A drug banned / restricted in one country may continue to be marketed in other countries as the respective governments examine the usage, doses, indications permitted etc. and overall risk benefits ratio and take decisions on the continued marketing of any drug in these countries.
Safety issues of drug formulations, as and when reported, are assessed in consultation with the Expert Committees / Drugs Technical Advisory Board (DTAB). Based on the recommendations of the Expert Committees / DTAB, the Central Government prohibits manufacture, sale and distribution of such drugs in the country through Gazette Notification.
The Central Government has prohibited / suspended manufacture, sale and distribution of following drugs during the last three years and in the current year in the country through Notifications in the Gazette of India:
1. Rosiglitazone.
2. Nimesulide formulations in children below 12 years of age.
3. Cisapride and its formulations for human use.
4. Phenylpropanolamine and its formulations forhuman use.
5. Human Placental Extract and its formulations for human use except its
(i) Topical application for wound healing, and
(ii) Injection for pelvic inflammatory disease.
6. Sibutramine and its formulations for human use.
7. R-Sibutramine and its formulations for human use.
8. Gatifloxacin formulation for systemic use in human by any route including oral and injectable
9. Tegaserod and its formulations
10. Letrozole for induction of ovulation in anovulatory infertility.
11. Serodiagnostic test kits for diagnosis of tuberculosis
12. Dextropropoxyphene and formulations containing Dextropropoxyphene for human use.
13. Fixed dose combination of Flupenthixol + Melitracen for human use
14. Analgin and all formulations containing analgin for human use.
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