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CONTENTS Vol.13 No.14 May 16-31, 2018 Chairman of the Board Viveck Goenka


NEVER TOO EARLY FOR QbD Excipients make up more than 90 per cent of each pill or tablet we consume but have not been a major focus of regulators in the past.With a significant number of drug recalls traced to inconsistent quality of excipients and faulty product design, the Quality by Design approach must be implemented as early as possible in the drug development lifecycle. Recent regulations and initiatives have attempted to modernise this segment of the pharma industry | P16

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

National Design Editor Bivash Barua Asst. Art Director Pravin Temble Chief Designer Prasad Tate Senior Designer Rekha Bisht Graphics Designer Gauri Deorukhkar



Senior Artist Rakesh Sharma Digital Team Viraj Mehta (Head of Internet ) Dhaval Das (Web Developer)


Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Harit Mohanty - West Kailash Purohit – South Debnarayan Dutta - East Marketing Team Rajesh Bhatkal Ambuj Kumar Ajanta Sengupta E Mujahid Nirav Mistry

Scheduling & Coordination Santosh Lokare CIRCULATION Circulation Team Mohan Varadkar





Automation solutions for PHARMA industry

Rishabh Bindlish, Managing Director, Accenture Strategy – Life Sciences, Accenture in India

PRODUCTION General Manager BR Tipnis Manager Bhadresh Valia


Sunit Sinha Managing Director, Accenture Strategy – Talent & Organization, Accenture in India



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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May 16-31, 2018


Diving deeper into pharma GMP


or the past two years, the May 16-31 edition of Express Pharma has been a GMP Special issue, highlighting topics crucial to quality in pharma manufacturing. Our first GPM Special issue dated May 16-31, 2016 asked a very pertinent question: Are we grappling skewed perceptions of GMPs? ( With the visual of five blind men trying to identify different non compliance issues related to data integrity, lab controls, etc, the edition made the point that quality issues were like the 'elephant in the room': too big to miss, yet most pharma companies were in denial and tackled these aspects in silos. A line up of global experts gave their perceptions on this vexing topic. With global regulators making it clear that senior managements would be held accountable for lapses in quality, we hoped that the ‘elephant in the boardroom’ has been finally acknowledged and addressed. We took forward this theme in our May 16-31, 2017 GMP Special issue ( docs/ep-20170531pages) in which we focused on the upskilling initiatives of pharma companies in India, as a way to prepare their employees to follow GMPs, data integrity protocols, etc. Hopefully, such initiatives will see a reduction in warning letters and import recalls, though it will take a few more years to see the results of these initiatives. This year, we decided to explore how GMPs can and should be implemented as early as possible in the formulation research and development (fR&D) lifecycle. Regulators are asking for more details and documentation of early phase development, to check for GMP deficiencies between the development and scale up phases. Sources relate how ANDAs that do not contain evidence of development of products in accordance with the principles of QbD could face a Refusal to Receive (RTR) action or a Complete Response Letter that is equivalent to a WL for failure of the site to adhere to GMP issues. This calls for a new approach, where an integrated quality team will review dossiers before submission to identify any gaps in GMPs between development and scale up. Pharma companies have also realised the hard way that what goes in, comes out. In other words, if they use low quality inputs (raw materials, active pharmaceutical ingredients (APIs), excipients and other constituents of the final medicine), in a poorly designed and controlled production process, the output is hardly likely to be of high quality. The result? Increased chances of batch failures and non-compliance. What if we could anticipate and solve these issues in the initial phases of fR&D? Besides drug design and testing the potency of API and finding the best drug delivery platform, for novel or generic formulations, this stage also involves the selection of ingredient and excipient manufacturers for the final formulation. With pharma supply chains spanning continents, the lack of



May 16-31, 2018

Express Pharma’s third annual GMP special focuses on the need to adopt QbD as early as possible in the drug development lifecycle

consistency in quality of these excipients poses a huge problem. Poor quality or inconsistent characteristics of even one ingredient could adversely impact patient safety. Hence, the excipient industry has evolved a system of independent third party audits and certifications to separate the wheat from the chaff. The idea is that rather than test for substandard products at the final stages, why not control the quality in the early stages to prevent creation of substandard products? This approach improves efficiency of the formulation and manufacturing workflows as well as shortens development times. Early stage testing may seem logical but pharma companies traditionally tested only the finished final product, or designated testing to the later part of the production process. By this stage, it was too late to make changes and save the batch. And worse, late stage quality testing merely detected poor quality product but did nothing to detect the case of the failure or prevent future non compliance. Due diligence at this stage, both from supplier as well as pharma companies, can nip most issues in the bud. (Read how companies are coping with these issues in the story: Never too early for QbD) Industry observers also point out that the CDSCO and DCGI's office are facilitating workshops, through various industry associations like IDMA, to help pharma companies in India to evolve from Schedule M to WHO GMP compliance. A gap analysis in August /September 2015 identified the gaps in GMPs in Schedule M and WHO GMP, and today many companies are reportedly working on these issues. Just as pharma companies in India are evolving from Schedule M to WHO GMP compliance on the GMP front, there is an urgent need for a similar evolution in serialisation and traceability for pharmaceuticals exported from India. While the Directorate General of Foreign Trade (DGFT) has been working for several years to implement this system, industry observers point out that a failed and under-resourced implementation could jeopardise India’s reputation within the global pharma industry. Technical challenges, such as product numbering that does not align with global standards, are preventing the distribution of product and this will definitely impact patient access. Security problems, such as requirements to load ‘dummy’ or fake serial number data into the government database, only expand the risk of counterfeiting. While DGFT has announced a sixmonth suspension of the requirements, if these problems are not addressed in that time frame, India’s reputation as a global leader will be significantly damaged. Just as we seem to have a plan to plug the GMP gaps, we need a similar strategy on serialisation and traceability. One that will allow pharma companies in India to be in harmony with global norms. Hopefully, that is next on the agenda.



We want to be the No.1 dermocosmetic brand in India France-based, science-driven derma company, NAOS, is present in the Indian market since November 2014, has grown considerably since. The company’s brands are growing across the world and recently, it organised the first Ecobiology Summit in Croatia. Sanjay Sahu, MD, NAOS Skin Care, in a detailed conversation with Usha Sharma, shares more details about the company’s details and their plans for the Indian market Tell us about NAOS. Operating in more than 100 countries, NAOS is among the top 55 global beauty companies and one of the only ones to have preserved its independence, but it is more than a beauty company. The company is a purpose-driven with a mission, inspired by a humanist utopia. Around, 40 years ago, Jean-Noël Thorel, a pharmacist-biologist, overthrew the established understanding of the beauty industry by giving birth to a disruptive but respectful approach: ecobiology, or the art of preserving the skin ecosystem by reinforcing its natural mechanisms. Rather than over-treating the skin, it must learn how to function properly. From this idea, the brands Bioderma, Institut Esthederm and Etat Pur were born, making NAOS a major international figure in skincare. Since 1988, we are a 100 per cent French manufacturing company that guarantees the mastery of know-how and quality. All our products are manufactured in Aix-en-provence and our laboratories meet strict quality standards derived from the pharma industry. Today, still as fiercely independent as ever, NAOS has the ambition to become globally known for the universal value and the originality of its approach.



May 16-31, 2018

NAOS is a cohesive system of three skin-inspired brands. How many of its research based products are available in the Indian market? For us (NAOS), India is on high priority. We started our operations through partnership with Palson in 2010 and later in November 2014, we begun with our own operations. Currently, we have seven product ranges in India consisting of 29 SKUs growing at significant double digits. We want to be the No 1. dermocosmetic brand in India through strong focus on dermatologists. Give us a brief understanding on the company’s three brands Bioderma, Institut Esthederm and Etat Pur. How are these brands perceived across the globe? Bioderma: The brand’s approach relies first and foremost on the knowledge of the skin and its biological mechanisms to formulate products directly inspired by the skin and treat skin pathologies or imbalances. The brand is available in more than 100 countries and is part of the top five skincare brands in the dermocosmetics/ pharma distribution channel in the world. It is heavily prescribed by dermatologists

NAOS has the ambition to become globally known for the universal value and the originality of its approach

across the globe. Bioderma invented the Micellar Water technology, leading to the creation of a new beauty care category. Sensibio H20 has therefore been the first micellar water and still #1 in the market today. Institut Esthederm: Inspired by professional aesthetics and the art of beauticians, Esthederm has a different approach of beauty and ageing: a positive vision of life based on the belief that the skin can stay young for longer if you optimise its natural resources. Its mission is to help women to age beautifully, radiantly, whatever the environment or lifestyle thanks to its formulation at the cellular level. For instance, the Cellular Water, inspired from the water of the skin use in all products, allow 100 per cent active formulas to reeducate skin and reawaken cell youthfulness. The brand is available in more than 40 countries. Etat Pur: To bring the skin only what it needs. Nothing more. Nothing less. The most advanced offer in terms of ecobiology as NAOS split the products of Etat Pur into two categories : 1/100 per cent Biomimetic daily care to nourish the healthy skin on a daily basis 2/ Pure actives with highly purified molecules at an effective dose to address a specific skin problem /

imbalance and those actives are to be used only in case the skin needs it and only where it needs it (to avoid unnecessary treatment). The brand has only been present in France so far as we were refining both its offer and commercial model. The international roll out begins now in 2018. What are your marketing strategies to create brand awareness and expand footprint in the Indian market? We are a niche brands for the discerning patients who have sensitive skin and require innovative well-formulated products. We intend to reach to these class of patients through top-end dermatologists as well as targeted digital activities. For some of our customer facing brands like Sensibio we will be targeting the make-up artist as well as direct endusers through variety of medias. Could you explain more about ecobiology? Ecobiology is based on the principle that the skin is an ever-evolving ecosystem that interacts with its environment and whose natural resources and mechanisms must be preserved. Rather than overtreating the skin, it must learn how to function properly and to reactivate its

natural mechanism. The success of the three NAOS brands - Bioderma, Institut Esthederm and Etat Pur - is rooted in this shared essence. In a way we believe traditional skincare is kind of obsolete (focus on skin only, over-treat symptoms and dismiss causes, over-promise and under-deliver, product classification based on skin type and age, guilt-creating communication). Therefore, we humbly try to define a new route with our positive approach of ecobiology which resonates with a positive approach to life: act with age, not against; sun light is necessary to skin health; environment is part of skin health evolution whether you want it or not. Aggressions will remain but it is possible to accompany the skin every day and help it to better

defend itself, adapt and preserve its natural biology. How are you designing products based on different geographies? Manufacturing is done in France and our internal lab is also based in France. However, NAOS has a global network of renowned academics with whom original solutions can freely be explored in all regions of the world, the MedILS in Croatia being one example of such partnership. Besides, our decentralised governance model allows each of our markets to provide feedback to R&D and we also have a strong network of dermatologists across the globe to be sure we understand local skin specificities and skincare needs.

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Do you have plans to conduct research work in India? Will the research work be done in partnership with pharma companies/ research institutes ? We are formalising clinical studies on impact of various environmental factors adversely impacting skin and role of our brands in managing myriad skin disorders. This will be collaborative studies with top skin centres and key opinion leaders (KOLs) from India. Overall, how much investment does NAOS plan to invest in India to grow organically or inorganically? We do not have plan to grow inorganically at this stage, neither in India nor

elsewhere in the world as we want our brands to be cohesive and follow the same philosophy of ecobiology. Buying out brands from other companies is not that easy given those constraints in terms of ecobiological formulation. Having said that, we are expanding in India through more field force, higher retail as well as digital availability of our brands and close engagement with customers as well as top dermatologists. Recently, NAOS organised the first Ecobiology Summit in Croatia. Give us a summary of the summit. We believe it is new as a movement and a different that we wanted to launch with the Summit. The aim is not to arrogantly pretend we invented from the get go a

new Science with capital. I believe the following quote from Pr. Miroslav Radman is a great summary of what we humbly try to do: “I doubt that it can become a science now when it is about to be born, but I would not be surprised that one day it becomes a scientific discipline - a holistic way of thinking truth and creating values and innovations that are conceived to serve human well-being and humanistic values. The summit was attended by KOLs and 50 of those dermatologists who are key opinion leaders were present at the Summit from 35 different countries. For instance, for India we had the honour to have with us Dr Raj Kubba as well as Dr Sachin Dhawan.



