CONTENTS Vol.13 No.23 October 1-15, 2018
Pharma companies are making a beeline to the tiny Himalayan state of Sikkim lured by good government policies, conducive business environment, low cost manufacturing and easy availability of labour| P17
Chairman of the Board Viveck Goenka Sr. Vice President-BPD Neil Viegas Asst. Vice President-BPD Harit Mohanty Editor Viveka Roychowdhury* BUREAUS Mumbai Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das, Swati Rana, Tanuvi Joe New Delhi Prathiba Raju DESIGN Asst. Art Director Pravin Temble
MARKET
MANAGEMENT
IT@PHARMA
PHARMA LIFE
Chief Designer Prasad Tate Senior Designer Rekha Bisht Graphics Designer Gauri Deorukhkar
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Senior Artist Rakesh Sharma Digital Team Viraj Mehta (Head of Internet )
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Photo Editor Sandeep Patil
EXPRESS PHARMA HOSTS SIKKIM PHARMA SUMMIT IN GANGTOK
Marketing Team Rajesh Bhatkal Ambuj Kumar Debnarayan Dutta Ajanta Sengupta E Mujahid Nirav Mistry PRODUCTION General Manager BR Tipnis
CIRCULATION Circulation Team Mohan Varadkar
EU FMD: UNIFORM PRACTICE FOR ALL
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THE ART AND SCIENCE OF PROSPECTING IN THE NEW AGE
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A PRESCRIPTION FOR BETTER CYBERSECURITY
RESEARCH
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3RD LOC MEETING OF 70TH IPC HELD AT PHD CHAMBER OF COMMERCE, NEW DELHI
Manager Bhadresh Valia Scheduling & Coordination Santosh Lokare
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A VAIDHEESH RE-ELECTED AS PRESIDENT OF OPPI
Automation solutions for PHARMA industry www.br-automation.com
P29: INTERVIEW Professor Dr P Gopinath IIT Roorkee
Express Pharma® Regd. With RNI No.MAHENG/2005/21398. Postal Regd.No.MCS/164/2016-18. Printed and Published by Vaidehi Thakar on behalf of The Indian Express (P) Limited and Printed at The Indian Express Press, Plot No.EL-208, TTC Industrial Area, Mahape, Navi Mumbai-400710 and Published at Express Towers, Nariman Point, Mumbai 400021. Editor: Viveka Roychowdhury.* (Editorial & Administrative Offices: Express Towers, 1st floor, Nariman Point, Mumbai 400021) * Responsible for selection of news under the PRB Act. Copyright © 2017. The Indian Express (P) Ltd. All rights reserved throughout the world. Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.
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EDITOR’S NOTE
India’s FDC saga and other stories
I
n my last edit, (Putting the bite into our laws, http://www.expressbpd.com/pharma/editorsnote/putting-the-bite-into-our-laws/40523/) I had analysed how our country's regulations have not evolved as fast as medical technology, citing the trauma faced by patients who had undergone ASR hip implants from DePuy International, a subsidiary of Johnson & Johnson (J&J). We then heard of the detection of traces of polio type 2 virus in some batches of oral polio vaccine (OPV) given to children as part of the government’s universal immunisation programme. The batches were traced to Ghaziabad-based pharma company Biomed, were withdrawn from circulation and the firm’s managing director was arrested. But, Biomed seems to be a repeat offender. On March 14 this year, a notice from the DCGI informed state drug controllers that certain batches of its typhoid vaccine were found to be not of standard quality (NSQ) by the Central Drug Laboratory, Kasauli and were hence instructed to withdraw these batches. The fact is, prevention is always better than cure. The presence of Polio Virus Type 2 strain in the vaccine, even after the central drug regulator ordered all manufacturers to destroy this strain in 2016, raises doubts on its proper destruction as well as the possible presence with other manufacturers. While it is good that the surveillance system detected this slip up, could a more stringent system, including surprise checks of manufacturers' stocks, etc. have prevented this episode? How many more Biomeds will it take for us to strengthen the implementation of our regulatory systems? How many more Biomeds are managing to stay below the radar? There are signs that there is a strong intent to close the loopholes. Two important draft guidelines have been released on the Central Drugs Standard Control Organization (CDSCO) website for comments from industry. On September 25, the CDSCO released draft guidelines on Good Distribution Practices for pharma products which are open for comments for three weeks. The guidelines intend to cover not just the manufacturers, but also the staff and outlets involved in the storage and distribution of pharma products, from the premises of the manufacturer to the post of sale. Interestingly, the draft guidelines include the manufacturers of bulk, finished products, wholesalers, as well as others such as suppliers, distributors, government institutions, international procurement organisation, donor agencies and certifying bodies, logistics providers, traders, transport companies, forwarding agents and their employees as well as health workers. Another draft guideline released on September 27 focused on guidelines for inspection of a
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Framing regulations is one thing, interpreting and implementing them quite another saga, allowing repeat offenders like Biomed to remain below the radar for too long
pharmacovigilance (PV) system. It proposed a risk based programme for PV inspections of manufacturers or importers of ‘drugs’, for the collection, processing and reporting of adverse drug reactions (ADRs) to licensing authorities. This follows a meeting on September 24 where these draft guidelines were presented to and discussed with representatives of industry associations. The draft, which is open for feedback till October 31, puts the onus of reporting ADRs on manufacturers/importers. CDSCO is currently making its own assessment of the existing PV systems of companies making or importing medicinal products including pharmaceuticals, phyto-pharmaceuticals, human vaccines, blood products, rDNA technology-derived drugs and stem cell therapeutics. Unfortunately, framing regulations is one thing, interpreting and implementing them is quite another saga, allowing repeat offenders like Biomed to remain below the radar for too long. Take the case of fixed dose combinations (FDCs). Even though the Ministry of Health & Family Welfare (MoH&FW) acted on the recommendations of the subcommittee of the Drug Technical Advisory Board (DTAB) and banned 318 FDCs, the Supreme Court of India, acting on appeals from various pharma companies, released 15 pre 1988 FDCs from the ban. The current ban impacts 0.8 per cent of the Indian pharma market (`1040 crores, as per AIOCD PharmaTrac MAT Aug 2018). The pharma sector, like any other industry, has thus always used the law to protect its interests, often to the detriment of patients. In his article, IPRs in Trade Agreements & Access to Medicines from the CPhI Annual Industry Report 2018, Dilip Shah, Secretary General, Indian Pharmaceutical Alliance warns that such practices will only harm the image of the industry. His article analyses how the global trend towards patent term restoration and extension will result in patients needing to wait an extra 5-10 years to access generic versions of medicines. He cautions that this trend may result in consumers and governments ultimately forcing a fundamental reform of how medicines are reimbursed. Commenting that the onus is on the pharma industry – both innovative and generic, he says, “Unfortunately, the lawyers and lobbyists are driving this agenda. It seems that Chairman and Board of Directors are not fully seized of the implications and the unintended consequences. They must wake up and question about the harm it will do to the industry’s image. No amount of PR or political donations can prevent this misfortune of own creation.” Will the pharma industry read the writing on the wall?
VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com
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MARKET POST EVENTS
Express Pharma hosts Sikkim Pharma Summit in Gangtok Discusses ways forward for Sikkim as pharma hub
Swati Rana and Sanjiv Das
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he first edition of Sikkim Pharma Summit 2018, recently held in the picturesque city of Gangtok, discussed ways to improve Sikkim’s destination as the pharma hub. The event having the theme 'The gateway to growth,' had more than 80 delegates from across the pharma sector who have their base in and around Gangtok. The summit started with the lamp lighting ceremony by Dr IL Sharma, Director cum Drug Controller, HCHs & FW, Sikkim, who was also the chief guest with Dr TK Rai, Deputy Drug Controller, Department of Healthcare Human Service and Welfare, Govt of Sikkim and Sanjiv Das, Deputy Copy Editor, Express Pharma. Dr Sharma during his speech emphasised on the need to not compromise on the quality. He mentioned that the State Government of Gangtok has taken a lot of initiatives to create a conducive environment for pharma companies to set up their base. The first session of the day was by Ramanuj Samal, Application Specialist – Particle Characterization and Counting, Beckman Coulter. He gave a lecture on facility monitoring and formulation particle characterisation study and talked about the company's principles. The next session of the day was by Kartik Khanna, Direc-
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Dr IL Sharma, Director cum Drug Controller, HcHs & FW, Sikkim, Dr TK Rai, Deputy Drug Controller, HcHs & FW and Sanjiv Das, Deputy Copy Editor, Express Pharma at lamp lighting ceremony
tor - Business Development, Shree Naina Glass. Khanna topic was 'Sree Naina Glass: Zero Defect Approach'. One of the important element of the summit was a panel discussion on 'Sikkim's Journey as a Pharma hub: What is the way forward?' The panel discussion had P Ramesh, Plant Head, Micro Labs; Dr Upendra Quenim, Plant Head, Swiss Garnier; Dr TK Rai, Deputy Drug Controller, Department of Healthcare Human Service and Welfare, Govt of Sikkim and Deepak Verma, GM, Zuventus Healthcare as a panelists. The
session was moderated by Sanjiv Das, Deputy Copy Editor, Express Pharma. Das started the discussion by asking the panelists about Sikkim's progress made so far in the pharma space and how the state will fair in days to come. Dr Quenim spoke about the challenges being faced by pharma companies which were agreed upon by Ramesh from Micro Labs and Deepak Verma from Zuventus Healthcare. Dr Rai from Government of Sikkim elaborated on the benefits which the Government of Sikkim is offering and a slew of measures which will
eventually help pharma companies in the long run. Tax incentives, easy approval for plant set up, conducive environment were some of the examples which Dr Rai mentioned. P Ramesh from Micro Labs emphasised on the need for technological upgradation which will help pharma companies. He discussed about the challenges which pharma companies face in Sikkim. Dr Quenim mentioned that Sikkim is very much in the limelight and the state has its own charisma. He talked about the requirement of QbD
and the need to follow the guidelines Verma laid emphasise on the need to upgrade the learning skills of people and embibing good practices. He talked about the importance of data integrity and the need to adapt newer technologies. The panel discussion was followed by a talk by Dr Anoop Kumar, Market Development Manager, Pharma/CRO Vertical, SCIEX India on SCIEX LC-MS/MS based solutions for various Qual and Quant workflows in Pharma/Small Molecules Application. Neelam Lalwani, Global
Ramanuj Samal, Application Specialist- Particle Characterization and Counting, Beckman Coulter
Suprateem Dutta, Professor head & Coordinator ADR Monitoring Centre, Dept of Pharmacology, Sikkim Manipal Institute of Medical Sciences
Kartik khanna, Director - Business Development, Shree Naina Glass
Dr IL Sharma, Director cum Drug Controller, HcHs&FW, Sikkim
Dr Prashant Dour, Application Support Manager, Separations Division, SCIEX India
Tulasi Krishna, Sales Leader - Particle Business, Beckman Coulter
Dr Anoop Kumar, Market Development Manager, Pharma/CRO Vertical, SCIEX India
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Neelam Lalwani, Global Quality Head - ACG Films & Foils
Quality Head- ACG Films & Foils was another speaker at the summit. She briefed the audience on emerging manufacturing technologies. Suprateem Datta, Professor Head and Coordinator ADR Monitoring Centre, Department of Pharmacology, Sikkim Manipal Institute of MedicalSciences in his speech talked about stringent compliance to good manufacturing practices, which will be instrumental in obtaining approval of US FDA and other regulatory agencies. “Strong quality management system, with focus on elements such as data reliability, good documentation practices and process validation will be imperative in achieving operational excellence,� he said. Sandeep Vadakattu, Deputy General Manager - Life Sciences Sector at Domino Printech India was gave an insight on 'Improving machine readable code quality as part of a reliable Track & Trace solution.' Dr Prashant Dour, Application Support Manager, Separations division, SCIEX India, talked about 'Analysis of small molecule drugs, excipients and counter ions in pharmaceuticals by capillary electrophoresis'. This was followed by the last session of the day by Tulasi Krishna, Sales Leader- Particle Business, Beckman Coulter who gave a lecture on 'Anatel TOC analysis in Pharmaceuticals waters.' The event ended on a high note with cocktails. swati.rana@expressindia.com sanjiv.das@expressindia.com
