The Drug Controller General of India’s directions regarding naming drugs after generic names like Paracetamol and Ciproflaxicin, instead of brand names, have stirred a hornets’ nest.
DCGI has issued circulars to all state drug controllers and principal secretaries of health stating that except for import and export purposes, drugs shall be named after generics and not with brand names. Doctors have to prescribe the generic names. For instance, for Ciproflaxicin alone there are around 4,000 brand names in the country.
Director-General of the State Drug Control Administration R.P. Thakur said, “We have received the orders and clarifications. Both single component and combination drugs have to be named after generic drugs.”
Though the move is aimed at decreasing the prices of medicines, experts say that without revising the MRPs of the drugs, this order will not have any effect.
Secretary-general of All India Drug Control Officers Confederation R. Uday Bhaskar said, “The MRP of generic and branded drugs are more or less the same. Unless the prices of generic drugs are reduced, this is of no use to the consumer. The profit margin has to be curtailed. There is no clarity on the prospective effect clause. Whether these directions are applicable to the new licences to be issued after the notification or for the existing manufacturers for the drugs produced after the notification is a big question,”
He added, “DGCI will issue licences in the name of the generic drug. However the manufacturer is at liberty to print the brand name along with generic name of the drug. There is possibility of the manufacturer coming up with several brand names for the same generic name and the drug controllers will not have knowledge of them.”