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The apex court, on Friday, instructed the Health Ministry to take a step back and reconsider banning 15 Fixed-Drug Combinations (FDCs).
The Drugs Technical Advisory Body (DTAB) had submitted a report to the Ministry to ban over 300 FDCs, including the 15 in question. The 15 FDCs include those of big brands like Abbott Healthcare's Phensydyl, Paras Pharmaceutical's D - Cold Tablet, Alkem’s Sumo,Franco-Indian Pharmaceutical’s Grilinctus and Cipla's NoCold, amongst others.
The Supreme Court said a technical advisory board report to ban those drugs which are being manufactured even before 1988 cannot be used and that the Ministry has to initiate a re-investigation to make a case for banning them. Most FDCs in question here are codeine-based, are habit-forming and have even been investigated for their addictive nature and for mimicking ‘narcotic’ nature of drugs. FDCs are those drugs that have two or more active pharmaceutical ingredients (API) banded together in one dose.
Griffon Labs has filed a case in the court challenging the DTAB’s report on banning the drugs.
The Health Ministry is still mulling over the DTAB report while a legal battle ensues between the government and the pharma companies on which FDCs to ban. The Health Ministry had earlier passed orders to ban 350 FDCs citing their irrational use in patients.
According to the final report submitted by the DTAB, the Ministry is considering banning 343 FDCs which could affect over the ₹2,000-crore industry.
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