Sandeep Vadakattu, Deputy General Manager - Life Sciences Sector, Domino Print India
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MARKET
GLIMPSES OFTHE EVENT
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MARKET
3rd LOC meeting of 70 IPC held at PHD Chamber of Commerce,New Delhi th
BR Sikri informed that in the 2nd IPCA meeting held at Mumbai with Dilip Shanghavi, most of the points were discussed with regards to arrangement and conduction of IPC THE 3RD meeting of LOC of 70th IPC began with paying homage to departed soul Atal Bihari Vajpayee and observing two minutes silence by all the members present in the meeting. BR Sikri, Chairman, LOC in his introductory remarks welcomed everybody and thanked everyone for attending the meeting in large numbers. Sikri informed that in the 2nd IPCA meeting held at Mumbai with Dilip Shanghavi, most of the points were discussed with regards to arrangement and conduction of IPC. He informed that the registration brochure was discussed in detail and modified as per the suggestions. He stated that Dilip Shanghavi is very much concerned about the budget and quality of participation. Atul Nasa acknowledged and thanked Ashok Chauhan for his formal consent to offer green, wireless Amity University, Noida Campus for the forthcoming 70th IPC. Nasa, Organising Secretary, LOC of 70th IPC, again thanked all the participants. He then invited senior members like SL Nasa, SL Sobti, PP Sharma, PK Jaggi, Bhanu Dua, Prof Roop K Khar, Prof Shahid Ansari for the release of the registration
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MARKET Every one appreciated the colours and design of the brochure. Similarly sponsorship opportunities brochure and advertisement cum souvenir brochures were released by other group members brochure. Every one appreciated the colours and design of the brochure. Similarly sponsorship opportunities brochure and advertisement cum souvenir brochures were released by other group members. Now the brochures are ready to be dispatched to all the members of the association. Nasa invited all the chairpersons of various task committees to conduct presentations on the progress of their respective committees. Dr Vijay Bhalla ( Registration), Dr Arun Garg (Scientific Services), Prof Roop K Khar (Reception), Dr Harvinder Popli (Inauguration), PK Jaggi (Press and Publicity), Bharat Bhushan (Accommodation), Dr Raman Dang ( Volunteers), Prof Shahid Ansari (Information & Promotion) discussed in details about the progress of their committees. Rajesh Madan (Industrial Relations), Aprajita Takiar ( Women empowerment), Kanchan Kohli (Ladies Hospital-
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ity), Dr Ajay Sachan (Finance), KB Gupta (Medical Services), Mahendra Singh (Transport), Arvind Manchanda (Training Placement & entrepreneurship), Sree Kumar (Exhibition), Sundeep BJ (Sight Seeing) also discussed the progress of their committees. The meeting then ended with a vote of thanks. EP News Bureau
MARKET EVENT BRIEFS KENYA PHARMA EXPO 2018 Date: October 17 -19, 2018 Venue: KICC, Nairobi, Kenya Summary: The international pharma exhibition on technologies and trade will focus on East & South African Pharmaceutical Industries. The expo will be organised by GPE Expo where pharma machinery and allied-industries OEMs across the world will exhibit their Technologies/ Services. Contact details: Paresh Jhurmarwala CEO KENYA PHARMA EXPO 2018 E-mail: contact@ kenyapharmaexpo.com Website: www.Kenya PharmaExpo.com
PHARMA CXO SUMMIT Date: November 23-24, 2018 Venue: Novotel Airport, Hyderabad Summary: Organised by Express Pharma and the Indian Express Group, the second edition of Pharma CXO Summit will bringing together over 50 leading pharma CXOs steering the industry towards greater progress. The theme for this year’s Pharma CXO Summit is ‘Acing the value game: Leveraging disruptive technologies’. The event would witness leaders, experts and veterans of the Indian pharma industry come together to discuss on the trends and transformations in the industry. They would share their experiences and pain points; and gain practical solutions to future proof their strategies with the help of disruptive technologies. Contact details Vinita Hassija vinitahassija@gmail.com
GLOBAL PACK 2018 Date: November 23-25, 2018 Venue: Labh Ganga Exhibition Centre, Indore, MP Summary: GLOBAL PACK 2018 is an International Trade
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Exhibition & Tech Summit for the packaging material, machinery and ancillary industry. Organised by Integrral Business Exhibitions & Media in association with SIES School ofPackaging, it is being
designed to serve as a platform for the packaging and printing industry, both in terms of business and technical content. Contact Email: info@ibem-india.com
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(
THE MAIN FOCUS
Pharma companies are making a beeline to the tiny Himalayan state of Sikkim lured by good government policies, conducive business environment, low cost manufacturing and easy availability of labour By Sanjiv Das
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cover ) S
ikkim, known for its picturesque valleys and lush green hills, is a renowned tourist destination. But, if you think that this is its only claim to fame, think again. The small Himalayan state is also home to more than 40 pharma companies. Till 201415, the state was able to attract investments worth of $414.73 million and the figures continue to grow. According to India Brand Equity Foundation (IBEF), between 2011-12 and 2016-17, Gross State Domestic Product (GSDP) expanded at a compound annual growth rate (CAGR) of 11.05 per cent to $ 2.93 billion whereas the Net State Domestic Product (NSDP) expanded at a CAGR of 11.30 per cent to $ 2.58 billion. The Gross State Domestic Product (GSDP) of Sikkim expanded at a high CAGR of 12.18 per cent between 2011-12 and 2017-18. The state has attracted Foreign Direct Investment (FDI) equity inflows worth $4.78 billion during the period April 2000 to June 2018, according to data released by Department of Industrial Policy and Promotion (DIPP). The state is not so far behind Gujarat, Maharashtra and Baddi in Himachal Pradesh in becoming a hub for the pharma industry. In fact, Express Pharma's August 2016 edition carried an article showcasing the state’s emergence as a pharma hub. Recently, Express Pharma organised the Sikkim Pharma Summit: The Gateway to Growth in Gangtok. It also highlighted Sikkim’s rise as a pharma hub. Delegates representing the pharma fraternity who took part in the summit were also optimistic about the states’ initiative in pulling in many pharma companies despite the odds which the state faces. So what are the factors luring the pharma players to this state? Let’s examine in detail
Creating a conducive business environment Hilly terrains with unpre-
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a much higher pace than expected.”
Pharma plants need to adapt GMP, GDP, proper process validation processes, data reliability methods and risk mitigation principles. These are very important points which needs to be addressed and this is possible only, when proper training is parted to the local people who are employed in the pharmaceutical plants in Sikkim Deepak Verma GM, Zuventus Healthcare
Sikkim has responded extra-ordinarily and performed better than expected. All big pharma giants have ensured their presence in the state and are prospering at much higher pace than expected P Ramesh Plant Head, Micro Labs
Sikkim’s growing economy has improved the living standards and generate employment. The rapidly growing pharma industry has facilitated bolstering downstream SMEs and ancillary units and upgrade skill development Supratim Dutta Professor Head and Coordinator, ADR Monitoring Centre, Department of Pharmacology, Sikkim Manipal Institute of Medical Sciences
dictable weather notwithstanding, Sikkim has been able to attract the attention of pharma companies. According to Edelweiss Securities, the overall revenue for the pharma sector is likely to grow 17 per cent YoY (year-on-year) and PAT 50 per cent YoY. Conducive government policies in Sikkim which offers 100 per cent excise and income tax benefits in addition to freight subsidy is one major reason for this rise. Dr Supratim Dutta, Professor Head and Coordinator, ADR Monitoring Centre, Department of Pharmacology, Sikkim Manipal Institute of
Medical Sciences points out, “The North East Industrial and Investment Promotion Policy (NEIIPP) 2007 has been the major driving force for pharma companies to make investments in the greenfield projects in the state. Benefits provided by the NEIIPP include excise duty and income tax exemptions as well as capital investment subsidies. Additionally, ample availability of land, uninterrupted supply of power, low manufacturing and labour costs provide a conducive environment for the industry.” Deepak Verma, GM, Zuventus Healthcare, informs,
“Sikkim contributes approx ` 10000-15000 crore annually, mostly to the domestic market, that means an average contribution of 10 per cent.” With government strategies focussing more to create a conducive environment for pharma companies to set up their base in the state, P Ramesh, Plant Head, Micro Labs informs that the strategies has been appreciated a lot. He says, “Sikkim has responded extra-ordinarily and performed better than expected. All big pharma giants have ensured their presence in the state and are prospering at
Economic benefits Apart from tourism, which adds to the bulk of the revenue, the pharma sector has also been able to add revenues to the state exchequer. Easy availability of labour, lower power and manufacturing costs, amongst others are also reasons why the pharma sector is attracted to the state. Says Dutta from Sikkim Manipal Institute of Medical Sciences, “Sikkim’s growing economy has improved the living standards and generated employment. The rapidly growing pharma industry has facilitated bolstering downstream SMEs and ancillary units and upgrade skill development.” According to Verma from Zuventus Healthcare, Sikkim has a huge scope for biomass research as the state is abundant in medicinal plants. He says that the rich cultural background, good administration, overall conducive business environment, etc. will help the state to go to new heights.
Better facilities Till date in order to reach Gangtok or upper reaches of Sikkim, people used to fly down to Bagdogra in West Bengal or alight at New Jalpaiguri if travelling by train, and then take a car for a five hour drive through a treacherous hilly terrain. Things will change after Pakyong airport was recently commissioned, the first greenfield airport in the entire North Eastern region. Better transport facilities with proper infrastructure will open the floodgate of opportunities for pharma companies. Says Ramesh from Micro Labs, “There are a slew of measures which have been adopted by the government, besides providing the necessary infrastructure for the industry to prosper.” Verma from Zuventus Healthcare says, “This state has all the resources where an
( R&D centre can be established, like the beautiful climate, incredible culture and it also has one of the best administrations. One very important opportunity in R&D is that the state has a huge scope of BIOMASS Research, as Sikkim is rich in medicinal plants.”
THE MAIN FOCUS
Adopting benchmark industrial waste management systems should also be a top priority for all facilities, to ensure that the fragile ecological balance of this beautiful state remains undisturbed
Challenges to conquer Thus, there are several advantages to investing in the state but challenges exist too. Ramesh admits, “Some regulatory challenges do exist which are on the environmental, clinical and logistics front.” According to Dutta from Sikkim Manipal Institute of Medical Sciences, the suspension of the NEIIPP in 2014, has been a challenge for the pharmaceutical industry to adapt to. However, he also feels that
therein lies the opportunity for the pharmaceutical industry of Sikkim to strengthen existing systems, and to look for viable avenues to diversify operations. However, Verma says, “There are no such challenges. We appreciate the efforts taken by our regulators in Sikkim, who really support us by their regular guidance, providing updates related to the CDSCO and DCG(I) guidelines.” He urges the government to
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establish a regulatory laboratory to support the regulators and mentions that the work of regulators has increased, as they are less in number and have to take care of almost 50 plants and hundreds of chemists.
