IPC 2018: Roadmap To Make India Global Pharma Leader

DECEMBER, 2018

www.expresspharmaonline.com This issue is brought to you by

FOREWORD Chairman of the Board Viveck Goenka Sr. Vice President-BPD Neil Viegas Asst. Vice President-BPD Harit Mohanty Editor Viveka Roychowdhury*

Pharma Vision 2030: What is your role?

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t’s December and time for another edition of the Indian Pharmaceutical Congress (IPC). As the Official Media Partner to IPC 2018, we thank Bodh Raj Sikri, Chairman,

BUREAUS Mumbai Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das, Swati Rana, Prabhat Prakash

Local Organising Committee (LOC) and Atul Nasa, Organising Secretary, LOC for entrusting Express Pharma with this responsibility. With their cooperation, we will

amplify the knowledge and insights that will be shared at this august gathering.

Now in its 70th edition, the very first IPC was held in the year after we gained inde-

New Delhi Prathiba Raju

pendence. As it grew over the past seven decades, each year has seen leaders from in-

DESIGN Asst. Art Director Pravin Temble

we have Dilip Shanghvi, Managing Director, Sun Pharma as President and Chief Patron, of the 70th IPC. His guidance has shaped the programme into a confluence of the best

dustry, academia and regulatory personnel taking on the role of the President. This year,

minds and insights from industry, academia and regulators.

Chief Designer Prasad Tate

This year, the grounds of Amity University Campus, Delhi-NCR will host IPC and the proximity to the nation's capital adds yet another layer of gravity to the theme: ‘Pharma

Senior Designer Rekha Bisht

Vision 2030: Indian Pharma Industry-Global Leader’. Secondly, the event is being steered

Graphics Designer Gauri Deorukhkar

ations of the Indian Pharmaceutical Congress Association. Thus, the focus of the pro-

Senior Artist Rakesh Sharma Digital Team Viraj Mehta (Head of Internet )

by the Indian Pharmacy Graduates' Association (IPGA), one of the five federating associgramme agenda will be to match industry's requirements with reality, so that each member of the industry will have some answers to the question: what is my role in Pharma Vision 2030? How can I prepare for this role and ensure that the Indian pharma industry becomes a global leader?

This special supplement from Express Pharma, to be distributed during IPC 2018, has a collection of messages and thoughts from a wide selection of the event organisers. They

Photo Editor Sandeep Patil

are stalwarts of the industry, people who have chosen to squeeze out time from their already busy schedules, to personally steer and attend to each painstaking detail of this

Marketing Team Rajesh Bhatkal Ambuj Kumar Debnarayan Dutta Ajanta Sengupta E Mujahid Nirav Mistry PRODUCTION General Manager BR Tipnis Manager Bhadresh Valia Scheduling & Coordination Arvind Mane CIRCULATION Circulation Team Mohan Varadkar

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event. They have sacrificed their precious family time, upset their work-life balance for the better part of the past year, all so that the event surpasses their aspirations for the sector.

Their messages serve as sneak peek into the thought process and planning that went into the event. A special mention must be made of the student volunteers who have infused this event with a special vibe. They are sure to learn a lot from this experience.

We also have a section featuring a glimpse of some key topics we covered in Express Pharma in The Year That Was. We hope this timeline will serve to help us pause and reflect on the hits as well as misses, the lessons learnt and gear up for the years ahead.

Do watch out for special detailed coverage of the IPC 2018 as it unfolds, on our Twitter handle: @ExpPharma as well as our website: http://www.expressbpd.com/pharma/.

And of course, catch a full report in a forthcoming issue of Express Pharma.

We wish all our readers and industry colleagues all the best for 2019!

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

I N T E R V I E W

‘70th IPC will showcase the latest technological developments in pharmaceuticals, drugs and formulations’ BR Sikri,LOC Chairman,70th IPC speaks on the need to restrategise to enhance our preparedness to a global pharma leader and elaborates on the initiatives undertaken by this year’s IPC in this direction,in an interaction with Usha Sharma Kindly elaborate on the theme for 70th Indian Pharmaceutical Congress (IPC). How will this year’s edition be different from previous ones?

The theme of 70th IPC is ‘Pharma Vision 2030: Indian Pharma Industry-Global Leader.’ According to India Ratings, the Indian pharma industry is estimated to grow at 20 per cent compound annual growth rate (CAGR) over the next five years. On the global front, the IPM is ranked 13th in terms of value.

Owing to robust growth, India is likely to be the 9th largest market globally in absolute size. Besides the domestic market, Indian pharma companies also have a large chunk of their revenues coming from exports. Many top pharma companies have revenues coming in from the sale of intermediates, active pharmaceutical ingredients (APIs), and formulations in

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various global markets.

These include developed markets like the US, Europe and Japan as well as semi developed markets across the world. Some companies also derive revenues by providing custom research and manufacturing services to innovator companies.

Biopharmaceuticals is also increasingly becoming an area of interest given the complexity in manufacture and limited competition.

India’s manufacturing sector contributes about appreciable per cent to the GDP. The Make in India campaign which was launched in September 2014 also aims to increase overall manufacturing share by 2022. So, the vision behind this campaign/theme is to put the country on the global manufacturing map and in turn, facilitate the inflow of new technology and capital, while creating a large number of jobs. This time we are focussed on industrial participation and improving preparedness to be a global leader in the pharma sector.

What is the core objective of this year’s IPC theme and how will it help the industry in expanding their international presence?

The core objectives of 70th IPC are – ◗ Project the latest technological developments in pharmaceuticals, drugs and formulations. ◗ Project the status, facilities and services on R&D, quality control, government . regulations and controls, rules and procedures. ◗ Supply of plant, machinery, process control equipment, projects and services etc. ◗ Showcase the latest products, machinery, equipment developments in the industry for generating business and test marketing. ◗ Technology adaptation and up gradation.

This year’s IPC will showcase guest lectures

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◗ It is also going to be the first time ◗ This time we have maximum industry speakers from India and overseas ◗ Training placement and entrepreneurship fair for student delegates ◗ Women empowerment sessions – A lot of importance is being given to women empowerment ◗ Spiritual and motivational session by Anandmurti Guru Maa ◗ Participation of medical devices and cosmetics manufacturers ◗ Better synergy between industry-academia

from internationally recognised speakers, scientific sessions, plenary sessions, key stakeholders’ Meet, Health Startup Hackathon, placement and entrepreneurship fair and pharmaceutical expo. This year’s conference will be hosted by Indian Pharmacy Graduates’ Association (IPGA), which is a Federating Association of Indian Pharmaceutical Congress Association (IPCA) along with other four associations namely; All India Drugs Control Officers Confederation (AIDCOC), Indian Hospital Pharmacists Association (IHPA), Indian Pharmaceutical Association (IPA) and Association of Pharmaceutical Teachers of India (APTI).

Dilip Shanghvi, Managing Director, Sun Pharmaceuticals have consented to preside over the 70th Indian Pharmaceutical Congress in 2018 at New Delhi and I, (Managing Director of ABS Mercantiles, would be the Chairman of the Local Organizing Committee

of 70th IPC. RC Juneja, CMD, Mankind Pharma and Dr Ashok K Chauhan, Founder President, Amity Group of Institutions are Chief Patrons of the Indian Pharmaceutical Congress.

This year our focus is mainly going to be on ‘IndustryAcademia Relations.’ To achieve this objective, we are expecting micro, small, medium and large scale pharma industry to get involved in this mega event so that this vital industry objective of broad-based development and large scale employment generation for young pharmacists is achieved.

Will there be any new initiatives during the congress? And how will it add value to the current IPC as well as to the Indian pharma industry?

Yes, there will several new endeavours such as: ◗ Interactive CEO conclave will be held for the first time ◗ Vice President of India to inaugurate the event

Besides participation from bureaucrats, pharma companies, regulators, academia and key opinion makers, this IPC will also see participation from embassy consulates, how it will further strengthen our relationships with them?

It will definitely help to: ◗ Promote peace and stability in regions of vital interest ◗ Help developing nations establish stable economic environments that provide investment and export opportunities in pharma sector ◗ Bring nations together to address global health problems ◗ Lead inter-agency coordination in developing and implementing foreign policy in pharma IPC is a platform that caters to both industry and academia, how has this concept evolved over years?

The academia and industry have been collaborating for over a century, but the rise of a global knowledge economy has intensified the need for strategic partnerships that go beyond the traditional funding of discrete research projects. World-class research universities are at the forefront of pioneering such partnerships. They are designed to run longer, invest more and gear up for future.

In short, they transform the role of the research university for the 21st century, anchoring it as a vital centre of competence to help tackle social challenges and drive economic growth. There are several advantages of industry-academic collaborations, including the merging of fundamental and applied research.

Universities are more focussed on the creation of fundamental knowledge, industry on the other hand is focused on innovation, i.e. applying fundamental knowledge for the development of products and technology. The role of the academic institutions can thus be seen as stimulating and enhancing the power of research and development in industry. Clearly, there exists an interdependent relationship between the universities and industry; created knowledge has to be applied and companies need to apply knowledge to ensure profits and sustain growth.

This interdependent relationship can be cultivated and maintained to enable both entities to sustain growth in their respective areas.

Why do you think pharma education need focus, how does it help to boost the overall pharma industry?

In this world of specialisation and globalisation, pharmacy education in India is suffering from serious backdrops and flaws. There is an urgent need to initiate an academic exercise aimed at revamping of curriculum, to keep pace with current and emerging trends in the field of pharmacy. Many patented drugs that are expected to go off patent.

This will trigger a war of sorts among generic manufacturers to file Abbreviated New Drug Applications (ANDAs). India, as a generic hub, will also be party to this. In 2013 itself, India had submitted 112 ANDAs to the Food & Drug

Administration (FDA) and Indian generic exports have an annual growth rate of 27 per cent. These figures itself lend credibility to the belief that Asia’s Diamond will continue to be a strong generic player. Although known for its generic prowess, a few Indian pharma companies have tasted success in manufacturing innovative drugs with Ranbaxy’s Synriam being the first New Chemical Entity (NCE) to emerge from India. Such breakthroughs in manufacturing both APIs and formulations can be attributed to the tenacity of the pharmacists working in the industry. But, as the industrial demand for competency is constantly increasing, the educational domain will have to undergo changes to match industrial requirements. India is producing well skilled pharmacists who are equipped with the requisite, specialised skills and technology and assured supplies of energy in all major domains of the pharma sectors.

Pharmacy practice is still in the initial stages of development in India, but the launch of Doctor of Pharmacy (Pharm. D) study programme has ushered serious discussions about clinical pharmacy in the country. As the profession is in budding stage in the country, the patients, physicians, nurses, other healthcare providers, will work on the collaborative manners in order to attract medical tourism. Newer pharmacy practice regulations are important to bring avenues in consultancy and counseling in pharmacy services for patient care and pharma care.

The medical devices sector has been identified by the government task force as one of five key sectors which can be a driver for the Make in India campaign.

Additionally, manufacturing

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and employment opportunities are huge as this sector is import dependant of over 70 per cent. Moreover, within the electronic medical device segment the import dependency is almost 90 per

cent. Genericisation is growing in leaps and bounds in our country where qualified pharmacists will play a pivotal role to make medicines accessible, available and affordable.

How many scientific research papers were sent and how may will be presented in the 70th IPC Congress?

We received 3127 poster presentations and 106 oral

presentations this year. After critical reviewing of the content/abstracts, the total number of accepted papers are 2163 and 35 respectively. u.sharma@expressindia.com

MESSAGES FROM THE INDUSTRY BR Sikri, Chairman, Local Organising Secretary, Indian Pharmaceutical Congress-2018

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et me at the outset congratulate Express Pharma for their long and untiring journey towards improving the healthcare sector by way of their positive and constructive reporting. Their official media partnership with LOC of IPC in the past and at present is also another feather in their cap as both the organisations are working towards a common goal, i.e. To create awareness among the masses about various growth challenges, new innovation, new concepts, market demand, world scenario of health care sector etc. Online as well as print editions are key features of Express Pharma which is attracting readers at large.

As pharmaceuticals are part of the life science industry, there is a lot we have to do to further accelerate the growth rate and make this industry

more inclusive. I am confident that our economy now has the steam and the energy to move to a higher growth trajectory. It is high time that the Indian pharma industry also comes forward to contribute our share in the growth of economy. I am confident that our Government will take all necessary steps to sustain the buoyancy in the economy and the optimism of investment in areas like R&D, innovation, drug discovery ecosystem and so on and so forth.

Strengthening this industry requires many inter-ministerial decisions as well as close coordination between the enter and the states. Active pharma ingredients (APIs) is another area which is almost neglected.

