States allowed 36 unapproved FDCs in 2 years; Himachal Pradesh okayed 9

Tribune News Service

Aditi Tandon

New Delhi, December 14

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 came to the notice of the government. Thirty-six 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.

Fixed Dose Combinations refer to products containing one or more active drug ingredients used for a particular disease indication.

FDCs cannot be manufactured or sold without approval from the Drug Controller General of India. 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 DCGI nod for production.

The ministry on Wednesday said in all 36 cases, the DCGI took up the matter with the respective SLAs for necessary action.

"During the Drug Consultative Committee meetings, State Drugs Controllers have also been requested to ensure that new drugs and FDCs are not permitted without the approval of the DCGI,” the minister said.

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.

The SLAs are empowered to take action in this regard, Pawar added.

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

“Every company would want to market its formulation as a new drug under the FDC category but the law requires DCGI to approve such a new drug combination to prevent its irrational use which can be very harmful to human health,” Dabade said adding that product recall, licence cancellation of the firm manufacturing an unapproved FDC were immediate actions under the law.

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