The Union Ministry has constituted a four-member expert committee to review the procedure and practices followed by the Central Drugs Standard Control Organisation (CDSCO) for granting marketing approval and clinical trials in cases.

The panel, headed by Prof T M Mahapatra, former director of Institute of Medical Sciences, Benaras 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.

The creation of the committee is a fall-out of the 59th report by the Parliamentary Standing Committee on the functioning of the CDSCO. The panel had cited several cases including the four particular cases above. The Ministry had assured the committee that an expert panel would be formed by the DCGI to look into these cases.

Prof Satyawan Singh, former scientist at CDRI, former drug controller of Kerala Venkat Krishnan and a representative of the Chief Vigilance Officer in the Health Ministry will be the other three members of the panel that will in detail examine the cases against the backdrop of the Parliamentary panel report.

FDC of aceclofenac with drotaverine is not permitted in any other developed country of North America, Europe or Australia. The CDSCO advised the manufacturers Themis Medicare Ltd not only to select experts but get their opinions and deliver them to the office of the DCGI, through a letter in February 2007. Many experts gave letters of recommendations in identical language apparently drafted by the interested drug manufacturer and finally the drug was approved, according to the terms of reference given to the expert committee.

“Buclizine (Applicant UCB, Belgium) was approved on June 28, 2006 for appetite stimulation without clinical trials and without consulting experts for use in children. Under the law of the land, if an old drug approved for a disorder (such as allergy) is to be used for another indication (such as appetite stimulation), then it is deemed to be a new drug and must undergo the entire procedure applicable to new drugs and meet all regulatory requirements. The company’s own core data sheet issued from its headquarters Belgium says: Because of lack of approved clinical studies and scientific data, the benefit/ risk is negative for the indication of buclizine for appetite stimulation. Thus it is not currently approved in Belgium, the innovator country, for appetite stimulation. Buclizine is not just one of the many drugs that have been approved in violation of Indian laws,” according to the terms of reference note.

In the case of Letrozole, an anti-cancer drug for use only in post-menopausal women, the Parliamentary panel had recommended that the DCGI may take action against those CDSCO functionaries who colluded with private interests and the drug got approval in violation of laws.