Strategies for further success The future looks bright for the state provided it manages to chart out plans with more in-
dustry friendly policies, better infrastructure and transport facilities so that pharma companies feel more comfortable conducting business. Fortunaltely, the companies have recognised this. According to Ramesh from Micro Labs, the pharma industry operating in Sikkim is able to maintain their high standard of manufacturing practices while ensuring availability of quality medicines for all in the
country. However, the industry should look for developing and implementing innovative strategies and best in-class practices. More number of injectables and ointment plants could also be explored.” He also mentions that by placing solar panels, solar energy can be converted to green energy, which will lead to save power and ultimately prevent generation of carbon. Verma from Zuventus Healthcare says, “Pharma plants need to adapt GMP, GDP, proper process validation processes, data reliability methods and risk mitigation principles. These are important points that need to be addressed and this is possible only, when proper training is parted to the local people who are employed in the
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pharmaceutical plants in Sikkim.” Dutta from Sikkim Manipal Institute of Medical Sciences is of the opinion that strong quality management system, with focus on elements such as data reliability, good documentation practices and process validation are imperative in achieving operational excellence which will help pharma companies do business in Sikkim in an easier manner. “Technical upgradation through instrumentation R&D mechanisms, achieving optimal automation capabilities, upscaling personnel skills through internal and external training programmes can all lead to value added quality enhancement. Adopting benchmark industrial waste management systems should also be a top priority for all facilities, to ensure that the fragile ecological balance of this beautiful state
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Good days await the state’s pharma sector, however, it should increase its readiness to leverage the growth potential. The Sikkim pharma industry should strive to be a part of the growing global demand, by ensuring export of highest quality drugs being manufactured in its facilities remains undisturbed,” he says.
Road ahead Good days await the state’s pharma sector, however, it should increase its readiness to leverage the growth potential. Dutta from Sikkim Manipal Institute of Medical Sciences advises, “The Indian pharmaceutical industry currently plays a major role in manufacturing and supplying
high quality, low cost medicinal products for the global markets, which include the US and the UK. The Sikkim pharma industry should strive to be a part of this growing global demand, by ensuring the export of the highest quality drugs being manufactured in its facilities. Stringent compliance to good manufacturing practices will be instrumental in obtaining approval of the US FDA and other
regulatory agencies.” He also mentions that there is scope for an industry academic collaboration, with the availability of two pharmacy colleges and one medical institute in Sikkim. The presence of two well established tertiary care hospitals in the vicinity: Central Referral Hospital under Sikkim Manipal University and STNM Hospital under the Sikkim Government, will ease target
patient recruitment for clinical trials. According to Verma from Zuventus Healthcare, Sikkim is ‘the’ place for the pharma industry. With negligible pollution in this state as well as the industry’s belief in negligible pollution, thus matching one of the Missions of this state makes it the ideal ground for pharma companies to grow. The Sikkim pharma industry should strive to be a part of the growing global demand, by ensuring export of highest quality drugs being manufactured in its facilities. Developing proper infrastructure, ease of transportation, building good roads, pharmacy colleges, and flexible financial schemes with more R&D centres can act as catalysts for progress. sanjiv.das@expressindia.com
MANAGEMENT
EU FMD: Uniform practice for all In less than four months, which is by February 9, 2019, the Falsified Medicines Directive (FMD) will be implemented in more than 30 countries in the European Economic Area. It imposes strict serialisation requirements on pharmaceutical manufacturers, distributors and dispensers. However, companies are slightly apprehensive about outsourcing serialisation to partners and ensuring compliance. A longer term strategy would be to look beyond the February 2019 deadline and see how these partners can help optimise supply chain management given these new data requirements. Usha Sharma finds out more
Need of the hour is to regulate 2D bar-coding machinery and software
I
n my considered opinion, this is akin to what we have been experiencing in terms of 2D bar-coding in India, which has been postponed for a while particularly on account of cost considerations besides complete collapse of DAVA portal which has been proved to be a big deterrant. However, in the case of the Europe situation it is different and we don’t foresee any chances of deferment of this decision under any circumstances. It will be in interest of the Indian pharmaceutical industry which is predominantly in Europe either to get organised for this, failing which exports to EU will get severely affected. As Chairman of Pharmexcil, this is my personal and profes-
DR DINESH DUA CEO and Director, Nectar Lifesciences and Chairman,Pharmexcil, Chairman,Entrepreneurship & Start Ups, CII North India
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sional endeavour to disseminate this message to all Pharmexcil member companies to start gearing up for compliance to this upcoming regulation. A word of caution here is about getting the right equipment and software support, which in the past has proven to not only mislead user industry but also has a hidden agenda of hiding cost in the initial offers and ballooning it up after a year or two under the pretext of ‘Software Upgrade’ which accounts to an virtual arm twisting and is also prohibitively expensive. Pharmexcil will reach out to its parent Ministry of Commerce to help contain and regulate these malpractices to ensure that the pharmaceutical industry gets a
fair deal as has happened in case of several pharmacos. To sum it up, the time has come for the Indian pharma industry to completely gear up for Post Marketing Surveillance (PMS) and also for the track and trace of the medicines supplied across the globe which sooner or later shall become harmonised all over the world particularly in North America, Europe, Japan, Korea, South Korea, Brazil, Mexico and emerging markets followed by African countries and rest of the world. Need of the hour is to regulate 2D bar-coding machinery and software and to make sure equipment manufacturers offer competitive prices and excellent quality as per global standards.
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MANAGEMENT
'It is a major step for anti-counterfeiting'
A
new era for the European Economic Area will begin on February 9, 2019. Marketing Authorisation Holders (MAHs) will be required to upload their products serialisation codes to the European Medicines Verification Organisation (EMVO) hub, while pharmacists will be able to scan them at the point of sale for verification. This will apply to almost all prescription medicines. All stakeholders that supply pharmaceutical RXproducts to European Countries will be impacted including originators and generics manufacturers, traders, re-packagers and CMOs. Anti-tampering devices on packages will also become mandatory, although no preferred feature is specified. First of all the serialisation has created an unprecedented
push for the life science companies to update their manufacturing processes. New equipment for serialisation at line level are required to perform the code printing and verification of individual packages; standalone units can integrate labelling functions, tamper-evident seal application and check-weighing functionalities, while printing and verification can also be integrated on any existing packaging line. The IT architecture must then be upgraded at plant level, to manage work orders with serialised data across multiple lines, as well as at corporate levels where data are exchanged across multiple stakeholders - including distributors - and ultimately notified to governmental authorities.
PARAG KOTHARI Chairman & Managing Director, Jay Instruments & Systems
Aggregation, the process of serialising all logistic units within the packaging line establishing a hierarchy between
packs, bundles, cases and pallets, is not in the current scope of EU-FMD regulatory requirements, yet it is becoming
mandatory for several other countries. This new, global approach requires the support of a comprehensive and scalable software and hardware platform that can be implemented to cope with different regulations on the same production lines and to efficiently manage the communications across the supply chain, enabling full product traceability. It is a major step forward for anti-counterfeiting, which will ultimately add value to supply chain management for manufacturers. But the current investment from manufacturers is set to generate further advantages for their businesses. Welcome to EU-FMD. New responsibilities in the approach to a huge market, as well as a big step in a new supply chain efficiency paradigm.
‘Serialisation can analyse business value’
T
he world is full of complex situations and almost every matter has two sides either brighter or darker in common sense. However, when it comes to medicines it is decidedly serious as it relates to health in general and life in particular of humans and animals. Existence of Falsified Medicines over the pharmacy counter thus has remained a grave concern for regulators all over the world. Until recently, the most frequently falsified medicines in wealthy countries were expensive ‘lifestyle medicines’ and high value ‘Branded medicines’ but the criminal and greedy elements of the society have now included medicines to treat ‘life-threating conditions’ also. The phenomenon of falsified medicines is on increase and hence dangerous to the human and animal life. To fight with this menace the regulators are constantly thinking of identifying ways and means to weed out falsified medicines from the market and ensure that authentic, authorised, safe and
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SHASHIKANT JOAG Technical Consultant, SynergyPharma Formulations India
quality medicines will be available to the patients. In November 2013, the Federal government in the United States passed the Drug Quality and Security Act to create a national pharmaceutical serialisation and track and trace regulation. The act is designed to hinder the production and distri-
bution of life threatening imitation or counterfeit pharmaceuticals. The act demands identification and authenticity features on primary, secondary and tertiary packaging levels in the form of unique, non-predictive, serialised and machine readable codes. The serialisation can also provide opportunity to view and
analyse product movement data and business value. On February 9, 2016 the European Commission also published delegated regulation that introduces two safety features to be placed on the packaging of most human medicines a unique identifier( a two-dimension barcode) and an anti-tampering device. Marketing authorisation holders must place these on the packaging of prescription medicines from February 9, 2019. EMA and the European Commission have prepared an implementation plan including regulatory requirements and timelines, to guide applicants and marketing authorisation holders in meeting these requirements. Supply chain and good distribution practices for wholesalers and brokers have also been introduced by the Directive. The European Medicines Verification Organisation (EMVO) a Belgian non-profit organisation representing stakeholders united will help in securing the legal supply chain from falsified medicines.
The EDQM in 2006 has also set up a data repository for network members involved in the testing of counterfeit / falsified and illegal medicines. This information platform is used by the Official Medicines Control Laboratories (OMCLs) on a voluntary basis to make test reports available in a standardised format. It allows network members rapid exchange of information on testing activities in the area of falsified medicines. In 2014 the data repository was replaced by a more advanced database ‘KnowX’ which now collates test reports from OMCLs and reports issued by customs, police and health authorities on falsified medicines. The CDSCO in India has also planned to create a working group to critically appraise its proposal to set up a ‘trace and track’ mechanism to identify fake medicines from the market using a 14 digit unique code number on the product pack based on recommendations made by Drugs Technical Advisory Board.
MANAGEMENT
'Implementation to be done in spite of lowering margins for generics in highly competitive environment'
A
s per the Directive of EU countries, we need to implement FMD. In case of UK, we need to comply to the FMD requirements before February 2019. Hence, it has become important for companies dealing with Europe and UK, to invest in FMD although it will add to
the cost, not only by way of initial investments, but also recurrent payments to the service providers. This has to be done in spite of lowering margins for generics in highly competitive environment. Our company Fourrts has already made the necessary plans and we are hopeful of
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being FMD ready before November 2018. I am sure, other companies also need to do the necessary compliance, so that their exports are not affected. The advantage of EU FMD implementation may result in better traceability and avoid spurious or non registered drugs.
SV VEERRAMANI Managing Director, Fourrts (India) Laboratories and Immediate Past National President, IDMA, Chairman
The disadvantage will be the additional cost involved and slowing down of produc-
tion. The advantage of serialisation is also not fully established.
