufacture essential drugs. A pharma manufacturer must be allowed to pass-on the increase in cost of raw material to the retail price, otherwise it will not be financially viable from business perspective. Thus, it is fair to increase the ceiling price of essential drugs by annual increase in WPI.” Besides policy makers, corporates, regulators, legal firm, research analyst firm also keep their watch on pharma activities as it is linked to market volatility. Avinash Lodha Associate Director - India Ratings & Research, a Fitch Group Company feels, “We believe that by implementing the provisions of DPCO in a timely manner, the government has now moved to ensure that the policy is implemented in its entirety. This is a good move and will also ensure affordability of life saving drugs which is maintained in the long run."

For betterment World Health Organisation states that essential medicines are intended to be available within the context of functioning health systems at all times, in adequate amounts, in appropriate dosage forms, with assured quality and adequate information, and at a price the individual and the community

can afford. The concept of essential medicines was pioneered by the WHO in 1977 with the introduction of the first essential medicines list (EML). The list has been revised every two years since then. As per the information available in the public domain, the prices of 509 medicines which have increased from its existing range includes alpha interferon injection which is used to treat hepatitis B and C as well as certain types of cancer, carboplatin injection used for cancer treatment and fluconazole capsules indicated for fungal infections, among others. Dr Gopakumar Nair, Chief Executive Officer, Gopakumar Nair Associates expresses, “Nation and national interests are paramount. Patients and public interests including affordable access is important within the national interest umbrella.” Commenting on the affordability aspect, Lodha says, “India Ratings believes that the issue of affordability was addressed while applying the cap on the NLEM listed drugs. With the price-caps, the government’s objective of removing wide disparity in retail prices of essential drugs was served and substantial drug price cuts were achieved.”

Hindrances Nair reaffirms the industry's dilemma and notes,

“India is acknowledged globally as the country producing lowest priced medicines. The hyperactive NGOs and civil society has been doing immense harm and damage to the Indian pharma industry’s innovative research efforts and activities by misguiding Supreme Court and other courts of India in areas like clinical trials, price control and related issues. Extreme activism in price control on drugs, such as recently practised by NPPA, has been detrimental to the much needed pharma research efforts, which is highly essential to upgrade Indian pharma globally from a pure generic manufacturer to innovative dosage form and new chemical entities (NCE) developing and inventing manufacturers. This route is being blocked for Indian pharma by the apparently wellmeaning but in practice, illmeaning relevant departments and ministries. They are hand in glove with the NGOs and civil societies whose only single-minded focus is to keep reducing the already low drug prices in India.”

Use of WHO model EML and implementation by National Health Systems According to WHO, lists of essential medicines also guide the procurement and supply of medicines in the public sector, schemes that reimburse medicine costs, medicine donations and local medicine production. IMS Institute for Healthcare Informatics in the report 'Understanding the Role and Use of Essential Medicines Lists' mentions that it is a cost-effective means of providing guidance toward safe, effective treatment for the majority of communicable and non-communicable diseases. Nearly all developing countries (95 per cent) have a published national EML, of which 86 per cent have been updated in the past five years. Some countries also adopt EMLs at a sub-national or state/province

MANAGEMENT

Nation and national interests are paramount. Patients and public interests including affordable access is important within the national interest umbrella Dr Gopakumar Nair Chief Executive Officer, Gopakumar Nair Associates

level depending on regional requirements and priority health needs. A few developed countries formally use the WHO model EML as guidance in the development and implementation of their pharma policy. While the WHO model EML serves as a guide for the development of national and institutional EMLs, the final list is decided based on regional factors such as patterns of prevalent diseases; availability of medicines, treatment facilities and personnel; affordability; and genetic, demographic, and, environmental factors. Standard treatment guidelines, national expenditure on essential medicines, and procurement practices are some of the factors ensuring optimum utilisation of the national EML. Relevant regional treatment practices also need to be considered. For example, in China where traditional medicine is widely practised, a separate medicines list is published to address this area. The report also says that changes in the structure of the list and categorisation of drugs are the most commonly seen modifications for adaptation at the national level. For example, the WHO EML includes anti-diabetic agents such as insulin and metformin in the category “Medicines Used for Diabetics,” while na-

The concept of essential medicines was pioneered by the WHO in 1977 with the introduction of the first essential medicines list (EML). The list has been revised every two years since then tional lists for India and China include it under “Hormones, Other Endocrine Medicines and Contraceptives” and “Hormones and Endocrinal Agents” respectively. Particularly, in India the important objective of policy is to maintain availability of drugs. It is to encourage availability that the DPCO allows manufacturers to maintain their viability. When the government is working on various programmes to make healthcare better accessible and reachable to the Indian population at affordable prices, NPPA’s recent memorandum of allowing pharma companies to increase medicine prices of 509 drugs by 3.84 per cent could raise doubts among consumers. Veerramani says, “Many people who are below the poverty line cannot even af-

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ford low priced medicines and they require free medicines. The increase in price is an option, given to the manufacturers. But, the manufacturers may not take this increase if their current prices are workable.” While commenting on the affordability part, Nair comments, “Affordability to travel is a two-sided coin. Affordability for manufacturers to make the drug is equally important as the affordable access. Access-less status, where drug is not available, in the market does not facilitate affordability.” Mishra-Ghosh avers, “If manufacturers are not allowed to cover increases in costs and increase in inflation, the industry will find manufacturing of these drugs a nonviable proposition. This is bound to cause more harm

than benefit to the patients.” She continues, “When prices are allowed to be increased only to the extent of increase in inflation (WPI), the manufacturers experience little, if any real revenue growth. There is invariably an increase in cost of raw materials, packaging materials, transportation and ever evolving regulations on quality standards and so forth. Salary payouts are traditionally always higher than increase in WPI.” Nair says, “While India’s exports to Rest of World countries can grow by leaps and bounds, the overseas clients do benchmark export price negotiations based on domestic prices.” Mishra Ghosh suggests, “The government on its part can help the patients by abolishing VAT and excise duty on essential medicines. A stronger drug procurement system in public health delivery would also go a long way.” Since the present government had given health priority status in their manifesto, they are duly bound to find different avenues to make healthcare affordable to the Indian population. But this cannot be at the cost of burdening pharma companies. u.sharma@expressindia.com

This move should not affect the government’s push for affordable healthcare Dr Milind Antani Legal and Tax Counselling Worldwide, Nishith Desai Associates

We believe that the issue of affordability was addressed while applying the cap on the NLEM listed drugs Avinash Lodha Associate Director - India Ratings & Research, a Fitch Group Company

EXPRESS PHARMA

May 16-31, 2015

RESEARCH RESEARCH UPDATES

Measles vaccine thwarts other infectious diseases: Study The research focused on a phenomenon called ‘immune amnesia’ in which the measles infection destroys cells in the immune system THE MEASLES vaccine provides benefits beyond merely protecting against that highly contagious viral respiratory disease that remains a leading childhood killer in parts of the world, scientists say. By blocking the measles infection, the vaccine prevents measles-induced immune system damage that makes children much more vulnerable to numerous other infectious diseases for two to three years, a study published found. The research focused on a phenomenon called ‘immune amnesia’ in which the measles infection destroys cells in the immune system, the body’s natural defense against disease-causing microbes, that ‘remember’ how to fend off previously encountered

pathogens. Prior research had suggested ‘immune amnesia’ lasted a month or two. The new study, based on decades of childhood health data from the US, Denmark, England and Wales, showed the measles-induced immune damage persisted on average for 28 months. During that period, children who got measles were more likely to die from other infections due to the long-lasting depletion of immune memory cells caused by the virus. “The work demonstrates that measles may have longterm insidious immunologic effects on the immune system that place children at risk for years following infection,” said Princeton University infectious disease immunologist

