The government has exempted new drugs patented under the Indian Patent Act from the price control order for five years from the date of their marketing, according to a notification.
The government has exempted new drugs patented under the Indian Patent Act from the price control order for five years from the date of their marketing, according to a notification. The Drugs (Prices Control) Amendment Order, 2019, by the Ministry of Chemicals and Fertilisers exempts “a manufacturer producing a new drug patented under the Indian Patent Act, 1970 (39 of 1970), for a period of five years from the date of commencement of its commercial marketing by the manufacturer in the country,” the notification said.
The provisions of DPCO 2013 shall not apply to “drugs for treating orphan diseases as decided by the Ministry of Health and Family Welfare”, it said. The DPCO fixes the prices of scheduled formulations and monitors maximum retail prices of all drugs, including the non-scheduled formulations.
The notification also mentioned that “the source of market-based data shall be the data available with the pharmaceutical market data specialising company as decided by the government, and if the government deems it necessary, it may validate such data by appropriate survey or evaluation.”
The notification said for “fixing or revising the ceiling price for formulations, the government may, if it is necessary so to do, consider market-based data available for any month, as deemed fit.”