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MANAGEMENT
‘If companies fail to comply to regulations,they will risk everything from production downtime to loss of business’
F
alsified and counterfeit medicines make up around one per cent of the volume of the global market, according to the EU, and up to 60 per cent in West Africa, putting already vulnerable populations of patients at risk. The WHO believes that falsified medicines could be the reason behind around 100,000 deaths per year in Africa. Pharmaceutical manufacturers must act now to avoid production scheduling clashes as well as technical and cost challenges ahead of next year’s Falsified Medicines Directive (FMD) deadlines. The trade in falsified medicines — medicines that look real but really aren’t what they seem — is a huge and growing one, and it is putting patients’ health and even their lives at risk. Along with regulatory authorities around the world, the European Union is putting directives into place that could begin to slow this deadly trade. The approaches include track-and-trace and mass serialisation, which use unique codes tied to central databases and allow genuine packs of drugs to be traced back to the license holders, manufacturers, and distributors. The addition of tamperproof technologies on the packs confirms that the product hasn’t been repackaged or tampered with in any other way. In combination, these make sure that users (doctors, pharmacists, and patients) can verify the packs are authentic and contain the correct drug at the correct dose. The implementation of this directive is expected to increase the cost of goods for drug manufacturers and lower short-term productiv-
24 EXPRESS PHARMA October 1-15, 2018
DR SANJIT SINGH LAMBA Managing Director, Eisai Pharmaceuticals ity as the companies face additional tech support, labour, and increased returns. A recent survey by Medicines for Europe found that the most compliant pharma companies were still only 55 per cent prepared for the FMD, while others are 30 per cent prepared or less, leaving a massive wave of work to be completed in 2018. In just terms of Information Technology (IT), the implementation of the FMD is a huge undertaking that will see the systems of more than 28 EU countries connected to an EU hub, the European Medicines Verification System (EMVS). While this will allow end-to-end tracking of products, only pharma companies can enter serial numbers into the system. This makes the process especially complex when CMOs are involved, as Drechsle explained that third-party suppliers will not be allowed to connect to the EU hub. To comply with the directive, companies need to put a number of processes and protocols in place. They need to buy and install hardware and
software that can generate and print unique barcodes or 2D codes. Then they need to be able to scan the codes and store and track the data. And all of this hardware and software will need to integrate with any existing enterprise resource planning (ERP) software. Packaging designs may need to be rethought because they will have to include space for the barcodes. Furthermore, those barcodes need to be clear enough and contrast well enough against the background for easy scanning. That means companies will need to have quality control in place, and they will need to ensure the codes remain stable and legible in storage throughout the product’s lifetime. This is the biggest change in the pharma industry in the last 40 years, and any system is only ever going to be as good as its worst part. Overall, the FMD covers three regulatory areas: serialisation, compliance reporting and verification. The directive requires companies to place ‘safety features’ on the packaging of
The directive requires companies to place ‘safety features’ on the packaging of certain medicinal products for the purposes of identification and authentication. In short, the next few months are crucial for companies looking to outsource serialisation certain medicinal products for the purposes of identification and authentication. Specifically, according to the directive, safety features include anti-tamper devices and unique identifiers. An anti-tamper device is very simply described as a device that allows the verification of whether the packaging of a medicinal product has been tampered with. The unique identifier is more complex and must be composed of a product code, serial number, national reimbursement number (where required), batch number, and expiration date. It must be carried within a 2D Data Matrix barcode, and in human readable text on the package. In short, the next few months are crucial for companies looking to outsource serialisation. Selecting appropriate partners to ensure compliance is important but companies should also look beyond the February 2019 deadline to see how these partners can help optimise their supply chain manage-
ment given this new data requirements. More problematic is the timeframe for selecting, delivering and validating line systems. Some vendors are currently proposing timescales of over 12 months to deliver line systems which will now take implementation beyond the EU deadline. Serialisation is not a task that can be completed overnight and the repercussions of missing the deadline will have a significant detrimental impact on the success and longevity of a business. Companies that fail to comply with the regulations risk everything from production downtime to the loss of business to more prepared companies in key markets.More proactive businesses should begin reviewing processes and exploring the opportunities to improve productivity and, in some instances, achieve a competitive advantage as part of their serialisation programme. u.sharma@expressindia.com
MANAGEMENT
The art and science of prospecting in the new age Mohan G Joshi, International Business Coach and Former President, SCHOTT Glass India, expounds on how prospecting has changed and its importance in the current times
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Like the game of Chinese Whispers, the real meaning of prospecting has diluted over time. Most sales persons would count every single target as a prospect. That’s exactly what needs to be set right. A prospect is not just someone who ‘looks’ at your product or ‘likes’ (on social media) your product. He is not someone who simply ‘enquires’ about your product; such a person becomes a ‘lead’. But you need to evaluate this ‘lead’ and check if you can put him in the ‘prospects’ bucket.
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What a prospect is not. 1. Anyone and everyone who likes your social media post – People have a habit of hitting the ‘like’ button
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MANAGEMENT without thinking 2. A person who is browsing your website and dropping off – he is probably just a window shopper 3. A person who writes to you but does not ask specific questions or who is not specific in the discussion – in such cases, he is not looking for anything specific 4. A person who does not fit your target audience description 5. A person who is talking too much into the future and it will be many more buying cycles or years before he actively considers buying 6. A sales lead or target is not a prospect. He may be a potential prospect but only when he is qualified, can he be called a ‘prospect’.
Prospecting techniques that can give you a reason to party! Target correctly The key to building a super prospect list is to define your target audience correctly. Your ‘target’ is not a generalised statement that defines a population segment with certain demographics and psychographics. It is not a generic profiling; your list has to be more specific to real people. You need to go beyond the popular ‘target audience’ and find real people. Define
what kind these people should be. Gun after them with the fanaticism of a killer. The classic mistake in prospecting happens when sellers go for targets on the wrong rung of the proverbial organisational ladder. Look for the decision maker, the boss and go after him/her. Starting from the bottom rung may set you back by many months or years. Prospecting demands you have a list you can be proud of and not be satisfied with a wishy-washy laundry list. Are you delivering value at every touch point and every interaction? Right from the first sentence you speak on the phone or right from the subject line of the email you send to your target, you are delivering value. Your sales spiel through any medium needs to be about the ‘Whys’ (Why your target should listen to you, why he should spend time talking to you on the phone or why he should read your email or why he should spend his valuable time in meeting you) and not about the ‘Whats’ (what your product is, what features it has, what your story or background is, etc.) or the ‘Whos’ (you may be the who’s who of your world, but your target is interested in knowing the whys and not who you are or who
your company is). Remember, you can offer value at every interaction with the target; it is not only ‘the value your customer will get from you after he buys from you’. As your target sees value at every point you interact with him, your prospecting becomes sharper and gets you better results.
The higher you target, the longer it takes – it’s a straight equation you need to master. It takes more attempts than most people think, to get through to top prospects. Sales is not a sprint, it is like running a Marathon. Endurance is key.
Play clean – a peaceful night’s sleep is the key to success Practice honesty, transparency and be known for your integrity. Playing dirty to close the deal or achieve your targets is a no-go. In the short run or the long run, there is no greater ground to own than ‘trust’ and trust is the first and the last word for winning good customers. Using gimmicks, tricks or false promises to win a sale is the first thing that will kill the sale and put you on the top of that ‘target’s blacklist.
Different ways work together to deliver Don’t lose your mind trying to choose the precise ways by which you will reach your prospect. Use multiple ways and means to reach him. Go for cold calling and email, telephone and social media (different channels in this), traditional advertising or direct marketing and digital marketing. Any media works best when used in an integrated manner. Standalone mediums do not work as effectively or as efficiently. With an integrated approach, you are going to have more hits than misses.
Keep trying – till you reach them Reaching your target will not be easy; whoever promises you that is fooling you. You have to be the person who chases, the person woos and wins them over. But winning is miles away, so, you must keep trying. It will take you 7, 8, 10 or more tries to get a breakthrough; but you will get it.
Data, digital and prospecting In a world that is going under the digital knife; where data is collected and dissected to reveal stunning facts, where analysis and over-analysis seems to have become the lifestyle; where does prospecting stand? Prospecting still stands on the intersection of digital and human (traditional). Sales is about real peo-
ple, so the sooner you realize that a H2H (Human 2 Human) connect is as important now as it was back then in the ‘PreDigital’ era, the better prospects you will have for your business. CRMs and sales software apart, it is best that you keep the human angle alive. ‘Calling’ is still a good practice – genuinely interested prospects will plan a time for the call and invest that time in knowing more about your offering. Face to face meetings will still happen despite virtual meetings and hangouts; real vibes will still work and cafes and business lounges won’t be going out of fashion anytime soon. You can take the ominous readings of ‘Traditional selling is dead’ with a pinch of salt and quietly go about your business. The old and the new make for a great pair of hands in prospecting; I am dead serious. It’s a deal! Prospecting, if done the right way, takes you closer to cracking the deal. But, sales is a game of patience, dedication, intelligence, determination and never-give-up attitude. It is a journey of creating interest, building desire, forging relationships, building trust and winning the customer. If your customer wins, you win!
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26 EXPRESS PHARMA October 1-15, 2018
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Aprescription for better cybersecurity Pankit Desai, Co-founder and CEO, Sequretek stresses on the implementation of tighter security measures as a need of the hour for the pharma industry
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The NotPetya malware has made American pharma giant, Merck, bleed more than USD 300 million per quarter, disrupted operations worldwide and affected its operations, research, and manufacturing verticals. Healthcare records, corporate espionage, leakage of confidential data, and insider threats from disgruntled/unreliable employees make the sector increasingly vulnerable to cyberattacks. Unlike the banking sector, where the main vulnerability can be identified as the financial records of customers, cyber attacks in the pharma and healthcare sector, in general, get more personal and real, as personal information regarding a patient's family, financials, health, and insurance records are exposed threats. Companies and security experts alike need to recognise that the pharmaceutical sector hosts a lot of sensitive information, which is financially valuable to many who don't have access to the information, magnifying the threat levels for the companies. The Indian pharmaceutical sector is just as vulnerable, given its
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hreat scenario 1: Pankaj Mishra* sits in his corner cubicle seemingly tying up loose ends at his current job as a clinical trial specialist at a mid-scale research company which performs the majority of the clinical trials for one of the largest pharma companies in the country. He is due to leave in a fortnight, but his exit interview has not gone as well as expected. Threat scenario 2: Imagine that you are the Head of Research at one of the biggest pharma companies in the country, and one day your IT department tells you that your computer has been hacked and all data has been breached. The above examples may sound like the teaser to the latest Netflix show, but, unfortunately, these are real life situations for pharma companies, the latter of which occurred in India. Although regulators and experts in India have been working the grind to shore up India Inc's cyber defenses, the diversity and complexity of cyber attacks have expanded, making it seem as though the regulators and experts can only play catch-up. In the past couple of years alone, according to Cisco's 2018 Annual Cyber Security Report, India Inc has lost damages amounting to USD 500,000 to cyber attacks across sectors such as pharmaceuticals. Take the example of NotPetya - India was the most affected country in the Asia-Pacific, and the seventh most in the world to this malicious software. The pharmaceutical sector has become particularly vulnerable to cyberattacks. While sectors like banking and utility companies such as electricity providers have implemented tighter security measures, the healthcare sector seems to lag behind, even globally. According to consulting firm, Crown Management Records, more than half the pharma companies worldwide have experienced data breaches and at least a quarter of them have been hacked.
