The union health ministry has constituted a committee to review the procedure and practices followed by the Central Drugs Standard Control Organization (CDSCO) for granting marketing approval and clinical trials in cases.
The four-member expert committee, headed by Prof. T M Mahapatra, former director of Institute of Medical Sciences, Banaras Hindu University, will examine the procedures and practices followed in granting approvals in fixed dose combination of aceclofenac with drotaverine, buclizine, letrozole and placenta extract. The committee will see if scientific requirements and the regulatory compliance were adhered while giving permissions. Other three members include Prof. Satyawan Singh, former scientist at CDRI and Mr Venkat Krishnan, former drug controller of Kerala, and a representative of the chief vigilance officer in the health ministry.
The possible reason behind the decision is that the earlier committee headed by Dr V M Katoch, director general, Indian Council for Medical research (ICMR), constituted by the health ministry last year, didn't fix any responsibilities on wrong doings at CDSCO in its report. Apart from that, the government has taken into consideration the critical remarks made in the 59th report by the Parliamentary Standing Committee on the functioning of CDSCO.