Govt collating data of all pharma companies for more transparency
New Delhi: To bolster transparency in the drug regulatory system, the union health ministry has directed all state drug controllers to profile pharmaceutical companies within their jurisdiction. Around 10,500 entities are currently producing varied dosage forms and active pharmaceutical ingredients (APIs) in the country. The objective is to ascertain the types of drug formulations being manufactured, imported, and exported, giving the central government a clear picture of the industry's landscape.
“All State Drug Controllers have been directed to collate data from the various manufacturing units located within our jurisdictions on urgent basis. This will allow us to keep a close eye on the functioning of such firms. The directions have come from the health ministry under the guidance of Drugs Controller General of India (DCGI) last week," said a state drug controller aware of the matter.
Pharma companies have been asked to give information about their manufacturing site, the number of sites they are holding, their unit-wise annual turnover, the kind of drug formulations they are manufacturing, exporting and importing, etc., the drug controller added. Meanwhile, the Indian Drugs Manufacturing Association (IDMA) has advised member companies to adhere to the government's directive promptly. To further boost domestic API production, the Department of Pharmaceuticals is pioneering a study on the challenges and gaps in the sector.
Pharma companies and industry associations have been asked to share API import and export data. This data will shed light on the domestic industry's financial and technological challenges in making India future-ready in the global market. This initiative follows a series of incidents where
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