After drive against spurious drugs, DCGI collating data on pharma plants

Drug Controller General of India (DCGI) has begun collating the profiles of pharmaceutical factories in the country after a major drive by the Centre against counterfeit and substandard drugs, according to a report in The Economic Times (ET).

The drug regulator has instructed pharmaceutical firms to provide details of each operational unit in the country.

If any of these firms are exporting their drugs, they must provide details on the importing countries, information about their units outside the country and whether they have obtained a World Health Organisation Good Manufacturing Practice certificate.

DCGI officials have also asked the firms to give details on the international permissions obtained from the US Food and Drug Administration, the European Union, Brazilian Health Regulatory Agency (Anvisa), and Japan's Pharmaceuticals and Medical Devices Agency, among other drug regulators abroad.

There are about 10,500 units in India which are making different types of active pharmaceutical ingredients, according to data from the Central Drugs Standard Control Organisation.

The DCGI, in a letter dated September 4, has instructed state drug controllers to obtain the details from the firms under their jurisdiction.

An official was quoted as saying that an exercise has been begun to collate data from all production units in India to get information about the drugs made for domestic and international markets.

The Centre had raids on over 75 pharmaceutical companies in several states. Over 25 firms were issued show-cause notices after being found to violate norms.

In the past few months, several cases have emerged where products exported from Indian pharmaceutical firms were found to be of spurious quality. At least 70 children died in Gambia last year after taking cough syrups made by a firm in India that were found to be contaminated with the toxins.