India probes charges of violations by drugs regulator

India's Health Ministry said Thursday it was examining charges that the government's top drug regulatory agency had colluded with pharmaceutical firms to approve drugs without proper clinical trials.

The accusations were levelled in a parliamentary panel report that said officials in the Central Drugs Standard Control Organization (CDSCO) were operating in wilful violation of regulatory practices.

The report, which named a number of international drug majors, said the CDSCO had approved a number of medicines without mandatory final trials, including drugs that are banned in some developing countries.

"There is sufficient evidence on record to conclude that there is a collusive nexus between , some functionaries of CDSCO and some ," the report said.

"Such irregular approvals spare drug producers the cost and efforts but put Indian patients at risk," it added.

India's pharmaceutical market has grown by an annual 14 percent in the past five years and, according to PricewaterhouseCoopers, could be worth up to $50 billion by 2020.

As Indian and international drug makers rush to get their products into the market, the parliamentary report suggested "expert" reports on were actually the work of the manufacturers.

"There is adequate documentary evidence to come to the conclusion that many opinions were actually written by invisible hands of drug manufacturers and experts merely obliged by putting their signatures," the panel said.

In a statement Thursday, the said the panel's findings were being "examined" and promised that "appropriate action would be taken ... wherever required".

The CDSCO is responsible for the licensing, marketing and trials of drugs in India.

add to favorites email to friend print save as pdf

Related Stories

Drug-resistant TB blamed on Indian treatment flaws

Mar 23, 2012

(AP) -- India's inadequate government-run tuberculosis treatment programs and a lack of regulation of the sale of drugs that fight it are responsible for the spiraling number of drug-resistant cases that are difficult to ...

FDA panel backs Pfizer drug for kidney cancer

Dec 07, 2011

(AP) -- A panel of advisers to the Food and Drug Administration voted Wednesday that the benefits of a Pfizer kidney cancer drug outweigh its risks, according to a company spokeswoman.

Bayer challenges India cancer drug ruling

May 06, 2012

German pharmaceutical giant Bayer AG has challenged a ground-breaking Indian ruling that allowed a local firm to produce a vastly cheaper copy of its patented drug for kidney and liver cancer.

Recommended for you

Merck completes sale of consumer unit to Bayer

9 hours ago

Drugmaker Merck said Wednesday that it completed the sale of its consumer care business, which makes products including Claritin allergy medication and Coppertone sun-care line, to German health care company Bayer for $14.2 ...

Viagra ads target women for first time

Sep 30, 2014

The maker of the world's top-selling erectile dysfunction drug on Tuesday will begin airing the first Viagra TV commercial in America that targets the less-obvious sufferers of the sexual condition: women.

User comments