The study, based on decades of childhood health data from the US, Denmark, England and Wales, showed that measles-induced immune damage persisted on average for 28 months and epidemiologist Michael Mina, whose study appears in the journal Science. “The work also demonstrates that, in these highly developed countries prior to the introduction of measles vaccine, measles may have been implicated in over 50 per cent of all childhood infectious dis-

ease deaths.” The study comes amid rising concern among public health leaders about parents who refuse to get their children vaccinated for measles, based on discredited claims about the vaccine’s safety or for religious and other reasons. Measles was declared elim-

inated in the US in 2000, but increasing numbers of cases have been reported in recent years as more people remain unvaccinated. Last year’s 668 US measles cases were the most since 1994, the Centers for Disease Control and Prevention said. The study showed preventing measles through vaccination lowered childhood deaths from pathogens that cause conditions like pneumonia, sepsis, bronchitis, bronchiolitis and diarrheal diseases. The World Health Organization said vaccination drove a 75 per cent drop in measles deaths from 2000-2013 globally, but there were still about 145,000 measles deaths in 2013. Reuters

New screening method may identify more ovarian cancers While the results are promising, the study’s lead author said it's too soon to use the new screening method in general practice 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

28 EXPRESS PHARMA May 16-31, 2015

the neurodegenerative disease, also known as Lou Gehrig’s Disease, which has severely 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 dispense 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 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. Reuters

Safety switches may aid CAR Tcancer therapies Approval of new therapies to combat blood cancers not expected for another three or four years NEW THERAPIES that clinical data show can eliminate blood cancers such as leukemia and lymphoma in 40 per cent to 90 per cent of patients may have to be genetically modified to include a switch that shields healthy cells from attack. The therapies could generate tens of billions of dollars in annual sales for drugmakers including Kite Pharma and Juno Therapeutics Inc, once they are approved. The therapies involve using what are known as CAR T cells, which are white blood cells taken from the body and genetically modified to have

the cancer-spotting traits of antibodies. These cells can circulate inside a person for years, even a lifetime, relentlessly seeking out cancerous growth. But a third of the patients in some trials given CAR T cells have developed lifethreatening fevers and inflammation. Doctors say the reason is that the modified T cells cause inflammation because they kill so many cancer cells so quickly. Another concern is that when the therapies are eventually targeted at solid tumors such as lung or kidney cancer, they could also attack healthy cells containing the

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same protein that's the target of the anti-cancer therapy. As a result, some drugmakers are building in ‘switches’ to suppress CAR T cells if serious side effects emerge, or to make them self-destruct if they attack healthy tissue, according to company executives. The switches involve an additional receptor on the CAR T cell that can be controlled by giving the patient a second medication, such as the widely-used cancer drug Rituxan. The so-called suicide switches being developed for CAR T cells are a refinement of the body’s own natural

process of apoptosis, by which defective or unneeded cells are programmed to selfdestruct. Approval of the new therapies to combat blood cancers are not expected for perhaps another three or four years, analysts said. Approval for therapies to fight solid tumours will take years longer, they said. Intrexon Corp and Cellectis SA are among the leading switch makers and could become acquisition targets or licensing partners for drugmakers that need their technology, according to analysts. Bellicum Pharmaceuticals

and Cellectis have their own pipeline of switches and experimental CAR T cells. Intrexon has given Ziopharm Oncology exclusive oncology rights to its switches. Juno has built safety switches into at least two therapies, including JCAR014 for patients with advanced leukemias. Kite has decided against using suicide switches until it better understands how its CAR T cells work in patients. Other major players, including Bluebird Bio and Swiss drugmakerNovartis AG, have not disclosed their plans. Reuters

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May 16-31, 2015

RESEARCH

Drug target for Ebolalike viruses identified Effective treatments such as vaccines and drug therapies are not available for many of these infections RESEARCH PUBLISHED IN the journal PNAS reveals that scientists have discovered a potential mechanism to combat diseases caused by haemorrhagic fever viruses such as Ebola. These diseases present a dramatic risk to human health as they often spread quickly and kill a high percentage of infected individuals, as demonstrated by the recent Ebola outbreaks, researchers said. Effective treatments such as vaccines and drug therapies are not available for many of these infec-

like the Rift Valley fever virus will help inspire additional research and eventually lead to the development of new therapeutic strategies to treat these deadly tropical infections," said Cyr. Researchers used Nuclear Magnetic Resonance (NMR) spectroscopy studies to investigate the structural properties of an important viral protein required for virulence of the Rift Valley fever virus, a virus that causes infections in both humans and livestock similar to the Ebola virus.

Viral proteins such as the non-structural protein (NSs) studied in the research bind to the transcription machinery of human cells via the p62 subunit of the TFIIH protein complex, which leads to the formation of nuclear filaments that are essential for propagation of the virus tions since the outbreaks mostly occur in developing countries with limited financial resources. Moreover, the genomes of many haemorrhagic fever viruses mutate rapidly, enabling them to quickly adapt to potential drug treatments and evade the immune system. "Although our work does not directly lead to treatments on a short term, it does identify a process where the virus could be vulnerable to drug therapy, or how we might design an attenuated viral strain for vaccine development," said first author Normand Cyr, a postdoctoral researcher at the University of Montreal. "Identification of the Achilles heels of haemorrhagic fever viruses

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May 16-31, 2015

PHARMA ALLY

PIC/S

GETTING ACLEARER PICTURE 32 EXPRESS PHARMA May 16-31, 2015

The Commerce Ministry will soon take a call on whether Indian pharma companies should join pharma regulator Pharmaceutical Inspection Co-operation Scheme (PIC/S) or not. Joining PIC/S will endorse Indian pharma companies as reliable exporters of quality medicines. However, meeting PIC/S' regulatory requirements is not going to be a cakewalk, especially for companies in the MSME pharma segment, who will have to invest to upgrade their facilities. Therefore convincing the apprehensive players is going to be an uphill task for the Ministry as well as industry organisations representing them. GMP trainers and regulatory experts are also crucial as they will have to train and prepare pharma companies and their personnel to upgrade to PIC/S' expectations. Joining PIC/S is therefore a challenging task for all stake holders but there is consensus that not joining PIC/S will create bigger hurdles. PIC/S should thus be seen as a huge leap towards global acceptance. If the Indian pharma industry wants to be global, it needs to think global. Pharma operators, industry organisations, regulators, GMP trainers give their opinion on this issue BY SACHIN JAGDALE

