At present the Central Drugs Standard Control Organisations (CDSCO) has 12 new drug advisory committees (NDACs) and six medical device advisory committees (MDACs), which assess applications under Indian Drug & Cosmetics rules.
However, in a letter published yesterday the organisation said it wants to expand these panels and asked experts in a range of medical disciplines (see box) who meet selection criteria to apply to join the review committees.
Key activities will include advising the Drugs Controller General (DCG) on regulatory matters related to the approval on new drugs, global clinical trials, fixed dose combinations and medical devices.
The CDSCO also said it wants committee members to help it prepare guidelines on clinical research, which will include “evolving acceptance criteria for marketing approval of new drugs of different therapeutic categories.”
The organisation does not give any more details and had not responded to a request for further information at the time of publication.
Conflict of Interest
Conflict of interest seems to be the most important selection criteria, with nominees being required to declare if they have been employed by or severed as consultants for pharmaceutical companies with products under review in the last two years.
The CDSCO also asks applicants to disclose if pharmaceutical companies have funded research over the same period, if they have investments valued at more that INR200,000 and if they or their family members would benefit or be adversely impacted by the outcome of any reviews.
Interestingly, the organisation also asks nominees to declare if they have worked with or received research support from tobacco companies in the last four years.
Successful candidates will be paid an INR1000 ($17) and will need to be available within six weeks of applying. Each review post is held for a maximum of three years, however renomination is permitted at the end of this period.
Additionally, if a review committee member retires during her or his tenure the CDSCO said it will accept replacements nominated by the institution that employed the original reviewer.
Interested parties are asked to send their CVs and proof they have no conflict of interest to the CDSCO at firstname.lastname@example.org. Nominations will be accepted for the next 30 days.