The apex committee on clinical trials, constituted by the Union health ministry on the directive of the Supreme Court to monitor the clinical trial sector in the country, has cleared a total of 41 new proposals, 26 proposals of global clinical trials and 15 in other areas. These trials were approved by new drug advisory committees (NDACs) and thereafter the technical committee, another high-level panel formed by the ministry on this purpose.
According to senior officials in the ministry, the apex committee in its 14th meeting held on June 17 deliberated in detail on the new proposals and ratified the recommendations made by the technical committee. Earlier, the technical committee in its two meetings had evaluated and recommended for 41 proposals of various categories of clinical trials.
As per the direction of the Supreme Court made in its order April 21, 2014, the proposals of global clinical trials/ clinical trials of NCEs are required to be evaluated with regard to three parameters like the assessment of risk versus benefit to the patients; innovation vis-à-vis existing therapeutic option; and unmet medical need in the country.
Out of the total 41 cases, 26 cases were global clinical trials/ clinical trials of NCEs and the rest 15 cases were related to clinical trials for approval of new drugs including fixed dose combinations, subsequent new drugs and biologicals.
Headed by union health secretary Lov Verma, other members of the apex committee are DHR secretary Dr VM Katoch, DGHS Dr Jagdish Prasad and Arun Panda, joint secretary, health ministry. DCGI Dr GN Singh and the RK Jain, additional secretary, health ministry are the special invitees of the apex committee.
Pfizer (Pregabalin, Lyrica), Bristol-Myer Squibb (Dapagliflocinpro panediol), PSI CRO Pharma India (Eravacycline, TP 434), GSK Pharma (Herpes zoster gE recombinant protein adjuvanted with AS01B adjuvant system), Spectrum Clinical Research (Apitox purified honeybee (Apismellifera) venom), Sanofi Pasteur India (Meningococcal (groups A, C, Y and W-135) polysachharide diphtheria Toxoid conjugate vaccine Menactra), Pfizer (PF-05280014, trastuzumab), Novartis Healthcare (INC424, Ruxolitinib), Cliantha Research (Bevacizumab biosimilar, BEVZ-92) are some of the companies who applied for global clinical trials and got the approval.