After crackdown on spurious medicines, India’s drug regulator collating data of pharma plants

economictimes.indiatimes.com:

India's drug regulator has started collating and compiling the profiles of pharmaceutical plants in the country.

The Drug Controller General of India (DCGI) has asked drug companies to provide details of each of their units operational in the country.

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The companies have also been asked to share information on international approvals obtained from the European Union, US Food and Drug Administration, Japan's Pharmaceuticals and Medical Devices Agency, Brazilian Health Regulatory Agency (Anvisa), among other regulatory bodies abroad.

If any of these companies are exporting their products, they must share the name of the importing countries, details of their units outside the country and whether they hold a World Health Organization-Good Manufacturing Practice certificate.
They should also provide details such as their annual turnover, domestic turnover, export turnover and production capacity.
As per data from the Central Drugs Standard Control Organisation, there are about 10,500 units in the country which are manufacturing different types of dosage forms and active pharmaceutical ingredients.

According to a letter dated September 4, the DCGI has asked state drug controllers to direct the companies under their jurisdiction and obtain the details. The DCGI has asked them to treat it as «most urgent». «The exercise has been initiated to collate data of all the manufacturing units in India to understand and know their status, the products that are made for the domestic market and export goods,» an official said.

In March,