As a result, our dependability of 70 to 80 per cent on one single country is a big threat to our national security. It is also

the duty of the government to create an environment conducive to improved economic performance. It is equally the responsibility of the industry to ensure that our companies become more globally competitive.

These are good times for our Indian pharma industry.

But with greater opportunity comes greater responsibility

too. We must pay due attention to improved corporate governance of the pharma sector. We must all be sensitive to the urgent need to protect our environment and to prevent degradation of our land, water and air resources. Our industry carries a big responsibility of doing R&D for new APIs to reduce the dependability on China, to protect the environment and maintain balance in both the areas. If we act wisely and with the best interest of the country at heart, we can transform our industry in a positive way with the overall interest of patients at large. I believe we are on the threshold of a new era of knowledge based developments. The country requires long term and strategic thinking. As captains of Indian pharma industry, we all can play a pro active and constructive role in this regard.

It is with this sense of patriotism and forward looking thinking, that the Indian Pharmaceutical Congress (IPC) came into existence. I urge the next generation to continue to work with that spirit of our founders and stay faithful to their grand vision and aspirations.

I wish Express Pharma a grand success for the noble cause which they have taken up. I also wish them a very happy and prosperous new year well in advance which is yet to come.

I wish Express Pharma a very active and productive time ahead. I am impressed by the quiet efficiency of the Express Pharma team thank them for the media support that has been extended for the many initiatives of our Congress.

Jai Hind Jai Bharat.

Dr Madhu Chitkara, Vice Chancellor, Chitkara University, Punjab he 70th Indian Pharmaceutical Congress envisages the rise of Indian pharma industry as a Global Pharmaceutical Leader by 2030 as a major force, as the theme of the conference and the vision statement. It sends out a strong signal that all the stakeholders that make the Indian pharma industry, viz, entrepreneurs, policy makers, regulators, researchers, innovators, executives, academicians, educational entrepreneur and the

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diaspora of young undergraduate, post graduate and doctoral students, may align their activities in the desired direction.

A good policy support by the Government of India in various aspects of working and business of pharma industry are making sure that Indian pharma industry projects the right picture globally of being appropriately regulated, rational and innovative. India has envisioned and attracted International companies domestic

manufacturing advantage with low cost and efficiency, and Indian entrepreneurs will take the vision forward.

By having achieved 30 per cent by volume and 10 per cent by value of $ 80 Billion generic market, and The Indian pharma industry is expected to grow at 22 per cent CAGR by 2020 to reach $ 55 Billion from $ 33 Billion and exports about to touch $20 Billion by 2020, making it the a leading player in generics, Phytopharmaceuti-

cals, biosimilars and the biologicals and biotechnology industry is taking great strides motivated by increasing share of biological in the pharma market with monoclonal antibodies and humanised proteins making therapy and management of complicated diseases like cancer, arthritis, diabetes possible. These with Phytopharmaceuticals industry will add to the vigour of Indian Pharma industry. Wishing all a very good conference.

Dr Ashok K Chauhan, Chief Patron, 70th Indian Pharmaceutical; Congress 2018 & Founder President, Amity Universities and Institutions In recent years, the profession of pharmacy is on a good growth path and India’s pharmaceutical industry has grown by leaps and bounds, which has resulted in India becoming the world’s third largest producer of drugs in terms of volume.

The Indian government has also taken concrete steps to reduce healthcare expenses, ensure speedy introduction of generic drugs into the market, introduction of new rural health programmes, lifesaving drugs and preventive vaccines which has been welcomed by the pharmaceutical companies.

However, with the changing global scenario, harmonisation of regulations in conformance

with the international standards and practices is the need of the hour. There is an urgent need to reinforce and rebuild standards with statutory bodies and to restore the confidence of pharmacy graduates.

The quality of education has to be improved by industrial participation so that the stakeholders are accepted in the global pharmaceutical industry. The regulatory policies of India are to be harmonised, so that India becomes global leader in pharmaceuticals including generics, API's, medical devices and diagnostics.

It gives me great pleasure that the historical event of the 70th Indian Pharmaceutical

Dr Mahesh Burande, Director, Institute of Pharmaceutical Education & Research, Medical Director, Nulife Pharmaceuticals and President 69th IPC

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s a Ex President of 69th IPC 2017, I wish 70th IPC a grand success under the Presidentship of Dilip Shanghavi. This congress will provide big platform to discuss challenges and opportunities for Indian pharma to build quality in their product and

give quality service in understanding the regulatory requirements of World. LOC under Chairmanship of BR Sikri with secretary Atul Nasa, Arun Garg and Dr Bhatiya and team members made all efforts to make this IPC most memorable.

To subscribe: bpd.subscription@expressindia.com

Congress, 2018 is being held at Delhi/NCR from December 2123, 2018 at Amity University Campus, Noida, with the theme

Prof ROOP KRISHEN KHAR(KILAM), Professor & Principal, B S Anangpuria Institute of Pharmacy

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he countdown for the 70th IPC has begun. Through the esteemed columns of Express Pharma group I send my good wishes for the grand success of the Congress. My good wishes to the office bearers of LOC and specially the dedicated team of volunteers. We are all ready for a great and memorable professional event.

"Pharma Vision 2030: Indian Pharma Industry - A Global Leader" bringing about the excellence of IPCA and Amity.

Five years back, in 2013, IPGA in association with Amity University organised the 65th Session of IPC with overwhelming response at the lush green, the State of the Art Amity Campus, Noida. The Congress was attended by more than 6,000 delegates, brilliant brains, highly successful and with great farsightedness, researchers, pharmacy graduates, post graduates and Ph D Scholars, professionals and opinion makers and thus the Congress was named as Maha Kumbh of the Pharmacy

attended by professionals from all states of the country as well as from different parts of globe.

This time, emphasis would be laid on the synergy of brains, the MISSION: CONNECT and the MISSION: OUTCOME which would result in providing opportunity to each delegate to achieve in his/ her academic and research career as well as professional career to fulfill own dreams.

I wish all delegates, the worthy speakers and all participants to have an enriching and fruitful time at this congress and return with great enrichment and memorable experiences.

Dr Subhash C Mandal, Vice President & Chairman, Regulatory Affairs Division (RAD) Indian Pharmaceutical Association

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feel proud to be associated with the Indian Pharmaceutical Congress (IPC) since 1988 and closely associated with Indian Pharmaceutical Congress Association (IPCA) since 1995.

I am sure that under the Presidentship of Padmashree

Dilip Shanghvi the 70th edition of the Indian Pharmaceutical Congress (IPC) will be successful and will give a fillip to every sector of pharma profession like- industry, research, regulatory, education, hospital and community pharmacy.

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LOC of 70th IPC organises review meeting at FICCI House Organisers of 70thIPC will be organising a breakfast meet of top 50 pharma CEOs with Venkaiah Naidu, Vice President, India Usha Sharma New Delhi

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he second last meeting of 70th Indian Pharmaceutical Congress (IPC's) Local Organising Committee (LOC) was held on December 1, 2018 at FICCI House, Delhi. The meeting was attended by key members of 28 different task committees. They reviewed the work progress of 70 th IPC. During the course of the meeting, it was announced that on December 8, 2018, LOC members will perform Bhoomi Poojan at Amity Campus, to begin work on this year's IPC. In his introductory address, BR Sikri, LOC Chairman of 70 th IPC motivated all the members and encouraged them to go the extra mile to make this year’s IPC successful and memorable. Anticipating the success of 70th IPC, he commented that the CEO meet over breakfast with Venkaiah Naidu, Vice President, India, which will comprise top 50 CEOs of pharma companies, will certainly add a feather to IPC’s cap. He also elaborated on how this year’s IPC will be different from past IPCs and help facilitate meaningful dialogue between the industry and the regulators.

Updating the members about key developments which are being finalised, Atul Nasa, Organising Secretary, 70 th IPC informed informed that Jagat Prakash Nadda, Union Minister of Health and Family Welfare has already sent his message for the success of 70th IPC and is likely to attend the congress.

Nasa also informed that Manasvi, an Indian supermodel, a Bollywood actress and a Former Miss India, will be the Chief Guest of Cultural Nite on December 22.

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After Nasa, the Chairperson of each committee showcased the development of their respective committees and highlighted their problems and majority of those issues have been resolved during the meeting.

Until now, the congress has

received 5000 registrations including volunteers. The numbers are expected to cross 6000 through spot and ongoing industry registration process. In anticipation of a huge number of participants, the LOC has also made strict security arrangements, and

all the entries passed will be QR coded at this year's congress.

With special emphasis on women's safety, the LOC has also made arrangements for the accommodation of 150 girls; student and volunteers within the Amity University

campus. The congress will also have a 'Walk for Cause' fashion show on Day 2 of the congress.

The LOC also informed that success stories of pharma companies such as sun Pharma, Zydus Cadila, Mankind Pharma, Hetero

Drugs and Delvin Surgicals will be deliberating their stories with delegates at the event. The congress will also have training and placement sessions during the three-day event. u.sharma@expressindia.com

CONTRIBUTOR’S CHECKLIST ❒ Express Pharma accepts editorial material for

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

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

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

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

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

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

I N T E R V I E W

‘Government can play an important role as a catalyst for encouraging many more Indian participation abroad’ Professor Sunita Shailajan, Professor and Head, Department of Botany; Dean, Research, Development and Innovation, Ram Narain Ruia Autonomous College; divulges details on her research projects, past and recent achievements, ways to encourage researchers in the country and more, in an interaction with Express Pharma

Congratulations on your student winning the gold prize at International HPTLC Symposium in Bangkok, last week.

Thank you very much. It was indeed a proud moment for me.

I owe my success to my research guide Dr Naresh Chandra (Former Pro-VC, University of Mumbai) and my mentor, late Prof. R. T. Sane, (Former Principal of Ruia College), who introduced me to the world of applied chromatography.

I could excel in my research

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CSIR-Indian Institute of Chemical Technology (Under Ministry of Science & Technology, Govt. of India) Tarnaka, Uppal Road, Hyderabad – 500007, Telangana, INDIA CSIR-Indian Institute of Chemical Technology (CSIR-IICT), Hyderabad, a constituent laboratory of Council of Scientific & Industrial Research (CSIR) is a leading research Institute in the area of chemical sciences. The core strength of institute lies in Organic Chemistry, and it continues to excel in this field for over seven decades. The institute is proud in celebrating its Platinum Jubliee, in the year 2018. The R&D efforts during these years have resulted in the development of several innovative processes for a variety of products necessary for human welfare such as drugs, agrochemicals, food and drugs, APIs and intermediates, organic coatings, polymers, catalysis, adhesives, fluorine products, renewable & nonrenewable energy and many more. More than 150 technologies developed by CSIR-IICT are now in commercial production.

One of the main strengths of CSIRIICT is its rich pool of scientists and research scholars numbering over 700 which creates the right ambience for generating knowledge and translational research for industry and society. This institute has active collaborations with several countries including France, Germany, UK, Switzerland, Italy, USA, Australia, Japan, Korea etc., and several students have been benefitted from various exchange visits and postdoctoral programmes.

CSIR-IICT provides knowledge based services for physio, chemical and thermal characterisation of heterogeneous and homogeneous catalysis, custom synthesis, molecular modelling for drug design, combinatorial libraries, drug master files, chemical finger printing, invitro & invivo entomological/toxicological/pharmacological screening of bioactive molecules, basic/design engineering packages for pilot plant and commercial plant for upscaling processes, process simulation, optimisation, control, process safety and reaction engineering. It has state of art facilities like National Molbank, HTS for chemical library generation & screening, LC-MS, NMR (upto 700 MHz), Laser Raman, Ultrafast Laser spectroscopy, Fluorescence correlation spectroscopy, Automated synthesizer, XRD, SEM, TEM, AFM, ESCA, etc.

CSIR- IICT encourages Public Private Partnership to undertake Innovative research by providing expertise and infrastructure.

Contact details: Director CSIR-Indian Institute of Chemical Technology Tarnaka, Hyderabad – 500 007, Telangana, INDIA Telephone: +91-40-2719-3030 : Fax: +91-40-2719-0387 Email: director@iict.res.in Website: www.iictindia.org

An Institute with Industrial Outlook and Academic Ambiance

work with the continuous support and encouragement that I received from my formal principal and current Vice Chancellor, University of Mumbai, Prof. Suhas Pednekar.

Finally, this was possible because of the constant proactive support received from the progressive College management.

Please tell us about yourself I have completed my masters and doctoral degrees in Botany from the University of Mumbai and have been in the field of teaching for the last 36 years.

