National Pharmaceutical Pricing Authority (NPPA) has asked the DCGI to take appropriate action against three pharmaceutical companies for changing the ingredients of an already approved formulation brand to circumvent the price control. NPPA had already warned the pharma companies to not to change the ingredients of an approved brand or change the brand names having same active ingredients some time back.

The cases referred by NPPA to DCGI for action are: Cetrizet-D, marketed by Sun Pharmaceuticals Ltd, Normet marketed by Emcure Pharma Ltd and Brakke Suspension from Franco India.

"NPPA has noticed that some manufacturers, without any reasons, change the ingredients of their brands to escape price control. Three such formulations were picked up by the authority and referred to the DCGI," an official said, adding that there are some grey areas in the existing DPCO which help the companies to indulge in such practices.

It was also found that some pharmaceutical companies were marketing different brands based on the same active pharma ingredients to escape the provisions and the agency has been keeping a close watch on them, official said.

The authority had issued a general instruction to the companies not to change the composition and made it clear that any company seeking to change an approved composition of a price-controlled drug has to follow the ceiling price of the drug with similar composition or get a price approved for the new composition.

There are at present 74 drugs under price control in the country. According to experts, a new drug is the one if it is a new molecule, includes a new ingredient, reduces or increases the quantity of any ingredient or if there is any change in the administration or indication. Hence, change in the composition would necessitate fresh approval from the DCGI.

Industry observers pointed out that many more companies, including some major firms, could face the action on the same count. Products like Evion 400 from Merck, Diprovate G from Ranbaxy and Novaclox from Cipla also changed the prices by adding some ingredients, it was alleged.