Tuesday, May 15, 2012

India - India’s Health Ministry To Review Serious Lapses In Drug Approvals

An Indian parliamentary committee has found serious lapses in approvals for some drugs, sparking the order for a panel of experts to look into the charges and suggest remedial measures.

T.V. Padma/SciDev.net: After a parliamentary committee criticized the bypassing of clinical trials and other irregularities in the approval of new drugs, India’s health ministry has ordered a panel of experts to look into the charges and suggest remedial measures.

The three-member panel led by the director-general of the Indian Council of Medical Research, Vishwa Mohan Katoch, will submit its report within two months, according to a statement released this week (11 May) by the health ministry.

The Katoch panel will “suggest steps to institutionalize improvements in other procedural aspects of functioning” of the ministry’s Central Drugs Standards Control Organization (CDSCO), which was criticized by the parliamentary committee in its report this week (8 May).

Saying that consumers’ interests were being ignored, the parliamentary committee suggested that CDSCO change its stated mission of meeting the “demands and requirements of the pharmaceutical industry” to one that will clearly protect public health.

The committee’s report was based on studies conducted in the manner in which 42 randomly selected medicines were approved by the body – 38 of them between 2004 and 2010.

Documents for three controversial drugs – which have not been approved in advanced countries – were missing, the committee said.

Eleven drugs were approved without conducting Phase III trials (multi-centric trials to test for populations’ differences in drug safety and tolerance), while trials for two drugs were conducted on 21 and 46 patients instead of the mandatory 100 before approval.

Phase III trials and expert opinion were dispensed with in the case of four drugs.

“The decision to approve these drugs was taken solely by the non-medical staff of CDSCO,” the committee said. “A review of the opinions submitted by the experts on various drugs shows that an overwhelming majority are recommendations based on personal perception without giving any hard scientific evidence or data.”

“Still worse, there is adequate documentary evidence to come to the conclusion that many opinions were actually written by the invisible hands of drug manufacturers and experts merely obliged by putting their signatures,” the report said.

The committee found “sufficient evidence on record to conclude that there is collusive nexus between drug manufacturers, some functionaries of CDSCO, and some medical experts.”

International drug makers named by the committee have responded to the committee’s charges saying that they had adhered to the law of the land, according to a report in The Hindu Business Line newspaper on 11 May.

One manufacturer told the Reuters news agency on 10 May that it would investigate alleged drug approval irregularities.

Source: SciDev.net.

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