ICRIER’s HPI stakeholder Seminar was organized to mark the culmination and release of Health Policy Initiative – research reports and policy briefs on “International cooperation for registration of medicines: Opportunities for India” and “Challenges and prospects for clinical trials in India: A regulatory perspective”.
The Inaugural address of the workshop was delivered by Shri K L Sharma, Joint Secretary, Ministry of Health and Family Welfare, GOI, who emphasized that through our research we are proposing a new set of rules completely harmonized with international practices while at the same time keeping in mind India-specific requirements are being brought out for regulation of new drug approvals and clinical trials.”
Dr G N Singh, Drugs Controller General of India Central Drugs Standard Control Organization, GOI also shared in the special address that we have established ourselves in generics space, drug discovery is the next phase – we have to channelize our energies towards generating new molecules and new therapeutics from India. India has resources, but there is lack of linkage between our academic institutions, national laboratories, and industry – we have strength but it is scattered – expertise is required to channelize towards meeting unmet needs.”
Dr Agnes Saint-Raymond, Head of International Affairs Division from European Medicines Agency said that Regulatory agencies are participating in complexities (of clinical trials) – we have more regulations, we are more picky, we want more data, more certainty and at the same time we are having to deal with the conundrum of having early access versus more data – uncertainty about the data – it is a very difficult situation.”
Shri Lov Verma, Former Secretary Ministry of Health and Family Welfare, Government of India in his Inaugural speech also shared that the next leap is towards generics with a legal binding.”
The seminar was attended by 157 participants representing various stakeholder groups including Government representative, CDSCO officials, academics, industry members, civil society members and Media amongst many others.