Currently, I am Professor and head of Botany department at Ramnarain Ruia Autonomous College and also the Dean of Research, Development and Innovation. I have guided ten doctoral students till date and currently 06 students are working for their doctoral research with me. My research interests are mainly in the areas of collection of authentic plant material, evaluation of quality and efficacyof medicinal plants and their formulations.

What are your research activities?

I have successfully completed several research projects funded by various governmental funding agencies such as Department of Biotechnology (DBT), National Medicinal Plants Board (NMPB), Department of Science and Technology (DST) (with Marico India. and CLRI, Chennai), Board of Research in Nuclear Sciences (BRNSDAE), AYUSH (With Zandu India.), Indian Council for Medicinal Research (ICMR) and by the University Grants Commission (UGC). I have completed 13 research projects till now and currently one extramural research project funded by DST – SERB, is ongoing in our Herbal Research Lab. Under the project funded by AYUSH, we prepared SOPs of twenty six complex Ayurvedic formulations and these SOPs’ have been submitted to AYUSH, GOI. I have also contributed monographs of

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I wish and hope that the final formulation reaches the market and is used by the clinical practitioners. I am also proud of the fact that my research students are making significant contributions in herbal Industries.

Which chromatography method you prefer and why?

As my area of research is medicinal plants, I prefer HPTLC because of its simplicity, convenience, flexibility and versatility.

medicinal plants in the Quality Standards of Indian Medicinal Plants published by Indian Council of Medicinal Research, Government of India and have published 111 research papers in peer reviewed national and international journals. 71 papers out of them are based on research on HPTLC fingerprinting, quantitation of phytochemical markers and pharmacokinetic studies using ICH and USFDA guidelines.

I am also the reviewer for research papers for many peer reviewed journals like Journal of Ethnopharmacology, PLoS One etc. and have also reviewed project proposals for the funding received by National Medicinal Plants Board, GOI. What is the title of your research paper that won this award?

The title of the research presentation which won the award was ‘Pharmacokinetic evaluation of a polyherbal

formulation using HPTLC technique’. The work encompassed the HPTLC based estimation of the potent phytomarker berberine from the well-known Ayurvedic polyherbal formulation Pushyanuga Churna using a US – FDA validated HPTLC method.

What are your past achievements?

Amongst the notable achievements of my research, I would list the inclusion of 23 SOPs developed at Herbal Research Lab (Ruia College) in Ayurvedic pharmacopeia as the best. HPTLC based quality evaluation method developed by me have been accepted by several manufacturers of Ayurvedic formulations. In addition to this, I could also provide HPTLC based methods for quality evaluation of medicinal plant based formulation to be exported from India.

How do you compare HPTLC with HPLC? HPTLC and HPLC have their own specific advantages depending on the objective of the analysis that you undertake.

In medicinal plants based research, HPTLC is more economical in generating baseline analytical profiles of complex mixtures of phytochemicals. In the analysis of complex herbal plants and their formulations, HPTLC is obviously the more convenient method as we can evaluate many parameters at the same time and can easily apply the method to a variety of samples with diverse matrices. It is more versatile and easy to carryout trial and error procedures while developing and standardizing analytical methods for complex mixtures.

One more important area where HPTLC scores over HPLC is sample processing.

Unlike HPLC, HPTLC does not require excessive clean-up of the biological matrix. But, HPLC definitely will be used by me at an advanced stage of

Team from Ramnarain Ruia Autonomous College with the organising committee of HPTLC ASIA - 2018

analysis requiring higher accuracy in quantitation as HPLC is more sensitive and more reproducible.

You and your team of four students managed to attend the Symposium Yes! The symposium gave a great opportunity to my students where theycould interact with scientists, industry personnel and young researchers on the same platform. I am sure this exposure will contribute in enhancing the quality of their research and eventually help them in their career.

Our team could attend this conference partly because of the sponsorship provided by Anchrom Enterprises Pvt. Ltd. towards the registration fees.

They have been doing it in the past also.

One of the students had received the Netravali Travel fellowship while another student had received the SBK travel fellowship from Ruia College. Both these fellowships have been instituted at Ruia College by our alumni.

For Indians to make such achievements abroad, what steps should be taken by the Govt.?

Government can play an important role as a catalyst for encouraging many more Indian participation abroad. One way to do it is to permit incorporation of expenses for presentations at foreign conferences in meritorious government funded research projects sanctioned to scientists. Encourage more government - industry collaborations in organising truly international conferences in Indian venues and provide sponsorships to invite good number of foreign experts to India for these events.

Main problem for an Indian researcher is finding financial support and this can be encouraged if industries are allowed to sponsor truly meritorious researchers including research scholars as a part of their CSR activities.

NEOMACHINE MFG CO: Aleader in automatic coating technology

K

olkata-based NEOMACHINE MFG Co was started in 1973 with an objective of manufacturing quality pharmaceutical machinery.

For a decade, the company catered to the requirements of the Indian pharma companies in injectables, liquid, tablet, capsule and ointment sections machinery.

NEOMACHINE started the process of developing an automatic coating machine for tablets. After, two years of research and development, the first NEOCOTA Automatic Coating System was manufactured in 1984.

During the last three decades, NEOMACHINE had manufactured and marketed more than 600 machines, out of which 100 machines were exported to the different countries like the US, Australia, China, Jordan, Yemen, the UAE, Uganda, Kenya, Sudan, Cyprus, Saudi Arabia, Austria, Brazil, Bangladesh, Bolivia, Nepal, Myanmar, Nigeria etc. and also going to export to Sri Lanka and Vietnam shortly.

NEOMACHINE, a professionally managed organisation now have two manufacturing Units. During the last three decades, NEOMACHINE had manufactured and marketed

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more than 600 machines units in Kolkata, which are equipped with state-of-the-art equipment like fabrication, machining, assembling, finishing and other related jobs.

The company has been strictly following all the quality control guidelines during manufacturing. The bought-out items are inspected at the manufacturers’ works periodically.

The company has got a dedicated team of engineers for providing erection and commissioning and prompt after-sales service to the clients.

The in-house R&D facility is abreast with latest technology up-gradation and developments

in ‘coating technology. This helps in continuous improvement of the product. We have developed in our R&D Machine called MINIMAX where coating can be started from 50 Gms.-150 Gms. & 150 Gms-250 Gms. NEOMACHINE also provides DQ/IQ /OQ/ documents for automatic coating system and are in the process of getting CE certification. NEOMACHINE being a single product company manufacturing only automatic coating system for coating of pharma tablets, pellets and gems products, have gained vast experiences in latest coating technology as well as validation and qualification of

coating equipment to qualify for the audit of various national and international agencies. The latest models of NEOCOTA are having all the constructional features for validation and qualification. The equipment are supplied with all the necessary documents for proper validation during installation and commissioning as well as trial production.

Over the years, the company has gained vast experiences in manufacturing 'Automatic Coating System' by interacting with various Indian and multinational pharma and confectionery units based in India and abroad.

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The United Engineering Company: Serving the pharma industry for the last five decades T

HE UNITED ENGINEERING COMPANY (UEC) with the brand name ‘UNITED’ is known for being the pioneer and commander in packaging machinery manufacturing in India.

UEC, which was started in the year 1963 by GD Roy, has attained high reputation in providing machines and services of highest standards since the beginning. With the founder’s innovative ideas and unmatched leadership quali-

With a vision to provide the best pharmaceutical manufacturing technology, UEC has also ventured into different industries such as distilleries, cosmetics, foods and beverage, paints, chemicals, home care, office and student stationery etc ties, UEC crossed various boundaries in different fields of work.

Initiating the business with

solutions for parenterals (ampoules and vials), UEC has diversified its business into the bottle packaging sector and

has also mastered in providing machines for automatic tablet coating. UEC also provides customised solutions for

its customers.

With a vision to provide the best pharmaceutical manufacturing technology, UEC has also ventured into different industries such as distilleries, cosmetics, foods and beverage, paints, chemicals, home care, office and student stationery and others.

The company has also expanded its footprints abroad in a large way. Today, ‘UNITED’ machines are exported to more than 21 coun-

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tries across the globe namely the US, Canada, Bolivia, Nigeria, Kenya, the UAE, Iran, Sri Lanka, Bangladesh, Malaysia, Indonesia, Vietnam, Korea and others.

UEC puts in a lot of effort for their R&D and strives to provide the best and optimised solution to its customers. By virtue of dedication and continuous hard work of their R&D team, ‘UNITED’ machines provide technically advanced solution for its cus-

been an active participant in numerous social events which help in uplifting the quality of living

of the deprived.

With almost every pharma formulation manufacturer be-

ing an ‘UNITED’ machine user coupled with more than 50 years experience, UEC

commits in becoming better than the best in the near future.

UEC puts in a lot of effort for their R&D and strives to provide the best and optimised solution to its customers tomers. Presently, UEC is having its head office in Kolkata.

It has three manufacturing units in West Bengal, covering an area of over 10000 sq ft.

UEC is having its marketing and sales office in Mumbai to cater to the eastern part of the nation and overseas. The company has also set up well equipped service shop in Mumbai to service its clients.

The United Engineering Company has been honoured by the prestigious ‘Innovator’s Award’ from the Indian Pharmaceutical Congress for their innovation and development and continuous value additions to the pharma packaging industry.

Today, at UEC, machines are equipped with the latest technology. For its customers, UNITED machines are cost effective but are guaranteed with the highest quality, optimum production and ensured unconditional service.

UEC is equally focussed on being a corporate citizen. It has never shirked the responsibility of the society and has always

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Entrepreneurship model for the biopharmaceutical industry Ratnesh Jain, UGC Assistant Professor, ICT Mumbai and Ibani Kapur, Intern, ICT outline that entrepreneurship in large biopharma companies should encourage innovation and compete with other emerging biotech companies, not just in terms of the output or drugs but also input or skills

T

homas Jefferson once said a couple of hundred years ago, “The best society is the one composed of the greatest number of entrepreneurs.” History is replete with examples of leaders who pioneered the art of entrepreneurship. One of the most prominent examples is the source of a number of Tata enterprises today, JRD Tata.

He not only successfully created Tata Group but also made sure that the Tata legacy continued even after his demise.

What is it that unites all these entrepreneurs, leading to incredible success in their respective areas of expertise? It is creative initiative. In simple words, they pursued an opportunity that wouldn’t have been so obvious to others. At times, there lies huge amount of uncertainty in their decision making and this is what sets them apart from the others. Also, this is where business-oriented scientists experience some conflict since science calls for precision. What science needs to learn and understand from business is that when calculating a commercial strategy, science becomes a means to an end and business comes ahead of science. With the rising number of start-ups aiming to grow into leading biotech firms, there are two areas which should be recognised. One is the risk component, which arises with reproducing science or a particular molecule and learning how to mitigate it.

The other one is allocation of resources, specific deployment of scarce resources and moving up the value curve in a capital efficient manner. When it comes to wiring entrepreneur-

20 EXPRESS PHARMA December 2018

Ibani Kapur

ship in large biopharma companies, it should be done in such a way as to encourage innovation and competing with other emerging biotech companies, not just in terms of the output or drugs but also input or skills.

Thus, as stated by Peter Kolchinsky, when it comes to a successful biotech entrepreneurship, it is less about biotech and more about good entrepreneurship. In a business environment where uncertainty thrives, effectuation models have proved to be of significant help. While causation focuses on a particular effect and chooses from available means to reach that effect, effectuation relies on a set of means already available and then helps determine between possible effects that can be created with the help of the means at hand.

Depending on the goal in the mind of the entrepreneur as well as the advantages and disadvantages in a given situation, either of the two processes can be followed. The model of effec-

tuation in particular has been explored in entrepreneurship and based on certain empirical tests; different dimensions to it have been presented specially with respect to the biopharma industry.

Elaborating in this area, it begins with the means or financial resources that the company possesses and based on its priorities, to invest in R&D or other segments accordingly.

This financial asset in the form of cash balances, borrowing capacity or stock market value forms an integral deciding factor on understanding the ‘means’ construct of the effectuation model.

Apart from the financial resources, there are other categories of resources like human, organisational and physical which are unique and characteristic of a particular firm, embedded deep in its organisational fabric. It is during times of encountering setbacks that this resource based view confers a competitive advantage to the company over the others.

These resources can also be defined as capabilities which an organisation builds and these, along with external partnerships, are what fuel the innovation system of an organisation.

Partnerships in the form of collaborations contributing significantly to product development, is evident in the biopharma industry where majority of public and private industries rely on investments funded through grants, public or private equity, and/or through resource partnerships with larger, better capitalised public biopharma firms. As Sarasvathy posits, strategic alliances is a way to eliminate or

pecting the unexpected which should be embraced and dealt with accordingly. Thus, with the innovation to create and aspirations to market, every researcher must look through the lens of entrepreneurship and extend a hand for collaboration so that every unmet need of the society is fulfilled.

