Web Date: December 29, 2017
India sets up panel to assist launch and pricing of new drugs
India has established a high-level, multidisciplinary committee of experts to provide recommendations concerning approval and pricing of new drugs or formulations, addressing issues that have been particularly contentious between the pharmaceutical industry and government.
In November, India’s National Pharmaceutical Pricing Authority (NPPA) slashed prices of 51 medications—including some that treat cancer, pain, and heart, kidney, and liver disease—by 6 to 53%. The move followed caps earlier this year on medical devices such as knee implants and heart stents.
The new panel will replace two existing ones—one that assesses new drugs and sets pricing, and another that evaluates issues related to packaging and innovation. The decision to combine these functions into one committee came from experience since India’s Department of Pharmaceuticals, part of the Ministry of Chemicals & Fertilizers, expanded pricing controls in 2013.
Part of the committee’s mandate will be to examine pharmaceutical industry claims about the novelty associated with drug formulations and whether a drug is exempt from the 2013 drug pricing control order.
The committee will include experts from NPPA as well as representatives from India’s Ministry of Health & Family Welfare and its drug regulation office, the Central Drugs Standard Control Organisation.
When NPPA receives applications for new drugs or formulations, it will have four weeks to refer issues to the committee. The committee will then have four weeks to give its recommendations, after which NPPA will have another four weeks to issue a decision.
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