AJAZ S HUSSAIN INSIGHT ADVICE AND SOLUTIONS LLC, FREDERICK, MARYLAND, US

he process of becoming a member of PIC/S (accession) can be a long and tedious, it can take up to a maximum of six years. Going through this process forces a re-examination of the current regulatory system, how is it organised or should be organised; what are the conflict of interests and how these are addressed, inspectional procedures, etc. Preparing for the accession will force certain improvements in India’s GMP inspection system and procedures as well as improve its emphasis on Quality System requirements. These efforts also help to improve harmonisation and efficiency. According to the information on the PIC/S website (29 April 2015) the following applicants are being considered Brazil/ANVISA, Croatia/HALMED, HongKong SAR/PPBHK, Iran/MoH, Mexico/COFEPRIS, Philip-

pines/PFDA, Thailand/Thai FDA, and Turkey/TMMDA. And, the pre-accession process is ongoing for Belarus/MoH, Chile/ISP, and Kazakhstan/ CCMPA. Quoting Mahatma Gandhi, “We but mirror the world. All the tendencies present in the outer world are to be found in the world of our body. If we could change ourselves, the tendencies in the world would also change. As a man changes his own nature, so does the attitude of the world change towards him. This is the divine mystery supreme. A wonderful thing it is and the source of our happiness. We need not wait to see what others do.” India need not to wait to see what others do – the reason for submitting India’s regulatory system to the scrutiny of an International Standard such as PIC/S should be for the right reasons – our families and their

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well-being in India. India has emerged as a ‘power-house’ of pharma manufacturing and a recognised supplier of affordable medicines around the globe. She aspires to be “pharmacy to the world”. To be legitimate in this claim India must have one quality standard for both, the domestic and the export market. Maintaining two different quality standards – a lower standard for domestic vs a higher standard for export markets (e.g., countries members of PIC/S) is not acceptable on any grounds. It is now the right time to provide our own families in India with medicines made to the same standards as the ones we export to US or Europe or Estonia, or Indonesia (all PIC/S members). Maintaining two different standards, I believe, is proving to be more costly (in terms of money, credibility and peace of mind) than having one

– internationally recognised (or peer reviewed by other ‘competent authorities’ ) – standards. This is an opportunity for the Indian pharma sector to establish itself as reliable drug supplier in India and abroad. To be successful, plan each step carefully – let not internal misalignment add to a difficult ac-

cession process. Do it for the right reasons – our families in India who deserve assurance of quality, safety and efficacy. This journey can also provide India with time to reflect and to position other indigenous medical paradigms (e.g., Ayurveda) more appropriately in the overall healthcare system.

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May 16-31, 2015

PHARMA ALLY

SANTOSH SAVARKAR ASSOCIATE VICE PRESIDENT – REGULATORY AFFAIRS, ALEMBIC PHARMACEUTICALS “There is nothing wrong with change...If it is in the right direction.” - Winston Churchill

harmaceutical Inspection Convention was established by European Free Trade Association in October 1970. At that time, it was titled as a legal treaty or the Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products. It was started with 10 members. Then, subsequently, expanded to include other eight members till 1993. In 90s, it was realised that convention, being legal treaty had limitations to add more members and expand further. Hence, in November 1995, Pharmaceutical Inspection Co-operation Scheme PIC/S was formed. PIC and PIC scheme are floated in parallel, PIC as a treaty with legal binding within limited original members. PIC scheme with similar aim and mission with an informal arrangement and no legal bindings. PIC/S is among the health and medicines control agencies for information sharing and exchange.

The aim of PIC/S is global harmonization of health and regulatory inspection procedures by establishing common standards in the field of GMP and by providing training opportunities to inspectors. It also aims at facilitating co-operation and networking between competent authorities, regional and international organisations, to enhance mutual confidence. Till date, there are 46 members of PIC/S with almost all major health agencies of developed nations already being members or willing to be member. Now, Indian government started thinking to be an applicant for PIC/S membership. It's great news. The Indian pharma industry is well aware of international GMP standards for medicine manufacturing. I think, 70 per cent of the Indian pharma manufacturers from various parts of India are regularly getting inspected as per PIC/S GMP standards and accepted for the systems and procedures followed in manufacturing and supply of medicines, active ingredients, pharma excipients and medical devices.

But, if one can see at Indian health and regulatory systems. I think change, improvement and up-gradation is necessary there. Hence, PIC/S accession is a good initiative by the Indian Government. I think, this can give us an opportunity to meet the expectations of global health agencies. With increasing globalisation of pharma manufacturing, this will have great importance and create huge opportunities for Indian pharma manufacturers. During 40th anniversary of PIC/S on May 31, 2011, USFDA commissioner, Margaret Hamburg mentioned. “Today, PIC/S is more important than ever, given the realities of globalisation.” For those willing to be part of PIC/S she further shared FDA’s experience of PIC/S accession…. “For those, who are considering becoming members of PIC/S, I want to share with you a little about FDA’s experience. Becoming a member of PIC/S was a long road for us. Our application was distinct because FDA is a very large organisation. Though not always easy, the PIC/S application

process helped FDA to mature as an organisation. The process required us to engage in rigorous self-examination. We improved our quality systems, focused on gaps in our regulatory processes, and became more cohesive internally.” For US FDA, if it was a long road then for Indian FDA; I think it is going to be definitely uphill task. But, from Indian manufacturers and industry perspective I think Indian government should take this challenge head-on to meet PIC/S requirements. As PIC/S acces-

sion takes three to four years from pre-accession application time, there will be time for small and medium manufacturers to upgrade their facilities to meet PIC/S GMP standards. This will help them to be competitive player in the global business. With PIC/S accession, Indian FDA’s GMP regulations shall become globally acceptable. I think Indian government should definitely go ahead; Indian drug industry shall wholeheartedly support the mission.

DR PV APPAJI DIRECTOR GENERAL, PHARMEXCIL

would like to say that, as per directions of the Commerce Ministry, Pharmexcil has sponsored a study on this subject to IMS India. The draft report of IMS India was discussed on 27 April, 2015 in the Ministry of Commerce & Industry. All government agencies like DoP, MoH, DCGI and

34 EXPRESS PHARMA May 16-31, 2015

national associations like IPA, IDMA, Pharmexcil have participated in the discussion. It is generally felt that while the approach to join PIC/s is good in the interest of nation and particularly Indian exports, a careful examination is needed and if decided to implement, adequate time (five to 10 years)

and adequate financial support to pharma companies at affordable cost should be provided by the government. The whole subject is at a preliminary stage and we are hopeful that the government will take appropriate decision with full involvement of pharma industry from all sectors.