IT@PHARMA increasing importance in the global pharma space. The Indian Brand Equity Foundation (IBEF) estimates that by 2020, the Indian pharmaceutical sector will likely be among the top three worldwide in terms of incremental growth, and is expected to touch USD 100 billion by 2025. Indian pharma companies are also the largest provider of generic drugs, with exports to more than 200 countries. According to a report by Assocham, the drug formulations market in India is expected to cross USD 20 billion by end of 2019. Relaxed FDI guidelines, policies such as 'Pharma Vision 2020', and the influx of sub-licence contracts to Indian pharma companies spur growth, but at the same time they also increase the threats that the sector faces. For these companies, while financial damages are calculated to measure losses, the value of a drug formula or sensitive information falling into the wrong hands is priceless. Unfortunately, most high security measures seem restricted to R&D labs alone, and do not extend along the network and verticals through which this data might be used or accessed. This is especially true for Contract Research Organisations with whom the data will certainly be shared, but who may not share the same security protocols.
Geo-political and blackmarket threats When it comes to the value of global innovation, pharmaceutical R&D chains are some of the most valuable properties in the world. As cybercrimes become more sophisticated - it is no longer the brilliant lone hacker out for some juvenile fun, it falls in the same range as organised crimes, some by Nation States even. No wonder then the governments around the world is also getting edgy about cybersecurity within their borders. A strong example can be found in India's alleged opposition to the Chinese pharmaceutical group, Shanghai Fongsun's, takeover offer for India's Gland Pharma. Indeed, geo-political cybersecurity threats are one of the most
28 EXPRESS PHARMA October 1-15, 2018
Pharma companies are also vulnerable in terms of loss of reputation and trust from consumers and stakeholders. The vulnerability of this loss is often underestimated, as it cannot be calculated directly in monetary terms significant threats for pharmaceutical companies. Operational loopholes in pharmaceutical companies are particularly lucrative to organised crime groups who access these to steal prescription drug data for black market sales. Another threat comes in the form of hackers substituting counterfeits for actual drugs in the supply chain, thereby supplying pharmacies, and eventually, consumers with counterfeit drugs. A recent example of this includes counterfeits for anti-rejection, cancer and diabetic medications being sold on the internet and the black market. In black markets, medical records of individuals can fetch anywhere up to USD 250. Even healthcare providers in sophisticated markets like the UK and the US have fallen prey to health and personal information record thefts. If these security breaches are not found or resolved, and patient lives are endangered and lost, the pharma companies expose themselves to punitive damages, lawsuits, and repeats of clinical trials, which will set the company and, indeed, the sector back by years and accrue extreme financial costs.
Hackers are in it for a long haul It is rather obvious that intellectual property and drug formula, and the manufacturing process behind these, thefts pose the biggest cyber security threat to pharma companies. Rival Nation States are a particularly interesting actor in this space. This is one aspect in which pharma companies’ scale of cyber threat differs. BoozAllen experts note that pharma hackers are usually in it for the long haul. Hackers or their plants tend to stay in the process from the Research, Conceptualisation, and Development through to the post-
marketing phase. Once upon a time the research function was akin to shooting in the dark, but with the evolution of knowledge and technology, research has become a more targeted and focused function. Corporate espionage in the form of stealth of IPs for molecular formulae, for example, can delay production and destroy the quality of the final product. Increased digitisation and data analytics in the sector offers avenues for operational efficiencies and enhanced productivity, however the increased global inter-connectedness calls for more stringent protocol and for security to be interwoven into design and manufacturing processes. Like many other sectors, the pharmaceutical sector has also been looking at IT security in isolation rather than using it as critical delivery function to enable higher performance. While IP and loss of drug formula is still considered the largest vulnerability in the pharma cyber security space, insider threat certainly comes in second place. Greed, revenge, threats and blackmail are some of the key drivers for insider theft of data, which, not surprisingly accounts for more than two-thirds of hacking in the pharma space. Lack of employee awareness and education about what constitutes risk is also a huge concern for pharma companies. For example, the fine-tuning of active ingredients to conceptualise drug-like entities on inadequately secured company devices poses a significant threat to the organisation. Instant messaging platforms among employees are also platforms for data theft and rogue codes. Consistent training in not clicking on suspicious links even if they come from legitimate senders (known to the employees), not storing sensitive information on cloud services and
data cards which do not belong to the organisation and taking them out of the premises, lack of encryption of data through access control, security for remote devices of executives working from home, exit processes for employees are all important measures to put in place to beef up cybersecurity measures.
Everyone is a target In the example in the beginning, we cited a real life example of a Head of Research being targeted for sensitive content on his devices. However, threats are not restricted to just Heads of Departments or the top brass alone. In fact, according to Symantec's 2014 Internet Security Threat Report, administrative or executive assistant and public relations personnel rank higher in terms of risk profiles for phishing than the top brass. In 2011, a former IT employee of the Japanese firm Shionogi remotely accessed the pharmaceutical firm's infrastructure and deleted e-mails and other information which resulted in a USD 300,000 loss for the company. Perhaps it is obvious to hackers that companies are more willing to spend on securing devices of the top brass rather than those lower in the food chain.
Vendor vulnerability Threats can also come in the form of risks along the supply chain - where sub-contractors and vendors are not trustworthy or their reliability has been compromised. Recently in the US, a sub-contractor for IT at a large pharmaceutical company was apprehended for stealing and selling the company's networking equipment on eBay. This happened even though the sub-contractor had been thoroughly checked for background and security, prior to his recruitment. The onus is on the management of the
pharma companies to ensure that their IT departments do not look for quick fixes in terms of hardware and inexpensive servers, thereby exposing the company to security risks. RFID tags intended to secure authenticity and monitoring in distribution have also become prone to hacking, with an aim to replacing the supplies with counterfeits. In 2015, the US FDA had to issue advisories on cyberattacks on certain medical devices after it was found that devices such as infusion pumps had been breached. Blinded data and vendor indifference are also significant risks when one considers the ease with which such data can be decoded and sold on the black market. Delays in the supply chain and security breaches can bring lawsuits from the vendors themselves against the pharma companies.
Reputational Risk Pharma companies are also vulnerable in terms of loss of reputation and trust from consumers and stakeholders. The vulnerability of this loss is often underestimated, as it cannot be calculated directly in monetary terms. If consumers learn that trial data or products have been compromised, doubts regarding integrity and quality can endanger trust and confidence in the company. Loss of reputation is a strategic risk, and can be one of the drivers for the cyber attacks by rivals. A loss in reputation in turn leads to loss of revenue and brand value as a result of customer churn and regulatory reprehensions. In effect, comprehensive security will arise from a solid foundation in employee education, integrating security into design and technology, and ensuring that human factor is also addressed in designing the security. The increased digitisation, the inter-connectedness of supply chains, higher number of licences and outsourcing, along with sophisticated cyber and geo-political risks need to be addressed as a package rather than in isolated solutions which are not cross-functional in effectively protecting the organisation, its employees, or its consumers.
RESEARCH I N T E R V I E W
Our research aims to develop low-cost efficient anti-cancer therapeutic options: Dr P Gopinath IIT Roorkee Professor Dr P Gopinath was recently awarded the GD Naidu award for his outstanding contribution in the field of biomedical nanotechnology. In an exclusive interview with Tanuvi Joe, he discusses about developing an economical and green way to detect and kill cancer cells and how this research can be a milestone in tackling cancer in India
Please elaborate on the process of how you managed to yield nanosized dots thus leading to detection of cancer cells? We have synthesised fluorescent carbon dots from rosy periwinkle plant leaves that can be used as nanotags for detecting and killing cancer cells. Current cancerdetecting techniques use quantum dots that use toxic metals. They are expensive to produce and break down
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RESEARCH easily when exposed to light. To develop a safe way to detect cancer cells, we have synthesised carbon dots by heating a solution of finely chopped periwinkle plant leaves under controlled conditions and then cooled it down to room temperature. This process yielded nanosized carbon dots. When incubated with specific cancer cells, the carbon dots entered the cells. These cells showed enhanced fluorescence, indicating that the dots reached inside the cells. The dots selectively bound to microtubules, filamentous intracellular structures that support cell division and help transport various molecules inside the cells. The dots destabilised the structure of the microtubules, converting them into fragments that accumulated inside the cells. This, in turn, inhibited the normal activity of the microtubules arresting cell division – a key property that makes the dots potentially useful for stopping the proliferation of cancer cells.
Therapeutic choices should be affordable and easily accessible in India. Our research aims to develop low-cost efficient anti-cancer therapeutic options. If this nanotag based approach is successful in animal and clinical trials, then it may be a low cost nanomedicine to cure the dreadful disease like cancer This is an economical and green way to produce fluorescent carbon dots from the leaves of a common medicinal plant. What were the previous resources you used to achieve the same result and why was periwinkle the most ideal? We have also done green synthesis of multifunctional carbon dots from coriander leaves and investigated their potential application as antioxidants, sensors and bioimaging agents. However
they are non-toxic and do not kill cancer cells.Rosy periwinkle plant (a common medicinal plant) is already in use in Ayurvedic medicine for treatment of various diseases. Therefore we have selected this particular plant source. How will this research help in tackling cancer in India? Therapeutic choices should be affordable and easily accessible in India. Our research aims to develop lowcost efficient anti-cancer therapeutic options. If this
nanotag based approach is successful in animal and clinical trials, then it may be a low cost nanomedicine to cure the dreadful disease like cancer. To make this treatment cost effective, we have used easily available common medicinal plant and simple hydrothermal method to synthesis these theranostic (therapy & diagnostic) carbon dots. Has this technique been put to use in clinics and companies in India? In India, this plant is already
in use as an Ayurvedic medicine for the treatment of various diseases. Thus once the efficiency and mechanism of our carbon dots are studied in animal models it can be translated to clinics. We have to understand the complete molecular mechanism and investigate the therapeutic efficiency using animal models before we approach any companies. Can you share with us some of your other works? We have also invented a portable nanofibrous membrane to make water clean. We will be filing a patent soon and try to conduct a technology transfer to make this membrane commercially available for use. We have even filed for a patent with respect to the 4D tissue engineering device. This scaffold can closely mimic the in vivo condition which may reduce the use of animal models in vivo studies. tanuvi.joe@expressindia.com
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PHARMA ALLY PRE EVENT
India Tech Conclave to be held in Mumbai The event will look at various components that are essential to the making of a good manufacturing process enabled by AI and automation technologies
I
ndia Tech Conclave will be held in Mumbai on October 24, 2018. The objective of the event will be to highlight how AI and automation will be the norm and break away from being a novel tool in core business processes especially for pharmaceutical and FMCG manufacturing companies in the near future. When AI becomes the industry standard domestically and internationally, the need to carefully compile and curate data will
be the driving force to successfully implement automation-enabled by AI. Variables selected by companies today are what will set the tone for AI efficacy in the long run, and the aim to achieve industry 4.0 will be the need of the hour for Indian pharmaceutical and FMCG companies. This will be possible only when AI and automation are implemented efficiently in various business processes. India Tech Conclave will look at various components
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that are essential to the making of a good manufacturing process enabled by AI and automation technologies. It will attempt to encompass a spectrum of topics and themes to adequately address important variables that may or may not affect manufacturing companies in India especially when competing in an ever changing technologically driven global market. The conclave will have top industry leaders share their experiences on the challenges
and issues that they face while conforming to current industry standard practices and what steps they are taking to break the mould to gain competitive edge domestically and in an international platform. The issues and challenges may vary from data integrity, regulatory issues to human cum technology synchronisation. In order to address, if not resolve, these challenges, the conclave will have Industry and technology experts
who will share their insights, technical expertise and knowledge on the best solutions to embrace while solution and technology providers will showcase their latest innovations that are designed specific to these issues. The focus areas at the conclave will be: a) 4.0 Industry; b) Smart Manufacturing; c) Regulatory/Compliance Issues; d) Data Integrity; e) Technology in R&D. EP News Bureau
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8th Edition of PharmaTech Expo 2018 and LabTech Expo 2018 held in Ahmedabad This year the event focussed on the pharmaceutical formulations, nutraceuticals, API’s, cosmetic and ayurveda sector PHARMATECH and Lab Tech Expo 2018, held recently in Ahmedabad was the perfect place for companies to pick up on the latest trends and innovations, which the market had on offer. Major movers and shakers in India’s pharma machinery, technology and formulations industry gathered in Ahmedabad to witness the latest trends and the competitive advantage that the industry had to offer to help grow their businesses. Dignitaries present during the inauguration were Jaimin Vasa, President, Gujarat Chamber of Commerce & Industry, PK Jha, Zonal General Manager, NSIC, Prakash Sanghvi, Chairman, Ratnamani Metals & Tubes, Gautam Shah, Ex Mayor, Ahmedabad, Nihar Lakhia, Joint Director & In Charge (WR), Federation of Indian Export Organisation (FIEO) and large number of entrepreneurs. PharmaTech Expo 2018 & LabTech Expo 2018 is an international exhibition on pharma machinery, lab, analytical, pharma formulations, nutraceutical and packaging equipment. The event provided opportuni-
ties to suppliers, manufacturers, industrialists, entrepreneurs, buyers and consultants to assemble at this common platform for networking and gaining knowledge on latest technologies and equipments available. This year the focus was on the pharmaceutical formulations, nutraceuticals, API’s, cosmetic and ayurveda sector. Drug Marketing & Manufacturer's Association (DMMA) was the event partner. PharmaTech Expo 2018 & LabTech Expo 2018 put up a largest pharma and lab expo in Gujarat and second largest pharma machinery expo in India. The exhibition was spread over in the space of 7500 square metres and en compassing 250+ exhibitors and the event was wit-
nessed by 7000+ quality visitors from the different parts of the country. Various kinds of high tech pharma machinery, lab and packaging equipment, formulation, nutraceutical products were on display. Successful deliverance of the past events of PharmaTech Expo 2011, 2013 & 2015 (Indore), PharmaTech Expo 2016 & 2017 (Ahmedabad) & PharmaTech Expo 2017 & 2018 (Chandigarh) with patronage of our repeated and new exhibitors and visitors have encouraged the organisers for sequential events which has gained immense interest from pharma companies and manufacturers and 8th edition of PharmaTech Expo 2018 surpassed the previous events’ performance. Indo-African Chamber of
Commerce & industry (IACCI) has organised reverse Buyer Seller Meet and invited 14 delegates from African countries including Botswana, South Africa, Sudan, Tanzania and Zimbabwe. During the three days interaction meet between Indian exhibitors, entrepreneurs and foreign buyers about 1000 meetings were held resulting into commercial dealing. The seminar on Indian Pharma Industry: “Gearing for Global Giant” was organised by Food & Drugs Control Administration (FDCA - Gujarat) on August 23, 2018. Also seminar on 'Current Trends in Compliance - The Role of Human Resources' was held on August 24 and supported by Pharma Knowledge Centre. The seminar on Indian Pharma Industry: 'Gearing for Global Giant' had the following speakers. They were Dr SP Adesara, Ex Commissioner FDCA, Gujarat, who delivered the keynote speech at the event. Shirish Belapure Managing Director, Zydus Hospira Oncology gave a speech on 'The Market Game: Generic v/s Branded'.
