States approved 36 banned drugs in 2 years; 9 in Himachal

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 alert after the death of more than 66 Gambian children, the Centre on Tuesday informed the Rajya Sabha that state drug regulators over the last two years granted manufacturing permission to as many as 36 drugs, which did not have the central drug regulator’s approval. Of these 36, nine were licensed for production in Himachal Pradesh and 11 in Uttarakhand.

“A few cases of grant of manufacturing licence of new drugs, including fixed dose combinations (FDCs), by some of the state licensing authorities (SLAs) without the due approval of the Drugs Controller General of India (DCGI) came to the notice of the government. Thirtysix cases of unapproved FDCs licensed by the SLA, considered as new drugs, have been reported from 2020 till date,” Minister of State for Health Bharati Pravin Pawar said in response to a question by AAP Punjab MP Harbhajan Singh.

An FDC refers to a product containing one or more active drug ingredients used for a particular disease. FDCs cannot be manufactured or sold without the approval of the DCGI. Under the law, state licensing authorities have no purview to grant production and marketing permission to unapproved FDCs which would fall under the category of “new drugs” requiring to go through clinical trials to get the DCGI nod for production. The ministry today said in all 36 cases, the DCGI took up the matter with the respective SLAs for necessary action.The break-up of the 36 cases of approval of the banned FDCs is as follows — Uttarakhand (10), Himachal Pradesh (9), Sikkim (5), Gujarat (4), Maharashtra (2), Karnataka (2), Uttar Pradesh (2), Telangana (1) and Daman and Diu (1).

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

Drug sector expert Gopal Dabade said production and sale of unapproved FDCs was “extremely worrisome and could be dangerous”.

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