May 16-31, 2018


Pharma sector clocks 66 deals worth $22.9 bn in April ’18 Crossborder acquisitions contributed majority of the deal value THE INDUSTRY reported 66 deals worth $22.9 billion in April 2018, as compared to five months average of 59 deals worth $14.9 billion. Crossborder acquisitions contributed majority of the deal value, with three cross-border acquisitions worth $15.3 billion taking place in April 2018. The biggest cross-border acquisition was Novartis’ proposal to acquire AveXis, a gene therapy company, for the purchase consideration of $8.7 billion to expand its position in the gene therapy and neuroscience sectors; another prominent crossborder deal was from Procter & Gamble, which proposed the acquisition of consumer health business from Merck for $4.2 billion to expand its consumer healthcare business. The industry reported 51 venture capital (VC) deals worth $1.7 billion in April 2018, as compared to five months average of 79 deals worth $1.7 billion. Some of the major deals announced in in April 2018 include: Allogene Therapeutics raising $300 million in series A financing; additionally, Innovent Biologics and Constellation Pharma raising $150 million and $100 million financing, respectively.

Deal Date

Acquirer (s)


Deal value (US$ m)


Novartis AG (Switzerland)

AveXis Inc (US)



The Procter & Gamble Co (US)

Consumer Health Business (India,Austria, Germany



Temasek Holdings (Private) Ltd (Singapore)

Bayer AG (Germany)



Les Laboratoires Servier SAS (France)

Oncology Business (Ireland)



Advent International Corp (US)

Zentiva Group as (Czech Republic)


Deal Date

Acquirer (s)


Deal value (US$ m)


Bellco Capital LLC; Pfizer Inc; The University of California’s Office of the Chief Investment Officer of the Regents; TPG Capital LP; Vida Ventures LLC; Undisclosed

Allogene Therapeutics Inc (US)



Ally Bridge Group; Capital Group Private Markets; Cormorant Asset Management LLC; Hillhouse Capital Group; Legend Capital Co Ltd; Lilly Asian Ventures; Rock Springs Capital Management LP; Taikang Insurance Group; Temasek Holdings (Private) Ltd

Innovent Biologics Inc (China)



Casdin Capital LLC; Cormorant Asset Management LLC; Deerfield Management Company LP; Fidelity Management and Research; Hillhouse Capital Group; NS Investment Partners LLC; OrbiMed Asia Partners; Sirona Capital; SR One Ltd; The Column Group LLC; Third Rock Ventures LLC; Topspin Partners LP; Venrock Healthcare Capital Partners LP; Undisclosed

Constellation Pharmaceuticals Inc (US)



Aperture Venture Partners LLC; BioStar Ventures; BRM Group; Deerfield Management Company LP; Edwards Lifesciences Corp; Endeavour Vision SA; Israel Secondary Fund LP; Johnson & Johnson Innovation - JJDC Inc; Pontifax L.P.; Pura Vida Investments LLC; Quark Venture Inc; Triventures

V-Wave Ltd (Israel)



Andera Partners; Biodiscovery V; EMBLVentures GmbH; IP Group Plc; Quan Capital; QUAN VENTURE FUND I, L.P.; Sofinnova Partners SAS; Takeda Ventures Inc

Crescendo Biologics Ltd (UK)


Majority of the Deal Value was Contributed by Acquisitions in April 2018

Source: GlobalData



May 16-31, 2018

Venture Capital Investments Remained Consistent in April 2018

Source: GlobalData


PharmaTech Expo 2018 & LabTech Expo 2018 to be held in Ahmedabad The event to be held from August 22-24, 2018 will see 200 exhibitors and 7000 visitors PHARMATECH Expo 2018 & LabTech Expo 2018, an international exhibition on pharma machinery, lab, analytical, pharma formulations, nutraceutical & packaging equipment, will be organised in Ahmedabad from August 2224, 2018. The event is dedicated to pharmaceutical innovation, technology and

knowledge, which will showcase the latest cutting-edge technologies needed to costeffectively develop and manufacture quality products. This year the focus will be on pharma manufacturing and processing technology, pharmaceutical systems and services, pharma formulation, nutraceutical, food and

cosmeceuticals, and ayurveda. More than 200 exhibitors with 7000 visitors are going to take part in the event. A concurrent event will be held on lab analytical and biotech instruments. Exhibitor's profile include processing plant and machineries, lab equipment, instruments and lab wares, biotechnology and clinical re-

search organisations, excipients and additives, healthcare products - ayurvedic and neutraceutical manufacturers, IPR standards and patent formulations bodies, trade associations, trade promotion bodies, software for pharma industry and management, packaging materials and machineries, water treatment,

waste water treatment and waste management, bulk drugs, intermediates and formulations, R&D, quality control laboratories, cosmetic and personal care, environment and pollution control bodies, safety equipment, track & trace solution and vision lnspection equipment. EP News Bureau

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May 16-31, 2018


iPHEX2018 held in New Delhi CDSCO announces one year extension of WHO-GMP certifications Usha Sharma New Delhi THE SIXTH edition of International Exhibition of Pharma and Healthcare (iPHEX), organised by Pharmaceuticals Export Promotion Council of India (Pharmexcil) set up by Ministry of Commerce and Industry, Govt. of India was recently held in New Delhi. The objective of three-day event was to showcase the capabilities of Indian pharma industry to the global markets. The event was attended by key decision makers of the pharma industry, regulators and representatives from the ministry. Suresh Prabhakar Prabhu, Minister of Commerce & Industry, Government of India, gave the chief guest address. In his speech he touched upon various issues and challenges faced by the Indian pharma industry. Prabhu also cautioned about the increasing health burden of non-communicable disease across the globe and spoke on how the pharma industry should leverage the opportunities. He pointed out that drying pipeline of innovative drugs and growing investment in research and development to develop newer molecules will throw up new opportunities. He opined that focussing on biotech and biosimilar products can be the future for our industry. Prabhu also pointed out the potential business opportunities existing in the African as well as LATAM markets. In his speech, he also mentioned about the initiatives being carried out by the Department of Commerce, Ministry of Commerce & Industry, and Government of India for Indian pharma industry in promoting the industry at global level. He informed that on March 26, 2018, a delegation from Chinese Commerce Ministry had visited India. They dis-



May 16-31, 2018

Suresh Prabhakar Prabhu, Minister of Commerce & Industry, Government of India delivering the chief guest address

Dignitaries during the launch of exhibitors’ directory

cussed on market penetration in India and had agreed to do a round table with their regulators to understand market requirements. While signing off, he also touched upon genomicbased science and how the industry can work in sustaining traditional medicines through advanced science platforms. The guest of honour at iPHEX 2018, Rita A Teaotia, Secretary, Department of Commerce, Ministry of Commerce & Industry, Government of India, also spoke about the growth opportunities in the de-

veloping markets and how important it is to understand their regulatory frameworks. She also indicated that the next decade is going to be an era of biotechnology and biosimilars as many drugs are going off patent and across the globe we do not have strong research pipelines. So this opens a door for us to explore and grow rapidly. Teaotia also informed about cumulative data for the fiscal year 2017-18, which shows a modest 2.91 per cent growth to $17.27 billion from $16.78 billion in 2016-17, with annualised

shipments increasing at a sharper rate, between 7-14 percent since November 2017. Shyamal Mishra, Joint Secretary, Department of Commerce, Ministry of Commerce & Industry, and Government of India spoke on how the iPHEX platform can be a win-win situation for Indian pharma companies and international visitors as well as exhibitors. Dr S Eswara Reddy, Drugs Controller General (India) shared a good news for the Indian pharma industry, and announced that the WHO-GMP

Certification has been extended to three years. Until now, it was for two years. The CDSCO office will issue an official announcement in a couple of days. He indicated that this will is increase the ease of doing business and it was a long pending request from the pharma industry. In his speech he also informed that in the last two years’ time there have been a rise of 300 per cent manpower in the regulatory framework. He also informed that the governing body has inspected 184 units of over 30 pharma companies and wherever they have found violation of rule and lack of adherance to WHO–GMP guidelines, the governing body, along with state regulatory body, are cancelling or suspending the manufacturers’ license. He also informed that in a bid to encourage clinical research in India, the CDSCO has issued a notice informing that if the applicants doesn’t receive communication from the applied regulatory authority within 45 days from application, then the applicants can consider their request as approved. Madan Mohan Reddy, Chairman, Pharmexcil said that the present government is taking steps to make India a happening place and through iPHEX, is bringing all stakeholders under one roof. He announced that next year’s iPHEX will be held in Ahmedabad. Dinesh Dua, Vice Chairman Pharmexcil delivered the welcome note and briefed on the capabilities of the Indian pharma industry. Ravi Uday Bhaskar, Director General, Pharmexcil gave the vote of thanks. He informed that formulations as bulk drugs accounting for over 90 per cent of the Indian pharma exports have shown a sharp turnaround.


Formulation Development and Drug Delivery (FDD) Conclave 2018

FDD CONCLAVE 2018 Date: 15-16 June, 2018 Venue: Novotel Airport, Hyderabad Summary: Organised the Indian Express (P) Ltd and Express Pharma, India's leading Pharma Business Magazine, Formulation and Drug Delivery (FDD) Conclave is the platform to learn about new technologies, innovations and applicable insights in a rapidly evolving segment. In its second edition, it takes a deeper dive into evolving regulations which are fundamental to the FDD scientists’ role as one of


PharmaTech Expo 2018 & LabTech Expo 2018

the key gatekeepers of a company’s future reputation and market leadership. Contact Rajesh Bhatkal T: 09821313917 Email: rajesh.bhatkal@ Vinita Hasija T: 09820590053


Gulf Congress on Pharmacy and Pharmaceutical Sciences

innovation, technology and knowledge, which will showcase the latest cuttingedge technologies needed to cost-effectively develop and manufacture quality products. Contact



Date: August 22-24, 2018 Venue: Ahmedabad Summary: The event is dedicated to pharma

Date: September 17-18, 2018 Venue: Abu Dhabi, UAE Summary: The theme of the conference is Global Innova-

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tions & Recent Advancements in Pharmaceutical Science. Pharma Conference 2018, an international event, will focus on the core knowledge and major advances in the everexpanding field of pharmacy and pharma sciences. Contact Catherine Jones Program Manager Pharma Conference 2018 47 Churchfield Road, London, W3 6AY, United Kingdom

GLOBAL PACK 2018 Date: 23-25 November, 2018 Venue: Labhganga Exhibition


Global Pack 2018

Centre, Indore, MP Summary: GLOBAL PACK 2018 is an International Trade Exhibition & Tech Summit for the packaging material, machinery and ancillary industry. Organised by Integrral Business Exhibitions & Media in association with SIES School of Packaging, 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:



May 16-31, 2018

cover )



May 16-31, 2018




Excipients make up more than 90 per cent of each pill or tablet we consume but have not been a major focus of regulators in the past. With a significant number of drug recalls traced to inconsistent quality of excipients and faulty product design, the Quality by Design approach must be implemented as early as possible in the drug development lifecycle. Recent regulations and initiatives have attempted to modernise this segment of the pharma industry

