Even as criticism is levelled that the meetings of New Drug Advisory Committees (NDACs) many times did not have the presence of all the experts, the government is planning to raise the number of the NDACs from 12 at present to 50 on a gradual basis.
The Central Drugs Standard Control Organisation (CDSCO), pushed by the Parliamentary committee on the functioning of the regulatory mechanism and under pressure from the judiciary, had formed 12 NDACs to advise on matters related to review and regulatory approval of clinical trials and new drugs (except for Investigational New Drugs).
The new proposal, as suggested by the technical committee and approved by the apex committee on clinical trials, is to increase the number of NDACs to 50 with a view to involve more experts in the process of clearing the clinical trials in a fool-proof manner. Sources said the process for getting approval for forming more NDACs had already been initiated.
The CDSCO is also planning to expand the panel of pharmacologists as in many cases, the absence of pharmacologist had hampered the decision-making process of the expert committees. It is learnt that several applications for clinical trials approvals were held up as pharmacologists, who are part of the NDACs, were not present during deliberations.
The Apex Committee on clinical trials headed by the Health Secretary has also reportedly taken note of the situation. It was pointed out that NDACs even made recommendations even without proper representation of specialists including pharmacologists in several cases in the past.
In some of the NDACs, the expert members have retired, some of the members are no more associated with the organisation and some had refused to attend the meetings, citing busy schedules and engagements, thus defeating the very purpose of the NDACs. The practice is that the pharmacologists specified for particular NDACs are only called to offer expert opinion, not full-time attendance at the meetings.
The apex committee has already directed that whenever a pharmacologist in the panel is absent, the minutes of the NDACs along with the presentation of the firms and supporting literature should be referred to the pharmacologist approved in the panel of NDAC for his opinion.