Committee condemns Indian government for failing to withdraw 33 drugs that lack evidence

BMJ 2013; 346 doi: (Published 07 May 2013) Cite this as: BMJ 2013;346:f2915
  1. Soumyadeep Bhaumik
  1. 1Kolkata

A parliamentary committee on health has severely criticised India’s government for its “evasive” response to recommendations it made in May last year on tightening the regulation of drugs.

It accused the government of “dillydallying and procrastination” in failing to enforce proper procedures for approving drugs, for not following global bans on harmful drugs, and for failing to withdraw 33 drugs that were approved without clinical trials.

The Parliamentary Standing Committee on Health And Family Welfare presented its 66th report into the operation of the Central Drugs Standards Control Organisation, India’s regulatory body for drugs, cosmetics, diagnostics, and medical devices, to the Rajya Sabha (upper house of India’s parliament) on 26 April.1

It said, “The government has done nothing concrete or conclusive even for the recommendations and findings of the committee, which directly concern the safety, and health of crores [tens of millions] of our countrymen.”

The committee’s 59th report, published in May 2012,2 made it obligatory for the government to submit an “action taken note” (ATN) within three months of the recommendations being published. However, the government missed the August deadline, and the committee described the ATN that it did submit as “evasive, inconclusive, dilatory and vague.” The committee said that the government had failed to reply to 19 of its recommendations.

The government submitted a revised ATN in December last year.

In its report the committee condemned the Central Drugs Standards Control Organisation for approving 33 drugs despite there being “no scientific evidence to show . . . [that they] are really effective and safe in Indian patients.” It also criticised the government for using tactics to delay indefinitely decisions and actions against several officials and others who had “indulged in rampant acts of omission and commission” in approving these drugs.

The report noted that the organisation had allowed about 13 drugs to be marketed in India that were not sold in many developed countries such as the United States, Canada, and European Union countries.

The committee said that the government was dragging its feet on the issue of punishing doctors who were involved in “sheer illegal activities which are totally against the public interest.” It said that the government had formed a plethora of committees that did no real work and whose membership was questionable, asking “whether expertise on drugs is confined to Delhi.”

The committee has again recommended action against people responsible for allowing the unlawful marketing of drugs.


Cite this as: BMJ 2013;346:f2915


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