India’s Drug Regulator Weighs Inspection of US Pharmaceutical Facilities

India’s drug regulator is looking to investigate US pharmaceutical facilities making “critical” medicines so only high-quality products are imported from them, three government authorities have said.

After taking a move against drug makers in China for quality lapses prior this month, the Central Drugs Standard Control Organization (CDSCO) has turned its consideration regarding different overseas manufacturers, including those in countries with stringent regulatory systems, for example, the US and European countries, the authorities said on condition of anonymity.

To the health ministry, proposal to this effect was sent toward the end of last week, one official aware of the development said.

By foreign regulators such as US Food and Drug Administration (USFDA), the move comes when Indian drug makers are trying to improve the quality of their facilities that have been flagged throughout the years.

ET has reviewed parts of CDSCO’s proposition. There are more than 28 manufacturing sites registered in India from the US, it said.

The authorities said, “in foreign countries, the critical new treatments or registered sites manufacture critical formulations which are not available because they fall into high-risk categories”.

“Inspection of these facilities to the Drugs and Cosmetics Act and Rules not only results in compliance and it will also give exposure to our drugs inspectors to new innovation adopted for the manufacturing and condition of art facilities.”


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