By Viveka Roychowdhury

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ood manufacturing practices (GMPs) are the foundation of the pharmaceutical sector, as they assure the patient that her medicines actually contain what they should, and will not harm her health further. Adherence to GMPs guarantee quality medicines and regulators like the US Food and Drug Administration (FDA), and European Medicines Agency (EMA), have taken the lead to demand more stringent quality standards each year. India’s drug quality watch dog, the Central Drugs Standard Control Organization (CDSCO) has also increased the level of its scrutiny of late. (See a previous story: These quality standards have evolved from testing the quality of the finished final product to testing the inputs as well as design of the entire production cycle, right from the formulation development stages. In other words, not quality by testing (QbT) of the final product but quality by design (QbD) of the process, including sourcing input ingredients of the desired quality. Industry observers point out that a lot has changed in terms of reviewing abbreviated new drug applications (ANDAs). Regulators have on occasion resorted to the Refusal to Receive (RTR) option if the application does not contain evidence that the products were developed in compliance with the principles of QbD. In some cases, if serious lapses in GMP compliance of the facility are found in the application, a complete response letter or its equivalent which is a warning letter (WL) may be issued. Thus a new approach in which an integrated quality team reviews dossiers, focussing on the possible GMP deficiencies of the concerned manufacturing plant, is very crucial. This will close the gaps between drug development and scale up. Putting the regulatory evolution into perspective, Dr Sanjit Singh Lamba, Chair- OPPI Technical & Supply Chain Committee and Managing Director, Eisai Pharmaceuticals India says, “FDA initiated quality by design (QbD) and process analytical technology (PAT) principles in 2003 with the purpose of building quality into the product right from the beginning of manufacturing. The traditional quality by testing (QbT) approach tests product quality by checking it against the approved regulatory specifications at the end of manufacturing stream.” Over the past few years, regulators have encouraged manufacturers and indeed mandated that testing should start as early as possible in the product development phase. The International Conference on Harmonisation (ICH), describes the principles of quality-by-design (QbD), in ICH Q8 (R2) as “a systematic approach to development that begins with predefined objectives and emphasises product and process understanding and process control, based on sound science and quality risk management.” As Lamba puts it, “QbD principles promote innovation and continuous improvement of the product. Knowledge-based commercial manufacturing ensures enough regulatory flexibility for setting specifications and post approval changes.” As part of this approach, he says that product and process are designed using innovative risk-based techniques to meet predefined quality objectives thereby satisfying the most critical patient needs and regulatory requirements at low cost. Innovative approaches such as quality management programmes, process capability measurements, Six Sigma, lean manufacturing and continuous improvement programmes



May 16-31, 2018

cover ) can be adopted to improve the quality of pharma products. Understanding the relationship between critical material and critical process attributes culminates in process control and continuous improvement.

Impact of low quality ingredients Ajit Singh, Chairman, International Pharmaceutical Excipients Council of India (IPEC India) and ACG, reminds us that excipients can be the major constituents of pharma dosage forms in comparison to the API. Thus they are functional and impact the performance of the finished drug product including drug delivery and stability. Suresh Pareek, Managing Director, Ideal Cures too stresses this fact, saying that excipients can make up more than 90 per cent of the dosage form and thus can no longer be considered inactive. It follows that quality of excipients have a direct impact on patient health. “Not ensuring effective quality standards of excipients used in manufacturing medicine, poses a great risk to patient safety. The impact of each excipient on the API must be studied as excipient quality impacts stability, quality, availability, tolerance and much more,” says Pareek. There have been many incidents across countries, when counterfeit or poor quality excipients in medicines have impacted patient safety, with some unfortunately resulting in fatalities. Singh recalls several incidents associated with excipients that led to the discussions that excipient pedigree must be known. For instance, incidents in Haiti, Panama and Bangladesh where substitution of the excipient glycerol by counterfeiters had lethal consequences. Similarly, in the 2006 Panamanian case, a Chinese factory was found to have exported diethylene glycol mislabelled as the glycerol suitable for use in medicines. The



May 16-31, 2018

result was some 100 fatal poisonings. The issue has been a longstanding one. Singh mentions a case from 1990, when cough syrup contaminated with solvents led to 47 reported deaths in Nigeria. Closer home, paracetamol syrup contaminated with diethylene glycol resulted in 236 reported deaths in India and Bangladesh between 1986 and 1998. A similar case of diethylene glycol poisoning led to 88 reported deaths in Haiti in 1996. Excipients cause havoc in related sectors as well, with the case of melamine contamination in baby foods manufactured in China making international headlines. The affected companies include some of the biggest names in the business. As an illustration, Pareek cites cases related to three companies Sun Pharma, Forest Pharmaceuticals and West-Ward Pharmaceuticals – which initiated recalls in 2014 due to dissolution problems related to excipients. Enforcement reports of the US FDA show that Sun Pharma’s Caraco Pharmaceutical Laboratories subsidiary initiated a recall of more than 40,000 bottles of ventafaxine hydrocholoride extended release tablets, due to failed drug release dissolution specifications. The recalled tablets were manufactured at Sun Pharma’s facility in Gujarat. Similarly, Forest Pharmaceuticals initiated a recall of 92,544 bottles of Bystolic (nebivolol) tablets due to failed stage III dissolution testing. West-Ward Pharmaceuticals recalled more than 26,000 bottles of TB drug isoniazid tablets, which failed dissolution specifications, as stability lots did not support dissolution past the 36-month time point. Such recalls are by no means restricted to US jurisdiction. Another example cited by Pareek, dated as recently as November 28, 2017,

A QbD approach (at the FR&D stage) can help avoid delay at the process validation (stage). The current scenario requires more efforts during the process validation stage which can be minimised by using QbD. Process can be changed within the design space (PAR values) which helps in avoiding updation of regulatory filings, variations and follow-ups, time and money Dr Sanjit Singh Lamba Chair- OPPI Technical & Supply Chain Committee & Managing Director, Eisai Pharmaceuticals India

concerns an alert posted by the UK regulator Medicines and Healthcare products Regulatory Agency (MHRA). Takeda UK issued a companyled drug alert for one batch of Calcichew-D3 500mg/400 IU Caplets due to traces of a nonapproved excipient. A brief description of the problem stated that the concerned batch was being recalled because ‘the product has been found to contain traces of a non-approved excipient (a Patchouli-like oil) which has inadvertently been added to the lemon flavouring used in the manufacture of the tablets. Takeda has no reason to believe that the non-approved substance poses a significant risk to public health.’

Never too early for QbD Early stage testing may seem logical but pharma companies traditionally tested only the finished final product, or designated testing to the later part of the production process. By this stage, it was too late to make changes and save the batch. And worse, late stage quality testing merely detected poor quality product but did nothing to detect the case of the failure or prevent future non compliance. Illustrating how this approach works at the drug formulation development stage, Lamba outlines four basic steps that formulation scientists need to follow to implement QbD principles as defined in ICH Q8 (R2). The first crucial step in any formulation development is to understand product profile which is called as quality target product profile (QTPP) in terms of regulatory. Once QTPP is identified, the second stage requires the formulation scientist to define what the ‘potential’ critical qualities are attributes of the product (critical quality attributes – CQAs). The third stage involves designing and implementing a risk assessment control strat-

egy to link raw material attributes and process parameters to CQAs. Once the risk assessment control strategy is implemented, the fourth stage kicks in, which involves managing the product lifecycle within the design, this becomes the basis for continuous improvement of the process. Global guidelines like the ICH Q9 Quality Risk Management, ICH Q8 (R2) Pharmaceutical development and ICH Q10 Pharmaceutical Quality systems are considered crucial to the product development stages, according to Lamba. Singh makes the point that all the stages in the product development lifecycle, from conception, product planning, design review, prototype preparation, pilot production, mass production and finally sustenance support, are interlinked system requirements for the designing, development and production. Thus, “the cost to fix problems increases exponentially as the project progresses further.” Explaining further, he says, “An ill-conceived product definition can lead to defective product design and ongoing operational problems during drug product manufacture. Each drug product is composed of an API, as well as several excipients, that serve to aid in the performance and manufacturability of the API in the drug product. Although it is clear that variability in the API will have an impact on the performance and manufacturability of the drug product, it is also now important to consider that, variability in the excipients may also impact the performance and manufacturability of the drug product. The level of impact of excipient variability will depend on the drug product, its formulation and the manufacturing process.”

The cost of QbD ... The general perception is that

( rules and regulations add to the cost and time taken. Hence introducing regulations always faces resistance and implementation challenges. But not if they are implemented from Day One of a project. Lamba stresses that there are many benefits of QbD at formulation research and development (fR&D) stage, which are crucial to deliver a cost efficient approach for delivering high quality drug substances and drug products consistently. For one, the product is developed /built considering the customer (patients') need. Secondly, a robust process is developed as it focusses on control strategy rather than testing. Thirdly, the overall development is systematic and multivariate experiments are conducted to understand the process and product which establish a design space. The fourth benefit is that the process is adjustable within the design space, which is not the case with a fixed process. And lastly, the product life cycle is managed as a preventive action rather than reactive problem solving. It boils down to managing cost versus risks. Proper implementation of QbD can in fact lead to savings in terms of both time and money. Explaining this, Lamba opines, “The proper risk assessment is key to avoid more experimentation, testing and documentation. If the control strategy and design space is well established, then there will definitely be benefits considering the product scale-up and commercialisation which can eliminate the risk of product failure and consistency in the manufacturing.� As he reasons, a QbD approach can help avoid delay in the process validation. The current scenario requires more efforts during the process validation stage which can be minimised by using QbD. The process can be



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changed within the design space (PAR values) which helps in avoiding updation of regulatory filings, variations and follow-ups, time and money.

... and how QbD cuts costs Lamba gives a classic example how having a well defined design space can be helpful for continuous manufacturing


and to provide an un-interrupted supply of quality product at a competitive cost structure. He refers to a product being manufactured at Eisai

Pharmaceuticals India for the Japan market. “During commercial manufacturing, we observed extended drying time for intermediate stage which resulted in a delay of

cover ) about seven days in the batch cycle. This is (a) huge (delay) considering the product demand and supply.” This observation required a change in the input quantity of solvents in the process. “When we approached the regulator, they accepted this change as very minor change. This is because we had considered a change within the design space and it was well mentioned and explained in the filing dossier.” In fact, not following QbD would result in significantly higher costs in the long run. As Singh puts it, “Quality issues in a product at the field level would have a very high cost to resolve the problems, these problems result in costly rework, lot rejections, product recalls and quality investigations for the manufacturer and also result in loss of credibility, low customer satisfaction, and potentially lead to plant shut downs. This

demonstrates a strong need for quality by plan and not by chance. Hence under the QbD paradigm even though costs are involved, pharma quality for generic drugs can be improved by understanding and controlling formulation and manufacturing variables.” Singh cites a few of many reports to highlight the fact that excipient variability is inevitable (See Box: Excipient variability and impact on final product). Emphasising that its influence on product quality needs to be accounted for, he says this is best done by the development of robust formulations since it is rarely successful to try to control the variability through use of tighter specifications which could have a significant impact on the availability of supply. Thus, he reasons that development of robust formulations avoids future hurdles of



arra et al. examined the physiochemical properties and lubricity of 13 lots of Magnessium stearate (MgSt) from three different vendors.They found that MgSt supplied by different vendors are unlikely to have the same physical properties, and variations in physical properties can be expected within lots supplied by the same vendor. The mean particle size of MgSt was found to be the key factor influencing its lubricant efficiency.The crystalline structure was also found to influence the compaction characteristics of the formulation, but with less impact than the mean diameter for the systems studied. In addition, Hamad et al. found variability in physical properties of different types of MgSt and these differences can influence tablet ejection force. Gamble et al. reported on the batch-to-batch and vendor-to-vendor variations in the solid-state characteristics of anhydrous lactose and the subsequent impact of these differences on functionality.The intravendor variability was generally low, although some batch-to-batch variation was observed. Not all the measured inter- and intra-vendor variations in powder properties were observed to have a significant impact on the compression/compaction characteristics. Albers et al. examined three lots of MCC type 101 from five different manufacturers for a total of 15 batches.The 15 batches showed different tableting behavior, and analysis of variance confirmed that the variation between different manufacturers and different batches of one manufacturer were statistically significant. Studies done by Doelker et al. and Williams et al. examined the impact of different MCC suppliers and within-grade, lot-to-lot variability on tableting properties. It was found that variations exist between various sources and sometimes between lots from the same suppliers.Those variations had a significant impact on tableting indices or tablet product properties. (Source: Ajit Singh, Chairman IPEC India & ACG)

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continued production, helps in the understanding of concerns during manufacture and enhances ability to appropriately attend to trouble shooting. This process also helps in answering any type of queries from FDA reviews.

