18 pharma firms producing spurious drugs lose licence

New Delhi, March 28

The Central Drugs Standard Control Organisation (CDSCO) and state drug controllers have cancelled the licences of 18 pharmaceutical companies for producing spurious drugs, official sources said today. Besides, show-cause notices have been issued to 26 firms on the basis of joint inspections conducted by teams of the Drug Controller General of India (DCGI) and state regulators and drug controllers.

Action triggered by three int’l tragedies

• Sonepat-based Maiden Pharma allegedly linked to the death of over 70 kids in Gambia
• Noida-based Marion allegedly linked to the death of children in Uzbekistan
• A Tamil Nadu-based firm allegedly linked to spurious eye drops that led to blindness and severe side-effects in the US

The officials did not share details of the erring firms, but said they had been hauled up over the production of substandard drugs. In all, 76 companies were inspected. The inspections, sources said, were part of a special drive conducted to check “red-flagged firms”. As many as 203 firms were identified for “special action”, of which 76 across 20 states and union territories were raided over the past fortnight, they said.

“The licences of 18 pharmaceutical companies have been cancelled for manufacturing spurious and adulterated drugs and for violating GMP (good manufacturing practice). Show-cause notices have been issued to 26 firms and the product manufacturing permission of three other firms has been cancelled,” a DCGI official said.

Among the 203 firms to be covered under the special drive, nearly 70 are in Himachal Pradesh, 45 in Uttarakhand and 23 in Madhya Pradesh. The inspections stem from three recent cases where exported Indian drugs have been found wanting. In October 2022, the WHO issued a global alert involving cold and cough medications made by Sonepat-based Maiden Pharma, which were allegedly linked to the death of over 70 children in Gambia.

Later, Noida-based Marion company was allegedly linked to the death of children in Uzbekistan. More recently, a Tamil Nadu-based firm was allegedly linked to spurious artificial eye drops that led to blindness and severe side-effects as reported by the US FDA in the US.