Department of Pharmaceuticals

Government of India

INDIA PHARMA 2019

4th International Conference on Pharmaceutical Industry
18th – 19th February 2019, Hotel Lalit Ashok, Bengaluru, India
Theme: Enabling Affordable Quality Healthcare
Conference Program

DATE / TIME EVENT

th
DAY 1, 18 February 2019
0930-1105 Inaugural Session and Awards Ceremony: India Pharma 2019& India Medical Device 2019
(Kalinga – I) 0830-0930 Registration
0930-1105 Inaugural Session
1130-1200
Media Interaction with Hon'ble Union Minister for Chemicals & Fertilizers, Government of India
(Board Room)
1130-1200
Tea Break
(Kalinga – I)
1200-1400 INDIA PHARMACEO Roundtable with Hon'ble Union Minister for Chemicals & Fertilizers, Government
(Lalit-III & IV)) of India (By Invitationonly)

1200-1330
SESSION:Promoting Innovation Ecosystem in India for Pharmaceutical Industry
(Siddhartha)
(Parallel) Session brief:
The Indian pharmaceutical industry is recognized as a global leader in the production of high-quality
generic drugs and is ranked third in terms of manufacturing pharmaceutical products by volume.
Alongside, India drug manufacturers have also steadily developed a healthy pipeline of New Chemical
Entities (NCEs) backed by laudable initiatives by BIRAC, CSIR, and DBT. This session aims to take stalk of
innovative ecosystem in the pharmaceutical industry in India and discuss latest developments and
technologies that will catalyse drug development. It will also discuss any policy initiatives required to
further strengthen industry and academia collaboration to strengthen new drug discovery.

Session Chair: Mr Rajneesh Tingal, Joint Secretary, Department of Pharmaceuticals, Govt. of India
Moderator: Dr. Surinder Kher, Advisor, Bioquest Solutions Pvt. Ltd.
Panellists:
1. Dr. Dhananjay Patankar, Head of Pharmaceutical and Biopharmaceutical Development at
Syngene International Ltd.
2. Dr.VasanSambandamurthy, Chief Scientific Manager, Biocon Limited
3. Dr Raviraj Pillai, Senior Director, Research and Development, Abbott India Ltd.
4. Prof. Kiran Kalia, Director, NIPER Ahmedabad
5. Dr. Taslimarif Saiyed, CEO and Director, Centre for Cellular and Molecular Platforms (C-CAMP)

Expected Participation:
Officials from Govt. of India, Clinical research organizations, Industry participants, Regulators – state
regulators and DCG, Academia, Trade and Business officials from Embassies / Foreign missions
(Seating plan: Dais and Theatre style)
1330-1430 Lunch for Delegates (Venue: Kalinga-I)
1400-1430 Lunch for CEOs/Dignitaries (Venue: Lalit I & II)
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 Department of Pharmaceuticals
Government of India

1430-1600 SESSION: Enhancing cross-border trade: Discussing Import and Export related opportunities and
(Siddhartha) challenges for Indian Pharmaceutical Industry

Session brief:
For India, US is one of the largest importers of pharma products while India imports majority of raw
materials and intermediates from China. Increasing protectionist measures and pricing concerns in the
global markets tend to put a lot of pressure on India companies with respect to market access and
business viability. In light ofcurrent global trade scenario, it is important to discuss how to optimize
import and export portfolio for Indian pharmaceutical companies to reduce risk exposure. In this
session, we strategically look at markets such as China, Vietnam, CIS Countries, Saudi Arabia and LATAM
to identify import and export opportunities for APIs/ intermediates as well as finished dosage
formulations.
Format of the session:
• Industry representative to make a presentation on target geographies (10 min each) covering
aspects such as
o Market Landscape of target geographies
o API Import opportunities from target geographies and registration requirements for
sale of export products
o Best business practices for marketing and distribution (Franchisee model vs. ownership
model)
o Taxation, Profit Repatriation & Incentives (if any) provided by foreign government to
Indian investors
• Presentation by WHO on findings of Survey of Indian Pharma Enterprises and presenting next
steps

Chair: Mr Rajneesh Tingal, Joint Secretary, Department of Pharmaceuticals, Government of India

Moderator: Dr.Sanjit Singh Lamba, Managing Director, Eisai Pharmaceuticals India Pvt. Ltd.