Will guidelines ...

There has to be a dialogue between the Indian regulators and excipient industry. There has to be a serious initiative to understand how excipients are controlled in highly regulated regions like US and EU. Simply controlling excipients like medicines should be avoided, instead a more practical approach needs to be developed Ajit Singh Chairman, IPEC India and ACG

Such incidents highlight the importance of monitoring the quality of excipients as well as APIs. As Singh of IPEC India & ACG stresses, “Quality of the excipient is critical to the drug product and this has not been a major focus of regulators in the past. Increase in type of dosage forms, use of multi-functional excipients, upgrading industrial grade by testing it, are some of the reasons that have attracted attention to excipient quality.” A vital part of a drug formulation scientist’s concerns about implementing QbD principles as defined in ICH Q8 (R2) is identifying and putting in place a secure raw material supply chain. Excipient manufacturers have stepped in to smoothen this process. As Singh puts it, “Excipient manufacturers are proactive collaborators in identifying the critical material attributes (CMA) that may affect the product quality and manufacturing process and provide the necessary data to the pharma manufacturer.” Policy makers too have taken steps to plug these gaps. For instance, Singh points out that the Directive 2011/62/EU (Falsified Medicines Directive) mandates the Manufacturing Authorization Holder to conduct excipient risk assessment and ensure appropriate quality and GMP from the excipient manufacturer. Pareek too cites three important latest global guidelines for excipient risk assessment and ensuring product safety: The EMA Guidelines on Excipient Risk Assessment (2015), IPEC-PQG (Pharmaceutical Quality Group) GMP Guide 2006 and IPEC GDP Guide 2006, which are broadly

recognised as industry standards and are voluntarily applied to excipient manufacturing and distribution and the the NSF/IPEC/ANSI 363 standard for pharma excipient GMPs provides a harmonised and comprehensive set of criteria for the quality management systems used in the manufacture of pharma excipients worldwide.

... and third party audits ... Today, excipient manufacturers have a well defined path towards compliance via EXCiPACT, a non-profit organisation, that owns and manages oversight of an independent, high quality, third party certification scheme. The EXCiPACT website reportedly lists over 60 certificate holders based across 15 countries, ranging from major international suppliers with multiple sites, to single site, smaller suppliers in Asia, Europe, the Mid-East and North America. Manufacturing facilities of both ACG and Ideal Cures are listed as EXCiPACT Certificate Holders. Such a process, though not perfect, serves the purpose of both excipient suppliers as well as pharma companies. Justifying the need for third party audits as the best solution, Singh reasons, “Pharma companies are experiencing an increase in regulatory demands for ensuring raw materials – including excipients used in the finished drug product are safe, high quality and sourced from qualified suppliers following appropriate GMPs. This has led to an increase in audits of excipient facilities by pharma companies and excipient manufacturers are in turn experiencing increase in demand of related documentation for ensuring their site and product meet the required regulations. It is difficult for both the pharma and excipient industry to cope up with this demand. Hence an audit by a third party who is

( independent of both the excipient supplier and customer would resolve any conflict of interest.” Pareek of Ideal Cures too endorses this approach saying, “A practical approach, third party auditing helps to overcome a number of obstacles such as import related is-

The EXCiPACT website currently lists over 60 certificate holders based across 15 countries, ranging from major international suppliers sues, unexpected delays, multiple locations for audit, insufficient knowledge of inhouse auditors regarding chemicals etc. Such certification schemes help bring about harmonisation in standards across the globe, bringing it all together under one body.”

... help the two to tango? The tricky question is: who is to blame for a pill that kills? The patient knows the pill by its brand name, while the several ingredient manufacturers, remain faceless on the chemist shelf. Assuming regulators can trace the erring inputs to the source, can excipient suppliers be brought to book? It seems that excipient manufacturers, at least the more established ones with their own brand image to protect, are willing to share



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this responsibility. As Singh says, "Although it’s the responsibility of the drug manufacturer to ensure safety of the drug, it is the excipient manufacturer’s

responsibility to adequately control the excipient manufacturing process to assure consistent excipient conformance to the agreed specifications and GMP guidelines.”


This seems to be the consensus in the industry. While Pareek opines that it is the responsibility of the pharma dosage form manufacturer to ensure the safety of their drug

product and the excipients used in the formulation, he also concedes to his responsibility as an excipient manufacturer. As Pareek explains,

cover ) "While the pharma formulator is primarily responsible for identifying the particular physical characteristics needed, it is the responsibility of the excipient manufacturer to adequately control the excipient manufacturing process to assure consistent excipient conformance to the agreed specifications.” If the excipients are not in line with the proposed specifications, he opines that the excipient manufacturer should reject the lot and not release it in the market. Citing from the IPECAmericas and IPEC Europe Guidance document – “Qualification of Excipients for use in Pharmaceuticals,” Singh lists three important criteria to be met for any excipient to comply as a pharma grade excipient. Firstly, excipients must be manufactured under appropriate cGMP conditions (Joint IPEC / PQG Good Manufacturing Practice Guide for Pharmaceutical Excipients 2017). Secondly, in order to label an excipient as compendial grade, regardless of the pharmacopoeia, all monograph and appropriate General Chapter or Notices requirements ordinarily must be met. Thirdly, traceability along the entire supply chain must be established and verified.

Compliance beyond pharma As Singh points out, the excipient supplier’s business is in diverse industries like foods, personal care and dietary supplement products and pharma being a small share amongst them. “However, if an excipient supplier intends to sell a product to the pharma industry then it has to share some responsibility towards the safety of the drug products. For this, it is necessary to first understand the intended functionality of the excipient in the drug product and carefully agree to the quality specifica-

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tion with the drug manufacturer. A quality agreement is necessary. The excipient manufacturer should remain aware of new regulations, compendial tests affecting their products and ensure compliance to them.”

GLOBAL GUIDELINES FOR EXCIPIENT RISK ASSESSMENT Directive 2011/62/EU (Falsified Medicines Directive) The EMA Guidelines on Excipient Risk Assessment (2015) IPEC-PQG (Pharmaceutical Quality Group) GMP Guide 2006 IPEC GDP Guide 2006 The NSF/IPEC/ANSI 363 standard for pharmaceutical excipient GMPs

Harmonisation with national guidelines India is home to many excipient manufacturers land excipients are exported to all major geographies. Thus India’s pharma sector regulators, the CDSCO and DCG(I), can play a huge role in monitoring quality of excipients. Singh emphasises that first and foremost, there has to be a dialogue between the Indian regulators and excipient industry. “There has to be a serious initiative to understand how excipients are controlled in highly regulated regions like the US and EU. Simply controlling excipients like medicines should be avoided, instead a more practical approach needs to be developed. IPEC India can play a vital role in providing guidelines for excipients that India FDA can adopt.” As excipient manufacturers cater to multiple end user industries, like food as well as pharma, they will have to coordinate with multiple regulators. Highlighting this aspect, he points out, “There also needs to be an understanding between CDSCO and FSSAI which excipient manufacturers will need to approach due to the usability of their products in both pharma and as food additives in foods. CDSCO and FSSAI can initiate an activity that can make regulation more adaptable for excipients – have clear guidelines for them rather than simply follow the drug or food/nutraceutical regulations. Experts from IPEC groups can help develop this or can be advisors or consultant to CDSCO and FSSAI develop this.” And thirdly, Singh highlights the role of the Indian

Excipient manufacturers and pharma companies need to have a shared responsibility of ensuring excipient safety. Both parties need to work in tandem to ensure excipient safety and quality. After all, excipients form more than 90 per cent of the dosage form Suresh Pareek Managing Director, Ideal Cures

Health authorities should have a panel team, who should work jointly with the global regulators and should bring up a common conclusion on excipient regulations pharmacopoeia and informs that IPEC India is also collaborating with the Indian Pharmacopoeia Commission to update/harmonise existing excipient monographs and add new excipient monographs. Pareek recommends that the CDSCO and DCGI will need to focus on core excipient manufacturers in same way as is done for drugs formulations and APIs. "The local health authorities shall examine and audit the excipient manufacturers in accordance to the pharma GMP norms or the IPEC guidelines, that are very apt for the excipients. The process ingredients, i.e. the intermediates used in the manufacture of excipients as well the processing stages such as chemical synthesis, extraction, purification etc. should be verified and understood for better improvements. The local health authorities will then need to collaborate with the global regulators (US FDA and European regulators / TGA) and accordingly, our norms or specifications / process manufacturing steps should be made stringent so as meet with the global regulatory needs.” To facilitate this process of

harmonisation with global norms, Pareek suggests that the health authorities should have a panel team, who should work jointly with the global regulators and should bring up a common conclusion on excipient regulations.

Sharing responsibility To conclude, Pareek stresses that excipient manufacturers and pharma companies need to have a shared responsibility of ensuring excipient safety. He refers to reports that regulatory bodies in the US, EU, and Japan, as well as those in the BRICK (Brazil, Russia, India, China, and Korea) countries, are modifying existing and/or introducing new regulations for finished pharma products that specifically address excipients, either directly or indirectly. He emphasises that discussions have to occur between both parties to clearly understand the impact of every excipient used on the API. This focus is good for the excipients sector as only bonafide suppliers will survive the scrutiny. Hopefully, this will result in a more secure supply chain and ultimately safer medicine for patients.



GMP: Acontinous process Vinod Arora, Principal Advisor Institute of Good Manufacturing Practices India–IGMPI, gives insights on ways to enable cGMP to assure safety and efficacy of drug products


ood Manufacturing Practices (GMP) is a part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by marketing authorisation. GMP represents minimum standards that are necessary. Many pharmaceutical manufacturers are already implementing comprehensive, modern quality systems and risk management approaches that exceed these minimum standards.

