The Ministry of Chemicals and Fertilizers issued the Drugs (Prices Control) Amendment Order, 2019 on January 4, 2019.
The government has exempted new drugs patented under the Indian Patents Act from the price control order for five years from the date of their marketing.
It exempts a manufacturer producing a new drug patented under the Indian Patents Act, 1970 for a period of five years from the date of commencement of its commercial marketing by the manufacturer in the country.
The provisions of DPCO 2013 shall not apply to drugs for treating orphan diseases as decided by the Ministry of Health and Family Welfare.