Panellists:
1. Mr Raghuveer Kini, Executive Director, Pharmexcil
2. Mr Gautam Swaroop, VP& Head - Geographies, EM, Portfolio and S&M,DRL Laboratories
3. Mr Chetan Bangera, Regional Head – Latin America, Cipla
4. Dr Viranchi Shah, Chairman, IDMA Gujarat State
5. Mr Manoj Kamra, VP, Corporate Affairs, Zydus Cadila Healthcare
6. Representative from WHO

Session Format:
Industry representatives to make a presentation (10-15 min duration) on the enlisted geographies to
put into perspective the pharma export opportunities to these regions. Post the presentations, the
session will open for a Q&A session with regulators from China, Vietnam, CIS Countries, Saudi Arabia
and LATAM.
Expected Participation:
Officials from Govt. of India, Industry Members, Contract Manufacturing Organizations, Trade and
Business officials from Embassies / Foreign missions
(Seating plan: Dais and Theatre style)
1600-1615
Tea Break
(Siddhartha)

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 Department of Pharmaceuticals
Government of India
1615-1745
Industry interaction with State Drug Controllers and CDSCO for Facilitating Ease of Doing Business
(Siddhartha)
Session Objective:
The objective of the session is to discuss ways to strengthen the pharmaceuticals regulatory framework
in the country to facilitate ease of doing business for the pharma industry and contribute to growth of
the industry, while maintaining high quality standards in pharmaceutical drug manufacturing.

Session Constituents:
Session Chair: Mr Navdeep Rinwa, Joint Secretary, Department of Pharmaceuticals, Government of
India
Session Co-Chair: Dr. S. Eswara Reddy, Drug Controller General of India, CDSCO, Government of India
Session Moderator:Mr B.R. Sikri, Co-Chairman Federation of Pharma Entrepreneurs (FOPE) and Vice
President, Bulk Drug Manufacturers Association (BDMA)
Panel Members:
Dr. H.G. Koshia, Commissioner, Food & Drugs Control Administration, Gujarat
Shri AmareshTumbagi, Drugs Controller, Karnataka

Special Invitees:
1. Shri K. V. Rajendranath Reddy, IPS, Director General, Drugs & Copyrights, Drugs Control
Administration, Andhra Pradesh.
2. Smt. Jyoti J. Sardesai, Director, Directorate of Food and Drugs Administration, Goa.
3. Shri Atul Nasa, Dy.Drugs Controller and Controlling & Licensing Authority, New Delhi
4. Ashim Kumar Nath, State Drugs Controller, Assam
5. Dr. Narayan Goswami, Dy.Drugs Controller and Controlling & Licensing Authority, Tripura
6. Shri Tajber Singh, Drugs Controller, Uttarakhand.
7. Smt. M. Pattnaik, Drugs Controller, Directorate of Drug Control, Odisha
8. Shri Dinesh Kumar Tiwari, Assistant Commissioner (Drug), Food Safety and Drug Administration,
Uttar Pradesh
9. Thiru K Parthipan, Assistant Director of Drug Controls, Salem Zone, Tamil Nadu
10. Shri Sanjeev Kumar, Assistant Drug Controller, Punjab

1745-1800
Tea Break
(Siddhartha)
1800-1930
JOINT SESSION: Interaction of Foreign Regulators with Pharmaceutical and Medical Device Industry
(Siddhartha)
Session Objective:
The objective of this session is to highlight the import registration procedure for pharmaceuticals and
medical devices in respective countries and to specifically point out any new initiatives taken which
eases the process the registering products thereby enabling faster access to global markets.

Session Constituents:
Session Chair: Ms. Shubhra Singh, Chairman, National Pharmaceutical Pricing Authority
Session Moderator: Dr. S. Eswara Reddy, Drug Controller General of India, CDSCO, Government of India
Representatives of Drug Regulators from Kenya, Malaysia, Russia, Saudi Arabia, UK and Uzbekistan
1930 onwards
Dinner Hosted by Department of Pharmaceuticals, Govt. of India
(Pool Side)

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 Department of Pharmaceuticals
Government of India

DAY 2, 19th February 2019

JOINT SESSION: WHO Regulatory Systems Strengthening and Prequalification Programme of Medical
1000-1130
Products- Recent Updates
(Siddhartha) Scope of the Session
The session will cover WHO activities and plans related to the regulation of health technologies
including regulatory systems support and the prequalification of finished pharmaceutical products,
active pharmaceutical ingredients, vaccines, and in vitro diagnostic products. The session will also
provide participants with information on important developments and updates of the prequalification
program, and the various ongoing and planned health product regulatory oversight strengthening,
work-sharing and capacity building activities that can inform their development strategies. The session
will also provide details on available expertise and technical assistance to achieve prequalification.