Challenges & Impact of Bio Equivalence in Pharma Industry in Current Scenario was discussed by Nayan Prajapati, Head - Training , Cliantha Research. Quality Assurance of pharmaceutical products throughout the lifecycle by adopting Quality by Design (QbD), was discussed by Dr MC Gohel- Ex. Principal, LM College of Pharmacy. Nearest Satellite in Regulatory Galaxy – PIC’s Compliance was discussed by Dr D Roy Ex Deputy Drugs Controller India. The seminar on “Current Trends in Compliance - The Role of Human Resources” had the following speakers. Pharmaceutical Culture of Quality was discussed by Dr Deepak Haldankar - President – Technical, Akums Pharmaceuticals; Quality Culture and HR Role was discussed by Farhat Umar, Managing Director – Credo HR Solutions. Charting the Path to Quality Culture was discussed by Deepti Patel, AGM- Quality & Regulatory , Ratnamani Healthcare, Ahmedabad. EP News Bureau
India Lab expo,analytica Anacon India and Pharma Pro&Packexpo held There were around 261 exhibitors from India and overseas at the trade fair WITH 9,641 visitors and 261 exhibitors, analytica Anacon India, India Lab Expo and Pharma Pro&Pack expo has chalked up the best-ever result in its decade-old history and surpassed all expectations. The number of visitors rose by 25 per cent over the previous edition in Hyderabad. Jointly held with Pharma Pro&Pack expo for the second year, the synergies between the trade fairs has resulted to setting of new records.
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Visitors from pharmaceuticals, chemicals, food processing, research and development among other segments explored the latest innovations from the laboratory technology, analysis, biotechnology, diagnostics, pharma packaging and processing. Almost all top companies within and around Hyderabad attended in large numbers and delegation trips were arranged by Messe Muenchen India for several companies. In view of the new record
figures, Bhupinder Singh, CEO of Messe Muenchen India, stated, “Huge participation at the networking forums has reinstated our position as the most important innovation platform for the industry.” Gautam Rajan, President, Indian Analytical Instruments Association on Anacon India conference said, “We organised the conference to cover advancements in analytical solutions for life sciences. This is a very relevant topic today, be-
cause the future of research and instrumentation lies in this industry.” The analytica Anacon conference which took place on the opening day focused on Advances in and Analytical Solutions for Life Science Research, where industry stalwarts shared deep comprehensions about the state-of-the-art development in the analytical industry. The Smart Lab Summit, which took place on the second day of the event focussed on the
theme ‘Building your lab for tomorrow’ where speakers from Aurobindo Pharma, Dr Reddy’s Laboratories, Lupin, Reliance Life Sciences, Wockhardt and others deliberated on the need to move towards the smart laboratories, the need for investing smartly in labs, transforming laboratories through Big Data, and understanding the future of workforce in smart laboratories. EP News Bureau
PHARMA ALLY PRODUCTS
Gandhi Automations’clean room high speed doors a necessity BETTER QUALITY or better yield is the primary reason for investing in a cleanroom space. It goes straight to the bottom line. Numerous manufacturing facilities now require a controlled environment in which one can limit the amount of dust and dirt in the area of the manufacturing. Medical instrument manufacturing and packaging, electronics and computer manufacturing, food preparation and some military applications are but a few of the instances that have strict requirements for maintaining a clean environment. One needs to know the requirement for specific product or process. Clean rooms have become integral part of pharma manufacturing facilities. One of the most important aspects of cleanrooms is the doors which needs to be chosen for cleanroom facility. Time for which door is open will play a critical factor in avoiding dust, outside temperature, humidity etc. Opening and closure of door has to be quick enough to isolate the outside environment and internal facility. Gandhi Automations provide clean room high speed doors specifically designed for above purpose. The clean room high speed doors are best suited for facilities when there is a requirement of controlled environment. The opening and closing of door is quick enough to separate outside environment and internal facility. High speed clean room doors designed by Gandhi automation are engineered carefully with feature below:◗ Concept of low air permeability in pressurised rooms
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The clean room high speed doors are best suited for facilities when there is a requirement of controlled environment
with positive and negative air pressure ◗ Designed to fit inside the columns ◗ Self-supporting construction ◗ Minimises air leakage ◗ Can be equipped with transparent PVC horizontal sections or vision windows ◗ Special side guides to tightly integrate the curtain ◗ High leak tightness due to the close filling curtain in the guide rails ◗ High door efficiency with and low permeability values, EN 12426 EN 12427: < 12 m3/m2 h Δ 50 PA . ◗ Control device enclosure in Stainless Steel SS 316
Contact details Gandhi Automations Chawda Commercial Centre Link Road, Malad (W) Mumbai – 400064, Off: +91 22 66720200 / 66720300(200 Lines) Fax: +91 22 66720201 Email: sales@geapl.co.in Website : www.geapl.co.in
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PHARMA ALLY
Flowcrete launches India’s warehouse flooring toolkit A POORLY designed or maintained warehouse can therefore have a long list of detrimental knock-on effects, as if the warehouse is not up to the task at hand then the movement of products might be slowed down, interrupted or stopped completely. Getting the floor finish right is critical to designing an effective warehouse, as it is the platform on which the racking is based and the surface on which the staff, forklift trucks and pallet trolleys move around on. The floor needs to provide a level surface so that the goods can be moved around quickly and safely. This surface regularity needs to be maintained despite a long list of challenges that warehouse floors typically face, such as impacts, point loading, exposure to corrosive chemicals, foot and wheeled traffic, regular cleaning and more. Distribution facilities that use automated storage and retrieval systems with racks that stretch up to the roof will need to be particularly careful with the surface flatness, as it is an important factor to reducing vibration in the fast-moving forklift trucks that move up and down the aisles. Incorporating colour and signage into the floor finish is another key consideration, as this is a very effective way to improve navigation around the site, and so speed up the warehouse operations, and also to highlight onsite hazards and so cut down on accidents and mishaps within a busy warehouse space. Warehouses in sectors such as the food & beverage, health-
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care and pharmaceutical industries will also need to factor in the strict hygiene demands that these businesses are held to. Seamless, impervious finishes are vital to maintaining a high standard of cleanliness, as this means that there are no gaps where contaminants and dirt can hide from the cleaning regime. Robust epoxy floor coatings are ideal for creating flat, durable and easy to clean surfaces within even the largest and most demanding warehouse environments. Flowcrete India’s wide range of epoxy systems means that warehouse designers and operators can choose the floor that best meets the specific needs of each site. Flowcrete India’s selection of products for warehouse flooring includes Flowcoat SF41, Flowcoat HS, Flowcoat LXP and the Flowshield range of self-levelling epoxy systems. These coatings have become popular around the world among warehouse developments thanks to the versatile, colourful and high performance finishes that this epoxy flooring collection can create. In addition to resin floor coatings, Flowcrete India can also provide a wide range of complementary construction products for warehouse projects, to ensure that each part of the facility operates to the highest standard. For example the macro-synthetic fibre solution TUF-STRAND SF can be utilised to minimise shrinkage and cracks in the floor. This patented polypropylene/polyethylene synthetic macro-fibre helps to give warehouse floors the flatness and surface hardness necessary to withstand the
various types of heavy loads that they will be subjected to. Developers can make use of the Eucon and Plastol admixture ranges to provide additional flooring properties and ensure a high standard of concrete during various process stages, such as the mixing, transportation, placement and curing. Some of the major benefits that these admixtures offer include increased compressive strength, durability and workability of the concrete. Floor hardeners and densifiers can be specified to improve
the hardness and lifespan of concrete, protecting against impacts, tyre mark stains, moisture and dusting. Hardeners use graded particles to increase the density of the concrete by filling up the smallest pores, thereby resisting disintegration and wear. Asides from the floor, the roof is one of the largest parts of any building, and it needs to be protected from leaks and corrosion. A waterproof seal installed between the roof’s lap joints will separate the roof sheets and prevent dust and water leaking
down into the warehouse’s stored products. Flowcrete India’s waterproofing solutions are able to provide improved adhesion and self-healing properties. When considering the products required for a warehouse project, either new-build or refurbishment, don’t forget to take into account all the joint fillers, sealers, repair solutions and bonding agents that will be required for the job. Contact details www.flowcrete.in/contact-us
PHARMA ALLY
Videojet launches Pharma Line App VIDEOJET TECHNOLOGIES has launched a brand new application - the Videojet Pharma Line App â&#x20AC;&#x201C; to provide instant information and guidance for customers looking to code or mark onto pharmaceutical and medical device packaging. The Videojet Pharma Line App is available for iOS and Android mobile devices and has been designed to provide information that relates to a customerâ&#x20AC;&#x2122;s specific coding needs and requirements. App users can select from the most common packaging formats in the pharmaceutical and medical device industry, view different coding options depending on the packaging selected and receive application-related information to help them make informed decisions. The app library contains numerous case studies, spec sheets, application notes, white papers and product videos to be viewed and shared.
