Five-year price control exemption for new medicines to give rare disease patients access to orphan drugs

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The Central government has amended the Drugs Price Control Order (DPCO) to exempt innovative medications developed by foreign companies from price control for five years. The move is expected to be a boon for many rare disease patients in India as it would give them access to novel drugs that are currently only available abroad.

As per a notification issued by the Ministry of Chemicals and Fertilisers, producers of 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.

DPCO sets the rules for regulating the prices of medicines through a National List of Essential Medicines, known as Schedule-I.

Orphan drugs are medications intended for diagnosis, prevention or treatment of life-threatening or debilitating rare diseases. As the number of people suffering from such diseases is very small, the pharmaceutical companies don’t find it feasible to develop and sell drugs for them. However, data released by the US Food and Drug Administration shows that 9 of the 22 new medications approved in 2016, or 41 percent, are orphan drugs to treat rare diseases.

It may be noted that the Indian government has been reviewing a Niti Aayog proposal to amend ‘Para 32’ of the DPCO to add orphan drugs, unbranded generic drugs and any other drugs decided by the proposed Standing Committee on Affordable Medicines and Health Products. Para 32 gives the power to the National Pharmaceutical Pricing Authority to exempt certain class of drugs from price regulations.

The World Health Organisation defines rare disease as an often debilitating lifelong condition or disorder with a prevalence of one or less per 1,000 population. But different countries have their own definitions depending on their specific requirements. India, as of now, doesn’t have a standard definition but experts consider disorders that affect less than one in 2,500 people as rare diseases here. It is estimated that one in 20 Indians is affected by one of the 7,000 diseases listed as rare diseases.

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