GMP guidelines The first version of GMP guidelines for manufacturing, processing, packing or holding finished pharmaceuticals was introduced by the US FDA in 1963. Four years later, the WHO version of GMP was prepared by a group of consultants at the request of the 20th World Health Assembly. From then there were several amendments and extensions of the guidelines and many countries developed their own GMP guidelines which are based on WHO guidelines ◗ WHO GMP Guidelines –



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cover ) Primarily used by pharma regulators in developing countries ◗ International Community of Harmonisation – GMP ◗ EU-GMP ◗ USFDA –GMP ◗ GMP Standards in other countries – Australia, Canada, Japan , Singapore ◗ International Organization for Standards (ISO) ◗ Pharmaceutical Inspection Cooperation Scheme (PIC/s) ◗ Common practices within the industry license reviews, crisis management, controls also sources of GMP In 1991, GMP standards were harmonised at EU level (MHRA 2007). In 1999, the ICH, a common project of the EU, Japan and the US brought GMP for Active Pharmaceutical Ingredients which apply in signatory countries, the EU, Japan and the US and also in other countries –Australia, Canada, Singapore. GMP standards is a dynamic process and are upgraded periodically. The enforcement of GMP rests on individual states; For the US, the responsibility is with the USFDA, in the EU with National Regulatory Agencies (e.g MHRA in the UK), in Australia with Therapeutical Goods Administration, in India with Central Drugs Standards Control Organization , Ministry of Health and Family Welfare The main regulatory standard for ensuring pharma quality is the Current Good Manufacturing Practice (CGMPs) regulation for human pharma. Consumers expect that each batch of medicines they take will meet quality standards so that they will be safe and effective.

What are cGMPs? cGMP refers to the Current Good Manufacturing Practice regulations. cGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the cGMP regulations assures identity, strength, quality and purity of drug products by requiring that manufacturers of medications adequately control manu-

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cGMP regulations to assure that quality is built into the design and manufacturing process at every step. Facilities that are in good condition, equipment that is properly maintained and calibrated, employees who are qualified and fully trained, and processes that are reliable and reproducible, are a few examples of how cGMP requirements help to assure the safety and efficacy of drug products.

How does regulators determine if a company is complying with cGMP regulations?

facturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. This formal system of controls at a pharma company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards. The cGMP requirements were established to be flexible in order to allow each manufacturer to decide individually how to best implement the necessary controls by using scientifically sound design, processing methods, and testing procedures. The flexibility in these regulations allows companies to use modern technologies and innovative approaches to achieve higher quality through continual improvement. Accordingly, the ‘C’ in cGMP

stands for ‘current,’ requiring companies to use technologies and systems that are up-to-date in order to comply with the regulations. Systems and equipment that may have been ‘top-of-the-line’ to prevent contamination, mix-ups, and errors 10 or 20 years ago may be less than adequate by today's standards.

Why are cGMPs so important? A consumer usually cannot detect (through smell, touch, or sight) that a drug product is safe or if it will work. While cGMPs require testing, testing alone is not adequate to ensure quality. In most instances, testing is done on a small sample of a batch (for example, a drug manufacturer may test 100 tablets from a batch that contains two million tablets), so that most of the batch can be used for patients rather than destroyed by testing. Therefore, it is important that drugs are manufactured under conditions and practices required by the

Regulators inspect pharma manufacturing facilities worldwide, including facilities that manufacture active ingredients and the finished product. Inspections follow a standard approach and are conducted by highly trained staff. Regulator also relies upon reports of potentially defective drug products from the public and the industry. Regulators will often use these reports to identify sites for which an inspection or investigation is needed. Most companies that are inspected are found to be fully compliant with the cGMP regulations.

Top 10 observations as per US FDA Inspection ◗ Procedure not in writing ,fully followed ◗ Scientifically sound Laboratory Control ◗ Investigations of discrepancies, failures ◗ Absence of written procedures ◗ Written procedures not established/followed ◗ Procedure for sterile drug products ◗ Testing and release for distribution ◗ Cleaning/sanitising/maintenance ◗ Calibration/Inspection/ checking not done ◗ Lack of written stability programme

GMP: Challenges and issues The challenges faced by manufacturing units are:

◗ Insufficient adherence to quality standards ◗ Schedule M compliance not in place ◗ Compliance problems due to lack of awareness ◗ Products banned or recalled ◗ 19 ‘import alerts’ to drug manufacturing factories across India in 2013 The reasons for GMP noncompliance are: ◗ Complex global regulations ◗ Compressed time to market ◗ Difficulty of GMP guideline interpretation ◗ Lack of uniformity between national and international guidelines Consequences of GMP Non compliance ◗ Form 483 issued to no of companies – Lupin/SUN/Micro Labs/Aurobindo etc ◗ Warning letters to Mahendra Chemicals manufacturing facility, Gujarat, India issued by US FDA. ◗ India and China top 2013’s GMP failures , according to EMA data ◗ Between 2010 and 2013, 67 warning letters have been about cGMP non compliance by US FDA. ◗ Generic Drug Manufacturer Ranbaxy pleads Guilty and Paid $500 million to the FDA. Many a times a debate is there that if a manufacturing facility is inspected/approved by a Local Regulatory agency how come Foreign regulatory agency finds gaps in c GMP. WHO upgraded 1992 version in 2002, 2006, 2008, 2014 etc with no of supplementary guidance document ; PIC/s guidelines on GMP revised every year while in India Schedule M of GMP was incorporated in 1988 and was revised in 2001 as per WHO TRS . To overcome these noncompliance issues and to fill up the gaps it necessary that every pharma industry must train its employees. This training is scheduled in several ways. There is a basic scheduling distinction between training that is delivered in response to a perceived deficiency in per-

( formance or qualification, and training delivered according to the calendar. Training according to deficiency in performance or qualification includes new employee orientation (NEO), training for business process redesign and standard operating procedure (SOP) revision, and most technical training. In each case, trainees lack skill, information, or motivation that can be remedied by the training intervention. Continuing education programme - The process of on-going learning should be considered an opportunity, an asset to one’s profession. As with any improvement strategy in business, continued education should be thoughtfully considered. A simple analysis of

The process of on-going learning should be considered an opportunity, an asset to one’s profession one’s competency status can identify key areas which may warrant improvement or specific attention. FDA regulations call for continuing cGMP training. The regulations for finished pharma are quite explicit: “Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with cGMP requirements applicable to them”. Three points in this passage should be highlighted: the training shall be “conducted by qualified individuals,” shall be conducted “on a continuing basis,” and shall address “cGMP requirements applicable to them.”



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The EU makes a similar point about the need for continuing training in GMPs. “Besides the basic training on the theory and practice of good manufacturing practice, newly recruited personnel should receive train-

ing appropriate to the duties assigned to them. Continuing training should also be given.” Health Canada also mandates continuing cGMP training, so that “all personnel are aware of the principles of GMP


that affect them, and all personnel receive initial and continuing training relevant to their job responsibilities. IGMPI believes in the statement well quoted by Socrates that “Education is the kindling

of a flame, not the filling of a vessel.” Continuing Education Program (CEP) is provided by Institute of Good Manufacturing Practices India (IGMPI). (With inputs from Soumaya, Somaya, Asstt Professor, IGMPI)

cover ) Tweaking VModel to accelerate GMP Automations and address data integrity issues Manne V Chowdhary, CEO & MD, AmpleLogic, elaborates on how to leverage digital technology to address regulatory challenges and to upgrade the verification and validation model in pharma companies


long list of data integrity warnings received by pharma companies have made them train their focus on building and fortifying their tracking mechanisms to prevent things from going wrong. One of the solutions is digitisation and building a data repository to make it easily available to analyse issues and predict challenges. However, the current challenge is that the digital transformation is going slower than expected, resulting in engagement of quality resources for a longer time. Implementation of prevalidated softwares like LIMS, DMS, QMS, LMS are taking longer than 12 months and electronic batch manufacturing records (eBMR) are taking more than three years. Most implementations are going beyond the scheduled time due to rework and mid-way requirement changes. This impacts all the documents and hence requires repeated updations with the latest changes. These complications should be addressed with smooth and flexible methods. In general, OQ duration is 60 per cent of the total effort of a project. It is questionable whether such an effort is constructive for configurable software packages (GAMP 5 category 4). Even after investing a good amount of money and resources, they are not able to realise the expected outcomes.

Key challenges On the pharma industry front ◗ Business user requirements are not documented properly ◗ Unstable senior management. ◗ Functional requirements are not detailed enough and do not

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have traceability to user requirements ◗ Very expensive change request. (Cost of change) ◗ Inefficient cycle times ◗ Traceability matrix is not maintained or updated

documents, have to be updated. The cost of major change/requirement gaps realised in the OQ stage will turn out to be very expensive and delays the validation process. From the past 10 years, regulatory inspections focus more on software and computer system validation. Deviations have been cited across all steps of computer validation from writing specification and risk assess-

On the supplier front ◗ Rigid systems (Need to write code for every major change) ◗ Lack of domain knowledge and unskilled programmers

◗ Traditional software implementation methodologies

V Model: Verification and Validation model Most of the software implementations in the pharma industry will follow this model. The success of V Model is when requirements are well defined with no ambiguity and acceptance criteria well defined. In the V Model there are long cycle times from user requirement specification to user acceptance test and require-

ments may change in the meantime. The modelling of user requirements without seeing a running piece of software is abstract and usually requirements for modification arise when the final user deals with the running software for the first time. The traditional V model software implementation methodologies will not create an interest among the business teams as it takes longer to address a change. If any changes happen midway, then the test documents, along with requirement

ment to IQ/OQ/PQ, revalidation, reporting and change control. The traditional V Model: It must be revisited based on our real time experiences One important aspect is the Configuration and Experimentation phase. The introduction of this phase in between the User Requirement Specification and Functional Requirement Specification of the V model will help the business users in understanding the pre-validated software and relating the soft-

ware with his problem statement. This approach helps in realising the requirements before the finalisation of functional requirement specifications. The business user’s clear on the software outcome. Adding the Configuration and Experimentation phase in the implementation cycle will address regulatory audit observations related to revalidation, deviations and multiple release managements. The Configuration and Experimentation approach cannot be achieved through traditional configurable softwares. The configurable Software must have visual modelling capabilities which are commonly known as No code/Low Code Development Platforms. These platforms support Visual Modelling (The user can see the making of application) The organisations must ensure that software service provider agrees to offer configuration and experimentation as part of the V Model. If the prevalidated software or configured software follows this model, implementation times can be reduced by 70 per cent. This way, gaps can be easily identified during the Configuration and Experimentation phase and as implementation time gets reduced and allows us to complete OQ in 25 per cent of the total project time.

No code/Low code Platforms These platforms allows business and IT to collaborate in realtime, using visual models to capture business requirements as well as quickly iterate and scale

( apps while ensuring nothing gets lost in translation. Platform allows users to quickly turn their ideas into building up applications and transforming their manual processes to digital within days. No-code development platforms provide drag-and-drop tools that allow business process engineering (BPE) teams to develop software quickly without coding. The platforms provide drag-anddrop components to quickly assemble and design applications at reduced timelines and efforts. They also help increase the business productivity and efficiency at the work levels. Both developers and non-developers can use these tools to practice rapid application development with customised workflows and functionality. Global enterprises are looking for No Code Platforms to build actionable digital strategies for every part of their business. When prevalidated GMP softwares like QMS, DMS, LMS, eBMR and Batch Issuance softwares were built on using this No Code/Low code Platforms then addressing the Requirement gaps or change will be faster and minimal time with less no of people involvement. Even change management becomes easy using No Code Platform. Processes can be changed every now and then, even for a small change in traditional approach will take months’ time, using No-code platform can happen in days’ time.

