The country's leading drug makers, including Ranbaxy Laboratories, Cipla, Cadila Pharmaceuticals, Nicholas Piramal and Wockhardt, will soon withdraw about 60 drug combinations from the market.
The voluntary move comes a little more than a year after the Central Drugs Standard Control Organisation, the central authority that approves new drugs for marketing, had asked the drug makers to withdraw the 'combination drugs' as they are 'unnecessary' and may pose health hazards.
The Drugs Controller General of India had banned 294 combination drugs sold under nearly 1,053 brand names from the market in June 2007. Since then, the pharma industry and the the drug authority have been locked in a legal battle.
Currently, three cases are pending in the Madras High Court. First, a group of five drug companies in Puducherry have obtained a stay on the ban order. A similar order was obtained by the Federation of South Indian Pharmaceutical Manufacturers Association and Confederation of Indian Pharmaceutical Industry in separate cases.
"We have decided to settle the issue with the drugs control department and will withdraw all the cases filed in this connection against the drug control department," said T S Jaishankar, chairman, Confederation of Indian Pharmaceutical Industries.
"There is a general consensus among most of the industry representatives on the FDC issue in the recent past, except with the CIPI. We are confident of resolving the issue soon," Surinder Singh, India's drugs controller, told Business Standard.
The combination drugs are called 'irrational' ones in industry parlance. For instance, a combination of paracetomol and analgin in one drug is needless as both drugs have the same action and only one of them is enough, say experts. This 'irrationality' of combinations is what the authorities want to do away with.
Though the market value of these 60 drugs could not be ascertained now, industry is unlikely to take a major hit as the drugs are mainly cheaper ones. However, if the manufacturers had to withdraw all the 294 drugs which the CDSCO demanded, the losses would have been a minimum of Rs 3,000 crore (Rs 30 billion), sources said.
The pharma industry's latest decision is based on the recommendations of an expert committee of pharmacological experts appointed by the industry associations.
A crucial meeting in this regard is slated to be held on July 14. The drug control department had asked companies to delve into the rationality of these drugs, also known as fixed dose combinations.
The CDSCO is of the view that these drugs qualify to be termed as 'new drugs' and were launched in the past without its approval.