References 1. Audra L. Stinchcomb*(2010) The Role of Entrepreneurial Activities in Academic Pharmaceutical Science Research. J Pharm Sci. 2010 June ; 99(6): 2532–2537 Ratnesh Jain

at least minimise uncertainty.

To the extent we can control the future, we do not need to predict it. This is suggestive of the fact that during unpredictable times it is better to attain flexibility rather than stick to pre-planned goals. The factor of unanticipated contingency is very evident in some cases of drug approval in the biopharma industry. For example, in the case of Biogen-Idec and Elan’s Tysabri (natalizumab), despite extensive clinical trials post original approval of the drug for a relapsing form of multiple sclerosis; two fatal cases of progressive multi-focal leukoencephalopathy were encountered. Thereby, the manufacturer withdrew the drug from the market performing a series of safety reviews and furthering clinical trials.

Eventually the same drug reappeared after a thorough lobbying by patients and other examinations.

This is another principle in the effectuation model of ex-

2. The Entrepreneurs guide to a Biotech startup by Peter Kolchinsky,PhD 3. https://www.mckinsey.com/industries/pharmaceuticals-andmedical-products/ourinsights/unleashing-the-powerof-entrepreneurship-in-science 4. Sarasvathy, S. D. (2001). Causation and effectuation: toward a theoretical shift from economic inevitability to entrepreneurial contingency.

Academy of Management Review, 26(2), 243–263 5. Makadok, R. (2001). Toward a synthesis of the resource?based and dynamic?capability views of rent creation. Strategic Management Journal, 22(5), 387–401 6. Mark J.Ahn,(2015)On valuing biopharmaceutical product pipelines:an effectuation model and evidence. Journal of Innovation and Entrepreneurship, 4:14

Skill always wins Mahesh Burande, Director IPER & Medical Director Nulife Pharmaceuticals, shares his views on skill development in pharma and its benefits

I

f China is known to be the manufacturing factory of the world, India should become the human resource capital of the world. Indians have a huge advantage due their varied capabilities. Education and training institutes in India should be dynamic to develop these skills. National Policy for Skill Development and Entrepreneurship 2015 and Pradhan Mantri Kaushal Vikas Yojana trust on empowerment of an individual through their skilling programmes. Education and skill together can make India ‘Kaushal Bharat, Kushal

Bharat.’ Skilling Indians will result in happy, healthy, prosperous and a strong nation. ‘Sarvada Vigyata Vijaya’ means ‘Skill Always Wins.’ In recent times the government has set a target to develop the skills of around 40 crore people by 2022.

Skill will bring pride and dignity. Sadly, only two to three per cent workforce in India has undergone formal skill training as compared to 60 per cent in the UK, 75 per cent in Germany, 52 per cent in the US, 80 per cent in Japan and 96 per cent in South Korea respectively.

With a mission to accept

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global challenges to provide skill force to the world, Indian pharmacy professionals and education experts should rethink on their long-term strategies to make India a pharma super power. At present, the Indian pharma industry is number three in the world with an annual turnover touching to 2,20,000 crore including exports, exporting drugs and medicine to more than 200 countries. We are second in the world for manufacturing generic drugs which are known to be of high quality.

To lead the world in

pharmaceuticals in keeping with the Make in India campaign, some strategic approaches to strengthen academic and industrial collaboration has to be worked out which will also become the policy to follow in future. ◗ Attachment of pharma industry: AICTE should see that any new pharmacy college should be permitted only when a pharmacy college has pharma industry attached with minimum two dosage forms.

Pharmacy Council of India gives permission for Pharm.D programme only when 300

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bedded hospital is attached to pharmacy college with agreement. This strategy definitely will develop skillful pharmacists to contribute for pharmacy profession. ◗ Syllabus by pharma industry experts: Mandatory participation of pharma industry experts in making syllabus match with the current needs of pharma professionals and it should be revised every four years. For new topics orientation should be given to teachers

by industry experts on continued basis. ◗ Teachers industry exposure: After every three years, teachers should upgrade themselves with a two months industrial training programme in their respective departments and should be certified by industry for advanced skill development.

Such teachers should be entitled to an increment or promotion in future in order to boast their career. ◗ Skill component: 30 per cent

component of the syllabus should consist skill development lessons. It should be mandatory for industry experts to contribute for pharmacy education and such pharma industry experts should get benefits in taxes from the government. ◗ Problem-based learning: Final Year B Pharm and M Pharm students should do projects of three-month duration and it should be problem based learning and finding solutions. This

strategy will contribute for the development of skills. ◗ Entrepreneurship development: Every college should establish a entrepreneurship cell involving consultants and industry experts. Students should get exposure and knowledge to start their own businesses in pharmacy. ◗ Young teachers training: Fresh pharmacy teachers should get training for teaching skills and soft skills. APTI’s Teachers Training Institute in

future will contribute in this area substantially.

With this approach and strategies, pharmacy profession in India will be benefitted to get competent pharmacists and that is why we say skill always wins.

“Winner don’t do different things, they do things differently.”

Late Dr APJ Abdul Kalam said, “ Thinking is the Capital.

Enterprise is the way. Hard Work is the solution.”

Pharma industry – Future lies in the hands of beholder Dr D Sreedhar, Associate Professor Senior Scale, Department of Pharmacy Management, Manipal College of Pharmaceutical Sciences and Dr N Udupa, Professor and Principal of Manipal.

College of Pharmaceutical Sciences, give an overview on the pharma industry and its growth trajectory in the years to come

T

he pharma industry has been one of the most versatile industries and will continue to be so in the years to come. This is evident from its small but consistent growth and frequently faced with challenges.

The current scenario Many market survey reports show a slowdown of pharma industry growth. This is largely due to saturation of major markets. However, the market is likely to witness better growth in coming years. It is expected that there are a few innovations happening with respect to telemedicine, nanotechnology, wearable devices etc., which might change the landscape of the industry. Biopharmaceuticals are also contributing in a big way, with several novel biologics and biosimilars entering the market. In its report, EvaluatePharma estimates that 50 per cent of the top 100 drugs will consist of biologics by 2021.

According to PwC India, the Indian pharma industry has been growing at a compound annual growth rate (CAGR) of 15 per cent over the past five

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Dr D Sreedhar

years and is likely to be in the top 10 global markets by 2020 in terms of value.

Indian pharma industry has always encountered challenges.

There has always been ups and downs in overall market growth as it depends majorly on the growth of big markets, like the US and Europe. It is anticipated from a few reports that there would be an overall slowdown in terms of market growth, especially in the US. Moreover, policy reforms, both within India and the US, will have an impact on Indian pharma. For instance, local

manufacturing of active pharma ingredients (APIs) is made mandatory by the US Government and Indian Government needs to have a closer look at the standards of drugs.

As there has been growth of biologics and biosimilars, small molecules market share might slightly be affected. Coupled with this, there were less drug approvals given from 2016 onwards when compared to previous years. It is difficult to ascertain the reason behind reduction in drug approvals.

Off late there is much attention given to consumers, this is resulting in more informed decision by the patients.

The way forward Although there are challenges, Indian pharma is poised to surge ahead with existing and emerging opportunities. Indian pharma is adopting new business models and nurturing new ideas to serve the consumers in a better way. It is grabbing the opportunities to ally and partner with big giants. Indian companies are investing in biologics and biosimilars which will also contribute to overall

Dr N Udupa

market growth in the coming years. It has become more consumer-focussed like never before where innovative products are said to be launched soon.

There have been fruitful deals with regard to mergers and acquisitions mainly to expand their product portfolio.

There has been an increasing demand for contract development and manufacturing organisations which have a wide range of capabilities. This is mainly due to increased cost of development and even manufacturing. It is time for Indian pharma companies to tie-up

with institutes to develop if not new molecules but to work on the unmet needs of the consumers. There should be a dialogue between industry and institutes on a regular basis by frequent visits by industry personal to institutes and vice versa. Industry need to trust institutes and partner. This will lead to a win-win situation for not just industry and institutes but also for students. There are a few examples where the students played an active role in developing innovative products. However, if there was support from industry the products would have come to market much faster.

Pharma companies should mix and match existing strategies and come out with some new strategies to overcome slow market growth. It is ultimately in the hands of the companies competing in the market place to convert challenges into opportunities and move ahead.

(Above mentioned facts were taken from reports of EvaluatePharma, PwC, India and other internet sources)

Pharma education: Keeping pace with industrial requirements Dr Madhu Chitkara, Vice Chancellor, Chitkara University, Punjab and Dr Sandeep Arora, Professor and Director, College of Pharmacy, Chitkara University, Punjab, outlines the various requisites of pharma education to match global standards

T

he pharmaceutical industry is an ever evolving and dynamic industry, which has to keep adding various dimensions and products to the therapeutic arsenal that is available to the healthcare team.

Mankind has benefitted immensely over the last century from this very enterprising nature of professionals associated with this industry, by way of getting hugely successful medicinal products, including those for pain management, antibiotics, diabetes and metabolic disorder management, cardiovascular dis-

Dr Madhu Chitkara

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eases and neurology. The parallel advances in diagnostics and surgical techniques have further helped.

Pharma education over the years has been designed to give exposure to all associated dimensions of research, manufacturing, operation, quality, development during under graduate and higher study in pharmaceutical sciences. The subject involved gives a deep insight into chemical synthetic methods, phytochemical methods, small and large scale formulation and manufacturing technology, manual and instru-

mental chemical and microbiological quality analysis, preclinical methods and recently added focus on pharmacotherapeutics which is very strongly reflected in various semesters of the Pharm D course, as compared to B Pharmacy course, which focuses more on impacting basic and advanced studies in pharma industrial research and operations.

Role of the pharma industry Dr Sandeep Arora

As pharma industry has evolved with regulatory procedures and documentation for

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product approval and marked authorisation has become more stringent, possibilities of newer categories of therapeutics products, including biologicals, phyto pharmaceuticals are emerging. Pharmaceutical science education has to ensure that these aspects are incorporated appropriately.

Thus subjects like molecular biology, genetics, bioprocess, RNA technology hold a lot of promise for future generations to specialise in and to make use of in the pharma industry.

The pharma industry should also be proactive in its participation with academic institutions as mentor and patron to specify the demand of the industry and make sure that it can be reflected and incorporated in pharma education.

Community pharmacy and pharmacy practice Community pharmacy and pharmacy practice services ensure that a pharma professional who is specifically trained in all aspects of pharma research, operations, quality and therapeutic care be available to analyse clinical and pathological diagnosis of the patient done by the clinical team, design an appropriate therapeutic regimen, counsel the patient and ensure that the same is complied with by the patient, taking care of possible interactions and developments. This ensures that the physician and clinical team can engage in attending to a larger pool of patients and in surgical procedures, which ensures better efficacy of these procedures.

The Indian healthcare sys-

tem needs to take care of this aspect, which is typically being critically underutilised. A better incorporation of pharma practice services in in-patient and out-patient services can also bring efficiency in pharmacoeconomics, adverse event monitoring and pharmacovigilance. Pharma science education also needs to incorporate the facets of community pharmacy and practice in a big way, to ensure Indian health services are at par with global services.

Quality of education Education is a profession demanding knowledge and mentorship skills and pharma science education also requires the teacher to be updated with industrial advances and present it in a lucid and exemplary manner to make sure

that the vast student diaspora from different strata can uniform learn and acquire the skills of research, operations, etc. Educational output and productivity in pharma science has to be measurable in the form of research, operational analytical, documentation or business skill developed after education by every student in a group assigned, and the uniformity in these acquired skills between various students and the uniformity in way they use and represent these skills. Every member of the education fraternity and institute need to be sensitive to same and there need to be a process of teaching validation to ensure best outcome.

There is an excellent system of organisations, associations and councils in India, in-

cluding Indian Pharma Association, Pharmacy Council of India, Indian Drug Manufacturing Association, which can work in tandem with the regulators, the CDSCO to continuously keep the level of pharma education matching the highest global standards. With Indian pharma industry poised to break into Top 2 major global players by 2030 by virtue of sales volume, generics, exports and sales value, it is time that pharma education too takes a great leap. Events like Indian Pharma Congress serve as great stimulators and initiators of change, bringing together the industry, regulators, educators, scientists and entrepreneurs, wherein the required purpose of designing appropriate vision and milestones is successfully achieved.

