Govt removes price cap on new patented drugs for first 5 years
New Delhi: 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 commcercial 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 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."
Meanwhile, Minister of State for Chemical and Fertilisers, Mansukh L Mandaviya told Rajya Sabha that fixing of medicine prices has resulted in Rs 11,000 crore benefit to people.
The Minister, who was replying during the Question Hour, said that to make medicines affordable, the government capped prices of 855 medicines and some medical devices.
He said the government has notified the Drug (Prices Control) Order (DPCO) to control and regulate the prices of medicines in the country. The prices of drugs are fixed by National Pharmaceutical Pricing Authority as per the provisions of DPCO and it does not distinguish between patented and non-patented drugs for fixing the ceiling prices of scheduled medicines, he said.