The government of India has decided to exempt innovative medicines developed by foreign companies from price control for five years.
The Centre has brought necessary amendments to the Drugs (Price Control) Order (DPCO), which sets the rules for regulating the prices of medicines through a National List of Essential Medicines, known as Schedule-I.
As per a notification issued by the Ministry of Chemicals and Fertilisers, new drugs patented under the Indian Patent Act of 1970 are exempted from price regulation for a period of five years from the date of commencement of its commercial marketing by the manufacturer in the country.
Prior to this amendment, the exemption for five years was available only to those new drugs which were patented in India, but were not produced elsewhere and were developed through indigenous research and development.
The amendment allows any new drug to get the exemption if it is patented in India under Indian Patents Act, 1970 and developed and manufactured by any patentee across the globe.
The move is expected to enable access to novel medicines, especially orphan drugs for treating rare diseases in India. The WHO defines rare disease as a lifelong disorder with a prevalence of one or less per 1,000 population. India, however, is yet to have a standard definition for rare diseases. It is estimated that one in 20 Indians is affected by one of the 7,000 diseases listed as rare diseases, if we go by the definition that rare disorders are those that affect less than one in 2,500 people in India.