Drugs being sold without safety tests, trials

How safe is the new medicine that you’ve been prescribed? No one knows — not even the Central Drugs Standard Control Organisation (Cdsco), the agency tasked with assuring the safety and effectiveness of all drugs approved for sale in India. Sanchita Sharma reports. Doctored dose

How safe is the new medicine that you’ve been prescribed? No one knows — not even the Central Drugs Standard Control Organisation (Cdsco), the agency tasked with assuring the safety and effectiveness of all drugs approved for sale in India.

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Cdsco has been approving medicines without trials, doesn't have documentation of many of the approved drugs and has even allowed in drugs banned in other countries. It has also been getting opinion of experts spoon-fed by manufacturers to bring the drugs in the market.

The parliamentary standing committee on health and family welfare has listed these alarming findings in its 59th report on the functioning of Cdsco tabled in Parliament on Tuesday.

"On an average, the Drug Controller General of India (DGCI) is approving one drug every month without trials, " says the report.

The DGCI heads Cdsco.

Apart from specified documentation (pharmacology, toxicology, animal studies, overseas trials etc), all new drugs discovered outside India have to be tested for safety and effectiveness on at least 100 patients in three-four hospitals in India, says the Drugs and Cosmetic Rules, 1945.

Independent expert opinions sought were also found biased. “There is adequate documentary evidence to come to the conclusion that many opinions are actually written by the invisible hands of drug manufacturers and experts merely obliged by putting their signatures,” says the report.

What was most shocking, perhaps, was the ministry of health and family welfare saying in its status report that the “mission of Cdsco was to meet the aspirations… demands and requirements of the pharmaceutical industry”.

Clearly, patients' safety is not a priority.