FEP tubing and its rising demand FEP tubing’s inability to absorb materials, high chemical inertness and full sterilisation capacity makes it ideal choice for sterile filling, diagnostic equipment, cell transfer and laboratory use. Shrikant Dethe, Business Development, Ami Polymer elaborates more Understanding FEP The accidental discovery of PTFE in 1938 by Dr Roy J Plunkett has turned out to have the lowest coefficient of friction of any known solid material. But as PTFE lacks the meltprocessability, a need of other fluoropolymers was generated.

FEP shares the same basic monomer and is commercially obtained by free-radical polymerisation in an aqueous media via addition of tetrafluoroethylene (TFE, CF2=CF2) and hexafluoropropylene (HFP, CF3CF=CF2).

Properties of FEP Structure of FEP is semi-crystalline, giving it not only a distinct and sharp melting point, but also generally better mechanical properties than those of the amorphous type of poly-

24 EXPRESS PHARMA December 2018

mers. Sterilisation of the tubing can be done by gas (EtO), steam (autoclave) and gamma radiation.

Scope of FEP tubing Applications Engineered fluoropolymer lining, tubing and fabricated prod-

ucts for aerospace industry relies on its ability to resist damage from aggressive chemical fuels and withstand wide variation in temperature.

Further its non-stickiness nature makes a top choice in

food and beverage processing industry. FEP tube is also used for hot sterilising water transfer in purification system and UV water treatment.

FEP tubing’s inability to absorb materials, high chemical

inertness and full sterilisation capacity makes it ideal choice for sterile filling, diagnostic equipment, cell transfer and laboratory use.

In electrical industry, FEP has well established itself due

its low dielectric constant value and high electrical breakdown voltage property.

Retractable coiled FEP tube: In the recent years, the gradual downfall of PFA retractable coil has been observed due to its incompatibility with solvents. This has increased the consumption of FEP tube which serves greatly because of its high chemical inertness, heat resistance and flexibility. Additionally it’s used in chemical dispensers, deionised water re-circulators and even in heat exchangers.

How different is it from PTFE and PFA? ◗ Most of the properties vary slightly among these three fluoropolymers. ◗ FEP and PFA can be extruded and thermoformed unlike PTFE.

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◗ FEP has a lower working temperature than PTFE and PFA. ◗ PFA deforms more under load compared to FEP. This indicates better retractability for FEP. ◗ Better abrasion resistance of FEP than PFA. This has resulted in the fact that in the whole family of recently developed fluoropolymers, FEP stands out in its range of applications. Current research is trying on a fluoropolymer which would resist harsh chemicals and is flexible too. This would serve for a large number of the applications and would serve universally.

Contact details Shrikant Dethe (Business Development) Ami Polymer +91 9152032304 shrikant@amipolymer.com

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Skill and will to make and serve quality pill: Contributions from pharmacy education, pharmaceutical manufacturing and pharmacy practice Dr D Sreedhar, Srinivas Mutalik and Dr N Udupa from Manipal Academy of Higher Education brief on three aspects, pharmacy education, manufacturing and pharmacy practice, which are required by competent pharmacists

P

harmacy education in India has evolved over the last nine decades. Traditionally it was oriented towards industry and most of the graduate pharmacists were aspiring to be placed in pharma industry.

With the advent of the PharmD programme we have pharmacists who can make valuable contributions in hospitals. It is quality education which gives birth to competent pharmacists.

The responsibility of making competent pharmacists lie in the hands of both students and teachers. Students need to be receptive and responsible whereas teachers should be updated and motivated to teach. Active participation of students would change the paradigms of learning. They should actively engage themselves in both theory and laboratory components. PCI and AICTE are making attempts to bring some uniformity in providing pharmacy education. Instead of blaming regulatory authorities, PCI and AICTE, students and teachers need to work together for better outcomes. PCI and AICTE might have procedural delays in putting forth regulations related to pharmacy education but would surely will not oppose if institutions are striving to educate students in a better way. So, pharmacy education is the starting point for pharmacists to begin their significant contributions.

Pharmaceutical manufacturing Next, we have manufacturing.

We can never eliminate manufacturing from the minds of pharmacists and budding pharmacists in India as the graduate

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Dr D Sreedhar

Srinivas Mutalik

Dr N Udupa

pharmacy curriculum is mostly oriented towards industry. It is essential for budding pharmacists to have skills required for manufacturing. Making a pharma pill involves various insights and principles related to formulation development which finally helps in therapeutic management of diseases. Formulation scientists are either involved in developing pharma formulations for newly synthesised drug molecules or in providing pharma formulations for already existing drugs.

During the drug development process, pharmaceutics related aspects play an important role in dosage form design, so that patented drug can enjoy the great market share. This is an applied science utilising the principles of biological science, chemistry, material science, engineering and other related disciplines to manufacture medicines. Pharmaceutics, which mainly is involved in making a pharma pill, is the science of formulation, manufacture and packaging of pharma and other healthcare products.

Pharmaceutics discipline involves various facets of formulation components, manufacturing, machineries and quality control aspects of dosage forms such as solid dosage forms (tablets, capsules, pellets), liquid dosage forms (monophasic, biphasic), sterile products (ophthalmic, parenterals) and semisolid products. Making of a pharma pill is a complex process which needs the knowledge of various fields as given below: ◗ Biopharmaceutics and pharmacokinetics: This area includes the study of factors involving/ mechanisms of absorption, distribution, metabolism and elimination of drugs. ◗ Pharma technology/Product development/Industrial pharmacy: This area focusses on the design of various dosage forms, challenges in the development of formulations, packaging and scale-up. This area also involves the study of the design and construction of manufacturing unit, manufacturing policies, cGMP requirements, ICH guidelines, scale up, plant maintenance,

material and vendor management, Quality by Design (QbD) principles and validation aspects. ◗ Drug delivery: This area includes basic concepts, design and evaluation aspects of novel drug delivery systems, devices and technologies.

Apart from above said areas, the personnel should also have knowledge of analytical techniques such as UV/ visible spectroscopy, FTIR, DSC, HPLC, LC MS, HPTLC, etc.

The thorough understanding of above areas helps in great positioning in production, quality control and research development sectors of the pharmaceutical industry. Thus design and development of a pharma dosage form needs the collaborative efforts of all scientists, especially pharma technical people having sound knowledge of formulations, quality assurance and regulatory affairs.

Pharmacy practice Emphasis was laid to strengthen clinical and hospital pharmacy with the intro-

duction of PharmD programme in 2008. Now PharmD students are equipped to serve patients better. However, PharmD students have to concentrate more on better ways of serving patients rather than prefix to their names and interfering with clinicians’ roles and responsibilities. PharmD curriculum has been designed to provide patient care. Pharmacists should be updated to tell the information related to disease and drugs to the patients.

They can also bring awareness about the lifestyle modifications that patients has to adopt which intern can increase prognosis. PCI had come out with pharmacy practice regulations to guide PharmD graduates to provide quality services to patients on 16 January 2015. But, it was misunderstood or misrepresented by a few people that the pharmacists are empowered under pharmacy practice regulations to open pharma clinics to diagnose the disease and prescribe medicines. PCI had clarified that there is no such provision in the pharmacy practice regulations 2015. It has said that registered pharmacists are required to dispense medicines on the prescription of a registered Medical Practitioner and can counsel the patients on medicine related aspects.

Overall, budding pharmacists should bear in mind from day one of their programme (BPharm or PharmD) that they are going to be an important member in the healthcare team and they should be equipped to make valuable contributions to make a healthy India.

Recent drug regulatory milestones in India Dr Subhash C Mandal, Vice President, Chairman, Regulatory Affairs Division (RAD), Indian Pharmaceutical Association, gives on overview on the various steps taken to regulate the pharma sector

D

rug legislation in India has been undergoing continuous change to assure quality, safe and efficacious medicines to the general masses at an affordable price since 1940. A few recent steps may be considered as important milestones to improve healthcare outcomes in India, such as:

Pharmacy Practice Regulation -2015 The practice of pharmacy in India exists since a long back, with a different name and structure and it has got a regulated structure since implementation of Pharmacy Act 1948. Engagement of Pharmacist in serving the prescription of a registered practitioner has been made mandatory by an amendment of sec 42 of Pharmacy Act 1940, in the year of 1984 and it was further bolstered by the amendment of Rule 65 of Drugs and Cosmetics Rules 1945 in the same year.

Publication of ‘The Role of the Pharmacist in the Health Care System’ by World Health Organization in the year of 1990 has given a solid platform to create more conducive environment for growing Pharmacy Practice in India. Dispensing by

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pharmacists is mandatory worldwide for better healthcare services.

Framing and notification of Pharmacy Practice Regulation 2015 in the month of January 2015 is a landmark event in the history of pharmaceutical profession in India, which will certainly help in giving proper shape to the unorganised state of Pharmacy Practice in India.

In the present regulation, pharmacy practice is well defined and the same has set up certain regulation to regulate the same. The document is available at http:// www.pci.nic.in/ Circulars/ Pharmacy%20Practice%20Regulations.pdf.

In the mean time, a few states like Kerala have implemented the same through notification by the state government. As per the provision of PPR-2015 a few state pharmacy councils and professional organisations have started refresher course for registered pharmacists which is considered quite insufficient in terms of need for a huge pull of registered pharmacists of India.

Hope all professional organisations will take up the issue with the concerned authorities, so that all state governments implement the act immediately for improving the health care outcome.

Pharmacovigilance system is mandatory for manufacturers/marketing authorisation holders Recently, Government of India created a mandate of pharmacovigilance system for reporting ADR to licensing authority by every manufacturer or market authorisation holder. They are required to have a pharmacovigilance system in place for collecting, processing and forwarding the report to the licensing authority for information on adverse drug reactions emerging from the use of the drugs manufactured or marketed by the applicants in the country. The entire exercise should be managed by a medical officer or trained pharmacists. They are also required to submit Periodic Safety Update

28 EXPRESS PHARMA December 2018

Reports (PSURs) as per the regulation.

The Pharmacovigilance Programme of India (PvPI), working since 2010 is now a matured one having strong infrastructure and manpower.

Presently, more than 250 AMCs are working successfully and generating a good number of ICSRs. On the basis of data collected through this system, PvPI contributed several data to the WHO-UMC collaborating centre. They have also provided several alert notices to the stake holders and made several recommendations to the CDSCO. CDSCO has already instructed Marketing Authorization Holders (MAH) to comply the same and also made suitable amendment of Drugs and Cosmetics Act & Rules.

Now, the Indian regulatory agencies are taking action on the basis of data generated in our country instead of depending entirely on the data generated in other countries. Being a stakeholder, the Indian Pharmaceutical Association (IPA) is trying its best to support the

programme in several ways to ensure safe medicine to the general mass.

Result of bio-equivalence study data made mandatory for approval of any oral dosage form of drugs belongs to BCS category II & IV. Through a notification vide G.S.R. 327(E) dtd. 03.04.2017.

Through this amendment several rules like -74, 74B, 76, 78, 78A have been amended by insertion of “the applicant shall submit the result of bioequivalence study referred to in Schedule Y, along with the application for grant of a licence of oral dosage form of drugs specified under category II and category IV of the biopharmaceutical classification system.�

This move made the process of approval more scientific to ensure bioavailability of the product. For effective implementation more alacrity required about classification of the drug candidate.

Submission of Stability study data, rationality etc. for approval of any product as amended through G.S.R. 360 (E) dtd. 10.04.2018.

Through this notification several rules like Rule 71B, 76, 76A of the Drugs & Cosmetics Rules have been amended.

Now it is mandatory to submit evidence and data justifying Stability, Rationality and safety for approval of any product.

Amendment of NDPS Rule to improve access of opoids in palliative care of terminal cancer pain.

As per the report published

by WHO, an estimated 4.8 million people suffering from moderate to severe cancer pain do not receive treatment. Similarly, about 1.4 million people suffering from moderate to severe pain at terminal stages of HIV annually, remain untreated. In India, a million people with cancer and an unknown number of people with other incurable and disabling diseases like HIV/AIDS, need opioids for pain relief and only a minute fraction (0.4 per cent) of the population in need of opioids have access to the drugs.

Major barriers to gain access to opioids are complicated regulations and problems related to attitude and knowledge among

health professionals, regulators, administrators and the public regarding pain relief and opioids. As a result of collaborative efforts among the WHO, certain Palliative Care Organisations and Pain & Palliative care activists, the Government of India has taken some steps like - asking all state governments to modify the narcotic rules and regulations following a model, extended schedule K exemption to morphine tablets.

