2023-04-22T06:07:01
Technical Review Committee
Background
Interaction with the pharmaceutical industry leadership and their associations, namely the
Organization of Pharmaceutical Producers of India (OPPI), Indian Drug Manufacturers Association
(IDMA), Indian Pharmaceutical Alliance (IPA) and Associated Chambers of Commerce and
Industry (ASSOCHAM), contract research organizations (CROs) conducting clinical trials in India
on behalf of the sponsors (i.e. the pharmaceutical industry) and representatives of civil society and
non-governmental organizations (NGOs) highlighted that there are a plethora of new drug advisory
committees (NDACs) - 12 in all, advising the Drugs Controller General of India (DCGI) on new
chemical entities (NCEs)/new biological entities (NBEs), new generic drugs and similar biologic
approvals. Each committee consists of 10 to 15 subject-specialty experts having little experience of
regulatory data review; some committees have even not met for over a year. Further, a committee
sometimes does not take a decision if just one or two members do not attend the meeting.
On the other hand, sometimes decisions are taken when only two members are present. There is
therefore a significant slowdown in consideration of applications and grant of approval for different
phases of clinical trials or marketing and manufacture of new generic drugs, similar biologics or
NCEs/NBEs. This concern of the entire pharmaceutical industry appears genuine. Delay in
approvals was also highlighted by the Parliamentary Committee and hence needs immediate
redressal. This committee feels that it is essential to clear pharmaceuticals applications speedily to
maintain vibrancy and the global impact of this Rs 1200 billion industry. It is therefore proposed to
constitute one broad expertise-based Technical Review Committee instead of the existing 12
NDACs to ensure speedy clearance of applications without compromising on quality of data and
rules and regulations.
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