PHARMA ALLY

PRASHANT NAGRE CEO, FERMENTA BIOTECH

n her speech given during the 40th anniversary of the international GMP inspectorate scheme addressing a gathering of regulators in Geneva in 2011, the then US FDA commissioner Margaret Hamburg had put forward a very pertinent point stating that no one country is capable of inspecting the world on its own. Due to increasing pressure of operating costs, many manufacturers and distributors across the regulated markets have decided to relocate to countries with less active engagement in drug quality assurance. This fact, coupled with the realities of globalisation, has made it important for a lot of regulatory bodies across the globe to partner with PIC/S. The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (jointly referred to as PIC/S) are two international instruments between countries and pharma-

ceutical inspection authorities, which provide together an active and constructive cooperation in the field of GMP. The benefit of joining PIC/S is multi-fold for various stakeholders. For our regulators, it would range from giving our GMP inspectors a plethora of training and skill development initiatives to opening opportunities to play a pivotal role in developing and harmonising international GMP guides and guidelines. Moreover, the PIC/S is a costsaving measure for the competent authority as they do not have to rely on sending their inspectors abroad, but can rely, if they wish, on other regulators' reports. For a country which is home to about 10,500 manufacturing units and over 3,000 pharma companies, this partnership does make sense. The very fact that India's pharma exports stood at $15 billion in 2013-14 coupled with an impressive CAGR of 21 per cent

over the last decade further reinforces the industry’s commitment towards abiding to global GMP requirements. India being accredited with almost 1,105 CEPs, more than 950 TGA approvals and 584 sites registered by the USFDA leaves no doubt that our pharma industry will definitely be benefitted by partnering with PIC/S. For the industry at large the major benefits would be reduced duplication of inspections. This in addition to export facilitation and enhanced market access to other member nations will bring in a positive change. Partnering with PIC/S will further enhance our image in the global regulatory community. Fermenta Biotech would welcome Government of India’s decision to become a member of PIC/S. This will bring in lot of value in terms of learning from such a diverse and large base of global regulators. I personally feel that

this will bring up the total cumulative learning and GMP understanding of our regulators which in turn will help us build up capabilities and processes to create much more robust GMP systems across all our units. In case of Fermenta, we do export to the regulated markets. Our plant is inspected by US FDA, our product has a CEP certification. Quality and

safety are the building blocks of Fermenta’s DNA and hence it is always of paramount importance to us. Needless to mention that we too would like to be aligned with our Government’s 'Pharma Vision 2020', which aims to make India a global leader in end-to-end drug manufacturing. Joining hands with PIC/S will take us closer to this goal.

S V VEERRAMANI PRESIDENT, INDIAN DRUG MANUFACTURERS’ ASSOCIATION (IDMA)

hile the pharma companies, already complying with USFDA, UKMHRA and EU Standards, can comply with PIC/S norms, a large number of SMEs are not yet ready. Many of them are Schedule M compliant and need to graduate themselves to WHO-GMP and PIC/S levels. The Pharma SMEs in India

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require funds for upgradation of their facility and equipment. We have sought Technical Upgradation fund from the government to help the SMEs graduate to WHO-GMP levels. The SMEs also require training on quality management systems, quality risk management, product quality review, stability studies and change control. IDMA is planning to conduct

training programmes all over India with the support of Department of Pharmaceuticals for SMEs in this regard. It may take three to five years for all SMEs to come to a level of WHO-GMP and PIC/S, provided they have given timely financial assistance and training. It may take another three to five years, to be accepted as a Member Country of PIC/S.

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PHARMA ALLY

RAJASHRI OJHA SURVASE MANAGING DIRECTOR, RAAJ GLOBAL PHARMA REGULATORY AFFAIRS CONSULTANTS (GPRAC)

oining the PIC/S forum will help the Indian pharma industry improve quality standards. It will help boost exports and strengthen India's credentials as amongst the best quality manufacturers of pharmaceuticals globally. It will help pharma companies to facilitate networking and confidencebuilding, to promote the quality of inspections and quality assurance of inspectorates, to coordinate training of inspectors, to provide a framework for the exchange of information and experience in GMP, and to enhance global harmonisation of GMP. It is going to impact Indian export growth as more and more countries are now looking for PIC/S compliance. India should join the league at the earliest. There is a need to har-

monise GMP inspection standards through the training of inspectors in developing countries to ascertain the quality of starting materials and manufactured pharmaceutical products and the PIC/S provides a platform for activities in this area.

Original goal ◗ PIC/S Goal “To lead the international development, implementation and maintenance of harmonised GMP standards and quality systems if inspectorates in the field of medicinal products”. ◗ Harmonised GMP requirements ◗ Mutual recognition of inspections ◗ Uniform inspection systems ◗ Training of Inspectors PIC/S is meant as an instrument to improve co-operation

in the field of Good Manufacturing Practices between regulatory authorities and the pharmaceutical industry mutual confidence. The PIC/S has been set up in order to provide, in the interest of public health, for the cooperation between pharma inspectorates with a view to ◗ fostering and maintaining mutual confidence; ◗ promoting quality management system for inspectorates and best practices and standards in the field of inspections; and ◗ contributing to global harmonisation of standards of good manufacturing practice (GMP) for medicinal products The Indian regulators should work towards making India a member of PIC/S within the agreed timeframe ◗ Developing and promoting

harmonised GMP standards and guidance documents. ◗ Training competent authorities, in particular GMP inspectors. ◗ Assessing (and reassessing) GMP Inspectorates. ◗ Facilitating the co-operation and networking for competent authorities and international organisations. Benefits of PIC/S Membership

◗ Accession forced improvements – i.e. discipline ◗ Cost saving – import control mechanism ◗ Facilitated exports of medicines ◗ Training (seminars, joint inspections, etc.) ◗ Involvement with developing international GMPs ◗ Facilitated MRA with EC ◗ Networking and personal contacts

DEEPALI CHILE CEO, BRASSICA PHARMA

ndian companies are not ready for PIC/S. Being ready for PIC/S means 100 per cent manufacturing units in India should follow GMP standards as a matter of regular practice and not only for audit. The concept of quality should percolate in every brain cell of all working in this industry. According to me, it is the mind set which needs a complete paradigm shift. It is true that the moment the companies resist, it will surely prove that they manufacture drugs of sub-standard quality. Rather, I would like to em-

36 EXPRESS PHARMA May 16-31, 2015

phasis that foreign regulators already believe that we are compromising a lot on quality. Indian pharma companies' action plan should be to invest in quality facility, quality machines, quality training and quality products in case it is made compulsory to join PIC/S. If business risk needs to be taken then it should be in making the mindset change and think like a regulated country. Once that is in place we can achieve it. We are talking of globalisation, it means uniformity across the world. In such a case, why will anyone allow disparity

in quality standards in medicines from India? There is absolutely no alternative to PIC/S or to follow GMP as in regulated markets. There are some countries, which are categorised as non-regulated markets. In the next four to five years, I can see harmonisation of quality systems worldwide and there will be nothing like nonregulated market. Non-regulated is, in other terms is considered quality compromised, and no one would like to take sub-standard drugs in their country.

PHARMA ALLY I N T E R V I E W

‘Schedulers Logistics has been built on ethos of providing value to customers’ Schedulers Logistics India is a recent entrant in the bio pharma space. In the last three months, the company provides its services to 10 customers ranging from blood plasma to vaccines to APIs to antibiotics. Akshay Sharma – Chief Operating Officer, Schedulers Logistics India shares the company’s plans with Usha Sharma

How big is the Indian pharmaceutical cold chain market and how fast is it growing annually? What is your projection from the current financial year? Indian pharmaceuticals market is dominated majorly by branded generics which constitute nearly 70 to 80 per cent of the market. The Indian

pharma industry is estimated to grow at 20 per cent compound annual growth rate (CAGR) over the next five years. Also, growing at an average rate of about 20 per cent, India's biotechnology industry comprising biopharma, bio-services, bioagriculture, bio-industry and bio-informatics may reach the

