CDSCO Bans 172 Human Drugs And 39 Veterinary Medicines Over 3 Years, Says Centre

Mumbai, Feb 06: The Central Drugs Standard Control Organisation (CDSCO) has banned 172 drugs for human use and 39 drugs for animal use over the last three years, Union Minister for Chemicals and Fertilizers Jagat Prakash Nadda informed the Lok Sabha in a written reply on Friday.

Banned drugs and enforcement

The Minister said that the manufacture, sale and distribution of banned drugs is a punishable offence under the Drugs and Cosmetics Act, 1940. Enforcement action against such violations is carried out by State Licensing Authorities (SLAs) appointed by the respective State governments.

However, following the ban on certain Fixed Dose Combinations (FDCs), several writ petitions were filed in different High Courts across the country. In some cases, courts granted interim protection for drugs that were already part of the distribution network.

Complaints and regulatory action

Nadda stated that whenever complaints related to the sale of banned drugs are received by the CDSCO, the matter is promptly taken up with the concerned State Drugs Controller for appropriate action under the law.

The Ministry of Health and Family Welfare reiterated that the regulation of manufacture, sale and distribution of drugs is governed by the Drugs and Cosmetics Act, 1940, and the rules framed under it.

Any change in the composition of active pharmaceutical ingredients requires prior approval from the CDSCO under the New Drugs and Clinical Trial Rules, 2019, before a manufacturing licence can be granted by the State authority.

Rules on branding and composition

Further, the Drugs and Cosmetics Rules, 1945, were amended in November 2019 through GSR 828(E) to strengthen oversight on drug branding. Under the amended rules, applicants intending to market a drug under a brand or trade name must submit an undertaking in Form 51, certifying that the proposed name does not already exist and will not cause confusion or deception in the market.

The undertaking must be based on searches conducted in the Trademark Registry, the CDSCO’s central database of drug brand names, relevant literature, reference books and internet sources.

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The Minister added that cases involving the manufacture or marketing of drugs with altered compositions without CDSCO approval are also referred to State Drugs Controllers for action under the applicable provisions of the Drugs and Cosmetics Act and Rules.

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