Issue Date: May 21, 2012
Faults Found In India’s Drug Agency
A committee of India’s Parliament has found that the agency charged with regulating pharmaceuticals in India has approved new drugs without ensuring that all requirements for approval were followed. The committee has also found that the agency is critically understaffed and underequipped.
In a 118-page report, the Parliamentary Committee On Health & Family Welfare stresses that many of the problems it identified at the agency, the Central Drugs Standard Control Organization, are caused by skewed priorities. Instead of supporting the development of the pharmaceutical industry, as it is currently mandated to do, CDSCO should focus on ensuring that drugs sold in India meet the needs of Indian patients, the committee concludes.
And to serve the Indian public, the report says, the agency needs more and better qualified employees. The committee recommends that the agency, currently headed by an interim manager, recruit a high-caliber person, comparable to Margaret A. Hamburg, the commissioner of the U.S. Food & Drug Administration.
CDSCO’s focus on serving the drug industry has had undesirable consequences, the committee reports. From a random sample of 42 drugs approved between 2000 and 2011, the committee found that 11 had been cleared without going through required Indian clinical trials.
Among the drugs the committee singled out is GlaxoSmithKline’s pulmonary arterial hypertension treatment Volibris, sold in the U.S. as Letairis. GSK responds that its 2010 approval was proper. Indian authorities had waived the need for local trials, the firm says, because the disease is debilitating and GSK had already conducted global trials on patients of various ethnicities.
The committee similarly faulted the approval of Novartis’ Afinitor, used to prevent the rejection of transplanted organs and to treat kidney cancer. Novartis says the drug was properly approved without late-stage Indian trials because it treats life-threatening and debilitating conditions.
Separately, the parliamentary committee notes that CDSCO lacks the staff and technology needed to manage documents. The committee identified three drugs on sale in India that are missing a paper trail for their approval.
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