Objectives
• To introduce manufacturers who are unfamiliar with WHO prequalification and/or are
considering submission of an application for evaluation for prequalification. To introduce recent
product additions to the prequalification scheme
• To provide information, insight and available opportunities from various regional harmonisation
initiatives for regulation and accelerated/facilitated approval of health products
• To share the updates on the South East Asia regulatory Network
• To provide updates in India on the regulatory landscape and access to medical products.
• To provide technical updates for the different prequalification product streams: contraceptive
devices, IVDs, medicines, vaccines and vector control products.

Speakers
• Mr Deus Mubangizi, Coordinator, Prequalification team, WHO Geneva- Update on WHO-PQ and
supportive activities and update on WHO Collaborative procedure
• Dr Manisha Shridhar, Regional Advisor, WHO South East Asia Regional Office- South East Asia
Regulatory Network Updates
• Dr Madhur Gupta, Technical Officer- Pharmaceuticals, WHO India Country Office- India Updates
in India on the regulatory landscape and access to medical products.
• Dr Gaby Vercauteren – Senior Adviser, Regulatory Systems Strengthening, WHO Geneva-
Update on RSS – Technical assistance, Capacity building, harmonisation and GBT

Government Participants:
Mr Navdeep Rinwa, Joint Secretary, Department of Pharmaceuticals, Government of India
Mr Rajneesh Tingal, Joint Secretary, Department of Pharmaceuticals, Government of India
Ms Ritu Dhillon, Member Secretary, National Pharmaceutical Pricing Authority, Government of India

1130-1145
Tea Break
(Siddhartha)
JOINT SESSION: Decoding applications of Artificial Intelligence in Pharmaceutical and Medical Devices
1145-1300
Industry
(Siddhartha) Session brief:
Artificial intelligence (AI) is a growing technology that is finding applications in all aspects of life and
industry: within the smart assistants found within the latest smartphones, and in the smart factories
that use AI to enhance their efficiency. Likewise, the healthcare industry especially pharmaceutical and
medtech industry are finding new and innovative ways to use this powerful technology to not only help
solve some of the biggest problems facing them today but also suggesting the newer opportunities in

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 Department of Pharmaceuticals
Government of India
the ways they offer their products.

The use of Artificial Intelligence (AI) in the pharmaceutical industry is envisioned from innovation stage
to supply chain management. AI has the potential to transform the drug development process making it
both more efficient and more effective, thus benefiting all stakeholders involved—from the companies
developing new drugs to the patients in desperate need of viable treatments.

Medtech Industry is also expected to benefit largely from AI. The value AI produces for medical devices
greatly hinges on typical hardware concerns of processing speed and storage capacity, both of which
are substantially greater today than compared to those of a decade ago. Subsequently, the
technological advancements that are most pivotal to AI’s impact on medical device technology include
machine size, connectivity, and computing efficiency.

In this session, the panellists will throw more light on various ways and avenues, where AI will
contribute to better access to medical products and contributing to growth of these industries.

Key Points of Discussion

• Use of AI in drug discovery – generating novel drug candidates, understanding disease
mechanisms, analysing pre-clinical data, improving drug distribution and supply chain etc.
• Case studies on how deployment on AI tools are helping companies improve quality in
manufacturing both in Pharma and Medtech.
• Use of AI in medical technologies - management of chronic diseases, improving medical imaging
and integration with IoT to better monitor patient adherence to treatment protocols

Chair: Mr Navdeep Rinwa, Joint Secretary, Department of Pharmaceuticals, Government of India

Moderator: Mr Abhijit Varma, Partner and Head of Data and Analytics, KPMG India
Panellists:
• Dr. Vivek Ahuja, Vice President – Medical Affairs & Head, Global Pharmacovigilance, Sun
Pharma
• Mr. Debashish Banerjee, Head- Innovation and Strategy, Novartis
• Mr Rama Chandra Dash, Delivery Leader, APAC & Greater China Group, GHHS, IBM Watson
Health, IBM
• Mr ParthaSarathi Guha Patra, Co-Founder and Director, SafetyKart.com
• Mr. Dileep Mangsuli, Chief Technology Officer, GE Healthcare
• Mr. Rahul Shingrani, Founder, ten3T

Who will attend:

