Source: The Economic Times, Aug 06, 2020
NEW DELHI: The government plans to tweak a provision that allows new medicines developed by foreign companies to be exempt from price control for five years after criticism that it goes against the Make in India policy and discourages local drug manufacturers.
The Department of Pharmaceuticals and the National Pharmaceuticals Pricing Authority are in discussions about revisiting paragraph 32 of the Drugs (Price Control) Order of 2013, which lists out the exemptions, people aware of the matter told ET.
The government broadened the five-year exemption from price control for new foreign drugs patented in India through an amendment in January 2019. The amendment removed a requirement that the drugs should have been developed through indigenous R&D. This included orphan drugs used to treat rare medical conditions.
Senior officials in the Department of Pharmaceuticals said the move was aimed at giving Indian patients access to drugs that are available only abroad.
However, domestic drug makers and civil rights activists criticised the amendment and complained of high prices and unequal treatment. Experts said the move went against the government’s Make in India policy because it discourages Indian companies from developing and producing patented drugs. The government would also be helpless in an emergency, they said.
“The move will restrict the government from putting expensive drugs under price control, regardless of a public health emergency. Most likely, it would encourage foreign pharmaceutical companies to manufacture and commercialise their new patented drugs and medical devices in India,” said a pharma expert.
The National Pharmaceuticals Pricing Authority also faces the problem of companies launching products and excluding them from the price control regime without first applying for exemption.
“The companies have tried to utilise it and the government is fighting cases in the court with these companies. The government should scrap this amendment as it has only helped multinationals to launch their products at exorbitant prices by claiming that they are patented products,” another expert said.