Costly patented drugs get protection under amended Price Control Order

Maitri Porecha | | Updated on: Jan 04, 2019

Costly drugs are not getting cheaper any time soon.

Any drugmaker who has brought in an innovative patented drug will be exempt from the price control regulations for five years since the start of commercial marketing of the product in India. This includes ‘orphan drugs’ used to treat rare genetic disorders.

The Drug Price Control Order (DPCO), 2013, has been amended to this effect and a gazetted notification was issued on Wednesday.

The amendments were made on the basis of the NITI Aayog’s recommendations to the Department of Pharmaceuticals (DoP).

Prasanna Shirol, Executive Director, Organisation For Rare Diseases in India (ORDI), observed that not bringing orphan drugs into price control will significantly impact patients, as the treatment [involving such drugs] typically costs crores. “Only MNCs are manufacturing orphan drugs at the moment. Lack of price control will have a detrimental effect on affordability,” he added.

Cancer drugs are increasingly patented with no generic competition, putting them out of the reach of poor patients, said a response issued by the non-profit Doctors Without Borders.


Cancer drug woes

For example, Dasatinib, a tyrosine-kinase inhibitor, is priced at ₹6,627 for a daily dose of 100 mg, adding up to nearly ₹2 lakh per patient per month.

Also, under the amended DPCO, the Centre will continue fixing prices in line with market-based data available on drugs. An alternative model, cost-based pricing, takes into account the actual money that went into developing the drug, sourcing the raw material and so on.

Market-based pricing

“The research on cost-based pricing is not robust, and hence, we are recommending a market-based model,” VK Paul, Member (Health), NITI Aayog, told BusinessLine. However, unlike earlier, the Centre can now take into consideration market data available for any month to fix or revise the ceiling prices of formulations.

Stakeholder opinions were not sought by the DoP before making the amendments.

Published on January 04, 2019
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