Domestic drugmakers and civil rights activists on Friday criticized the government over its decision to exempt foreign-made orphan and innovative drugs from price control, complaining of high prices and unequal treatment.
The government had on Thursday exempted innovative medicines developed by foreign firms from price control for five years. These include orphan drugs used for treating rare medical conditions.
In amendments to the Drugs Price Control Order (DPCO), the ministry of chemicals and fertilizers exempted producers of new drugs patented under the Indian Patent Act, 1970 (39 of 1970), from price regulation for five years from the date of commencement of its commercial marketing in India.
While senior officials in the department of pharmaceuticals (DoP) said the move is aimed at giving Indian patients access to drugs that are only available abroad, civil rights activists called it a “pro-pharma” step, with “no element of public interest”.
Leena Menghaney, South Asia head of the Access Campaign by Médecins Sans Frontières (doctors without borders), demanded immediate withdrawal of the notification. “This leaves patients at the mercy of big pharmaceutical corporations who charge exorbitant prices for monopoly medicines. The fact is the department of pharma has not consulted those who have been working on intellectual property (IP) rights and access to medicines. This is also against India's position at the World Trade Organization that calls for stronger implementation of TRIPS flexibilities.”
TRIPS stands for the Agreement on Trade Related Aspects of Intellectual Property Rights, to which India is a signatory.
Deepnath Roy Chowdhury, national president of the Indian Drugs Manufacturers' Association (IDMA), said the move ran against the government's Make in India policy as it discourages Indian firms from developing and producing patented drugs.
Exempting “orphan drugs” from price control also ran counter to the national policy for the treatment of rare diseases (NPTRD) submitted in Delhi high court in May 2017, said Malini Aisola, co-convenor of the All India Drugs Action Network (AIDAN).
“The policy itself was an outcome of orders passed by the high court in cases filed by patients struggling to access highly priced drugs. Pursuant to the orders, the policy was framed on the basis of recommendations of three expert committees, all of which noted the prohibitive costs of treatment which could end up in crores of rupees per year (a child's enzyme replacement therapy can range from ₹18 lakh to ₹1.7 crore annually),” said Aisola.
“As a result, the chief policy recommendation was setting up a ₹100-crore corpus for funding the treatment of rare genetic diseases between the centre and the states,” Aisola said.
A senior DoP official said the policy will encourage more drugs for orphan diseases. “As the number of people affected by rare diseases is low, not many companies invest in these drugs. The step has been taken to incentivize companies, to encourage them to manufacture drugs for rare diseases. The most powerful incentive is to grant exclusive marketing rights to them,” said the official.
NPTRD 2017 India lists 450 such rare diseases, including hereditary cancers, autoimmune disorders and congenital malformations.