Manufacturers of non-scheduled formulations are not allowed to increase the price of their products by more than 10% per year, D V Sadananda Gowda, the minister for chemicals and fertilizers said in Lok Sabha recently.
As per the provisions of Drugs (Prices Control) Order (DPCO), all manufacturers of scheduled medicines, whether branded or generic, have to be sold within the ceiling price fixed by the government.
The National Pharmaceutical Pricing Authority (NPPA), under the ministry, fixes the prices of scheduled medicines, which are monitored closely. However, as far as non-scheduled drugs are concerned, the agency only keeps a close watch on their price movements.
Both generic drugs without any brand name and branded drugs are treated alike for the fixation of a ceiling price under DPCO. In case a violation of an order issued under DPCO, action for overcharging is taken, informed the minister
while responding to queries during a parliamentary session. MPs had asked whether the prices of generic drugs are cheaper than other drugs available in the open market with the same composition.
Explaining the reasons behind the variation in the price of similar products, Gowda said drugs imported, manufactured and sold in the country are regulated under the provisions of the Drugs and Cosmetics Act, 1940 and Rule. There is no definition of “generic drugs” prescribed in the rule book.
However, generic medicines are generally those which contain the same amount of active ingredient(s) in the same dosage and are intended to be administered by the same route as that of the corresponding branded medicine.
“The medicines, whether branded or generic, imported or manufactured for sale, distribution in the country, are required to comply to the same standards as specified in the Second Schedule to the Drugs and Cosmetics Act, 1940,” he added.