New Delhi: In a major setback to Sun Pharmaceuticals Ltd, the drug price regulator the National Pharmaceutical Pricing Authority(NPPA) has refused to give it relief in terms of price cap exemption for its anti-cancer gemcitabine hydrochloride injection from price caps set by the government.

The NPPA, however, has decided to refer to its application to ‘Standing National Committee on Medicines for revision of NLEM’ with a request to examine the products from the perspective of any significant therapeutic advantage and increased efficacy that may merit an exemption under para 32 of DPCO, 2013.

Medical Dialogues had earlier reported that drug major Sun Pharma said it had received approval from the US health regulator for its INFUGEM injection used for the treatment of cancer. The approval from the USFDA was for INFUGEM injection (gemcitabine in 0.9 per cent sodium chloride injection) 10 mg/mL, for intravenous use in a ready-to-administer bag. Gemcitabine fights cancer by preventing the growth of cancer cells, which eventually results in their destruction.

Also Read: Sun Pharma gets USFDA approval for cancer injection INFUGEM

The firm had forwarded an application to the NPPA to consider exempting Gemcitabine Hydrochloride Injection from price cap. In case the exemption is granted, it will be valid for five years.

After detailed deliberations, the Authority decided to refer the case to the Multi-Disciplinary Committee of Experts, which after co-opting suitable expert/(s) in the Committee, shall make a recommendation to the Authority.

Thereafter, a meeting of “Multidisciplinary Committee of Experts” was held on February 7 2019, wherein the committee found that the submission of documents by Sun Pharma met the requirements of para 32(ii) of DPCO, 2013 and hence held that the product is eligible for price cap exemption.

NPPA verified the committee’s submission and referred the applications to the Standing National Committee on Medicines. However, the authority noted that any decision to exempt drugs from price regulation has to be taken in holistic perspective.

“Authority noted that the expert Committee had not applied itself fully to the important agenda pertaining to public interest as stated above. It was decided to refer both applications to ‘Standing National Committee on Medicines for revision of NLEM’ with a request to examine the products from the perspective of any significant therapeutic advantage and increased efficacy that may merit exemption under para 32 of DPCO, 2013.”

NPPA states that any decision to exempt drugs from price control has to be taken in holistic perspective;

“In public health, choice of consumer is impeded by information asymmetry and lack of knowledge regarding quality and efficacy of drugs/ medical devices. Often, high priced items are prescribed/ preferred on the premise of improved quality. It is, therefore, important that pricing policy is not operated in silos. Any decision to exempt drugs from price regulation has to be taken in holistic perspective.”

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