Establishment of simple standard operating procedures to implement the simplified regulations, advocacy, and aggressive and improved education of professionals are essential for further improvement of the situation. In the meantime, Government of India has amended NDPS Act 1985 to improve access to opoids for medical purposes vide The Narcotic Drugs and Psychotropic substances (Amendment) Act, 2014 dated 10th March 2014. Govt. of India has notified six narcotic drugs as Essential Narcotic drug Again it was further amended on May 5, 2015 making some easy provision for improve accessibility of Essential Narcotic drugs including opoids. At present, major regulatory barriers of accessibility of opoids for medical purpose have been removed. It is high time to educate prescribers and other stakeholders against the myths and fear about narcotic drugs used for medicinal purposes.

Implementation of Medical Devices Rules 2017 In a historical move, the Government of India published Medical Devices Rules 2017 on January 31, 2017 which has take effect from January 1, 2018. Medical Devices were not regulated in India till 1989 when three items were notified as Drugs vide GSR 365(E) dtd.

17.03.1989. Thereafter a small number of medical devices are regulated by Drugs and Cosmetics Act & Rules. In the meantime, it was revealed that India is dependent on imported medical devices to the extent of around 75 per cent and the Government of India

included this industry under Make in India initiative. In order to make India self sufficient in manufacturing medical devices in India and to ensure quality and efficiency of the same, India has framed its regulation after a long exercise. About one year has been allowed before its implementation so that industry could get sufficient time to be ready to implement it. It has also been notified that medical devices require to print MRP on the packs of Medical Devices from January 1, 2018. The main feature of this rule is partly self regulating and evaluation by third party unlike Drugs and Cosmetics Act and Rules. the government will also categorise all medical devices in to four categories as per the extent of risk like-Class A (Low risk), B (Low moderate risk), C (Moderate high risk) & D (high risk). As per the rule, state licensing authority will issue licenses of the class A & B on the basis of submitted documents or third party audit report, whereas Central Licensing Authority will issue licenses to Class A & B after official inspection by Medical Device Officers. Industry experts feel that the said rule require some fine tuning and medical device officers require adequate training.

Hope medical device industry will take this advantage and will make necessary changes in manufacturing technologies and provide adequate qualified manpower as per the rule.

Notification is mandatory for pharmacy, chemist and druggist to curb the menace of death by tuberculosis The recent notification by Government of India directing all pharmacies, chemist and druggist dispensing anti-tubercular medicines, shall notify respective tuberculosis patients along with details of medicines to local Public Health Authority, namely, District Health Officer or Chief Medical Officer of a district and municipal health officer of urban local bodies in

whatever way they are known; or their designated district tuberculosis officers.

Pharmacy, chemists and druggists, failing to notify may attract the provisions of sections 269 and 270 of the Indian Penal Code (45 of 1860), as the case may be, which are reproduced below: “269. Negligent act likely to spread infection of disease dangerous to life. Whoever unlawfully or negligently does any act which is, and which he knows or has reason to believe to be, likely to spread the infection of any disease dangerous to life, shall be punished with imprisonment of either description for a term which may extend to six months, or with fine, or with both. 270. Malignant act likely to spread infection of disease dangerous to life. - Whoever malignantly does any act which is, and which he knows or has reason to believe to be, likely to spread the infection of any disease dangerous to life, shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both.” This is an appropriate step to ensure proper tuberculosis diagnosis and its management in patients and their contacts and to reduce tuberculosis transmission and further to address the problems of emergence and spread of drug resistant-tuberculosis, it is essential to collect complete information of all tuberculosis patients.

This direction is also applicable for medical practitioners and medical laboratories as notified vide F.No. Z28015/2/2012-TB dtd. 16th March 2018 (available at: http://www.cdsco.nic.in/writer eaddata/management%20in%2 0patients.pdf ).

This is a golden opportunity for the pharmacists engaged in community pharmacy to establish them as one of the important health care provider.

Making pharmacist mandatory for wholesale medicine shop- waiting for final notification Government of India is going to amend rule 64 of the Drugs

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and Cosmetics Rules, 1945 by substituting clause ii of the 2nd proviso of the sub rule (2) by “(ii) in the charge of a competent person who is a registered pharmacist: Provided that the person already registered with the state Licensing Authority as competent person for the purposes of grant of license in Form 20B or Form 21 B or both prior to the coming into force of the Drugs and Cosmetics (………Amendment) Rules, 2016, shall continue to be considered as a competent person for the said purposes.”.

This is a long pending issue to be resolved by the government considering the public health in our country. Pharmacists are well qualified and well trained on “inventory management and storage of medicines, certainly ensure proper handling, storage, preservation and quality assurance of all medicines and medical devices. Considering this fact Drug Technical Advisory Board (DTAB) in a meeting held in August 2015 taken a resolution resulting notification vide GSR.1179 E dated 28th December 2016 by the government for amendment of the Drugs and Cosmetics Rules, 1945. This move is welcomed by almost all of the stakeholders as this will safeguard health of the people.

This will be an important milestone in the pharmacy profession.

Food Safety Standard Act of India Nutraceuticals, Food supplements, Micronutrients are flooding the market with tall claims. The gullible public is consuming them with or without prescriptions. Physicians are prescribing those products to their patients. In most of the cases without evidence of its safety, quality, and not considering drug-food interactions, drug – drug interactions. Possibility of Drug-food interaction and Drug- Drug interaction is many fold more in case of herbal food products.

More research must be carried out to develop evidence of safety of such products.

Though the Food Safety & Standard Act & Rules 2011 have prescribed measures for ensuring quality, it is yet to be implemented seriously and uniformly, because of weak infrastructure and insufficient manpower in the major part of the country. There is overlapping between drugs and food products, creating more confusion in case of applying for Drugs and Cosmetics Act & Food Safety and Standard Act. Using these loopholes, drugs are being marketed as food to circumvent the Drugs & Cosmetic Act and price control.

There is an urgent need to resolve these issues to protect the health of the people.

As per a recent notification issued by FSSAI vide F. No. 194/FSSAI/SP (Claims and Advertisements)/2017 dtd.

19.11.2018, Food businesses in India will not be able to use words or phrases such as natural, fresh, original, traditional, authentic, genuine and real on food labels except under specific conditions. Any person, including a third party, who advertises or is a party to the publication of any misleading advertisement not complying with these regulations would be penalised with a fine extending up to ` 10 lakh, as per Section 53 of the Food Safety and Standards Act, 2006.

These new restrictions will take effect from July 1, 2019. It is to be hoped that proper implementation of this notification will help in rationalising advertisement of food products in India.

Steps to harmonise drug legislations in India In a recent meeting, DTAB approved DCC recommendations for uniform implementation of provisions of D&C Act and Rules throughout the country. It is a milestone in the history of India's Drug Regulatory system. It has recommended cadre restructuring in the state Drug Control departments to make it uniform for uniform implementation of the Drugs and Cosmetics Act, 1940 and Rules, 1945. It is recom-

mended that Drugs Inspectors will be re-designated as “Drugs Control Officer” with uniform pay scales. It is also recommended that the central government should issue direction to the state governments to ensure adequate regulatory officials which will be commensurate with the number of sale outlets and manufacturing units located in the respective States considering that there should be one official for every 200 sale outlets and one official for every 50 manufacturing units. There should be provisions for deputation of State regulatory officials to the Central regulatory system and vice versa. The minimum experience for Licensing Authorities (LA) relating to manufacturing and sale of drugs should be raised adequately. It is also recommended that there should be a single Licensing Authority for manufacturing activity in each state, appointment of a nodal officer of intelligence cell for market surveillance and conducting investigation in respect of spurious, adulterated drugs in coordination with CDSCO, guidelines should be developed by CDSCO for uniform implementation, the medical device officers to be appointed under the Rules should have B. Pharm/M. Pharm. qualification. Such officer should undergo training in medical device regulations under a training module being developed under joint collaboration between Delhi Pharmaceutical Science and Research University and IPC, Ghaziabad or any other institutions which deems fit for such activity.

Uniform nomenclature of CDSCO and state drugs control. Apart from this, there are some other important recommendations, which are considered as very much needed for strengthening the drugs control mechanism of India. It is expected that the fate of this recommendation will not follow several such recommendations in the past.

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Refrigerated warehouse makes every doorway count New facility’s doors separate ambient, refrigerated and freezer storage to reduce energy consumption while optimising uptime. An insight by Gandhi Automations

G

andhi Automations is one of the leading diversified suppliers to the pharma sector, serving pan India customer accounts in more than 23 cities. Clean room doors (Prime Clean Reset) are designed for inside applications requiring limitation of leak flow.

The perfect sealing properties of Prime Clean Reset provide environmental control and protect the inside environment against draughts, dust and dirt. Clean room doors provided by us also has self- repairing system.

One of the most imperative aspects of clean rooms is the door you choose for clean room facility. Time for which door is open will play a critical factor in avoiding dirt, temperature, humidity etc. Opening and closure of door has to quick enough to isolate the two areas.

At Gandhi Automations, we provide clean room high speed doors specifically designed for above purpose. Our clean room high speed doors are best suited for pharma industries where you need to have controlled environment. The opening and closing of door is fast enough to separate two areas.

In the high-volume, 24/7 facility, turns in the cooler happen twice a day and, in the freezer, inventory turns occur every day and a half. With traffic streaming in and out of the building through 47 dock doors, losing a single high-traffic door could severely jeopardize deliveries.

Prime Freeze High Speed Doors are a perfect solution where cold storage with negative temperatures to as low as – 22°F is required. The curtain is made of reinforced PVC vinyl with heated side guides. Optionally a special and innovative insulated flexible curtain is also available.

High Speed Freezer Doors are the solution when temperature control is critical and where forklift traffic is high.

“If a cooler door is down, that

30 EXPRESS PHARMA December 2018

ator safety at all times. Highspeed freezer duo doors curated

by Gandhi Automations are sturdy, dependable and an ideal fit for maintaining temperature control. To prevent ice formation during intensive cooling, the high-speed freezer duo doors have a functionality of partial and full opening. Its intelligent dual curtain technology - simultaneous open-and-close operation has blower/dryer to maintain temperature balance.

Fast door speed also reduces the likelihood of panel collisions with tall-mast forklifts. In the event of a collision, the self-repairing system automatically resets the panel back into its guide without human intervention.

To avoid accidental contact with door panels, an LED safety light system along the door columns warns employees when

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could be detrimental to our operation,” says warehouse manager, who notes that a single inoperable door could cost 30 per cent of shipping capacity. “We cannot afford to lose an opening.

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Indian pharma industry: Current opportunities and challenges Prof Roop K Khar, Principal, B S Anangpuria Institute of Pharmacy, Faridabad, Haryana and Gaurav K Jain, Assistant Professor, Department of Pharmaceutics, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi

H

ealthcare is one of the important indicators of any country’s development and status of health care indicates the nature of the development of a country. Pharma companies are working consistently towards improvement of the healthcare among people.

Pharma products or drugs are one of the important components of the healthcare management and its expenses. The increase in the income of the individuals and the change in lifestyle are contributing to the increase in the expenses of the healthcare management of an individual. The pharma companies not only contribute to the health care of the people, but also contribute to the economy of the country by creating jobs, developing ancillary industries, export earnings and contributing to the GDP. Hence, the growth of pharma sector of a country is important for the growth of the country’s economy.

The Indian pharma industry has contributed enormously to Indian as well as to global healthcare outcomes. The development phases of Indian pharma industry are shown in Figure 1.

India continues to play a substantial role in manufacturing various essential, vital, high quality and low-cost drug products for Indian and global markets. Literature shows that India is a supplier of nearly 25 per cent of all the medicines dispensed in the UK, 40 per cent of generics consumed in the US and about 50 to 60 per cent of global demand for many vaccines and anti-retrovirals (ARVs). Interestingly, over the

new product pipeline, completion of pricing corrections, the launch of next-gen assets and scaling up of the rest-of-world business. Technology and emerging business model innovations, too, could prompt a transformation.

manufacturing hubs by up to 40 per cent and India has the second highest number of US FDA approved facilities. While the headwinds are likely to continue for the next two to three years, Indian pharma companies need to adapt to the changing landscape, and emerge stronger.

Indian Pharma: Trends Indian Pharma: Market dynamics and implications

Prof Roop K Khar

last five years, about 40 per cent of total ANDAs approved have been filed from Indian sites and 30 per cent of the annual UNICEF requirement of ARVs. Over the last few quarters many pharma companies have experienced significant value erosion and registered much lower profitability and growth leading to hindrance in capacity expansion and R&D plans. Despite recent headwinds, India’s pharma market has a stable growth and India is likely to become one of the top three pharma markets by 2030. This has been driven by two major enabling factors: (a) Increasing demand in global markets: Generic penetration in high value healthcare markets has grown significantly, with India supplying more than 20 per cent of the generics demand in major geographies and (b) Low cost manufacturing capability in India: Labour costs in India have been lower than other

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Indian pharma industry is number thirteen in terms of value and the third largest in terms of volume in the world market. It accounts for about 2.4 per cent in value terms and 10 per cent in volume terms of the world market. The present market size of the Indian pharma sector is $30 billion and expected to reach $55 billion by the year 2020 with a compound annual growth rate of 15.92 per cent between 2015 and 2020. It is projected to grow more than the annual growth rate of the world pharma sector, which is estimated about five to six per cent between the same period. The Indian pharma market is dominated by branded generics, which contribute 70 per cent of market share in terms of revenue. The patented drug contribute 21 per cent whereas, over the counter (OTC) drug market contribute nine per cent of total $30 billion revenue of the Indian pharma market.

