Health Ministry bans 80 more fixed-dose combination drugs

Team Udayavani, Jan 18, 2019, 5:21 AM IST

New Delhi: The Union Health Ministry has banned80 more fixed-dose combination (FDC) drugs which include antibiotics, painkillers, medicines used for treating fungal and bacterial infections, hypertension and anxiety, officials said Thursday.

A notification was issued by the government, stating that the ban has come into force since January 11, they said.

With this, the total number of banned FDCs now stand at 405. Another 325 drugs were banned in September last year.

The latter, however, remain available on account of the legal challenge mounted by affected pharma firms, the officials said.

A fixed-dose combination contains two or more drugs combined in a fixed ratio of doses, available as a single dose.

“Eighty new FDCs have been banned under the Drugs and Cosmetics Act, 1940 (23 of 1940), which prohibits the manufacture, sale and distribution of these drugs,” a senior Health Ministry official said.

According to the notification, some of the drugs that have been banned include antibiotics like Cefglobe OZ, Taxim -OZ, drugs used for treating bacterial and fungal infections like Orflaz kitand Vaginobact, hypertension drugs like Telipril H and Loram H and anti-anxiety drug Resta (combination of Paracetamol+ Alprazolam).

These drugs were banned on the recommendation of the Drugs Technical Advisory Board (DTAB), which examined the rationality and safety of these FDCs.

These FDCs are among over 294 drugs that were banned in 2007, but the pharma companies approached court, sources said.

Later, the matter reached the Supreme Court, which send it to the DTAB to examine their efficacy, they said.

On December 15, 2017, the DTAB submitted its recommendations and the apex court accepted their suggestions and recommended that certain FDCs, out of 294 FDCs, are not rational and are required to be prohibited or withdrawn, sources said.

In September last year, the Health Ministry banned 325 FDCs, out of which the Supreme Court allowed the sale of three drugs, including Saridon. The ban on the other FDCs was challenged, they said.