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BMJ. Aug 23, 2003; 327(7412): 414.
PMCID: PMC1142494

India to introduce death penalty for peddling fake drugs

India plans to introduce the death penalty for the sale and manufacture of fake and counterfeit medicines that cause grievous harm. The move follows widespread concern that existing regulations pose little deterrence to unscrupulous drug vendors.

An expert committee last week recommended stiffer penalties for violating the drug laws and improvements in the nation's drug regulatory infrastructure. India's health minister Sushma Swaraj pledged that she would accelerate the process of enacting the changes.

"Profiting from spurious drugs that might harm or kill innocent people is equivalent to mass murder," said Mrs Swaraj, after receiving an interim report from the committee. Testing of drug samples by state government inspectors last year showed that 9% of samples were poor quality drugs and that fake medicines made up 0.3 % of the samples.

The committee recommended that the maximum penalty for the sale or manufacture of fake medicines that cause grievous harm or death should be changed from life imprisonment to the death penalty and that the minimum prison sentence for these offences should be increased from five years to 10 years. The committee has also called for higher fines for those convicted for trading in fake drugs.

It said the regulatory system is plagued by inadequate drug testing, a severe shortage of drug inspectors, and lack of enforcement.

"The infrastructure in some states is pathetic," said Dr Raghunath Mashelkar, director general of India's Council of Scientific and Industrial Research and head of the expert committee.

At least 11 states in India do not have laboratories for testing drugs. In 15 states with functional laboratories, only seven are adequately equipped and staffed.

Drug industry officials say that common fake drugs are antibiotics, drugs for tuberculosis and malaria, and cough syrups.

"We've seen counterfeits of many fast moving brands," said Harinder Sikka, president of Nicholas Piramal, a leading Indian pharmaceutical company. He said that fake cough syrups containing double the permitted codeine levels are sold as counterfeits of well known brands.

Investigations sponsored by pharmaceutical companies in the past have revealed counterfeit drugs containing chalk powder.

The industry suspects drug regulatory officials are often in collusion with manufacturers of fake medicines. "The makers and distributors of fake drugs get tipped off just before raids, and all evidence vanishes," said Ranjit Shahani, president of the Organisation of Pharmaceuticals Producers of India and chairman of Novartis, India.

The committee has proposed a Central Drug Administration to control licensing of all drugs. This move is expected to result in the abolition of the current multiple licensing system (whereby state drug regulatory agencies allow the manufacture of drugs not approved by the central regulatory agency).

The committee has urged greater surveillance, more frequent testing, and the introduction of payments to informers who might help track down makers of fake drugs. Dr Mashelkar said that later this year the committee would suggest the investments required to boost the regulatory infrastructure.


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