Even though companies anticipated a fair set of challenges in last few quarters, the sheer speed and impact of these has been overwhelming. Many leading Indian generics players shed up to 40 per cent of their market capital in few months due to varied reasons including regulatory sanctions and litigation,

Gaurav K Jain

impairment charges to generics market dynamics in the US, and raw material price volatility in China. Various dynamics in international markets are eroding value from the generic value pools. These are: ◗ Consolidation among distributors and pharmacy chains in the US, the largest healthcare market in the world, leading to steep fall in generic drug prices. ◗ Increased product approvals, and resultant competition in the generics space. This will keep up the competition and consequently, price erosion. ◗ Drop in new product launch due to lower value of drugs going off patent. ◗ Increasing price control and protectionism in various global markets Despite the likely severe impact of these factors in the short term, the industry could eventually be buoyed up by a sustainable cost advantage, a robust

Focus on Research & Development: Compared to global trend (15 per cent of sales), India has 5-fold less investments in R&D (2.5 per cent of sales) until beginning of the new millennium.

The investment was a peak in 2005-06 and showed slower rate in further years. At present, R&D investment in India is about 10 per cent of total turnover, which is less than a global investment in R&D and it is expected to increase further because of competition.

Export: Indian pharma export market is flourishing due to the strong presence in the generic market. Pharmaceuticals Exports Promotion Council estimates export of $18.02 billion in the year 2017.

Joint venture: In pharma sector, the focus on joint ventures is increasing. Many international players are joining hands with Indian pharma players for development of novel therapeutics. The primary reason for this is availability of skilled employees, government policies and incentives and cost effectiveness.

Less time for approval: In order to compete with global market, the drug approval process has been simplified and approval time for new facility and product has been reduced.

In the draft Patent (Amendment) Rules 2015, the time

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period of patent grant has been reduced from 12 months to four months.

Indian pharma: Opportunities Due to low growth rate in developed market like the US, EU and Japan and due to change in the global pharma market, multinational pharma companies are looking towards pharmerging countries. The Indian pharma sector offers a wide range of opportunities for these multinationals. Supportive regulatory framework, availability of skilled professionals, large domestic market, developed R&D infrastructure, low production cost and low labour cost make India as one of the favorite destinations for pharma companies.

Fig. 1 Development phases of Indian pharma industry

Supportive regulatory framework The Indian government has taken many steps to accelerate the pharma sector in India. As per new guidelines, the approval time for new facility has been reduced and export licenses is said to be issued within two weeks. Signing of MoUs with WHO, US FDA, Health Canada and other bodies in the world has benefited the Indian pharma sector. The Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers, GOI aims at making India as a major hub for end-to-end discovery under Pharma Vision 2020. Customs duties and excise duty has been exempted for the HIV/AIDS drugs and diagnostic kits supplied under the National AIDS Control Program and zero duty is applicable through the Export Promotion Capital Goods (EPCG) Scheme to the pharma sector for technology up gradation. Nonetheless, government is planning further relaxation in FDI norms in the pharma sector.

Large domestic market: Recently, due to change in lifestyle, stress level and eating habits there is a paradigm shift in types of disease. This change in addition to demand for quality health care and the size of the population makes the Indian domestic market, favourable for

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multinationals.

Contract Manufacturing Services (CMS): The global Contract Manufacturing Services (CMS) market is estimated at $10 billion in 2017 compared to $3.8 billion in 2012. It is presently having more than 1000 players.

India is recognised as a global manufacturing hub due to availability of a large number of scientific human resources. In addition to this, production cost will be about 40 per cent less compared to US and European countries. The CMS companies in India already showed the presence in clinical trials, APIs and low value and high volume space. In future, CMS companies going to focus on high potential APIs, biopharma outsourcing, finished dosage form and indictable manufacturing, which are other potential space for contract manufacturing pharma sector in India.

Biologics and biosimilars: Biologic market is in nascent stage and only few MNCs entered in the market. The entry barriers are high in this segment, however, India pharma companies can get first mover advantages.

Mergers & Acquisitions: The domestic companies are looking for strategic tie-ups with the global players to expand their operations in the foreign market. The global players will have

benefit of R&D facility and a distribution network of domestic players to operate in the huge Indian market. Thus, the winwin situation prevails in the Indian pharmaceutical sector. The global players are showing increasing interest in generic market and looking for acquisition opportunities, this in turn, provide financially lucrative opportunities for domestic companies which are looking for cash out. In the last three years, pharma sector in India, accounted for more than 70 per cent of deals.

Indian pharma: Challenges Although, the diversity of the Indian pharma market, health care objectives and legal system make India a favourable destination for global pharma companies but they also pose unique and complex challenges. Some of these challenges are: Intellectual property protection: The patent application process for the pharma products in India is interpreted as targeted to create burdensome for International applicants. It is due to, Section 8 (1) requires patent applicants to notify the Controller and “keep the Controller informed in writing” of the “detailed particulars” of patent applications for the “same or substantially the same

invention” filed outside of India.

Section 8 (2) requires a patent applicant in India to furnish details to the Indian Controller about the processing of those same foreign patent applications if that information is requested.

Indian patent (Amendment) act 2005 formed as per the requirements of TRIPS. According to OPPI, “the section 3 (d), impermissible hurdle has been added to this, which is a fourth substantive criterion of “enhanced efficiency” to the TRIPS requirements. This hurdle appears only for pharma products and some substance like salts, esters, ethers, and other derivatives of known substances are presumed to be the same substance of original chemical and cannot be patented unless it is proved these substances differ significantly with respect to efficiency”. Further, India relies on test data submitted in another country, which is seen as unprofessional.

The price barriers created on account of the patent for the medicines required for the treatment of diseases like TB, Diabetes, Hepatitis C, Cancer, and HIV/AIDS, are seen not as affordable. The government grants Compulsory License under special provisions of section 92 and section 66 of Indian

Patent Act, which makes patent holder more difficult to defend their patents.

Market Access barriers: Presently, fixing of ceiling price for the essential drugs by NPPA, under the Drug Price Control Order (DPCO) 2013, is costbased policy and it take into account simple average of all the drugs with a market share of 1 per cent or more. The industry expects, it is more appropriate to adopt market based policy rather than cost based policy.

The contribution of government in the areas of health care is unsatisfactory and is only 1.2 per cent of the GDP. In addition to this, healthcare infrastructure is far below expectation.

The pharma companies expect the government to improve the systems in the public healthcare administration, so as to reach the medicines to the needy people, which will improve overall health care of the country.

Reaching the rural market, which is very large in India, the pharma companies have to work with innovative marketing and sales tools to reach these markets, which adds to the cost.

Other challenges: The Indian regulations on clinical trial policies need to be structured and matured. Presently, the regulations in clinical trials are uncertain, which may hinder the

clinical research environment in India and have an impact on the availability of new treatments and vaccines to Indian patients.

The ethical concern in the Indian pharma industry is not seen up to the mark, although new measures and guidelines have been adopted. Many international agencies believe more improvement is needed in the ethical scenario of the Indian pharma sector, especially in the field of clinical trials and marketing practices.

Conclusion The Indian pharma market is huge and diverse compared to the world market, but the contribution is less than its potential. The focus on other than generic market is the need of the time and Indian pharma

Fig. 2 Revenue share of Indian Pharmaceutical sub-segment in 2018

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companies are persistently searching for new avenues in the innovation driven sector.

The constant increase in the size of the Indian pharma market, due to high demand for quality health care and a change in life style, make this sector as a one of the promising contributors of the Indian economy.

The regulatory policies need be improved, especially in the area of price control and patent, to boost the growth and create an impression as the destination for new generation pharma market. In the coming year, we expect Indian pharma companies to adopt operational and manufacturing excellence, differentiated drugs business model, digital and advanced analytics and Talent to Value approach for accelerated growth.

Bibliography Indian pharma industry: An Overview Gulshan Akhtar, IOSR Journal Of Humanities And Social Science (IOSR-JHSS), Volume 13, Issue 3 (Jul. - Aug. 2013), PP 51-66 M. Mazumdar, Performance of Pharmaceutical Companies in India, Contributions to Economics, Springer- Verlag Berlin Heidelberg, 2013.

Trends and opportunities in Indian Pharma, White paper published by FICCI. U. Chandra et al., Opportunities and Challenges of Indian Pharmaceutical Sector: An overview.

International Journal of scientific research and management. 2016; 4 (06); 4287-4302

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Monitoring product safety beyond clinical trials – Industry practices Dr J Vijay Venkatraman, Managing Director & CEO, Oviya MedSafe, details on the need to foster adherence to good pharmacovigilance practices within the industry to ensure its future progress

M

edicinal product safety monitoring is an ongoing activity that starts long before a product is introduced into the market and continues until the product remains available in the market. In clinical trials, only a few hundreds to thousands of carefully selected people get involved for a fixed period of time. The safety data from clinical trials may therefore not necessarily suffice to assess how safe the product would be in the longterm when it will be used by millions of consumers in the real world. A medicinal product may appear to be safe and well-tolerated in the pre-marketing phases which may result in it gaining marketing approval too but the real safety profile of the product will be understood only after it has been used by large numbers of patients over a longer period of time and in different parts of the world. For this to happen, it is imperative for product safety data to be collected, organized, analysed and reported in a proper manner in the post-approval scenario also.

The term ‘Pharmacovigilance’, defined by the World Health Organization (WHO) as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem, is generally used in the context of safety monitoring beyond clinical trials.

While the pharma industry is not the only stakeholder of pharmacovigilance, it is the primary stakeholder that is mandated by regulation to monitor the safety of the me-

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dicinal products it manufactures and/or markets. Although regulations may significantly vary between countries, they are usually derived from overarching guidelines which have garnered considerable acceptance across the globe. This article aims to provide an overview of the various pharmacovigilance processes in vogue in the industry without specific reference to the regulations of any particular country/region.

Pharmacovigilance system in the industry Once a medicinal product is approved for marketing, it is the responsibility of the manufacturer/marketer to implement a pharmacovigilance system within their organisation. In addition, they must proactively assess and manage the risks associated with the product throughout the lifecycle of the product.

In the post-marketing scenario, the following processes are followed for purposes of regulatory compliance in the context of pharmacovigilance:

Dr J Vijay Venkatraman

Adverse Event (AE) Handling Collection of safety information Pharmacovigilance commences with collection of safety information from various sources such as patients, consumers, healthcare professionals, company partners/ employees, e-mails, phones, fax, letters, journal publications, clinical trials, surveys of patients or healthcare providers, regulatory reports, social media, etc. Published medical and scientific litera-

Figure – 1 –Pharmacovigilance processes followed in the industry

ture articles are particularly considered as important sources of safety information and therefore a periodic (usually monthly) search and review of literature databases is mandated by the pharmacovigilance requirements in many countries.

These sources will also give information like frequency of adverse drug reactions (ADRs), patients with highest risk of ADRs, effects in chronic and long-term use, drug-drug interactions, drug-food interactions, misuse or abuse of drug products, medication errors, etc. Each of these reports needs to be evaluated for its causal association with the product and needs to be communicated to the appropriate regulatory agencies either as an Individual Case Safety Reports or as part of Aggregate Reports within the specified timelines.

Individual Case Safety Reports Individual Case Safety Report (ICSR) is a format and content that is used for the reporting of one or more suspected adverse reactions in relation to a medicinal prod-

uct that occurs in a single patient at a specific point of time.

One of the fundamental principles of single case reporting is the determination of validity. During the triage phase, the case report will be checked for validity against the four minimum criteria: an identifiable patient, an identifiable reporter, a suspect drug, and an adverse event. If any of these elements are missing or unknown, the case report will not be qualified as valid. Hence, it is the responsibility of the company to take up the appropriate measures to find out the missing data element. Once the missing element is found, the case report will be qualified as valid. Further, the seriousness and expectedness assessments will play a major role in determining the reportability of ICSRs to the relevant regulatory authority. The process flow of the steps involved in single case processing is provided below:

Signal detection A signal is essentially a hypothesis of a risk with a

Figure – 2 – Process flow of ICSRs

medicine, with data and arguments that support it, and derived from data from one or more of many possible sources. According to the World Health Organization, a ‘signal’ is ‘reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously.’