$7 billion mark by the end of FY15. Biopharma is the largest sector contributing about 62 per cent of the total revenue, with revenue generation to the tune of over ` 12,600 crores ($2.03 billion). The bio-pharma sector comprises vaccines, therapeutics and diagnostics. The Indian pharma cold chain market is evolving, and will

grow in the light of the above two industries growing. One could say that the market is evolving and hence it is little difficult to put in exact numbers. What per cent of the market share has been captured by the Schedulers Logistics and how do you plan to expand it

PHARMA ALLY

further? We are a recent entrant in the bio pharma space and in the last three months have signed and are servicing 10 customers ranging from blood plasma to vaccines to APIs to antibiotics. From the interaction we have had with the customers and market intelligence gathered from point of retail we shall be carving out “Schedulers+” with dedicated resources and people to serve the pharma space with a service span to cater from bulk movement to last mile delivery to retail outlet ensuring temperature adherence and visibility pan India. Our growth will be based on offering tailor made solutions ensuring adherence to GDP with visibility to customer. How much investment did Soros Economic Development Fund (SEDF) made in the company in July 2014, and currently what are the stake holding patterns? SEDF has committed ` 20 crores in four tranches of which we have received three. The stake is currently held equally between the promoters, tiger warehousing and SEDF. What services do you offer to the pharma sector and who are your major clients?

GDP is an important issue which needs to be addressed by Indian logistics player as most of the international cold chain operators working in India rely on local resources available in India and simply outsource the orders domestically Currently, we are offering transportation service between from the factory gates to the C&F location. This could be a truck load or load as low as 500 kg ensuring temperature adherence. In the near future we shall be offering multi temperature movements, multi temperature city distribution to ensure economies and end to end cold chain adherence. Is your service cost effective and how? Our costs are heavily optimised due to clever scheduling, reverse logistics and consolidation. However such costs are not at the expense of quality parameters in cold chain which is very essential to human life. Besides we are not willing to take short cuts and are digging in for the long term. Customers continue to find value in our service. The Indian pharma industry is facing quality issues in the

global pharma market, and regulators are trying to fix the gaps and supply chain players need to play an important role. How difficult and challenging it is for the logistic players? Good Distribution Practice (GDP) is an important issue which needs to be addressed by Indian logistics player as most of the international cold chain operators working in India for surface movement rely on local resources available in India and simply outsource the orders domestically. What a customer gets is only brand name without content. We at schedulers are working on developing a seamless chain from the manufacturing location to the point of retail ensuring temperature and time adherence ensuring online visibility. This means we need to enhance our capability to handle small quantities ensuring temperature sensitivity of the given drug.

What is the USP of Schedulers Logistics and tell us about the company’s business strategies? Schedulers Logistics has been built on the ethos of providing value to the customer through lean logistics for cost optimisation and business excellence. This has been the thought behind extending our reach to over 100+ towns that the customers can leverage on besides taking advantage of our less than container load offerings of as low as 500 kg, which in the coming days will be brought down to 10 kg. Schedulers is one of the few players operating in tier II & III towns in India that offers temperature-controlled loads as small as 500 kg. How relevant and useful it is in the pharma sector? Schedulers understand the sensitivity of the pharma sector. The consignments are compact and light but could be

very expensive and rare. It is not so much the bulk but the value of it as a life saving necessity. Hence care and quality is of utmost importance here. Schedulers Express LCL service ensures temperature adherence along with economies. The company offers services to food and pharma sector. Which sectors are money makers and how are you going to expand it further? Food and pharma sectors are both recession free to a large extent but then they are very price sensitive in nature due to direct impact on the consumers. Schedulers has always taken care to understand these concerns and the service offerings are steady in their price points and heavily optimised. Our pricing mechanism is directly linked to input costs. This we share with our customers upfront and hence all their decisions are based on a value approach to cold chain management. We strongly believe is offering service delight and in near future we shall be playing a important role in giving reach to farmers and pharma manufacturers on pan India basis by innovative service offerings. 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.

38 EXPRESS PHARMA May 16-31, 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 VALUE ADD

Scale down — scale up of batch—semi batch ops using VisiMix Software Moshe Bentolila, Sales and Customer Support, VisiMix Software and Roberto Novoa, Sales and Customer Support, VisiMix Software show a method for 'Scale Down – Scale Up of Batch – Semi Batch' operations built under hydrodynamics study of the mixing procedure in the reactor system

Proposed method Process development at the chemical industry (pharmaceutical, API, food, fine chemicals, biotechnology among others) is performed in small glass reactors. From this lab small glass reactors experience is common to obtain kinetic constants and mixing effects. Akiti [2005] demonstrated the dissimilarity of these reactors since a small glass reactor is not an ideal reactor. Good data for scale up is obtained from the combination of the experimental data with the computation facilities. One of the first authors that thought about this concept was Eng. Berty. In his

LABORATORY

BENCH SCALE 1- 10 liter

PILOT SCALE 10-1000 liter

Final Design

Scale Down Build

A N A LY Z E

required to solve any topic like scale-up or even improve process that running regularly in the large scale. (Bentolila 2011). The company’s goal is to develop a method, based on calculated parameters that will run properly in the first trial on a new scale or site, similar to the successful results in the lab or in the old facility. The main parameters changed are the hydrodynamics of the system. If the company is able to identify and control these parameters, it will be able to achieve the available and optimal solution.

DESIGN

CHEMICAL PRODUCTION is a result of several chemical reactions and purification steps. Purification steps and processes yield are a direct function of the level of understanding of the reaction system. Reaction quality results have a tremendous impact in separation technology. Chemical production is frequently performed on stirred vessels that are operated at batch or semi-batch configuration. The choice process configuration is determined at the development stage of the project. Therefore, if the chemical reaction and mixing are not well understood, wrong selections will be adopted in the process development. Once the process (chemical, biological or physical) is known well, a common situation during the process transfer from lab to production or from site to site is the gap between the old and new results. If the hydrodynamics knowledge is integrated with the chemical phenomena, it will be possible to set up small and automatic equipment to prove the relationship between mixing and chemistry. In this way, it may be the first time that the process will be evaluated at large scale similar conditions. The main advantage of the methodology is the combination of neither realistic conditions in small equipment and of course catching the main normal gaps between the lab and the production results. The combination of equipment and calculation decrease drastically the experiments work

PLANT 1000 – 6000 liter Figure 1. Feedback loops in experiment-design-analysis cycles [Berty 1979]

paper he explained how the computation tools are more developed and the equipment and sensors are more exact. In this way he presented in his paper the follow flow chart, Figure1 and confirmed by Basu [1999] and Ka Ming Ng [2003]. The basic principle (Figure 1) is to collect data from bench scale equipment, exploit the data by designing commercial-scale process configuration (not for construction but for detailed critical analysis) using mathematical and computation knowledge. After few loops of bench scale experiments and design calculations it will be possible to scale up the designed plant to

pilot plant facilities and confirm the hybrid model-experimental data at plant facilities conditions. After the last critical step it will be possible to perform fine tuning and design the commercial process. Typical flow path for process development in companies are presented in the follow flow chart, Figure 2. In this pathway, a vast disconnection has been found between all the required knowledge to develop the process, including the communication between different departments in the company. Flow charts for the best organisation of scale up activities were presented for differ-

ent authors. Normally, all of them wrote in industrial journals. The common factor is to try to intensify the number of experiment requires for achieving a good knowledge of the process. Lastly, the scaledown concept is used in order to characterise the process in small scales. The main question is how after having a good understanding of the scale-down study, the authors continue to have a gap between lab results, pilot result and production results in the process. A well set up of lab equipment, based on the intrinsic change in the scale up activities will focus the best set of experiments to avoid this gap. Based on the Figure 1, the advised flow chart was despoiled in a completed method that contains the follow steps: ◗ Chemistry or biological mechanism of the process ◗ Design the future feasibility according to the business company plan ◗ Calculate by different simulations tools how will be the process in the commercial scale. ◗ Set the lab equipment in the possible scale that will provide the most approximate conditions that in the commercial production scale. ◗ Optimise the process based in the possible range work

