Hole in scheme to fight medicine menace



A health ministry plan to reward whistleblowers who help authorities seize adulterated or fake drugs will leave substandard medicine — a bigger threat to health — untouched, drug regulators and medical experts said.

The health ministry has launched a scheme to reward whistleblowers an amount of up to 20 per cent of the value of the adulterated, spurious, or misbranded drugs, cosmetics, or medical devices seized by authorities.

But the government’s own data suggest that adulterated or fake drugs in India make up less than 1 per cent, perhaps as low as 0.3 per cent, of domestic drug sales. Surveys by government drug regulators and the results of a recent study suggest that the level of substandard medicines in India appears to vary from 5 per cent to 12 per cent, as was reported in The Telegraph earlier this year.

“The whistleblower reward scheme will apply only in cases that involve clandestine activities where people intentionally bypass all the standard licensing processes,” a senior drug regulator in the central government said.

The scheme will not cover drugs found to have quality problems as long as they have been manufactured through standard licensing processes, according to the regulator who requested not to be named.

Medical experts who have been monitoring drug issues said the whistleblower plan appears to be a “gimmick” introduced to create the impression that health authorities in India are taking action to ensure high quality of drugs.

“The health ministry is possibly worried about India’s drug exports — and is trying to improve India’s image through this scheme,” said Gopal Dabade, the co-convener of the All India Drug Action Network, a non-government organisation.

“This is a gimmick — the (health) ministry should try to tighten regulations and improve the efficiency and reliability of our drug controllers,” Dabade said.

India’s pharmaceutical industry exports drugs worth about Rs 350 billion from total sales of about Rs 850 billion, according to data available with the health ministry. Central drug regulators are currently engaged in an all-India survey to determine the extent of availability of fake or spurious drugs.

“Early results show that the extent of the problem is much less than 1 per cent,” a drug regulator said.

“The whistleblower plan has nothing to address India’s more significant problem of substandard drugs,” said Chandra Gulhati, editor of the Monthly Index of Medical Specialities, India, an independent journal of drugs.

Variations in manufacturing process standards as well as transportation and storage practices may influence the quality of drugs available at retail outlets, Gulhati said.

Over the past year, US drug regulators have sent warning letters to at least two Indian drug companies, raising concerns over their manufacturing standards and the quality of domestic oversight by India’s state and central regulators.

A senior drug official said given the size of India’s pharmaceutical industry, even a 1 per cent proportion of spurious or fake drugs has the potential to harm many patients. The problem may be small, but it cannot be ignored, the official said.
Source: The Telegraph

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