No fresh approval for cocktail drugs: Government

No fresh licence will be granted by state licensing authorities to companies for manufacturing "cocktail" drugs, the government has made it clear.

No fresh approval for cocktail drugs: Government

No fresh licence will be granted by state licensing authorities to companies for manufacturing "cocktail" drugs, the government has made it clear.

The government will tightening the noose around "irrational and unsafe" fixed-dose combination (FDC) drugs. Recently, two licences for FDC drugs, issued by Uttarakhand and Daman, were cancelled, official sources said.

An FDC drug is a cocktail of two or more active drug ingredients in a fixed ratio of doses. Under the law, a combination drug is a 'new' drug, and should undergo stringent clinical studies to prove it is safe and efficacious.


There have been close to a dozen FDC launches, mostly by small pharma companies, in the diabetic, dermatology, respiratory and anti-infective categories, waiting for approval.

In March, the government had banned common combination medicines, including Crocin Cold & Flu, D-Cold Total, Sumo, Oflox, Chericof, Kofnil, Dolo Cold, Decoff, O2, dermatology drug Panderm Plus, gastro-intestinal drug
Zenflox and cough syrups Phensedyl and Corex. The notification included medicines "likely to involve risk to human beings", where safer alternatives to the drug are available, and which were found to have "no therapeutic justification".


Since the ban would have caused a huge loss to the industry, eroding value of thousands of crores, pharma companies went to court and finally managed to get it quashed in the Delhi high court.

The government is now preparing for its legal fight against the pharmaceutical industry by filing an appeal in the Supreme Court against the Delhi high court's December 1 order that overturned the health ministry's ban on 344 FDCs.