Figure 2. Typical flow path for process development in companies LABORATORY (R&D)

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BENCH SCALE (MINI PILOT)

PILOT SCALE

DEMO – SIMULATION (CAPE)

PLANT Production

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May 16-31, 2015

PHARMA ALLY available in the commercial step ◗ Use the medium scale to verify your model. The company considers VisiMix the better simulation tool to estimate hydrodynamics characteristic parameters for batch and semi-batch process. Hence, the proposed method, that take into account upper six steps is like in general view which is shown in Figure 3. Thus Visimix is not just mixing, but the entire spectrum of mixing related phenomena Visimix represents the next generation of chemical engineering software. The mathe-

Figure 3

Once the Science of the process (Chemistry, Biology or physics) is known well: ● Process Transfer from Laboratory to Production ● Process Transfer from site to site

S CA L E

PRODUCTION

Final Design

VisiMix

D O W N

S C A L E

U P

LABORATORY (R&D)

matical models incorporated in Visimix creates a single system which allows for performing several steps of simulation. VisiMix is chosen one of 2014’s 20 most promising chemical technology solution provider that help customers in the chemical industry to optimise their technology investments and deploy new capabilities. For more information on VisiMix simulation software please contact Skytech systems Pvt Ltd, Thane at 022-41533326 or mail us at ankur.pandey @skytechindia,com

VENDOR NEWS

Waters introduces eDATA2.0 proficiency testing portal

Abbott and Sekisui collaborate

Streamlined reporting and empowering new tools to help quality assurance managers monitor and improve laboratory performance

To offer coagulation testing for laboratories worldwide

WATERS CORPORATION announced that ERA, a Waters business, introduced the new eDATA 2.0 Proficiency Testing (PT) portal enabling environmental laboratories to manage their proficiency testing data more efficiently and gain greater insight into their laboratory’s performance. The portal features new statistical analysis, data visualisation and reporting tools that give environmental lab managers the ability to track results over time, flag potential issues and take preventive steps before corrective action becomes necessary. “The new PT dashboard

ABBOTT AND Sekisui have signed an agreement to offer coagulation testing solutions for laboratories worldwide. Coagulation tests measure a person’s blood clotting ability, which can help doctors assess risks of excessive bleeding or developing clots. Under the agreement, Abbott will be the exclusive distributor of Sekisui’s new CP3000 coagulation instrument in the US, Europe and other regions that recognise CE Mark. Coagulation testing helps clinicians in assessing people before many medical treatments and in monitoring

40 EXPRESS PHARMA May 16-31, 2015

makes it easier and faster to manage PT studies and offers quality assurance professionals more options for analysing and interpreting data,” said Michael Yelle, Vice President Consumables Business Unit, Waters Division. “Moreover, eDATA allows us to better address the proficiency testing requirements of our international customers. ERA’s in-depth knowledge of major international accreditation and regulatory bodies enables us to expertly guide customers through the analytical challenges they face.” In a newly-published webinar, ERA’s proficiency testing

experts demonstrate the new features of eDATA 2.0 and the ease with which test results can be managed. Environmental laboratories are required to conduct periodic proficiency tests to maintain their accreditation. Proficiency tests measure a laboratory’s ability to generate high-quality, credible results for their clients. Laboratory managers use proficiency test data to assess their lab’s state of compliance with industry standards and identify areas for improvement in terms of productivity and efficiency. EP News Bureau-Mumbai

those who take medications that can affect clotting. It is also useful in the diagnosis of blood-related disorders, such as haemophilia (when blood does not clot normally) and thrombosis (formation of a clot that blocks blood flow). Sales of the CP3000 are expected to begin later this year in Europe, countries that recognise CE Mark and non-regulated countries, and in the US in 2016. Abbott will have non-exclusive distribution rights with Sekisui in China, Hong Kong, Japan and Macau. EP News Bureau-Mumbai

PHARMA ALLY

CFDAapproves Waters ACQUITY UPLC IClass IVD/Xevo TQ-S IVD System The system was approved for clinical analysis of a variety of compounds that include diagnostic indicators and compounds for treatment monitoring THE CHINESE Food and Drug Administration (CFDA) has approved the Waters ACQUITY UPLC I- Class IVD/Xevo TQ-S IVD System for in vitro diagnostic (IVD) use in China. The system was approved for clinical analysis for a variety of compounds that include diagnostic indicators and compounds for treatment monitoring. “The practice of medicine is changing from a reactive approach to treating disease,

to one that is more proactive and preventive,” said Jeff Mazzeo, Senior Director, Health Sciences for Waters Division. “To facilitate this transition, better diagnostic and predictive tools are needed so that disease can be detected earlier or even prevented. That is where Waters technologies like the ACQUITY TQD System and ACQUITY UPLC I-Class IVD/Xevo TQ-S IVD systems, approved for IVD use by the

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CFDA in 2014 and 2015, respectively, can make a significant impact.” Using LC-MS technology, clinical laboratories perform qualitative and quantitative analyses of patients’ samples to aid clinicians in many ways. These tests may be used to confirm a clinical suspicion (including making a diagnosis); assist in the selection, optimisation and monitoring of treatment; provide a prognosis; screen for disease in the

absence of clinical signs or symptoms; and establish and monitor the severity of physiological disturbance. Liquid chromatography separates analytes and interferents within a given sample, while mass spectrometry technology is used for detection and confirmation of those analytes. The recently CFDA approved ACQUITY UPLC IClass IVD/Xevo TQ-S IVD System features Waters' Ul-

traPerformance LC technology coupled with a tandem quadrupole mass spectrometer designed for the most demanding UPLC-MS/MS quantitative analysis. This system uses StepWave, a breakthrough off-axis ion source technology, and RADAR, an information rich acquisition method, enabling the system with sensitivity and robustness. EP News Bureau-Mumbai

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PHARMA ALLY POST EVENT

West Pharmaceutical Services discuss plans to introduce Daikyo Crystal Zenith product line in the coming months Hosts seminar to highlight benefits of CoP over glass Sachin Jagdale Ahmedabad WEST PHARMACEUTICAL Services recently organised a half-day seminar on 'Daikyo Crystal Zenith — The new life cycle solution for drug containment,' in Ahmedabad. The seminar was attended by potential clients from the pharma industry. West introduced Crystal Zenith (CZ) components, which are made of a proprietary cyclic olefin polymer (CoP), during the seminar. While the product is yet to be commercialised in the Indian market, a few pharma companies in India have bought these products for evaluation on a trial basis. The products are

manufactured by West’s partner Daikyo Seiko in Japan. During the event, Priyatanu Pathak, National Sales Manager, India, gave an overview of West Pharmaceutical Services. Kevin E Cancelliere, Director, PDS Marketing, informed the audience about the market trends in the injectables drug market. Kennedy Clarke, Sr Director, Business Development CZ Products, spoke about Crystal Zenith syringes; whereas Dr Nicolas Brandes, Business Development Manager, CZ Products, Europe, spoke on Crystal Zenith vials. Guest speaker, Dr Santhanakrishnan S, Sr Director - Global Complex Generics, Amneal Pharmaceuticals, made the comparison between glass and

