Central drug regulator preparing list of dual-use APIs imported from unregistered firms

The central drug regulator is preparing a list of active pharmaceutical ingredients (APIs), the chemicals used for making medicines that have dual-use and are being frequently imported from unregistered firms, to stop their misuse and improve quality, officials said.

"Dual-use APIs, which are being imported from unregistered companies, are comparatively cheaper and of low-quality," a senior government official said.

Dual-use APIs are the ones that can be used in making special food products such as nutraceuticals apart from medicines.

"The Central Drugs Standard Control Organisation (CDSCO), the Ministry of Health and the Department of Pharmaceuticals want to put a stop to the misuse of such dual-use APIs that are being frequently imported from unregistered sources," said another senior government official.

Once the list of such APIs are prepared, it will be submitted to the Department of Pharmacueticals, he said.

The CDSCO is strictly monitoring the import of such dual-use APIs for the last few months so as to get an idea on what kind of action should be taken, he added.

India imports almost 80 per cent of its API requirement from China.

In India, if a company has to import a dual-use API, it has to give an affidavit to the CDSCO that a particular API is being imported from a specific registered company and it will be used in making a particular medicine or medicines only.

According to the first senior official quoted above, most of such dual-use APIs are in high demand in the pharma industry as well as special food products industry.