Indian Drug Regulation Agency Face Corruption Probe
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Officials at India’s top drug regulatory agency have been accused of colluding with major international pharmaceutical companies in order to bring in medication that had been previously banned overseas.
Officials at India’s top drug regulatory agency have been accused of colluding with major international pharmaceutical companies in order to bring in medication that had been previously banned overseas.
According to the Financial Times, a parliamentary investigation concluded that the Central Drugs Standard Control Organisation (CDSCO) had deliberately approved a series of drugs without any clinical trials, with thirteen of the drugs listed having already been rejected by drug enforcement officials in the United States, Canada, Australia, the United Kingdom and the European Union.
[quote]“What we have found is very alarming,” said Brajesh Pathak, chairman of the Standing Committee on Health and Family Welfare, to Reuters. “The Health Ministry should investigate the matter and take urgent action on the report.”[/quote]Related: The Cost of Corruption in India
Related: Corruption on The Rise in India
According to the parliamentary report, “there is sufficient evidence on record to conclude that there is collusive nexus between drug manufacturers, some functionaries of CDSCO and some medical experts.”
[quote]“On an average [the CDSCO) … is approving one drug every month without trials. This cannot be in public interest by any stretch of imagination. Such irregular approvals spare drug producers the cost and efforts but put Indian patients at risk,” it said.[/quote]Presently, the Indian pharmaceutical market is the fourth largest in the world in terms of volume and generates close $12 billion in sales every year. Due to a ban on prescription-drug advertising, companies use sales force of close to 100,000 people to sell drugs. This is predicted to at least triple by 2020.
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Tapan Ray, director-general of the Organisation of Pharmaceutical Producers of India (OPPI), which is the main lobby foreign group for foreign drug-makers, however insisted to FT that all his members had complied with domestic regulations, and as such, “the issue now appears to be in their appropriate implementation by the regulatory authorities.”
“So far as clinical trials are concerned, OPPI members remain committed to sponsoring clinical trials that fully comply with all legal and regulatory requirements in India,” he said.
Major drug company Pfizer added: “we abide by stringent ethical, scientific and medical standards in addition to the local laws and regulations of the country when we launch our products.”