CoP as packaging material in his presentation. “West is looking at opportunities for CZ in India across the product portfolio—including vials, syringes and cartridges,” said Cancelliere. He adds, “We think that our products have significant potential in important healthcare areas such as stem cell research, because of the extreme temperature requirements.” The pharma industry has traditionally used glass as a primary material for containment systems due to a variety of characteristics that enable a generally safe and efficient drug storage. However, there are many risks associated with glass, including breakage,

delamination, physical compatibility with the system components, chemical compatibility with the drug product (resulting in shifts in pH, reduced activity or potency, leachables or active formation of particles). On the other hand, the use of CZ may help overcome these risks. West offers a variety of containment options like Daikyo Crystal

PRODUCT

Thermo Scientific launches TSX ultra-low temperature freezer THE THERMO Scientific TSX ultra-low temperature freezer features natural refrigerants for lower environmental impact and higher cooling efficiency. Due to its intuitive design, the TSX freezer uses up to 50 per cent less energy than conventional refrigerant ultra-low freezers and delivers temperature uniformity that continuously adapts to a laboratory’s environment. Conventional ultra-low temperature freezers use single-speed compressors that continually cycle on and off, resulting in poor temperature recovery following door openings. The TSX ultra-low temperature freezer is the only freezer of its kind equipped with the unique V-Drive technology. When conditions are stable, the V-Drive is designed to operate at a low

42 EXPRESS PHARMA May 16-31, 2015

speed to reduce energy consumption while maintaining a uniform temperature. When dealing with frequent door openings or when samples are added to the freezer, the control system detects the activity and increases the drive speed to bring temperatures quickly back to the set point. The V-Drive also helps limit sound output to 46 db(A), making the TSX freezer up to 20 times quieter, comparable to a conventional refrigerator. For busy labs, the constant, disruptive noise created by compressors can compromise communications and create a less–than-ideal working environment. What’s more, the freezer utilises water-blown foam insulation, which eliminates the off-gassing typical of urethane-insulated freezers. Additional product features in-

clude a 600-box sample capacity to maximise storage within a 1.06m2 footprint, intuitive touch screen interface for access to vital freezer information, and on-board computer and USB port for data storage and exchange. Contact Meenal Malkar Sr Executive — MarCom Laboratory Solutions - India Thermo Fisher Scientific India 403-404, B-Wing, Delphi, Hiranandani Business Park, Powai Mumbai - 400 076, India Telephone : +91 22 6716 2200 Direct No: +91 22 6716 2259 Fax: +91 22 6716 2244 Toll Free No: 1800 22 8374 www.thermofisher.com or www.thermo.com

Zenith Vial and Syringe Systems, FluroTec barrier film, and NovaPure components. “As CZ is a premium product, pharma companies should consider the total cost of ownership evaluating CZ,” said Cancelliere. “That being said, West is sensitive to the pricing structure in the Indian market.” sachin.jagdale@expressindia.com

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Tel: +91-22-24166630 Fax: +91-22-2662776 E-mail: support@rosalina.in Web: www.rosalina.in 56

May 16-31, 2015

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BUSINESS AVENUES

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

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

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

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

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

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

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

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May 16-31, 2015

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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

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Business Avenues Please Contact: ■ Mumbai, Ahmedabad: Rajesh Bhatkal 09821313017 ■ Delhi: Ambuj Kumar 09999070900 ■ Chennai: Arun J 91-9940058412 ■ Bangalore: Khaja Ali 09741100008 ■ Hyderabad: Mujahid 09849039936 ■ Kolkata: Ajanta 09831182580 60

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PHARMA LIFE AWARDS

Aditi Kare Panandikar receives the Ohio State UniversityAward

Recognised for consistent efforts in quality enhancement

She received the award for her outstanding contribution to the pharma industry ADITI KARE Panandikar, Managing Director, Indoco Remedies received the 2015 Jack L Beal Post-baccalaureate Alumni Award from ‘The Ohio State University College of Pharmacy’ in US on April 28, 2015, for her outstanding contribution to the pharmaceutical industry. This award is presented to alumni of the college who have made outstanding contributions to the pharma sciences and the profession of

pharmacy. The committee concluded that Panandikar was an excellent choice to receive this award noting that since receiving her degree, she has distinguished herself in the pharma industry through her work. The committee also stated that she is a unique individual who is a credit to their programme in pharma administration and to the OSU College of Pharmacy. EP News Bureau-Mumbai

Aditi Kare Panandikar, Managing Director, Indoco Remedies and Dr Henry J Mann, Dean of the Ohio State University College of Pharmacy

Paul TAnastas awarded Emanuel Merck Lectureship 2015 The prize worth €10,000, was recently presented to Anastas at the Technical University (TU) Darmstadt during a special public lecture MERCK ANNOUNCED that the American chemist professor Paul T Anastas has been awarded this year's Emanuel Merck Lectureship. In the 1990s, Anastas coined the term 'green chemistry' and with it more sustainability-oriented chemical value chains. The prize worth €10,000, was recently presented to Anastas at the Technical University (TU) Darmstadt during a special public

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Jubilant Life Sciences conferred with Golden Peacock National QualityAward

lecture. Anastas' visionary idea was to observe the whole life cycle of chemicals and, building on this, develop the best, least harmful and safest manufacturing process. “With his twelve principles of green chemistry, Paul Anastas has shown us a modern form of chemistry, the most important pillar of which is the principle of sustainability. The chemical

and pharma industries will take these principles more strongly into account in the future. I am very pleased to award him the Emanuel Merck Lectureship, together with the Technical University of Darmstadt,” said Thomas Geelhaar, Chief Technology Officer Chemicals at Merck and President of the German Chemical Society. EP News Bureau-Mumbai

JUBILANT LIFE Sciences was recently conferred the ‘Golden Peacock National Quality Award-2015’ in Dubai. The main theme of the summit was ‘Leading 21st Century Organization through ICE'. The award was presented to Jubilant in the ‘Chemicals and Pharmaceutical category’ for consistent efforts in manufacturing quality products and continuously striving to bring quality improvements. Sheikh Nahyan bin Mubarak Al Nahyan, Minister of Culture, Youth and Community Development, Govt of UAE felicitated CB Bhardwaj, Senior Vice President – Manufacturing (Unit Head-Gajraula), Jubilant Life Sciences in the presence of Lt Gen JS Ahluwalia, PVSM (Retd), President, Institute of Directors, India, HE Hani Rashid Al Hamli, Secretary General, Dubai Economic Council, Ranjan Dhawan, Managing Director and Chief Executive Officer, Bank of Baroda, Justice (Dr) Arijit Pasayat, Co-Chairman, Institute of Directors and former Judge, Supreme Court of India, TP Seetharam, IFS Ambassador of India to United Arab Emirates, Mohammed Sharaf, Group Chief Executive Officer, DP World etc. Shyamsundar Bang, Executive Director – Manufacturing & Supply Chain, Jubilant Life Sciences said, “Manufacturing is the foundation of our business and we bring with ourselves a rich heritage of over 36 years. For the last two decades, Jubilant has produced products which are globally competitive, which means products meeting global quality standards and expectations of customers in different parts of the world. At Jubilant, we are committed to continuous improvement to make quality products at an affordable cost.” EP News Bureau-Mumbai

