Discussions were held on APIs, generic formulations, betterment of Pharma SMEs, diagnostics and medical devices, biosimilars, pharmacovigilance; clinical research and more; under the theme Pharma Vision 2030
The 70th edition of the Indian Pharmaceutical Congress (IPC) was inaugurated at Amity University, Noida. Organised by the Indian Pharmaceutical Congress Association, a federation of five professional pharmaceutical bodies, and hosted by the Indian Pharmacy Graduates’ Association. IPC 2018 saw industry veterans and thought leaders discuss and deliberate on the challenges and solutions in the road to achieve Pharma Vision 2030. The event saw a gathering of more than 6,000 delegates from all the sections of the pharma fraternity, with participation from 125 national and international speakers.
IPC 2018 was inaugurated by the Vice-President of India, M Venkaiah Naidu in the presence of Dilip Shanghvi, President of 70th IPC and Managing Director, Sun Pharma. BR Sikri, Managing Director, ABS Mercantile, Chairman – LOC, 70th IPC; Atul Nasa, Head of Office/Controlling Authority, Drugs Control Department, Delhi and Organising Secretary, LOC of 70th IPC; Dr Ashok Chauhan, Chief Patron IPC, Founder President , Amity Universities & Institutions; and Pawan Kumar Jaggi, Former Assistant Drugs Controller and other dignitaries were present.
“India is already on the road to become the third largest economy in the world and the pharma industry is an important stakeholder in the growth. The Union Budget 2017-18 shows that there is an increase of 23 per cent in health expenditure which will benefit the pharma industry. The government has proposed amendment to the Drugs & Cosmetic Rules which will ensure the availability of generic medicine at affordable prices to promote the use of generic medicines,” said Naidu in his inaugural address.
Naidu praised the Indian pharma industry for all its achievements over the past decades to make medicines more affordable globally, making special mention of anti retrovirals for HIV/AIDS. He listed the initiatives taken by the government of India to support the Indian pharma industry as well as price control through NPPA keeping the needs of patients in mind. He exhorted the industry to keep an unwavering focus on drug quality and good manufacturing practices. He earned a resounding round of applause from the delegates when he said, “Regulations should not become a strangulation.” In his address Shanghvi welcomed all the delegates and briefed the audience on the topics which would be covered over the three days IPC 2018.
Welcoming all the attendees and participants to the 70th IPC, Sikri said, “For the first time, the Vice-President of India has met 50 CEOs of top 50 companies in the Indian Pharma Industry. We welcome Venkaiah Naidu and thank for his support. It is a proud moment for me to declare that India is the only country to provide efficacious medicines to more than 150 countries worldwide at affordable price.”
Dr S Eswara Reddy, DCGI, India also addressed the august audience at IPC 2018. The first session of IPC 2018 began with BV Patel Memorial lecture by Dr S Eswara Reddy, Drugs Controller General (India). He gave a brief introduction about CDSCO, its activities and the challenges faced by the regulators. Dr Chandrasekhar Rao, Deputy Drug Controller (India), CDSCO continued with the lecture and informed the audience about the various measures taken by the Government of India such as online submission of data through SUGAM portal, single window clearance for transparency, ease of doing business etc.
Nasa proposed the vote of thanks to conclude the inaugural session of the 70th IPC. Day one of 70th IPC commenced with a lot of positive vibes and expectations about building a bridge between industry and academia for future progress. In one interesting segment industry leaders and entrepreneurs shared inspirational stories about their journey success. Sikri, moderated the session and encouraged the students to follow in the footsteps of successful entrepreneurs. J Jayaseelan, Director, Delvin Group of Companies shared his dreams and the difficulties he faced and overcame in the initial days of career.
Later, Sandeep Singh, Director, Alkem, who is furthering and nurturing the legacy of his father and grandfather is now leading his company towards continued progress. SV Veeramani, Chairman and Managing Director, Fourrts also took the stage to share details about the commendable role he has played in the growth of the Indian pharma industry.
Later, Rajeev Juneja, CEO, Mankind Pharma shared his tale in which he mentioned that unlike any other successful company, Mankind has less of failures and more of success. Chauhan also shared his success story. He stressed that for a successful life, a person has to decide his goals, believe in them and work towards them relentlessly. Several interesting knowledge sharing sessions were held of which one was on building and protecting intellectual property in pharma for continued progress. In a session, moderated by Shirish Dabhade, Ex- assistant commissioner, FDA Maharashtra and co-chaired by Nitin Deore, Assistant Commissioner, FDA Maharashtra, experts in IPR shared their views and insights to update the industry and the academia about this sphere. Dr Gopakumar Nair, an IP expert outlined the strategies for larger Indian pharma companies to become a preferred super generics and value added generics supplier to the world.
Dr Pearl Sobti, Senior Manager intellectual property, Sun Pharma Industries spoke on the road ahead for pharma and explained how IP will play a crucial role in its progress. Dr Guru Nagraj, Patent Attorney, Delhi spoke on the roadmap for growth through protective innovation. In his presentation he presented factors that can not be ignored, informed about creative enforcement strategies by IP owning pharma companies and ways of extending patent expiry.