The platforms offer ◗ Visual modeling of business logic and workflows, with the ability to extend with custom code ◗ Visual definition of data models ◗ Drag-and-drop implementation of modern user interfaces for multiple devices ◗ Application change and lifecycle management

Way forward for pharma organisations This is the time for pharma organisations to step towards se-



May 16-31, 2018

lecting prevalidated softwares with visual modelling capabilities (No/Low Code Platforms) that helps business users in appealing digital experiences with human readable application models by keeping the cost


Way forward for IT organisations Software suppliers must focus on increasing speed with visual modelling instead of focusing on


the documentation during finalisation of requirements. IT wings of pharma companies/IT organisations should invest in No/Low code development platforms, limiting the communication by keeping less resources

and more productivity. The adoption of these platforms that are designed to empower application development professionals in IT to accelerate app delivery for more architecturally complex applications


Pharma companies – using digital to create connections and customer value Life sciences companies now have a new source of competitive advantage. – use digital to build direct relationships with customers and partners, highlight Rishabh Bindlish, Managing Director, Accenture Strategy – Life Sciences, Accenture in India and Sunit Sinha, Managing Director, Accenture Strategy – Talent & Organization, Accenture in India


eaders are already doing it. They are using digital technologies to connect directly with physicians, healthcare service providers and patients, augmenting existing channels. Several of them are using apps and websites to provide comprehensive medical information to build differentiated relationships. Take the case of Ciplamed1 which is being used by Cipla to connect with healthcare professionals. The portal provides a range of evidence-based and clinically relevant practice resources across 18 medical specialties. There’s also Teva’s ‘Pharma Touch’2, a mobile application complete with drug libraries, dosing guides, drug interaction tools, daily summaries of research published in medical journals, detailed clinical recommendations and much more. These companies are using digital technologies to also reach out to end users. Again, Cipla has strengthened its

28 EXPRESS PHARMA May 16-31, 2018

Rishabh Bindlish Managing Director, Accenture Strategy – Life Sciences, Accenture in India

brand connect with patients with respiratory illnesses using ‘Breathefree’3, a mobile applica-

tion and a website that answers patient queries on asthma, its treatments, myths, patient stories, and local events, and also links them to the right doctors in their vicinity. Similarly, Sun Pharma’s ‘RespiTrack’4 app tracks treatment progress by allowing patients to record details of attacks along with medication details. It also helps them increase their compliance to medication via medication reminders and alerts. Novartis and Sanofi5 are leveraging social media to target relevant consumer groups with personalised communication. Sanofi has a dedicated Facebook page, twitter account and blog for diabetes patients, while Novartis launched a HeyMS campaign on YouTube and Facebook with patients sharing their own stories to create awareness about Gilenya, its drug for the treatment of multiple sclerosis. Mobile apps are also handy for medical sales representa-

Sunit Sinha Managing Director, Accenture Strategy – Talent & Organization, Accenture in India

tives who get very little time with healthcare practitioners. The average length of a medical

sales representative’s call with a healthcare provider (HCP) has dropped from six minutes several years ago to three minutes. With the reduced face face-time with doctors, apps help medical representatives make the most of the time available with them, increasing productivity. The apps guide the entire selling process including supporting pre-call planning based on previous interaction records and doctor’s preferences, and providing timely and relevant content recommendations – maximising the use of face time with doctors. The sales representatives can order real time on apps, while they are talking to the doctor, saving on note taking and follow up time, as well as reducing errors. Over time, digital tools like mobile applications or websites create a wealth of user data that companies can use to sharpen service delivery and retain customers, helping enhance their competitive advantage.

Needless to say, merely building mobile applications and websites is not enough. Special attention has to be paid to design a user experience which caters to all the constituents in the value chain including sales representatives, doctors, hospital representatives and patients. The focus should be on creating a unique and end-to-end user experience that considers all touchpoints of the user journey, but more importantly recognises that the broader, enabling role that a healthcare company can play in providing holistic solutions that add real value to patients.

To build a user-friendly experience, companies must Listen through multiple channels: Monitor what patients are saying across multiple forums including company website, Facebook, Twitter and other social media platforms to get critical insights. Companies can now receive alerts when there is a potential brand reputation crisis and have systems in place to respond to the situation effectively. Instead of conducting timeconsuming focus groups and market research questionnaires, they can benefit from lower cost interactions with customers, and by providing more opportunities for customers to self-serve through shared information and mutually supportive relationships online. Create a strong value proposition: Create a patient-centered marketing strategy and integrated communication plan, including both online and offline interventions. Patients are consumers, too, and their digital experiences with direct-to-consumer leaders have conditioned them to expect engaging interactions organised around their interests and requirements—a far cry from the forms and boilerplate on offer from most healthcare providers. Life sciences companies need to engage patients at key moments along their individual journeys – facilitate understanding of risk, create awareness of the disease, engage customer at the point of diagnosis, facilitate doctor discussions, drive behaviour change in the first 90 days of treatment initiation, as well as help monitor and support patient lifestyle on an ongoing basis. Build profitable patient relationships: Work in tandem with patients in building solutions, in partnership with institutions, physicians and patient associations. If an ongoing sustainable relationship is built with patients, institutions and physicians, by establishing mutual trust, companies can benefit by getting a plethora of useful data on

patient preferences, effectiveness of medicines in the market, key pain points of patients and physicians, and so on. These insights, if then used for product development and for improving service, will directly benefit the patient and physician communities. Capture the value: While profits are a clear indicator of the value captured, healthcare outcomes and positive patient behaviour are clear indicators of sustainable value. This value can be captured only through two-way communication between patients and lifesciences companies. If lifesciences companies get access to timely patient feedback on products and services and potential future needs, value can be captured faster and create competitive advantage for companies. Patients would also get benefit of this two-way communication as it can be used to raise awareness and nudge patients to take proactive action. Accenture research6 shows patients value services but are often unaware of them. Combining information and services with medication builds relationships, reduces costs and improves outcomes. Designing, implementing, managing and leveraging digital platforms to deliver an integrated and differentiated user experience requires investment, not just in technology but also in people. The workforce needs to be skilled for a digitally evolving environment. Together with a digitally savvy workforce, companies that capture the imagination of consumers and become part of their daily wellness experience will lead the life sciences industry.

References 1. 2. . 38527898/pharmatouch-pharmacyreource-application 3. 4. https://cio.economictimes.indiatimes. com /news/mobility/sun-pharmasrespitrack-mobile-app-to-boosttreatment-compliance-amongstasthma-patients/52190194 5. /110117/ digital-pharma-sanofi-discuss-diabetes-blog 6. T225006__w__/hk-en/_acnmedia/PDF21/Accenture-16-2058-Adobe-Life-Science.pdf

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May 16-31, 2018


The story of the pill Is a pill, just a pill? Most definitely not. In the first of a series of six articles, Organisation of Pharmaceutical Producers of India (OPPI) launches the Know Your Pill initiative, to educate patients on the untold story of the medicine and the intrinsic value of quality that make a pill much more than just a pill

Have you ever heard the story of the pill? As we set out to tell you the fascinating story of the pill from the lab to the market, we recognise that some of the chapters in this story would read- A pill is more than just a pill; Good medicines come in quality packages; The journey of the Pill; The Pill House and finally The Rotten Pill. Each time we pop a pill, feed syrup to littles ones, vaccinate our babies or inject a medicine into our critically-ill loved ones, the most obvious is the hope that all the above will work. But, we are totally oblivious to the untold story of the medicine. While it owes its existence to research and discovery, the intrinsic value of the pill in its living form lies in its quality. Quality does not confine itself to manufacturing only. It includes packaging, labelling, transportation and storage of a medicine. All of these elements in the supply chain are critical for a medicine to retain its effectiveness. Quality in general is a comparison to standards. Pharmaceutical quality is very specific because for each pharma product like a tablet or capsule, there are specifications. And within tablets there are individual specifications for each individual product. There is a specification for each pharma dosage form and there is also a quality specification for each therapy area product that they need to comply to if one says that these products are meeting the quality specifications. Packaging and labelling of medicine is

30 EXPRESS PHARMA May 16-31, 2018

critical. Uniform standard needs to be adhered to, in terms of aesthetics as well as functionality of the medicine, to ensure patient safety is not compromised. The journey of the pill from the factory to where the pill will be housed, or the pharmacy, needs to be strictly adhered to as it can alter the efficacy of the drug. Fluctuating temperatures and humidity levels can render pills less effective. Temperature-controlled supply chain including transportation and warehousing need to be complaint to acceptable quality standards for the drug to maintain the chemical balance in the human

body. The presence of the pill in the pill house needs to follow standards of storage: the way it is shelfed and arranged, the temperature conditions at the pharmacy, the display of medicines, cannot be under -valued. Finally, we have the problem of the rotten apple, or rotten pill as in the case of medicines holds true. According to WHO estimates, one in 10 medical products circulating in low- and middle-income countries are either substandard or falsified. That includes pills, vaccines and diagnostic kits. Another concurrent concern are counterfeits which pose a huge threat to patient safety. A stringent use of the law on sale of spurious drugs and constant surveillance to weed the rotten pills would be most needed. Sub-standard quality especially in medicines is unacceptable. Millions of people all over the world are alive and in good health today because they have ‘trusted’ the pill to do its job. Trust that is a result of doctor patient relationship and in the pill that is expected to do its work. Good manufacturing practices, good distribution practices, good storage practices and good quality control practices make for a ‘good’ pill. Thus, making for a good end to the story of the pill being more than just a pill! -Issued in public interest by OPPI Watch this space for the second in the KYP series- Why a pill is more than just a pill?


IITRoorkee Researchers identify molecule with antiviral activity against Chikungunya virus The research was funded by the grant from the Department of Biotechnology


ndian Institute of Technology Roorkee researchers have identified a molecule that exhibits antiviral activity against Chikungunya virus. The antiviral activity achieved around 99 per cent reduction in the virus. At present, there are no drugs or vaccine available in the market to treat Chikungunya disease. The Research Team led by Prof Shailly Tomar, Department of Biotechnology, IIT Roorkee, used structurebased studies of Chikungunya virus specific nsP2 protease to identify molecules — Pep-I and Pep-II — that exhibited protease inhibitory as well as antiviral activity. Speaking about the importance of this research, Prof Shailly Tomar said, “The nsP2 protease is a strict viral enzyme. Means it is absent in humans, and thus, is an excellent antiviral drug target for chikungunya virus. Our re-

search group has targeted nsP2 using biochemical and structure-based approach. We identified a molecule that not only possesses anti-nsP2 activity but also effectively kills the chikungunya virus in the cell based assays.” The Research was funded by the grant from the Department of Biotechnology (DBT) and published recently in the Elsevier journal. One of the two molecules — Pep-I — has higher antiviral activity against chikungunya virus. The PeP-I molecule inhibits the enzymatic activity of nsP2 viral protein and in cell based assay proves to be an effective antiviral molecule. Speaking about the future work that is going to be done in this direction, Prof Shailly Tomar said, “Derivatives of PeP-I and PeP-I like molecules are being developed that will be tested for their antiviral potential in animal model” According to the researchers, any molecule that inhibits nsP2 protease should possess antiviral activity. To test the hypothesis they carried out antiviral studies using cell lines. The PepII molecule showed reduced antiviral activity of only 50 per cent even at a higher concentration of about 200 microMolar. The antiviral activity was tested by adding the molecules directly into the virus culture. The two molecules also reduced the viral RNA thus confirming the antiviral activity. According to Harvijay Singh, the research scholar from the Department of Biotechnology, IIT Roorkee, the other first author of the paper, “We developed a high throughput FRET based nsP2 protease assay and inhibitory activity of the two molecules PeP-I and Pep-II was confirmed using this biochemical assay.” EP News Bureau