The application contains: A packaging library, which currently contains aerosol cans, blister packs, folding cartons, HDPE bottles, stick packs, tubes, syringes and vials. These options will be extended over time An app library which will be updated frequently with the latest materials (case studies, white papers, spec sheets, application notes, product videos)
A push-message function to ensure users receive the latest news and updates the second
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they are posted. The Videojet Pharma Line App is available to download
now in a wide variety of languages, including Chinese, English, French, German, Italian
and Spanish. Contact details www.videojet.com/pharma
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PHARMA ALLY VALUE ADD
Not yet REACH compliant? Here’s what you need to know Joaquim Pires, is responsible for DKSH’s Business Unit Performance Materials Regulatory Affairs in Europe. He informs about the benefits companies can gain from becoming REACH compliant IT’S ALREADY been eleven years since the introduction of REACH, the European Union’s regulation for the Registration, Evaluation, Authorisation and Restriction of Chemicals. The latest milestone in its history came recently when chemical companies were given the final deadline to register substances they manufacture or import from outside of the EU of over one metric ton per year. Until this deadline, companies were able to sell and import pre-registered substances of this quantity freely on the EU market. Companies must now commit to a complex and lengthy registration process through the European Chemicals Agency (ECHA) to become REACH compliant. Failure to comply can result in administrative and/or criminal penalties, which are managed on a national level in each member state. If you are not yet on the road to becoming one of the 13,620 companies already registered under REACH, here are some important thoughts for you to consider.
Safety and commercial benefits: There are many benefits to gain from becoming REACH compliant. Ultimately, the aim of REACH is to help build better knowledge and awareness on the hazards of chemicals. Having a standardised approach to managing these hazards offers better protection for those working in the chemical industry, as well as
36 EXPRESS PHARMA October 1-15, 2018
registration process. It is possible that some companies, for business reasons, may decide not to pursue the registration process and withdraw specific substances from the market. If so, downstream users would need to secure an alternative manufacturer, or importer, to avoid production issues.
Working with business partnerts:
for the environment. With instant access to a wealth of online reports and news articles, today’s consumers are far more conscious of health and safety issues surrounding the chemical industry. As a downstream user, being REACH compliant would help boost final consumer confidence in your products and give your business a competitive advantage in the market.
Getting it right the first time: To make a registration, a technical dossier containing all required data on physiochemical, toxicological and eco-toxic properties, manufacture and uses of a sub-
stance must be submitted. If a substance classified as hazardous is to be sold in quantities of over ten metric tons per year, the registrant must additionally carry out a chemical safety assessment to define the conditions of use and exposure levels under which the risks can be controlled. The assessment data must then be documented in a chemical safety report, to be submitted with the technical dossier to ECHA. Registering just a single substance requires a huge investment in both time and cost. Companies must make sure that a registration is compiled accurately with the scientific data behind a substance to avoid rejection or
even withdrawal dossier.
of
the
Availability of s ubstances: According to ECHA, out of the 106,211 substances listed in the European Chemical Inventory, only 21,551 were registered under REACH as of August 6, 2018. The most common chemicals, like ethanol, propane-1, 2-diol, silicon dioxide and titanium dioxide, have already been registered by various companies. If your business relies on using substances that are not very common or readily available, you will need to work closely with your supply chain network to ensure long-term commitment and investment in the REACH
Becoming REACH compliant can be a tedious and timeconsuming process. Many businesses have opted to work with an experienced European-based business partner to help them become compliant and undertake the tasks and responsibilities of importers. Companies with extensive supply chain networks and a broad knowledge of regulatory environments can act as invaluable consultants, helping inexperienced companies to maximise their return-oninvestment. For example, DKSH, a global distributor of specialty chemicals, supports its business partners to become REACH compliant through its dedicated regulatory function. It has already registered more than 70 substances to date and is currently working on the registrations of more than 20 additional substances for this year. Understanding REACH is only the beginning of the journey but it is never too late to make sure your product portfolio is REACH compliant. Do contact me to find out more.
PHARMA ALLY VALUE ADD
Leveraging smart manufacturing Pooja Patil, Corporate Communication, B&R Industrial Automation emphasises the need for smart manufacturing practices to tackle quality challenges that arise in the industry SMART MANUFACTURING is trending in manufacturing sectors, which includes the Internet of things, edge computing and cloud computing. With strict regulations to follow, pharma industry faces several challenges related to quality, productivity, efficiency and wastage. Smart manufacturing practices offers the industry various ways to tackle these challenges cost-effectively. With ever-growing market and increasing complexity in the way drugs are manufactured, stored and distributed, this industry is required to remain competitive. Being one of the heavily regulated industries, there is always a constant need for continuous product monitoring right from the raw material until finished product. Traditionally, pharma companies were heavily relying on the human factors whereas with Industry 4.0, which is all about digitalisation, automation and collaboration, now the processes are more autonomous and computerised. Any deviations or untoward occurrence can be predicted and corrected, to avoid the down time or loss, which can damage the reputation of a pharma manufacturer. Smart manufacturing allows manufactures with continuous and real-time monitoring of all required processes helping companies keep track of prescribed parameters. By applying digital technology, data further can be analysed and used to make better and faster decisions. Digitalisation allows full integration of operations and improving manufacturing processes by making them more adaptive and responsive resulting in accurate planning, manufacturing efficiency, productivity, raw material management, efficiency,
tems using open source OPC UA or MQTT communication. Installing the Orange Box requires no changes to existing hardware or software in the factories. Equipment owners can achieve a substantial boost in productivity with a remarkably small investment in time and cost. It is as simple and intuitive to operate as a smartphone. Orange Box is also equipped with advanced energy function, which can evaluate energy data collected from the machine. Energy consumption is measured directly on the machine and viewed on an industrial HMI screen. The software is also able to break down energy consumption by device and displays it in a clear graphical overview. At a glance, operators are able to get an overview of any machine or entire factory power consumption.
Secure data connectivity with OPC UA quality assurance and waste reduction. Despite numerous benefits, which Industrial IoT is offering to pharma manufacturing, certain challenges do exist. The unknown cost required for upgrading legacy equipment to more digitised equipment is one of the major barrier. Moreover, in factories, owing to various islands of automation, having seamless vertical and horizontal communication i.e. machine-to-machine and machine-to- cloud is another challenge. Moreover, with connected shop floors vertically and horizontally, the amount of data within the factory is immense raising concerns of cybersecurity. Pharma companies needs to find ways to mitigate these risks and take steps to adopt technology trends within their factories and leverage its benefits.
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Retrofitting brownfields plants Adoption of smart manufacturing practices looks conceptually difficult in brownfield plants owing to legacy systems. In India, many factories have decade old infrastructure and upgradation of existing equipment, machines, devices, and sensors would incur high costs, which acts as a major barrier for technology adoptions. One of the challenge associated with these brownfield factories is collecting data and moving it to upper layers and IT. In order to overcome these challenges, setting up new Greenfield facilities from scratch is not a viable solution. With minimum capital investment and small modification, brownfields facilities too can leverage smart manufacturing benefits within no time. Orange Box from B&R was developed with this in mind to
provide Greenfield installation benefits to brownfield installation in a cost effective method. Orange Box enables users to access energy and process data from previously isolated machines and lines, making them Industrial IoT ready with minimal effort. An Orange Box can substantially reduce downtime and boost availability of existing machines and lines, which makes operations more productive and profitable. Orange Box consists of a controller and preconfigured software blocks. The controller is able to collect operating data from any machine via its I/O channels or a fieldbus connection. With this data, the software module generates and displays overall equipment effectiveness (OEE) and other KPIs, and can share the information with higher-level IT sys-
The increase networking in digitised shop-floor requires 24/7 connectivity and continuous access to the machinery. However, with this connectivity, organisations entails new security challenges which need to be address systematically. For any pharma company data of drug formulation, R&D, production knowledge is very sensitive and needs to be protected, otherwise, data, machines, and devices might be compromised or external entities might monetise this valuable data. OPC UA is the best solution, which insures data integrity and data confidentiality securely. OPC Unified Architecture (OPC UA) is a vendor-independent communication protocol for industrial automation applications. It is based on the client-server principle and allows seamless communication
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PHARMA ALLY from the individual sensors and actuators up to the ERP / MES system or the cloud. The protocol is platform-independent and features built-in security mechanisms. Since OPC UA is flexible and completely independent, it is regarded as the ideal communication protocol for implementation of Industry 4.0 ready factory. OPC UA bridges the gap between the IP-based world of IT and the production floor. Interfaces, gateways and the associated loss of information are a thing of the past because all production process data is transferred via a single protocol – within a machine, between machines or between a machine and a cloud database. OPC UA is eliminating the need for traditional factory-level fieldbus systems. By adopting this industrial automation solution, Pharma companies can leverage the manufacturing advances where connectivity and security are major concerns.
Achieving operational excellence with Cobots With growing demand for new drugs and medicines, pharmaceutical companies are continuously looking for new ways to increase efficient production leading to increased reliance on robotics. Incorporating robots in pharma production and packaging, which operate at very high speed, as the volumes to be handled, are high can be benefited in terms of mass handling, super high cleanliness, accurate measuring and higher productivity. In laboratories, developing new drugs or performing some tests, usually involves repetitive tasks such as blending, stirring, titration, moving fluids and test tubes. Robots are the perfect fit as they provide a high level of accuracy and consistency. By using robots in such menial tasks, scientist can focus on important activities as new drug development and research. Robots can work on certain tasks 24/7, enabling humans to avoid hazardous zones or repetitive tasks. They help in eliminating human error, increasing accurate repeatability and reproducibility, and in cleanrooms, removing the potential for human contamination. B&R’s openROBOTICS has
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B&R's Orange Box enables machine operators to collect and analyse data from previously isolated machines and lines and get them fit for the smart factory
OPC UA enables seamless communication from the individual sensors and actuators up to the ERP / MES system or the cloud
opened up new dimensions of robotics for easy and quick integration of robots in any machinery and production lines. With completely uniform programming for every component in the line – including robotics – customers around the world gain full benefits of holistic approaches to operation, diagnostics and maintenance. openROBOTICS, provides an option for total integration with a possibility
of a single controller from B&R for robot as well as machine control. These systems run on open source, vendor independent, high-speed, real-time network Ethernet POWERLINK and a fieldbus independent, open source, TÜV certified openSAFETY protocol. B&R has already a successful implementation for a human robot collaboration application where the robot is not bounded by cage
and works together with humans satisfying entire safety requirement.
To the future Even though pharma has been typically seen as a risk averse industry, it is slowly and steadily moving towards digitalisation. With the easy to adopt technologies, the barriers are falling. These new technologies are actual game changers
and lead to higher profitability. B&R offers machine builders and factories complete hardware and software solutions, comprehensive service and hard-earned expertise in automation. Further, B&R enables digitalisation of machinery helping machine builders and factories in their digital transformation journey, necessary to remain competitive in this new environment.
