Regulatory Focus™ > News Articles > Scathing Parliamentary Report Blasts India's Drug Regulatory Authority

Scathing Parliamentary Report Blasts India's Drug Regulatory Authority

Posted 09 May 2012 | By Alexander Gaffney, RAC 

A parliamentary report authored by India's Standing Committee on Health and Family Welfare (SCHFW) is blasting the country's Central Drugs Standard Control Organisation (CDSCO), India's drug regulatory authority, calling it a "collusive nexus" between industry, government and medical experts, reports Reuters.

The report follows an account published in April 2012 by The Times of India, which reported CDSCO's Drug Controller General of India (DCGI), which oversees subsets of drug products in India, has "washed its hands from drug approvals."

"DCGI has become a defunct body, as it has no powers in decision making," said one unnamed official to The Economic Times of India at the time of its report.

The depth of chaos at CDSCO is so bad SCHFW recommended "the government re-examine certain drugs that had been approved, investigate the 'gross violation' of Indian laws it had uncovered and take action against officials alleged to have colluded with the drug companies," reports Reuters.

To assess the drug regulatory authority, SCHFW conducted a sample audit, explains Live Mint.

"The investigators picked 42 drugs available in the Indian market and asked DCGI and the health ministry to furnish approval papers," explains Live Mint. "The committee found that an 'overwhelming' majority of the drugs were being approved on the basis of personal prescriptions and without any scientific evidence."

SCHFW also found "adequate documentary evidence to show that (expert) opinions are written by the invisible hands of drug manufacturers and experts merely oblige by putting their signatures."

Numerous drugs have been approved without being subject to clinical trial requirements, notes The Daily Mail, with some drugs being approved after being tested in just twenty patients and others being investigated at just two hospital centers. Still others had no Phase III clinical trials conducted or any expert opinions backing the respective drugs.

The parliamentary inquiry laid blame for many of India's drug quality problems squarely at the feet of CDSCO, saying "most of the ills besetting the system of drugs regulation in India are mainly due to the skewed priorities of CDSCO".

Read more:

SCHFW's Report

Reuters - Probe uncovers serious problems with India's drug regulator

Live Mint - Panel exposes flaws in India's drug approval procedure

The Financial Express - Possible nexus between pharma firms, DCGI officials: Panel

The Daily Mail - India's drug regulation system is in a total shambles

Regulatory Focus - Report: Indian Drug Regulator's Office Has 'Washed Its Hands From Drug Approvals'

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