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May 16-31, 2018


Research team uncovers mechanism of action for pore-forming bacterial toxins The findings could help combat associated diseases and advance crop protection PORE-FORMING toxins are common bacterial poisons. They attack organisms by introducing holes in cell membranes. A team of scientists at the Technical University of Munich (TUM) has now unravelled the mechanism of action for one of these toxins. The findings could help combat associated diseases and advance crop protection. Pore-forming toxins are bacterial poisons that destroy cells by creating holes in the cell membranes. Many bacterial pathogens produce such toxins, including, for example, some strains of the intestinal bacterium Escherichia coli as well as Yersinia enterolitica, a pathogen related to the plague. They attack all kinds of organisms with the help of their toxins – from plants to insects, and even humans. Scientists all over the world are trying to understand how these toxins produce the fatal openings in cell membranes in hope of one day inhibiting the pathogenic, pore-forming poisons. After several years of research, an interdisciplinary team from the Technical University of Munich managed to

elucidate the mode of action of a toxin subspecies in which two components interact to develop the deadly effect. Combining crystallographic and cryo-electron microscopy methods, Bastian Bräuning and Professor Michael Groll from the Department of Biochemistry, in collaboration with Eva Bertosin and Professor Hendrik Dietz from the Department of Experimental Biophysics, managed to shed light upon the precise molecular structures of the soluble indi-

vidual components, as well as the pore complex. “We determined that only one of the two components is able to bind to the membrane. In a second step it recruits the other component and the base domains of two proteins together form the basic pore unit,” explains Bräuning. “This is a new kind of mechanism from which we can obtain much useful insight.” The structure of the resulting hole in the cell membrane resembles a crown, whose

teeth comprise 40 subunits of the two interacting partners. The team of researchers led by Bräuning and Groll investigated the interaction of the two partner proteins in form of toxins from Yersinia enterolitica and Photorhabdus luminescens. The latter is a symbiotic bacterium in nematodes that attack insects and might prove useful for the development of novel insecticides. These new insights put the development of substances that inhibit the interaction of

two toxin components, and therefore prevent the formation of pores into the realm of the conceivable. “Our combination of crystallography and cryo-electron microscopy was key to understanding the necessity of the two-component construction of the toxin from a biochemical perspective,” explains Professor Michael Groll. “This insight will also help us understand more complex variants in the future, for example those in which three components work together.” The work is the result of close a cooperation between the professors of Biochemistry and Biophysics at the Technical University of Munich. Both working groups are part of the Cluster of Excellence Center for Integrated Protein Science Munich (CIPSM). The results were validated by the Department of Pharmaceutical Chemistry and Bioanalytics at the Institute of Pharmacy of the Martin-Luther University Halle-Wittenberg. The X-ray structure data were collected at the synchrotron light soYour data has been truncated. EP News Bureau

FDA approves Novartis combo therapy for aggressive type of thyroid cancer This is the first FDA-approved treatment for patients with this form of thyroid cancer and the third type of cancer with this specific gene mutation, the FDA said THE US Food and Drug Administration (US FDA) approved Novartis' combination therapy to treat an aggressive type of thyroid cancer. The therapy, which uses Novartis’ Tafinlar and Mekinist, was approved to treat anaplastic thyroid cancer that cannot be removed surgically or has spread to other parts of



May 16-31, 2018

the body, and has a type of abnormal gene known as BRAF V600E. This is the first FDA-approved treatment for patients with this form of thyroid cancer and the third type of cancer with this specific gene mutation, the FDA said The company has been expanding the use of this drug

for other diseases as well. In combination, Tafinlar and Mekinist are approved for use to treat a type of lung cancer that has the BRAF V600E gene. The FDA had last month approved the combination to treat a type of melanoma. Reuters


It’s serialisation – Just not as you know it If Indian pharma firms are to continue to manufacture and export internationally, then they must start taking a hard look at the evolving international serialisation requirements. Rose Campasano, Vice President of Professional Services, rfxcel, gives an insight


n recent years, India has come to the fore as a major player in the global pharmaceutical market. According to the India Brand Equity Foundation (IBEF), the Indian pharma market is the third largest in the world by volume and 14th largest by value (approximately `1.95 trillion, or $30 billion)i. Today, pharmaceuticals manufactured in India account for approximately 10 per cent of the world’s pharma volume and are exported to more than 200 countriesii, with further growth expected. While India has taken important first steps in helping to ensure the security of the global pharma supply chain - largely through its leadership in recognising the importance of pharma serialisation and traceability processes - recent international regulatory changes are now having a significant impact on the data, connectivity and technology infrastructure companies must have in place. With the clocks counting down for pharma companies to not only comply with the EU Falsified Medicines Directive (EU FMD) and US Drug Supply Chain Security Act (US DSCSA) regulations, but also to understand the unwritten rules of supply chain best practice, if Indian pharma firms are to continue to manufacture and export internationally, then they must start taking a hard look at the evolving international serialisation requirements.

Serialisation Law Serialisation is the process by which products are marked with a standards-based unique identifier— typically a unique number or alphanumeric code—and is the enabling technology for systems and processes to enhance supply chain security.

The regulatory push to secure the pharma supply chain comes as a result of rising drugrelated criminal activities and supply chain inefficiencies. Efforts are aimed at addressing drug counterfeits, unauthorised parallel supply chains, improving supply chain visibility, difficulty in tracking returns/ recalls and scarcity of data-driven tools for predicting patient behaviour. However, serialisation of pharma (i.e., applying the unique identifier to medication packaging) itself provides virtually no benefit to the supply chain. Rather, it is the use of that serialised data in a manner to efficiently realise the goals of the end-to-end system that enhances supply chain security. This complementary use of the serialised data is commonly referred to as ‘traceability’ or ‘track-and-trace.’ India has made great strides toward improved supply chain security through serialisation requirements and the creation of a traceability system, with most manufacturers beginning their serialisation programmes to satisfy the Directorate General of Foreign Trade (DGFT) requirements for export markets, laid out in early 2011. In 2015, a further draft proposal for domestic drugs was published, but no timelines have been established for the adoption of that set of serialisation, labelling, and reporting regulations. Latterly, further regulations across the globe have started to take shape. Passed in 2013, the US DSCSA roadmap for end-to-end traceability is stretched across a period of 10 years, with deliverables outlined for all entities of the supply chain. In the US, lotlevel traceability began in January 2015 under the act with

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package-level serialisation to be completed by November 2018, following an extension granted by the FDA in June 2017. The entire supply chain is expected to be electronically integrated and all nodes of traceability to be established by November 2023. The European Union (EU) has followed suit with a compliance requirement by enacting Falsified Medicines Directive (FMD). Unit-level serialisation and dispenser authentication has been mandated by February 2019. India being a major exporter to the US, Europe and other regulated markets, these regulations have a significant impact on Indian pharma manufacturers, and the trend is now clearly visible. The end objective of all the regulations is traceability, where serialisation is acting as the key enabler. Taking a cue from these global proceedings, Indian manufacturers are being urged to review at their serialisation programmes with traceability as a core component of their strategy.

Serialisation in practice Serialisation and traceability require three key components: an understanding of all products distributed through the supply chain; an understanding of all

parties that participate in supply chain; and a mechanism for identifying and ensuring the good standing of all parties that participate in the supply chain. To achieve this understanding, and then be able to act it, is a significant undertaking. It requires the implementation of processes and software to generate, affix, and capture data related to the unique identifier. It may also require the potential reconfiguring of packaging lines, which in itself takes time to install and validate. In addition, systems and processes between downstream trading partners, such as wholesalers and pharmacies, must be in place to receive, ship and dispense products. And, particularly in relation to the US market, full traceability requires serialised packages to be aggregated to cases, bundles, pallets, and other logistical units. As its most basic, if the data isn’t in the system, then the product can’t get through the supply chain. Finally, the systems must be in place for the serialised data to be submitted to the relevant regulators and databases, from DAVA, to the FMD EMVO hub and the FDA in the US. Finding a serialisation partner who is GS1 compliant and registered with the EMVO hub is critical.

Implementing serialisation and traceability Appreciating the complexity of the regulatory requirements, those organisations embarking on their serialisation and traceability journey should adopt a comprehensive approach to ensure success. 1: Get executive buy-in Serialisation is a board level issue, with ramifications that could directly affect business performance. It is a business continuity risk that touches

every aspect of an organisation. So the first step is to appoint an executive sponsor, ideally with board level oversight, to lead a holistic strategy. 2: Assemble a multi-disciplinary team Multi-disciplinary engagement is essential. Many organisations don’t understand all their business processes in sufficient detail to overlay serialisation. It’s therefore vital that a multi-disciplinary team (MDT) is convened at the earliest opportunity to map the process flow of the business and establish a roadmap of how serialisation can be applied across multiple organisational boundaries. An MDT should actively engage representatives from manufacturing, supply chain, IT, legal/regulatory and partner/contract management. 3: Understand the data implications of FMD The barcodes required must include 4 lines of data; the unique identifier or Global Trade Item Number (GTIN), serial number, batch number and expiry date. These datasets often live in disparate systems within organisations. The master data – including GTINs – is fixed information that’s commonly stored in an enterprise resource planning (ERP) system. Having said that, many Indian pharma companies, whilst serialising, currently may not be applying numbers that are internationally compliant. Today’s serialisation and traceability requirements demand that organisations are registered with the global standards authority GS1. As part of the GS1 registration process, organisations are effectively buying the licence to use the intellectual property known as the GS1 identifiers (GTINs) to globally identify your company and products



May 16-31, 2018

PHARMA TECHNOLOGY REVIEW and converse with other companies. around the globe. Even with the relevant licences and identifiers in place, the master data still requires attention to ensure it’s clean and accurate when uploaded to the repositories. In terms of variable data, the processes required to generate serial numbers, transfer them to production and ensure they’re used appropriately are complex. Managing that immensity of numbers throughout the supply chain lifecycle is hugely important; mistakes can lead to expensive delays, medicines shortages and loss of revenue. Serialisation software is therefore an essential requirement to help you maintain control of all aspects of fixed and variable data. 4: Choose the right software There are numerous factors to consider when selecting software: Quality Serialisation should not be divorced from the founding principle of Good Manufacturing Practice (GMP) – quality. GMP guidelines, as well as data integrity advice from regulators

such as the UK MHRA, state that users of computer systems must always be in control. However, multi-tenant serialisation solutions (where multiple independent entities share the same instance of a software solution) can sometimes impose software updates without prior dialogue, leaving users out of control. The potential impact on quality is significant. Passive acceptance of change is not an option. Multitenant solutions require licenseholding companies to ensure that risk assessment processes are in place to monitor and adapt to change. By contrast, the most effective solutions allow users to maintain control of their specific software instance and to dictate the timing, relevance and nature of upgrades. Data validation An effective solution will focus on both connectivity and data integrity. Some systems concentrate on enabling a connection and flow of data across and between organisations but are blind to data quality. Companies should never assume that the data entering, or generated

within, their systems is clean, tidy and accurate. Internal data checks are essential. The best solutions routinely monitor data to detect human error, inaccuracy and duplication. Smart solution providers validate data flowing through a system – in some cases up to 70 data validation checks on incoming records to ensure its integrity - essentially preventing bad data entering the EU or DAVA hubs. Network connectivity It’s not enough to ensure your own business is ready: your partners must be ready too. With outsourcing now common across the industry, it’s important that the software you use connects all parties to a single version of the truth. The most effective solution providers understand the varied nature of the connections you are going to have to make and will commit to connecting your entire partner network as standard. This means more than just having a potential connection – it means working with you and your partners to make

sure that data really flows end-to-end across the supply chain. 5: Choose the right partner Finally, it’s important to find a vendor that can partner with you to design responsive solutions that go beyond technology. As stated above, certification of your vendor by the European Medicines Verification Organization (EMVO) is a pre-requisite if you want to be compliant. In addition, a partner should be a recognised provider with experience, credibility and evidence that shows it can implement effectively within tight timeframes, including a “follow the sun” implementation model, operating across a number of time zones to ensure that time zone issues don’t become your stumbling block. A good partner will be committed to your success, keeping you abreast of fluctuating global regulations, and collaborating with you to customise solutions that adapt to changes in your business and the wider market place.

