India’s Drug Regulator To Collate Data Of Pharma Plants After Crackdown On Spurious Medicines

The companies have been requested to provide details regarding any international approvals by EU, USFDA, or the like
India’s Drug Regulator To Collate Data Of Pharma Plants After Crackdown On Spurious Medicines

India's pharmaceuticals regulator has started to gather and compile the profiles of pharmaceutical factories in the country, following a significant push by the government against fake and inferior medications.

Drug companies have been ordered to disclose information on each of their locations that are active in India by the Drug Controller General of India (DCGI), according to a report by ET.

Additionally, the companies have been requested to provide details regarding any international approvals they may have received from agencies such as the European Union, the US Food and Drug Administration, the Japanese Pharmaceuticals and Medical Devices Agency, the Brazilian Health Regulatory Agency (Anvisa), among others.

If any of these businesses export their goods, they must disclose the names of the importing nations, information about their overseas facilities, and whether they have a certificate from the World Health Organization for Good Manufacturing Practices.

The companies are also expected to 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 on 4 September, the DCGI has asked state drug controllers to direct the companies under their jurisdiction and obtain these 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.

The government had carried out raids in more than 75 pharmaceutical companies in several states, in March. Over 25 companies were found to be in violation of regulations and were issued show-cause notices. "The move was initiated by the DCGI to crack down against spurious and substandard drugs. The non-compliant companies were closed down," he said.

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