Cracking The Whip: 18 Drug Companies Lose Licence Over Spurious Medicines

In the aftermath of substandard and contaminated drugs exported from India by several pharmaceutical firms since December 2022, the drug regulator has now cancelled the licences of 18 drug firms, sent show-cause notices to 26, and inspected 76 as part of a special drive.

The names have not been disclosed yet, but sources indicate they will be made public in the days to come.

According to the Ministry of Health and Family Welfare (MoHFW) sources, the Drugs Controller General of India and his team have inspected 76 drug firms across India to check for compliance with good manufacturing practices, and cracking down on spurious and non-standard quality drugs. This was done as part of a special nationwide drive in which 203 drug firms have been identified and will be inspected in phases.

“In Phase 1 of the drive, 76 companies were inspected across 20 states, of which 26 were sent show-cause notices and 18 had their licences cancelled. Product permission was cancelled for three firms,” informed an official source.

The source added that the drive will continue to inspect drug manufacturing units across the country.

In December, the MoHFW had said that a committee of two joint drug controllers had been constituted at the Central Drugs Standard Control Organisation (CDSCO) headquarters to monitor the process of inspection, reporting, and subsequent action to ensure compliance with the Drugs and Cosmetics Act, 1940 and Rules, the statement said. This will ensure high standards of quality compliance concerning drugs manufactured in the country.

In the last week of December, the CDSCO said it had started conducting inspections of identified drug manufacturing units jointly with state authorities across India. This was in the immediate aftermath of the Maiden Pharmaceuticals-manufactured cough syrups being linked to the deaths of 70 Gambian children.

Thereafter, in mid-January, the World Health Organization issued a medical product alert for two substandard (contaminated) products made by Noida-based Marion Biotech, allegedly causing the deaths of 18 children in Uzbekistan. Uttar Pradesh state drug regulator suspended Marion Biotech’s licence in January, eventually cancelling it later.

In February, Chennai-based Global Pharma Healthcare suspended production of a line of eye drops it sold in the US market after the American drug regulator warned patients against using the ophthalmic solution due to potential bacterial contamination allegedly causing blindness.

Industry sources estimate that India has 10,500 drug manufacturing facilities. Most of these are concentrated in the manufacturing hubs - Himachal Pradesh (HP), Sikkim, Gujarat, Maharashtra, Andhra Pradesh, etc. HP, for instance, has 642 units and 40 state drug inspectors.

In Dec, MoHFW set a panel of two joint drug controllers to monitor the process of inspection, reporting and subsequent action to ensure compliance with the Drugs and Cosmetics Act, 1940 

The action was in the aftermath of the Gambia incident where Maiden Pharmaceuticals-manufactured cough syrups were linked to deaths of 70 children