PHARMA LIFE

Kiran Mazumdar-Shaw ranked No.2 in Global ‘Medicine Maker Power List’2015 She is the only India-based business leader featuring on the list KIRAN MAZUMDAR-SHAW, Chairperson and Managing Director, Biocon, has been ranked No. 2 on ‘The Medicine Maker Power List’ 2015, an index of the 100 most influential people across the globe in the field of

medicine. Mazumdar-Shaw appears on the list alongside global leaders from the industry, including CEOs, professors, Nobel Prize winning researchers and many other celebrated scientists from the pharma world. The Top 5 on ‘The Medicine Maker Power List’ are Anthony Fauci, Director, National Institute of Allergy and Infectious Diseases, US, Kiran Mazumdar-Shaw, Chairperson and Managing Director, Biocon, Sir Andrew Witty, Chief Execu-

tive Officer, GlaxoSmithKline, Arthur D Levinson, Chief Executive Officer, Calico and Heather Bresch, Chief Executive Officer, Mylan. The list also includes names like Pascal Soriot, Chief Executive Officer, AstraZeneca; Robert A Bradway, Chairman and Chief Executive Officer, Amgen; Ian C Read, Chairman, Pfizer; Prof. Tyler Jacks, Koch Institute for Integrative Cancer Research; Prof Charles Cooney, Massachusetts Institute of Technology, US; Prof Harold

CAMPUS BEAT

He will take over the Chairmanship from Venu Srinivasan, who steered the workings of the Council since July 2011

specialised courses and workshops across the nation, carries out safety audits and

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EP News Bureau - Mumbai

COURSE

Satish Reddy appointed as Chairman of National Safety Council SATISH REDDY, Chairman, Dr Reddy’s Laboratories, has been appointed as the new Chairman of the National Safety Council (NSC). Reddy takes over the Chairmanship from Venu Srinivasan, who steered the workings of the Council since July 2011. The National Safety Council is the apex body set up by the Govt of India, Ministry of Labour and Employment, to generate, develop and sustain a voluntary movement on safety, health and environment at the national level. As a part of its mandate to make safety in India a way of life, the council conducts

Varmus, Weil Cornell Medical College and many more. Mazumdar- Shaw is the only India-based business leader featuring on the list. The Medicine Maker is a UK-based publication that is distributed worldwide to a targeted European and North American industry professionals. The power list has been compiled from reader nominations with the help of expert judges and is based entirely on merit.

risk assessments, facilitates awareness camps in organisations and so on. On his appointment Reddy said, “It is an honour and privilege to be nominated as the Chairman of the National Safety Council. The apex body has been doing commendable work since its inception. I look forward to working with my fellow council members in carrying forward key initiatives on health, safety and environment. Safety continues to be a critical factor in contributing to India’s positive growth trajectory.” EP News Bureau - Mumbai

CII launches online certification courses on IPR The courses will be run under the guidance of eminent personalities from industry and academia CONFEDERATION OF Indian Industry (CII) recently launched a series of online certification courses on Intellectual Property Rights (IPR) under the aegis of its Intellectual Property Education Initiative (CII – IPEI). With an aim to develop a skilled and literate IP workforce for the Indian industry, CII has tied up with leading agencies and experts in this domain to devise courses meeting the requirements of industry. The CII-IPEI was launched by NN Prasad, Asst Director General and Chief of Staff (Office of the Director General), World Intellectual Property Organization during the National IPR Conference organised on April 24, organised

by CII to commemorate the occassion of World IP Day. A key highlight of the initiative is the wide variety of courses developed by notable authors based on the requirements of the industry as well as the tie-ups with leading national and international academic institutions and international bodies. Lectures are to be conducted by esteemed legal luminaries, academicians and stalwarts in the domain of IP having years of experience and a say in shaping India’s policy on IPR. The courses will reportedly be run under the expert guidance of eminent personalities from industry and academia. EP News Bureau - Mumbai

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May 16-31, 2015

PHARMA LIFE INITIATIVE

Cadila Pharma celebrates World Day for Safety and Health at Work Activities conducted at Bhat, Dholka, Ankleshwar, Kadi and Hirapur locations to commemorate International Labour Organisation CADILA Pharmaceuticals celebrated ‘World Day for Safety and Health at Work’ across its company locations in Bhat, Dholka, Ankleshwar, Kadi and Hirapur on April 28. The company organised various activities to promote occupational safety and health, like banner displays, trainings, quizzes, safety equipment exhibitions, slogans, posters, essay and debate competitions, emergency drills and screening of videos on safety precautions. Dr Rajiv Modi, Chairman and Managing Director, Cadila Pharmaceuticals said, “We consider employees as partners of the organisation and endeavour to ensure a safe, secure and

friendly work environment for all employees through many initiatives. Only a healthy and safe

workforce can bring value to the workplace and we truly value this significant contribu-

tion of our workforce to the growth and success of the group.”

World Day for Safety and Health at Work is commemorated every year by the International Labour Organisation (ILO) on April 28. The ILO acknowledges the shared responsibility of key stakeholders and encourages them to promote a preventive safety and health culture to fulfil their obligations and responsibilities for preventing deaths, injuries and diseases in the workplace, allowing workers to return safely to their homes at the end of the working day. The theme of the campaign for 2015 is ‘Join in building a culture of prevention on OSH’ (Occupational Safety and Health). EP News Bureau - Mumbai

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Novartis India announces next edition of BioCamp BioCamp will be held in Hyderabad from July 6 to 8, 2015 NOVARTIS Biotechnology Leadership Camp (BioCamp) will be held in Hyderabad from July 6 to 8, 2015. The BioCamp is a pioneering seminar organised by Novartis that brings talented students from diverse faculties and different universi-

64 EXPRESS PHARMA May 16-31, 2015

ties closer to the pharmaceutical industry. The programme is open to postgraduate students and young researchers in natural sciences, medicine, biotechnology, bio-informatics, pharmacy, business administration or law

(specialisation in Intellectual Property Rights) interested in pursuing a career in the pharmaceutical/biotechnology industry. “BioCamp has created share of voice in the lives of many bright, young minds in the country. It provides a unique opportunity for a broad range of students to interact with leaders in the pharmaceutical in-

dustry. More than that, it helps them make career choices. Novartis’ commitment to BioCamp is a reflection of our deep interest in furthering the cause of healthcare and education,” said Ranjit Shahani, Vice Chairman and Managing Director, Novartis India. Selected students will have the opportunity to learn from and network with leaders in the

pharma and business sector as well as hone their team building skills. The top three students from the India BioCamp will represent India at the International BioCamp being held at Novartis global headquarters in Basel, Switzerland from August 23 to 26, 2015. Over the last five years, India has had two global winners, both women. EP News Bureau - Mumbai

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