States lose power to certify drug exports

State governments will no longer be able to certify medications for export from next month. Instead, all pharmaceutical companies will have to get approval from the centrally-controlled Drug Controller General of India, according to media reports.

This follows guidelines issued by the World Health Organisation recommending that there should not be multiple authorities with power to sanction drug exports. According to The Times of India, DCGI will now be the sole authority to issue 'good manufacturing practices' certification.

In a letter to state regulators, DCGI has said that certificates will be issued by the Central Drugs Standard Control Organisation ''after inspection of manufacturing facilities by CDSCO regulatory officials'', the paper said, quoting an unnamed health ministry official. CDSCO works directly under the controller general.

Currently, companies can take state drug regulators' approval to export medicines. But now, ''DCGI has asked all state drug regulators to stop issuing export certificates (technically known as certificates of pharmaceutical product or COPP),'' the report said.

''The WHO has time and again expressed concerns on the quality of pharmaceutical products moving in international community,'' the official said. There must be uniformity in issuing certificates to establish their authenticity and that is possible through a centralised system, he added.

Exports constitute about 40 per cent of the Rs75,000 crore-a-year Indian pharmaceutical market. The medicines manufactured here are in demand in many parts of the world, mainly due to India's expertise in making relatively inexpensive generic versions of drugs patented by international pharmaceutical giants.