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P.T. Jyothi Datta

Mumbai, July 15 The call for death penalty for makers of spurious drugs has long been given a silent burial. And the Centre still does not have the numbers to indicate the extent of the problem in India. But the issue of spurious and counterfeit drugs is expected to raise its head in Parliament again, more than three years after a committee chaired by Dr R.A. Mashelkar looked into it.

The Union Health Ministry is set to bring the issue back on centre-stage this monsoon session, seeking a hefty penalty on makers of spurious drugs and compensation for victims, a source told Business Line. The money from penalties w ill not go into the Government kitty, and will instead be used to support the victims, he said. Though pharmaceutical industry officials laud the intention, they point out that it could be difficult to implement on the ground.

The Drug-Controller General of India has only 700 inspectors countrywide. The regulatory body has about 600 vacancies, an official source said. Drug inspectors were last recruited in 1993. While the pharmaceutical industry has increased several-fold since, the number of drug inspectors has dwindled, the source observed.

Concerns over the prevalence of spurious drugs had peaked in 2003, forcing the then Union Health Minister Ms Sushma Swaraj to propose death penalty for the “merchants of death”. But the Bill proposing death penalty lapsed as the National Democratic Alliance (NDA) government was unseated at the Centre.

The death penalty has since been converted into a life sentence. Other penalties that the apex ministry proposes include increasing the fine amount and making the offence cognisable and non-bailable. Penalties should be “severe, sure and swift,” Dr Mashelkar told Business Line, quoting from the report he had chaired three years ago.

Though the Centre had then thrashed the number being cited globally on the prevalence of spurious drugs in India, a precise number still eludes the Government in 2007, the official admitted. There is need for a scientific, statistical and fast-track project to get a clear picture on the prevalence, he said. Earlier industry estimates had indicated that about one in four drugs, or medicines worth about Rs 4,000 crore, were believed to be spurious.

“It is inexcusable that a Bill that had acceptance across parties has faced such massive delay,” said Mr Harinder Sikka with drugmaker Nicholas Piramal India Ltd. Mr Sikka had recently filed a Public Interest Litigation on the issue. “The non-availability of a provision to prosecute such producers (of spurious medicines) has caused embarrassment to the country and the industry, in markets like the European Union,” he said. A recent European Commission report had alleged that counterfeit drugs from India made their way into the region.

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