Surbhi Sharma, Senior Patent Associate at ipfeathers touched upon the pre-TRIPS scenario and its impact on the industry. Comparing the earlier and current situations, she highlighted that during the pre-TRIPS regime the industry was self-reliant whereas in post-TRIPS Indian pharma companies took a step in setting up of research facilities and innovative research programmes.
The Presidential Session on day one of IPC 2018 was followed by a series of memorial lectures. Delivering the KC Chatterjee Memorial Lecture, Dr Anil Kumar Negi, Assistant Drugs Controller /Licensing Authority, Drugs Control Department, Government of NCT of Delhi gave an introduction to the role of state regulatory authorities in medical devices regulations.
The session on AMR was chaired by Prof (Dr) Bhudev C Das, Chairman and Hargobind Khorana Chair Professor, and Dean, Health and Allied Sciences, Amity University UP and Co chaired by Prof (Dr) Chanderdeep Tandon, Dean, Faculty of biosciences and biotechnology, and director, Amity Institute of Biotechnology.
The first speaker Dr Anita Kotwani, Professor, Department of Pharmacology, VP Chest Institute, University of Delhi. She spoke on the smart regulation of antibiotic use. She started with a background on what is AMR, and why we are now in the post antibiotics era. Kotwani also covered how smart regulations could redeem the situation.
The second speaker, Dr Jyoti Joshi, Head-South Asia and GARP, Asia Coordinator, Centre for Disease Dynamics, Economics & Policy (CDDEP), spoke about an AMR scoping report which revealed that Indians were the largest consumer of antibiotics in 2019, followed by China and the US. She mentioned that policies and practices have become very defensive as doctors want to save their practice and don’t what to be sued. While she appreciate
d FDCs, she also pointed out how the 118 odd combinations could increase antibiotic resistance levels.
IPC 2018 emerged as a platform for the healthcare and life sciences fraternity to deliberate on the transformations in these industries and the factors driving them. They also speculated on the impact of these changes in the future. Sudhakar Mairpadi, Head-Quality and regulatory, Government Affairs- Health Systems Personal Health Home Co Division, Philips gave a talk on the growing acceptance of wearables and other mobile health technologies. It also addressed the crucial aspect of regulating these technologies.
On the second day, several pertinent discussions on issues which would be crucial to the industry’s glorious future. In one such session, pharma captains and game changers came together to examine sphere of biologics and biosimilars and outline strategies for India Pharma Inc to tackle the challenges and optimise the growth potential. The discussion, moderated by Dr Surinder Singh, Director, National Institute of Biologicals; also had eminent panelists comprising Dr Subhash Chand, Scientist-III and Head, National Institute of Biologicals; Dr Akundi V Sriram, Senior Vice President and Head Regulatory, Biocon and Dr R Chandrasekhar, Deputy Drug Controller (I), CDSCO.
The experts addressed various aspects in this sphere such as challenges in quality control strategy of biosimilars in India; regulatory requirements for approval of biosimilars and development of biosimilars from concept to commercialisation of the drug product.
Day 2 of IPC 2018 saw industry captains and regulatory authorities come
together with the aim of building better synergies and strengthen their relationship to serve patients better. Eminent panelists discussed the various nuances of this relationship in the much-awaited session titled, ‘Can industry and regulators go Hand in hand? To gain the Glory of pharma sector. It’ was moderated by Sikri. SV Veeramani, Chairman and Managing Director, Fourrts Laboratories emphasised that regulators should be facilitators, educators and coaches to the industry. He opined that regulators need to guide the industry and requested the regulators to take the industry’s views while creating new regulations. Dr SM Mudda, Chairman, Regulatory Affairs, Indian Drugs Manufacturing Association, highlighted that there is a need for collaboration between the industry and regulators at the operation level.
Dr Rajendra Kumar Sanghavi, Chairman, Medical Committee, Indian Drugs Manufacturing Association talked about the UCPMP code, cross-prescription by non-allopathic practitioners, non-availability of DPCO drugs, BCS class II and IV, clinical trials regulations like video recording, banning of drugs like Pioglitazone based on few response and later ban withdrawal and FDC etc. NK Ahooja, State Drug Controller, Haryana, emphasized on do’s and don’ts for regulators. He suggested that in a proposal of changing a name of CDSCO we should consider making changes of drugs inspectors to drug controller officer, it will change the perspective and create positive vibes.
Dr HG Koshia, Commissioner, FDA- Gujarat, briefed the audience on pharma industry’s problems and the furore during the implementation of Schedule – M. The event concluded at the Amity University Campus, Noida. The event was graced by Anand Murti Guru Maa as the Chief Guest and Bejon Misra as the Guest of Honor. Atul Nasa, Head of Office/ Controlling Authority, Drugs Control Department, Delhi, said, “The coming months will see stricter implementation of quality standards and increased awareness of the risks of online pharmacy. OTC drugs need greater regulation to prevent unmonitored use and abuse.” The programme concluded with a valedictory function and address by the Chairman, Secretary reports, Scientific reports, motivational and spiritual talks, a fashion show, prize distributions and felicitation ceremonies and the singing of the national anthem.
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