Pharmacologists at 150 ADR centres to work as experts to assist DCGI in drug approvals

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Faced with crunch of sufficient experienced pharmacologists in the new drug advisory committees (NDACs), the Drug Controller General of India will tap the strong pool of senior pharmacologists available with Adverse Drug Reaction (ADR) centres in the country.

This was decided after it was found that many NDACs could not deliberate and take a decision on approval of clinical trials and drug approvals properly due to the absence of pharmacologists during the meetings.

The decision is to make use of the pharmacologists available at the 150 ADR monitoring centres under the Pharmacovigilance Programme of India (PvPI), as they happen to be senior pharmacologists of the medical colleges. They will be treated as a panel of experts and the DCGI would call them for the meetings as per the need of the proposal. This will make sure that one or more pharmacologist would be present in every meeting.

It has been pointed out that several applications for drugs and trials were being 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. The Technical Committee has found that some NDACs even made recommendations even without proper representation of specialists including pharmacologists in several cases in the past.

The functioning of the NDACs has been hit after some members retired and  some of the members are no more associated with the organisation and some had refused to attend the meetings, citing busy schedules and engagements. Te practice is that the pharmacologist 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.

Source: PharmaBiz

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