Conclusion Serialisation and traceability are significant undertakings, but compliance to international regulations and understanding of supply chain best practice are vital to the continued growth and success of the Indian pharma market. Investing in a trusted partner, who understands all the nuances of the international landscape and has the relevant registrations, resources, technology and processes in place, can help you successfully navigate hitherto uncharted territory. The serialisation standards by FMD will impact all corners of the pharmaceutical industry. Choose a partner wisely to ensure they have the expertise and experience to assist you on your journey. References i. India Department of Pharmaceuticals, Indian Pharmaceutical Industry—A Global Industry, available at: ii. Indian Brand Equity Foundation, India Pharmaceutical Industry.


Clean room high speed doors a necessity DOES YOUR business plan include the development of an area in your plant for clean manufacturing? 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

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clean room high speed doors specifically designed for above purpose. The clean room high speed doors are best suited for facilities where you need controlled environment. The opening and closing of door is quick enough to separate outside environment and internal facility.

process. Clean rooms have become an integral part of pharma manufacturing facilities. One of the most important aspects of cleanrooms is the door one chooses 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 quick enough to isolate the outside environment and internal facility. Gandhi Automations provide

High speed clean room doors designed by Gandhi automation are engineered carefully with feature below:◗ Concept of low air permeability in pressurised rooms with positive and negative air pressure ◗ Designed to fit inside the columns ◗ Self-supporting construction ◗ Minimises air leakage ◗ Can be equipped with trans-

parent 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, India Off: +91 22 66720200 / 66720300(200 Lines) Fax: +91 22 66720201 Email : Website:


Compliance guide to 21 CFR part 11 The execution of 21 CFR Part 11 might look costly as well as might require a lot of work, but this has definitely standardised the process for electronic records. An insight by Pooja Patil, Corporate Communications, B&R Industrial Automation

EVERYONE IN in the pharmaceutical industry is well aware of the stringent laws and standards being set by the US Food and Drug Administration (FDA). The US FDA is responsible for the safety and efficacy of medicines and food products. It has comprehensive laws and regulations for pharma manufacturing practices to ensure quality, purity and safety for individuals. Sometimes, the smallest deviation from standards can result in entire batches being rejected or recalled after they are out in the market. In grave circumstances, a company’s license could be at stake. Compliance with standards, allows pharma companies to enhance product quality and meet standards. All these stringent requirements, task pharma companies across the globe to examine data at every stage of the manufacturing process, right from the time raw material arrives until the final product is packed and shipped for distribution. In many ways, data quality is extra important for pharma companies. After all, mistakes in this industry can literally be fatal. In traditional pharma facilities, the references and information about drug formulation, production and equipment and data of QA-QC were manually entered in data sheets, which were prone to human errors or could stand a chance of manipulation. The pharma industry needs accurate and reliable data to ensure safety, efficacy and quality of products. FDA has answered these challenges with 21 CFR Part 11 regulations.

Benefits of 21 CFR Part 11 The 21 CFR Part 11 regulations

and customise necessary audit trail functionality. mapp Audit runs directly in B&R automation system. System manufacturers and end users benefit from maximum security without having to implement organisational measures to prevent tampering on the control system.

Automatic data exchange made possible

allow pharma companies to use electronic records and signatures in lieu of paper records and handwritten signatures for documentation. Several benefits of compliance were identified by pharma industry in terms of data authenticity, increased speed of information exchange, cost savings from reducing storage space, reduced errors and data mishandlings, product improvement, streamlining manufacturing process, improved process control and reduced vulnerability of electronic signatures to fraud and abuse. The execution of 21 CFR Part 11 might look costly as well as might require a lot of work, but this has definitely standardised the process for electronic records. The early adoption of this regulation can lead to more efficiencies and productivity within organisations. Eventually, this regulation can also reduce products time to

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market and increase traceability, which is better for manufacturers, distributors and consumers.

B&R making audit trails easy As use of automated processes has become more prevalent in pharma industry so too has the use of electronic records with the introduction of 21 CFR Part 11. B&R’s automated solutions directly addresses all regulations prescribed by 21 CFR Part 11. B&R satisfies FDA requirements by its range of hardware and software that are fully compliant with FDA 21 CFR Part 11 regulations. With mapp Technology, B&R provides customers an add-on package of technology libraries that support all FDA criteria for electronic records and signatures. Data security, data integrity, traceability and electronic signatures are a few basic require-

ments of 21 CFR Part 11. B&R thoroughly addresses these requirements of security by restrictive access to data through mapp Technology. It allows different levels for access control so users can only access data that is at their assigned level. Applications subject to FDA's 21 CFR Part 11 requirements can be developed faster and with less investment risk using mapp Audit. All user actions are logged with a timestamp and username. The data can be exported as an encrypted PDF. It has the ability to retrace actions performed on a machine that can also be of great service to its manufacturer in event of warranty claims. Pharma companies demand ability to log operations performed by users seamlessly without the risk of being tampered with. B&R’s mapp Audit component serves as a quick and easy way to implement

Designing audit trails can be difficult and time consuming. However, with mapp Technology, there is no need to write programmes for audit trail function; all that is needed is to configure the machine-specific parameters. Thus, mapp Technology enables users to configure more and programme less with mapp Audit eliminating the need of writing lengthy programs for audit functions. Machine builders only need to configure the machine-specific parameters. The data can be output in an encrypted file or viewed on the HMI screen using the integrated mapp Audit visualisation. mapp Audit automatically retrieves information it needs about operators from mapp User component using the client-server principle. Audit trail data is stored in memory with a checksum mechanism for tamper resistance. mapp Audit enables pharma machine builders to review operator activity in order to determine whether a system has been used appropriately. It is equally possible to determine whether equipment has been used outside the specified operating times – an indication that employees are engaging in unauthorised production for their own profit.



May 16-31, 2018

PHARMA TECHNOLOGY REVIEW A revolution in automation software The advances in software offers integrated approach to pharma machine builders to achieve operational excellence, increase effectiveness, comply with everincreasing regulations, improve time-to-market and meet business goals. With mapp Technology, B&R offers modular software components that handle the basic functions of any pharma machinery and equipment. mapp Technology helps machine builders to configure more and programme less. The modular software blocks simplify the development of new programmes and reduce the development time for new machines and systems by an average of 67 per cent. mapp Technology is preprogrammed software components, which are thoroughly tested â&#x20AC;&#x201C; ready to use with just a few configurations by the developer. mapp Technology has been developed from vast experience gained by B&R in implementing hundreds of thousands of automation solutions around the world making them extremely reliable. With mapp, machine downtime

Applications subject to the FDA's Title 21 CFR Part 11 requirements can be developed faster and with less investment risk using mapp Audit

due to programming errors is a thing of the past. The investment risks are drastically reduced. In addition, efficiency is

increased and maintenance costs are reduced by using mapp that have been fieldtested in thousands of applica-

tions. In addition, they are maintained by B&R. mapp Technology also comes with full documentation and help functions to

round off the toolkit. In addition, machine builders can lest rely on the world-class support provided by B&R across the globe.


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Global leaders bring invaluable skills, knowledge Troubled by regulatory authorities due to quality issues, Indian pharma companies are looking at global talent, both expat and Indian, primarily in the R&D, manufacturing and quality domains, explains Vishnu Channon, Delivery Leader - Healthcare and Lifesciences, Stellar Search to Viveka Roychowdhury Brian Tempest was one of the earliest examples of global talent heading a key function (R&D) at a big Indian pharma company (Ranbaxy). As Indian companies grow their geographical footprint not just in sales but also the manufacturing side, they have recruited expats. For example, US nationals to head their US business. But have they also hired expats for India HQ-based roles? Has the trend picked up? Definitely! Indian pharma majors have been quite open to the idea of hiring expats for HQ-based roles in the recent past which is clearly an emerging trend in the industry. Though I believe there is a long way to go as it’s still in an exploratory mode. Who are the prominent examples of this trend in the recent past and today? The most recent example is Dr Reddy’s Labs as they hired former Teva executive Erez Israeli as Chief Operating Officer and Global Head Generics & PSAI Business. Sun Pharma also hired Benny Klener as Global Head of Manufacturing Operations. Klener stayed with Sun for almost four years and moved back to Israel in 2017. Sun hired another senior leader from Teva to integrate their global supply chain operations who left last year. What has been the average tenure of such expat postings? It ranges between 2-4 years. In most of the cases, expats aren’t too comfortable to be based outside their home

54 EXPRESS PHARMA May 16-31, 2018

country for a longer tenure. Which are the functional areas where Indian pharma companies look for senior level global talent? In order to deal with cutthroat competition in the generic pharma space, companies seek innovation, continuous improvement and cost efficiencies and hence, they look at global talent primarily in the R&D, manufacturing and quality domain. Global leaders bring invaluable skills and knowledge with regards to the next generation technology, high quality standards, best practices and state-of-the-art facilities. Most of the Indian pharma companies have been in trouble with regulatory authorities due to quality issues. Hence, it becomes extremely important for them to have excellent manufacturing and quality leadership to ensure that globally accepted quality practices are followed. With Indian organisations aspiring to lead the global biopharmaceutical market, we also foresee the growing demand of biopharma technocommercial experts in India. Besides expats, we also have examples of India-origin talent who have experience overseas and then are headhunted by the top 10 Indian pharma companies for key positions. Any prominent examples and again, what drives this trend? After spending over a decade working overseas with global pharma companies, leaders of

Recruiting Indian talent from overseas is comparatively of greater comfort for both employers as well as candidates

Indian origin hone their skills to stand at par with expat talent. Recruiting Indian talent from overseas is comparatively of greater comfort for both employers as well as candidates. While being a better cultural fitment and an assurance of a longer tenure from employers perspective, candidates also have greater motivation of returning to their native place and living closer to their family, especially when they are in late 40’s/ early 50’s. In many such cases, it’s a winwin situation. Prominent examples include Gaurav Mathur, Managing Director, Teva API India; Pradeep Sanghvi, Executive Vice President, R&D, Sun Pharma; Umang Vohra, Chief Executive Officer, Cipla; Kailash Pathak, President, Manufacturing Operations, Neuland Labs; Vishvesh Bhupathiraju, Vice President & Quality Head Biologics, DRL and Parth Sampathkumar, Associate Vice President & Head Quality Control, Biologics, Biocon . Some of them have completely relocated to India while a few travel extensively between India and the US. We also have the example of a India-origin talent heading global pharma, like Vasant (Vas) Narasimhan, who was Global Head of Drug Development and Chief Medical Officer for Novartis and now is CEO. Do you see such possibilities increasing? Absolutely. Global pharma giants like Merck, Teva, Mylan have outstanding Indian talent in their management teams which significantly

increases the probability of having more Indian CEOs’ in the next few years. Other market leaders like Pfizer, GSK and BMS also have several seasoned professionals who have showcased exciting accomplishments and potential of leading a large organisation. While their Indian peers are looking at global talent, most MNC pharma have chosen to hire Indians to head their India operations. Beyond the rationale that local talent would understand the local market pressures better, do you think there are other considerations? For most pharma MNCs, overall India and South Asia operations are predominantly managed by home grown leaders with well rounded and recognised experience of working across geographies. They have deep-rooted understanding of systems and processes, policies and culture of the organisation. The scale and size of technical operations of MNC peers is relatively smaller than the Indian companies, their facilities are highly automated and also very closely overseen by the regional/global teams. Do you see this trend, of hiring Western talent for key positions, in pharma companies of other nations, like China, Japan, etc? It’s a rising trend in pharma companies across Korea, China and other South Eastern countries.


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Express Pharma (Vol.13, No.14) May 16-30, 2018  

India's Foremost Pharma & Biotech Magazine

Express Pharma (Vol.13, No.14) May 16-30, 2018  

India's Foremost Pharma & Biotech Magazine