Policy Matter

Drugs bringing risk to human being banned


The following drugs have been banned/suspended during last three years and current year keeping in view the likely risk to human drugs-bannedbeings and availability of safer alternatives in the country:

  1. Serodiagnostic test kits for diagnosis of tuberculosis on 7thJune, 2012.
  2. Dextropropoxyphene and formulations containing Dextropropoxyphene for human on 23rdMay, 2013.
  3. Analgin and all formulations containing Analgin on 18thJune, 2013. [Suspension of this drug was subsequently revoked on 13th February, 2014 subject to the certain conditions.]
  4. Suspension of fixed dose combination of Flupenthixol + Melitracen on 18thJune, 2013. It was subsequently prohibited on 11th July, 2014.

No case of manufacturing and marketing of unapproved New Drugs / Fixed Dose Combinations (FDCs) have been reported in the recent past. The manufacturing and marketing of banned drugs is a punishable offence under the Drugs & Cosmetics Act, 1940 and the State Licensing Authorities are empowered to take action in such cases.

The Central Government has, on 1st October 2012, issued statutory directions under Sections 33P of the Drugs and Cosmetic Act, 1940 to all the State/Union Territory Governments to instruct their respective Drug Licensing Authorities to abide by the provisions of the Drugs and Cosmetics Rules, 1945 while granting manufacturing licenses for drugs falling under the definition of the term “New Drug” and not to grant licenses for manufacture, for sale or for distribution or for export of such new drugs, except in accordance with the procedure laid down under the said Rules including obtaining approval of the Drugs Controller General (India) before granting such licenses. The State Drug Controllers have also been requested to ensure that New Drugs and FDCs are not permitted without approval from the office of DCG (I) and the drugs prohibited by the Central Government are withdrawn from the market with immediate effect.

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