The session will be for future focused technology leaders. This unconventional session is designed to
discuss the current innovations and technology trends in the Pharma and Med-Tech industry. From
presentations to discussions, to latest industry insights, participants will discuss and experience the
latest innovations in the pharmaceutical and med-tech sector, and further have deliberations upon the
same.
1300-1400
Lunch Break
(Pool Side)
SESSION: Promoting Growth of Biologicals Sector in India by Enabling Quality in Manufacturing
1400-1515
Standards and Ease of Market Access

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 Department of Pharmaceuticals
Government of India
(Siddhartha) Session brief:
The Indian biosimilar market is poised for high growth augured by the launch of new products. Indian
life science firms are investing in biosimilar development to acquire skill sets, latest manufacturing
technologies and to be able to succeed in the complex regulatory environment globally. The session
aims to discuss:

1. Status of the biosimilars market in India. Highlighting success stories of the sector in both
domestic as well as global markets
2. Regulatory requirements for marketing authorization of similar biologics in India.
3. The role of CDSCO and National Institute of Biologicals (NIB) in ensuring provision of quality
biological drugs and development and validating standards for quality control testing of
biologicals.

Session Chair: Shri Navdeep Rinwa, Joint Secretary, Department of Pharmaceuticals, GoI
Session Co-chair: Dr.J.P. Prasad, Scientist Grade-I & Head, Quality Management Unit, National Institute
of Biologicals
Moderator: Mr Narayanan Suresh, COO, ABLE India
Session Constituents:
1. Dr Davinder Gill, CEO, Hilleman Laboratories Ltd
2. Dr. Rajesh Ullanat, VP, Technical Development, Biologics, Mylan Labs.
3. Dr. Sunit Maity, Director – Product Development, Zumutour Biologics Pvt. Ltd.
4. Ms. MeenuBatolar – Country Lead, UCB India

Expected Participation:
Officials from Govt. of India, Industry Members, Contract Manufacturing Organizations, Trade and
Business officials from Embassies / Foreign missions
(Seating plan: Dais and Theatre style)
1515-1530
TeaBreak
(Siddhartha)
1530-1700 JOINT SESSION:Pharmaceuticals and Med- Tech: Gearing up for Ayushman Bharat
(Siddhartha) Session Brief:
Track 1: The session would revolve around Ayushman Bharat, and how the entire ecosystem can move
together towards Universal Healthcare.
• Role of Medical Technology & Pharmaceutical Industry
• Learnings from AB-PMJAY and road ahead for gearing up to serve a population of 500 Million.
• Role to be played by med tech and pharma sector in skilling and capacity building of healthcare
professionals, doctors, physicians, nurses, technicians etc. and institutionalizing this initiative for
constant up-skilling of capabilities in the healthcare system
• Steps towards a more inclusive Universal Healthcare coverage—International best practices

Track 2: Enabling Med-Tech & Pharmaceuticals to Efficiently Serve Ayushman Bharat

Ayushman Bharat’s roll out makes a promising start to expand the market size and fill the longstanding
demand side gaps in the medical device industry. The next BIG question arises on the supply side
preparedness to meet this rising demand. In this evolving backdrop, this session aims at deliberating the
short/medium/ long term structural/ operational changes required to enable this industry to serve this
most aspirational health scheme rolled out by GoI.

Keynote Address on Ayushman Bharat

Dr Indu Bhushan, CEO - National Health Agency, Government of India; Secretary – GoI

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 Department of Pharmaceuticals
Government of India

Chair: Dr Indu Bhushan, CEO - National Health Agency, Government of India

Moderator: Mr Parijat Ghosh, Partner – Bain & Company*

Panellists:
Government Officials:
• Ms Shubhra Singh, Chairperson, NPPA
• MrJawaid Akhtar, Principal Secretary - Health and FW Department, Government of Karnataka
• Mr Navdeep Rinwa, Joint Secretary – Department of Pharmaceuticals, Government of India
• Dr Vijay Tadia, Senior Resident Administrator, AIIMS

Industry
• Mr S Sridhar, Chair FICCI Pharma Committee; Managing Director- Pfizer India Ltd
• Mr Vivek Kamath, Managing Director, MSD Pharma
• Mr BadhriIyenger, Chair - FICCI Medical Device Committee; Managing Director - South Asia & South
East Asia, Smith & Nephew Healthcare Ltd.
• Dr Alok Roy, Co-Chair – FICCI Health Services Committee; Chairman, Medica Hospitals

(Seating plan: Dais and Theatre style)

1700 Close

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