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PVC RIGID FILM FOR BLISTER FORMING
TRIPLEX LAMINATE
US FDA Type III DMF: 032495
US FDA Type III DMF: 032497
ALU ALU LAMINATE
PVdC COATED PVC FILM
US FDA Type III DMF: 032494
US FDA Type III DMF: 032496
EMERGING AS THE MOST PREFERRED PRIMARY PACKAGING SOLUTIONS PROVIDER FOR THE PHARMA INDUSTRY. CALENDER
Uniworth Enterprises LLP with it's location at Ahmedabad, INDIA, is ideally suited to cater efficiently to the Indian market and with ICD facility and excellent connectivity by road to Nhava Sheva port, Mumbai, can also service the export market with minimum time lag between production and export.
Ÿ Dust Free & Fully Air Conditioned Factory Ÿ Fully Equipped Analytical Lab
SLITTER COATING LINE
Ÿ Producing 60 Micron PVC Film by Direct
Calendering without Stretching. Ÿ ISO 9001:2015 & ISO 15378:2017
Manufacturing site Ÿ 29000 Sq. Mtr. of Manufacturing Area
LAMINATOR
Ÿ 6000 Sq. Mtr. Built-up Area
WE PACKAGE GOOD HEALTH. Corp. Off: 804, Siddhi Vinayak Tower B off. S.G. Highway, Makarba, Ahmedabad -380051 Factory: Chharodi - Sanand (Gujarat) +91 -9726430369 / 7433966038 info@uniworthllp.com • www.uniworthllp.com EXPRESS PHARMA
October 1-15, 2018
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GLOBAL LEADING MANUFACTURER OF PHARMACEUTICAL PURIFIED OILS Highly Purified Soybean Oil Highly Purified Olive Oil Highly Purified Sesame Oil
Suitable for Injectable, Oral or Topical Formulations Supported by DMF & CEP angwal
Our Highly Purified Oils Comply With European Pharmacopoeia US Pharmacopoeia cGMP (ICH & IPEC Guidelines) FDA / EDQM Inspections
®
Contact for more information
Gangwal Chemicals Pvt. Ltd. :
706-707, Quantum Tower, Rambagh Lane, Behind State Bank Of India, Malad (west), Mumbai - 400064 Tel.: +91 22 2888 9000, Fax: +91 22 2883 5347, Email: info@gangwalchem.com, Web.: www.gangwalchem.com
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KILITCH HEALTHCARE INDIA LTD. Avoid the
Harmful Side Effects of Preservatives
India’s first ever Preservative Free Ophthalmic Manufacturing Facility Widely accepted by Ophthalmologist
Patented Pure Flow Technology For contract manufacturing contact: Kilitch Healthcare India Ltd. 902/B Godrej Colesium, Behind Everad Nagar, Near Priyadarshani Cirlce, Sion (East), Mumbai – 400022. Tel. : 022 6137 2222 Mr. Divya Mehta : +91 9819724957 www.kilitchhealthcare.com info@kilitchhealthcare.com
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SANITARY HOSES & FITTINGS Performance matched to your production needs
Industries Served
Pharma Biotech Food & Beverage Chemical and Petrochemical Shah Brothers Email:priyanka@shahbros.com
To Advertise in
Business Avenues Please Contact: ■ Mumbai: Rajesh Bhatkal 09821313017 ■ Ahmedabad: Nirav Mistry 09586424033 ■ Delhi: Ambuj Kumar 09999070900 ■ Chennai ■ Bangalore: Rajesh Bhatkal 09821313017 ■ Hyderabad: Mujahid 09849039936 ■ Kolkata: Ajanta 09831182580
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PHARMA LIFE APPOINTMENTS
AVaidheesh re-elected as President of OPPI A Vaidheesh is the Vice President, South Asia & Managing Director, GlaxoSmithKline Pharmaceuticals and has been re-elected as the President for OPPI, for the second year
T
he Organisation of Pharmaceutical Producers of India (OPPI), which represents the research-based pharmaceutical companies, announced the newly elected Board of Directors for 2018-19 at its statutory AGM held recently. Speaking on his role, A Vaidheesh, President- OPPI said, “2017-18 has been a year of big changes for healthcare in India. Universal Health Coverage, Big Data and personalised medicine continue to define this healthcare transformation. With the launch of Ayushman Bharat,
health has gained its well-deserved attention. OPPI members are consistently innovating and investing in science and patient care for better patient outcomes. OPPI continues to collaborate with the government on access to quality medicines and to establish the value of innovative medicine in the country. OPPI will continue to partner with all the stakeholders in the healthcare ecosystem and work towards building ethical, innovative and progressive pharmaceutical ecosystem in India.”
Kanchana TK, Director General-OPPI said, “We congratulate Vaidheesh on his re-election as the President. Under Vaidheesh’s leadership in 2017-18, OPPI had worked on a focused approach to innovation, access to quality medicine and an ethical ecosystem to foster trust with patients. We look forward to his guidance in leading us as we advocate for policies that promote scientific temperament and innovative mindset for a progressive India where health meets hope.” EP News Bureau
Lupin appoints Alok Sonig as CEO – US Generics and Global Head –Generics R&D & Biosimilars He will also be responsible for Lupin’s global Biosimilars business LUPIN ANNOUNCED the appointment of Alok Sonig as CEO – US Generics and Global Head – Generics R&D & Biosimilars. Sonig will lead and have overall responsibility for the US Generics business including Research & Development in India and the US and the Commercial side of the business in the US. He will also be responsible for Lupin’s global biosimilars business. With over 23 years of experience in the industry, Sonig brings an established track
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record of success in the pharmaceutical and healthcare sectors to Lupin. Most recently, Sonig was CEO of Developed Markets (US, Canada, Europe and Japan) at Dr Reddy’s. He joined Dr Reddy’s in 2012 and ran their India business till 2015 before moving back to the US to run their North America business. Prior to Dr Reddy’s, Sonig spent nearly 15 years at Bristol-Myers Squibb, where he held several positions of increasing responsibilities in General Management, Coun-
try leadership roles, Global Strategy and Marketing. Sonig holds a Bachelor’s of Engineering from Punjab Engineering College in India, and an MBA from American University, Washington, D.C. Commenting on the appointment, Vinita Gupta, CEO, and Nilesh Gupta, MD, Lupin said, “We are delighted to welcome Sonig to Lupin. His global experience, strategic perspective, and operational focus will help accelerate our team’s efforts to
strengthen and evolve our US generics business as we execute on near-term growth opportunities and navigate new platforms in complex generics and biosimilars.” Sonig will be based out of Somerset, New Jersey and split his time between Lupin’s Somerset, Baltimore and India offices. He will report to Vinita Gupta – Chief Executive Officer, Lupin and Nilesh Gupta – Managing Director, Lupin. EP News Bureau
PHARMA LIFE
Pfizer to replace longtime CEO Read with veteran Bourla Pfizer Chief Executive Officer Ian Read will hand over responsibilities of the largest US drugmaker to veteran insider Albert Bourla AFTER EIGHT years at the helm, veteran insider Albert Bourla will take over in the backdrop of increased scrutiny over drug pricing. Under Read, a Scot who joined the company in 1978, Pfizer has weathered patent expirations of several blockbusters, including cholesterol drug Lipitor, through dealmaking, expansion in emerging markets and cost cuts. Pfizer won 30 approvals from the US health regulator during his tenure. Read, however, failed to pull off two mega deals – acquisition of British drugmaker AstraZeneca in 2014 and Botox maker Allergan in 2016 – that would have helped lower its corporate taxes. Bourla, 56, was promoted to the newly created post of chief
operating officer at the start of this year and was widely seen as the leading candidate for the top job. Before becoming COO, he led the drugmaker’s innovative health business, which holds its newer, patentprotected medicines, since the start of 2016. The unit
recorded an eight per cent rise in revenue in 2017 to $31.4 billion. “Now is the right time for a leadership change and Albert is the right person to guide Pfizer through the coming era,” Read, who will become executive chairman, said.
Shares of the drugmaker, which have risen about 160 percent since Read took over as CEO in December 2010, were trading up nearly a per cent at $44.42. The stock had earlier touched 17-year high of $44.51. “This looks like a well-considered transition, thus I’m not convinced it will herald a major change in strategic thinking, particularly as Ian will still stay on as chairman,” Berenberg analyst Alistair Campbell said. The leadership change comes at a time when the Trump administration has been pressuring drugmakers to lower prescription costs. Read, after a conversation with President Trump in July, had decided to defer price increases for no more than six months. Pfizer, which has been trying to sell its consumer healthcare
business for the past one year, is bracing for patent expiration of its neurological disease treatment Lyrica, which raked in $1.2 billion in second-quarter sales. The company’s drug pipeline has the potential for about 25-30 approvals through 2022, Pfizer said, adding that it expects up to 15 of them to fetch multi-billions in sales. “The timing of this transition makes sense given Reed’s age and the company’s current strong portfolio of new products,” Edward Jones analyst Ashtyn Evans said. Last week, rival Merck & Co said it would amend a policy to allow its head, Kenneth Frazier, to remain CEO beyond 2019 when he was expected to retire. EP News Bureau
Dr Manoj Nerurkar, COO steps down from role at Syngene The announcement of the appointment of his successor will be made shortly SYNGENE International, a global contract research service provider, recently announced that Dr Manoj Nerurkar, Chief Operating Officer, will step down from his role with effect from October 1, 2018. Dr Nerurkar will continue his association with Syngene, taking a new strategic advisory role focused on innovation across Syngene’s services, in addition to pursuing an external start up opportunity outside of contract research services. Kiran Mazumdar Shaw, Managing Director said, “Manoj has played a key role in
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Dr Nerurkar will continue his association with Syngene, taking a new strategic advisory role focused on innovation across Syngene’s services, in addition to pursuing an external start up opportunity outside of contract research services establishing Syngene among the world’s leading discovery and development services CROs. Throughout his tenure, he has actively engaged in developing the next generation of leadership talent as well as en-
suring we have established world class infrastructure and capabilities. His proven track record of building successful businesses through a focus on innovation and world class delivery will hold him in good
stead in the future. I wish him the very best in his business endeavours.” Jonathan Hunt, Chief Executive Officer, commented, “During his nine years as Chief Operating Officer, Manoj has
made a pivotal contribution to Syngenes success; playing a central role in scaling the organisation, building world class capabilities and establishing a strong R&D leadership team as well steering the company through a successful IPO. I know both colleagues and clients will miss their day to day interactions with him, at the same time, I look forward to working with him in his new strategic advisory role and wish him great success with his new business venture.” EP News Bureau
REGD.WITH RNI NO. MAHENG/2005/21398, POSTAL REGD. NO. MCS/164/2016 – 18, PUBLISHED ON 5TH / 20TH EVERY FORTNIGHT, POSTED ON 5TH, 6TH, 7TH & 20TH, 21ST, 22ND OF EVERY FORTNIGHT POSTED AT MUMBAI PATRIKA CHANNEL SORTING OFFICE, MUMBAI – 400001
Ideal Cures launches
A film-coating that ruptures in 5 - 10 seconds and helps in faster disintegration
Product Applications: • Quick disintegrating coating for Pharmaceutical and Nutraceutical applications • Recommended where drug release related issues occur due to the interaction between film coating formulation and API • Suitable for drug layering applications
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