As per provisions of DPCO, all manufacturers of Scheduled medicines (branded or generic) have to sell their products within the ceiling price fixed by the Government. As regards non-scheduled formulations, the manufacturers are not allowed to increase the price by more than 10 % per annum.
New Delhi: The Minister in the Ministry of Chemicals and Fertilizers D. V Sadananda Gowda recently said in Lok Sabha that the drug manufacturers are not allowed to increase the price of non-scheduled formulations by more than 10 per cent per annum.
This comes while responding to queries raised by Kalyan Banerjee during a parliamentary session, asking whether the Government has introduced generic drugs in the country and if so whether the prices of generic drugs are cheaper than other drugs available in the open market with the same composition.
He further asked about the reasons behind the price variation of the same products and whether the Government proposes to fix “one product-one price” all over the country.
In response to this, Gowda said drugs imported, manufactured and sold in the country are regulated under the provisions of the Drugs and Cosmetics Act, 1940 and Rules made thereunder. There is no definition of „Generic drugs‟ prescribed in the said Act & Rules made thereunder.
However, generic medicines are generally those which contain the same amount of same active ingredient(s) in same dosage form and are intended to be administered by the same route of administration as that of corresponding branded medicines.
“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,” said Gowda.
He further informed the Parliament that the Central Drugs Standard Control Organization (CDSCO) grants permission to Manufacturer/import of new drugs under the provisions of Drugs and Cosmetics Act 1940 and Rules made thereunder in the proper name.
Details of the number of permissions granted during the last three years are as below;
Both generic drugs without any brand name and branded drugs are treated alike for fixation of ceiling price under the provisions of Drugs (Prices Control) Order (DPCO). As per provisions of DPCO, all manufacturers of Scheduled medicines (branded or generic) have to sell their products within the ceiling price fixed by the Government. As regards non-scheduled formulations, the manufacturers are not allowed to increase the price by more than 10 % per annum.
The prices are both fixed as well as monitored in case of scheduled medicines and monitored only in case of non-scheduled medicines by the National Pharmaceutical Pricing Authority (NPPA). In case a violation of an order issued under DPCO is detected, action for overcharging is taken as per provisions of DPCO.