Usually, more than one report is required to generate a signal, depending on the seriousness of the event and the quality of the information.

Generally, unexpected ADRs or new aspect of a known ADR, specific adverse reactions like Steven Johnson syndrome or toxic epidermal necrolysis or some severe hematological conditions like agranulocytopenia or aplastic anaemia that do occur naturally and do have other causes but are very often associated with drug therapy, are considered signals. Reports with these kinds of reactions need

to be analysed to understand if there is a reasonable possibility that the suspect drug has caused the clinical conditions.

The process of signal management must systemically address the following steps: All steps taken and recommendations made must be accurately tracked and documented at every stage. There are resulting legal obligations which must be fulfilled in an accurate and timely manner but the ultimate goal is to confirm or refute whether there is some new issue with the safety of a medicine so that action might then be taken to reduce the risk.

Periodic reporting Periodic reporting is otherwise known as aggregate reporting. It provides the broader view of safety profile of the medicinal product and helps to evaluate the safety of the medicinal product in a periodic manner. It is the compilation of safety data for a par-

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ticular period of time and submitted to the regulatory authorities at defined time points by the company in both pre-approval and post-approval phases of the product.

A pre-approval aggregate report is known as Development Safety Update Report (DSUR) and post-approval aggregate reports include Periodic Safety Update Reports (PSUR) / Periodic Benefit Risk Evaluation Reports (PBRER), Periodic Adverse Drug Experience Report (PADER, which is US-specific) and Addendum to Clinical Overview (ACO) in many regions including in Europe.

An aggregate report helps to evaluate the benefit-risk profile of the medicinal product and to identify the safety information that would require further investigation of the product in order to optimise the use of the product or make changes to the medicinal product label. Depending on the significance of benefit/risk profile of the

product, the company may need to implement a Risk Management Plan to protect public health.

Risk management A Risk Management Plan (RMP) is a document that describes the current knowledge about the safety and efficacy of a medicinal product. It is a set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise the risk relating to medicinal products including assessment of the effectiveness of those interventions. It is ensuring that the benefits of the medicinal product exceed the risks by the greatest achievable manner for the individual patient and for the target population as a whole.

In many countries, risk management plan is required as part of the medicine’s approval and renewal process and to retain the marketing approval status. Risk management plan includes the infor-

mation on the medicine’s safety profile and how the medicine’s risks will be prevented or minimised in patients and describes the plans for studies and other activities to gain more knowledge about the safety and efficacy of the medicine. Also, the scope of risk management also includes the effectiveness of risk minimisation measures.

Communication of safety information Communication is interactive exchange of information and opinions concerning risk and risk-related factors among regulatory authority, HCP and consumers. Safety communication is a broad term covering different types of information on medicines, including statutory information as contained in the product information (i.e. the summary of product characteristics (SmPC), package leaflet (PL) and the labelling of the packaging) and public assessment reports.

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Safety communication aims to providing timely, evidence-based information on the safe and effective use of medicines, promoting changes to healthcare practices (including self-medication practices) where necessary, changing attitudes, decisions and behaviours in relation to the use of medicines, supporting risk minimisation behaviour and facilitating informed decisions on the rational use of medicines. In addition, high-quality safety communication boosts public confidence in the regulatory system.

Communication tools and channels have become more numerous and varied over time, offering the public more information than was previously possible. Relevant communication tools and chan-

Figure – 3 – Process of signal management

nels should be considered when issuing a safety communication in order to reach the target audiences and meet their growing expectations.

Different communication tools and channels are direct healthcare professional communication (DHPC), press communication, website, bulletins and newsletter, social media and other online communications.

The primary target audiences for safety communication issued by regulatory authorities and the company should be patients, carers and healthcare professionals who use (i.e. prescribe, handle, dispense, administer or take) medicinal products. Effective safety communication enables them to take adequate actions to minimise risks and to give clear and useful information

to their patients. This ultimately promotes patient safety and confidence in the regulatory system. Both healthcare professionals in clinical practice and those involved in clinical trials should be provided with appropriate information on any safety concern at the same time.

Regulatory consequences Since the industry practices described above are primarily targeted towards regulatory compliance, it becomes important for us to see how the regulatory agencies respond to the safety information submitted by the industry. A regulatory agency may choose to order the manufacturer/ marketer to do any of the following, based on the gravity of the safety issue: ◗ An update to the product information – warnings and contraindications; ◗ Restriction to the approved indication/population; ◗ Conduct of a post-authorisation safety study (PASS); ◗ Perform risk minimisation activities – if risk is acceptable / preventable; and ◗ Suspend/withdraw the medicinal product – if risks outweigh benefits.

Conclusion

Figure – 4 – Risk Management Cycle

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The pharma industry is necessitated by regulation to carry out a wide range of pharmacovigilance activities with the sole aim of ensuring that the benefit-risk ratio of a medicinal product is always in favour of the patient who is treated with the concerned drug. Time and again, there have been several cases in which hitherto approved medicines with extraordinary efficacies had to be recalled from the market after review of the real world safety data which got accumulated post-approval. This clearly establishes the vitality of the need for fostering the further growth of good pharmacovigilance practices within the industry and for furthering the adoption of such practices among all players in the industry.

I N T E R V I E W

‘We have to align with this thought process and make it at ease for innovators and industrialists’ Atul Nasa, Organising Secretary, 70th IPC, in an interaction with Usha Sharma, reveals about the responsibilities for making the 70th IPC a success and how the event has been able to create a new benchmark

We have constituted 28 task committees and we are in regular touch with each and every member of the committee so as to achieve our goals To subscribe: bpd.subscription@expressindia.com

Tell us about the highlights of your journey so far in the lifesciences industry?

My professional journey of 32 years from student life to reach at the rank of the Head of Office/Controlling & Licensing Authority/Deputy Drugs Controller, Drugs Control Department, Delhi was challenging, but successful.

As it is said, “Your positive action combined with positive thinking results in success”, I always believe in positivity and hard work and try to do things in a planned manner, which has given success in all spheres. It has been a great journey till date and with the blessings of the almighty and support from everyone, I have been honoured with various professional awards like Best Alumni Award

by Delhi Institute of Pharmaceutical Sciences & Research (DIPSAR), New Delhi, Best Drugs Inspector Award 2001 at Mumbai by All India Drugs Control Officers Confederation (AIDCOC), Outstanding Young Professional Achievement Award 2003 during the 20th Annual Conference of IPGA held at Chandigarh, Regulatory Person of the Year award 2009 by 54th IPC Welfare Trust, Pune, KC Chatterjee Memorial Award 2015, IPGA Professional

Excellence Award-2015, Best Drugs Control Officer Award from All India Drugs Control Officer Confederation in appreciation of meritorious services in the Drugs Control Administration in the year 2017 and Fellowship of Indian Pharmaceutical Association for distinguished and dedicated services in the profession of Pharmacy in 2017.

Apart from the above, I have been nominated by the Government of NCT of Delhi as a member of Pharmacy Council of India in March, 2017 and also I have been nominated on the panel of various committees constituted by Government of India from time to time.

You are the organising secretary of 70th IPC, tell us your key responsibilities in making a success of 70th IPC and how did you execute it?

It is said that “with great power comes great responsibility”.

Being the organising secretary as well the President of Indian Pharmacy Graduates’ Association, it is a challenging job and it requires a proactive approach to execute the best of the congress and set a benchmark. It is great that I had the support of Sikri, the Chairman of LOC. He is very helpful and has an optimistic

vision for executing excellent IPC. Moreover, all the senior stalwarts of IPGA are always available for their inputs and support. To achieve another benchmark, it really requires to have the best of the team from different sections of pharmaceutical / allied field. All the members of LOC are aspiring and dedicated and having like-a-mind thought process. We have constituted 28 task committees and we are in regular touch with each and every member of the committee so as to achieve our goals for the success of 70th Indian Pharmaceutical Congress.

How has your experience as a regulator and being part of several past LOCs helped this year's IPC to set a new benchmark?

Each of the IPC organised by us in the past was considered as a benchmark in itself and this time we are in competition with our own set benchmarks, which were created in the year 2001, 2008 and 2013 editions of IPC held in Delhi-NCR. Moreover, it is difficult and a challenging one, as being on the highest position as a state regulator.

Routine work pressure, official meetings, regular updates and issues to resolve

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and keeping the duties on utmost priority and holding additional responsibility to be organising secretary is a herculean task. It is well said that one has to have the goal oriented work process and it is good on my part, that I had organised IPC as a President or organising secretary for two times previously as well. This experience really helps in setting up the goals and we also have identified mistakes from the past IPCs and we could easily overcome those with a proactive approach.

Extensive technological advancements are creating oceanic change in today’s regulatory environment, posing significant challenges for regulators, who strive to maintain a balance between innovations and protecting consumers.

Regulators need to undergo thorough reviews and understanding of pertinent existing regulations and also look for those that might be blocking innovation and are outdated

This is the fourth time that Delhi/NCR is hosting the IPC. How will this year's edition be different from past three IPCs? Five years ago, IPGA organised the 65th Indian Pharmaceutical Congress and at that time I was honoured with the prestigious position of being the President of the IPCA. Thanks to everyone for giving me such respect and recognition at such a young age.

Each IPC organised by IPGA has set a remarkable benchmark each time and this time we are again in the same phase where we have made strong efforts to make 70th IPC excellent and benchmark of all the IPC organised so far irrespective of us or other bodies. This time the LOC formed by the Central IPGA core team is working very hard and making all necessary arrangements to make this

year IPC more eventful and memorable one. This congress has many unique features which have been identified by the core members. For the first time in the history of IPC, we have a Women Empowerment Committee as well as have organised special session for women empowerment. There is also a 'Health Awareness Walk' for all the age groups for better understanding of living the life in a positive and optimistic way.

On a very previous day of the conference, we are having an awareness campaign to promote 'Swachh Bharat' mission by our Prime Minister.

First time, we are going to have 'Training and Placement Committee', which is going to organise a job fair for the entire fellow pharmacists attending the Congress. Moreover, to promote young minds, Student Forum of IPGA is working on various social media platforms

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for promotion of 70th IPC. Tell us the role being played by the Indian regulators in shaping up the Indian pharma industry as a global pharma hub?

Extensive technological advancements are creating oceanic change in today’s regulatory environment, posing significant challenges for regulators, who strive to maintain a balance between innovations and protecting consumers. Regulators need to undergo thorough reviews and understanding of pertinent existing regulations and also look for those that might be blocking innovation and are outdated. As emerging technologies evolve, regulators from around the world are rethinking their approaches, adopting models that are agile, iterative, and collaborative to face the challenges posed by emerging technologies and the

fourth Industrial Revolution.

We have to align with this thought process and make it easy for innovators and industrialists.

Do you think pharmacy graduates from India are well trained and can compete with their counterparts in the developed countries?

Yes, pharmacy graduates from India are well trained and can compete with their counterparts in the developed countries. We have been talking about bringing change in the pharma curriculum but there is a lot that still needs to be done.

Our syllabus of B. Pharmacy and M. Pharmacy must be skill oriented not theory oriented.

Further, amendments are needed in the Drugs and Cosmetic Act, 1940 as the existing act mentions that any B.SC graduate can become part of the pharma formulation

industry. We should revise the qualification from BSc graduates to B Pharm in different fields, regulations so as to drive positive changes in the industry. India is on verge of becoming the global leader and to make our fellow pharmacists more smart and skilled, we need to re-define the role of pharmacists in each of the pharmaceutical segments and give priority in skilling them and making them competent professionals.

What message would you like to share with the pharma industry and academia for 70th IPC? Congress will bring an opportunity to each and every delegate to explore plethora of knowledge and wisdom. It will provide a common platform to the every pharmacy practitioner and will also create ample opportunities for national and international collaborations as well as industry-academia partnership. With the existing caliber of Indian pharma sector; newer advances as a vision; excellent industryacademia partnership and economic-driven government policies will take India to newer heights and India will be considered again the most promising global leader in innovation and this congress will give a platform to each stakeholder to make this possible. u.sharma@expressindia.com

REGD.WITH RNI NO. MAHENG/2005/21398, POSTAL REGD. NO. MCS/164/2016 – 18, PUBLISHED ON 5TH / 20TH EVERY FORTNIGHT, POSTED ON 5TH, 6TH, 7TH & 20TH, 21ST, 22ND OF EVERY FORTNIGHT POSTED AT MUMBAI PATRIKA CHANNEL SORTING OFFICE, MUMBAI – 400001