Usha Sharma – Mumbai
In order to bring more transparency, consistency and accountability in the approval process of drugs, Central Drugs Standard Control Organization (CDSCO) is increasing the number of members of New Drug Advisory Committees (NDACs) and Medical Devise Advisory Committees (MDACs). CDSCO plans to increase the number of members to around 30 and it has invited applications for the same. The last date for the submission of applications is on September 28, 2012.
In an interaction with Express Pharma, Dr GN Singh, Drugs Controller General India said, “The Parliamentary Standing Committee has suggested increasing the existing staff members from across India and has advised us to appoint members from universities and hospitals.”
CDSCO is in the process of expanding the pool of such experts in areas of oncology, gastroenterology, hematology, opthalmology, gynaecology, immunology, cardiology, nephrology, psychiatry, urology, paediatrics, rheumatology, microbiology, pharmacology medicine, anesthesiology, vaccines and dental.
Singh commented, “In each and every committee, we plan to increase the number of members to 25 – 30. We also have permission from the Ministry of Health and Family Welfare to recruit more people from the Centre if required. In MDACs, we plan to have 30 members depending upon the nature of the drug which needs to be approved. Out of the total number, we will be inviting only 10 members at a time for discussion.”
The experts will evaluate the proposal under Terms of Reference (TOR) spelling out their responsibilities which range from advising DCGI in matters related to regulatory approval of new drugs, global clinical trials, fixed dose combinations, medical devices; preparing guidelines for clinical research industry in evolving acceptance criteria for marketing approval of new drugs of different therapeutic categories. The experts are also tasked with defining a roadmap for research of new drugs relevant to the Indian population.
The applicants will be evaluated either through meetings or by circulation. For review of each proposal, experts will be paid an honorarium of Rs 1,000 as per government rules, Travelling Allowance (TA) and Daily Allowance (DA) for attending the meetings. The expert nominated as a member for the committee should not have any conflict of interest as per the declaration given in the annexure.
The members of the committee will hold office for three years but will be eligible for re-nomination provided the persons nominated continue to hold their offices in their respective organisations by virtue of which they are nominated. In case a member retires during the terms of validity, a suitable alternative member probably from the same institute or from some other institute will be nominated as the member for the committee. The members of these committees should be in a position to give their expert opinion within a period of six weeks from the receipt of such proposal. The members of these committees should follow the principle of confidentiality with respect to the documents submitted by the applicants.
While speaking about the payments, Singh said, “The Centre will pay these members similar to what it is paying other members.”
Experts interested in such positions have a month to apply in the set format, more details of which can be found on the CDSCO website. Singh said, “After this deadline, we will take another two months to finalise the appointees.”
