India to Set Up Centralised Drug Licensing Authority

India to Set Up Centralised Drug Licensing Authority
Concerned over the rampant spread of spurious medicines in India, the government is planning to disallow states from issuing licences to drug companies and to set up a federal authority instead on the lines of the US Food and Drugs Administration (FDA).
"Currently, both the centre and the state governments are empowered to issue licences for the manufacturing of drugs. But this will change in the near future," Health Secretary Naresh Dayal said.

"Unfortunately, the control mechanism of state regulating bodies is not efficient. And their inefficiency is one of the key factors why spurious drugs are flourishing in the country. We will withdraw the drug-licensing power from them and start a centralised licensing system," Dayal told IANS.

The secretary said the centre has moved a bill to form a central drug authority and it has been referred to the standing committee.

The new body will be fully autonomous and be modelled on the lines of the FDA in the US. It will have 10 sections like a clinical trial division, biotech division and pharmaco vigilance division.

"We are quite hopeful that by the coming budget session we will have the power to do so. The process of withdrawing licensing powers from states will start thereafter," he said.

"The central drug authority will follow the Good Manufacturing Practice (GMP) norms set by the World Health Organisation (WHO) and thus give India a better name in the field of drug export."

He said recently India had signed an agreement with the Philippines. "Our drug market is growing and the Philippines Friday signed an agreement with us to make India a source for importing medicines."

"Medicine costs there are too high and nearly 40 percent of the population is below the poverty line. They want to take advantage of our low cost medicine. When the global community is looking towards us, we should make our vigilance mechanism stronger," Dayal added.

He said his ministry is going to fill up many vacancies of drug inspectors and this will help the cause of surveillance.

Dayal said the Drugs and Cosmetics Act will be amended in the near future to put a high penalty on spurious drug manufacturers and those involved in their marketing.


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