States granted manufacturing licenses to 36 banned drugs over 2 years, nine licenses were given by Himachal: Centre admits in Rajya Sabha

Tribune News Service

Aditi Tandon

New Delhi, December 13

Close on the heels of Sonepat-based Maiden Pharma’s cough and cold syrups attracting WHO’s global medical alert over links to the deaths of more than 66 Gambian children, the Government on Tuesday informed the Rajya Sabha that 36 banned drugs were licensed by different state drug regulators across the country between 2020 and 2022.

Of the manufacturing licenses granted to unapproved drugs in 36 cases, nine are in Himachal Pradesh and 11 in Uttarakhand.

“A few cases of grant of manufacturing license of new drugs including Fixed Dose Combinations (FDCs) by some of the State Licensing Authorities (SLAs) without due approval of the Drugs Controller General (India) came to the notice of the Government. 36 cases of unapproved FDCs licensed by State Licensing Authorities considered as New Drugs, have been reported during the year 2020 to 2022 till date,” Minister of State for Health Bharati Pravin Pawar said in response to a question by AAP MP Harbhajan Singh.

The Ministry said that in all the cases, the office of DCGI took up the matter with respective SLAs for necessary action.

“State Drugs Controllers have also been requested in the Drug Consultative Committee meetings to ensure that new drugs and FDCs are not permitted without approval from the office of DCGI,” the Minister said.

The break-up of the 36 cases of approval of banned FDCs is as follows -- Uttarakhand (10), Maharashtra (2), Daman and Diu (1), Himachal Pradesh (9), Karnataka (2), Gujarat (4), Sikkim (5), Uttar Pradesh (2), Telangana (1).

The government said manufacture, sale and distribution of prohibited and banned drugs is a punishable offence under Section 18 of the Drugs and Cosmetics Act.

State Licensing Authorities are empowered to take action in this regard, Pawar added.

Harbhajan Singh had asked whether certain cases of manufacturing and marketing of banned or unapproved drugs have been reported in the country.

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