NPPA Approves Retail Price Of 51 New Drugs

New Delhi : The National Pharmaceutical Pricing Authority (NPPA) has approved the retail price of 51 new drugs under the Drugs (Prices Control) Order, 2013 with various combination drugs treating diabetes, blood pressure and others.

The Authority, in its latest meeting held on September 9 under the chairmanship of Kamlesh Kumar Pant, chairman of NPPA, discussed cases of retail price fixation of 52 new drugs and approved 51 of them, while deferring price fixation of paracetamol and dicyclomine hydrochloride tablets manufactured by Prosperity Drugs and marketed by Torrent Pharmaceuticals.

The Authority said that on this formulation, one of the authority members observed that seven companies have been considered for the retail price fixation, but as per web-sources there are other companies also marketing this formulation.

Based on this, the Authority decided that fixing price of the formulation may be deferred and confirmation may be obtained from Pharmatrac, the agency from which the Authority sources the market data for price fixation.

The formulations for which the prices were fixed include various combinations, strengths and drug delivery forms of anti-diabetes drugs linagliptin, teneligliptin, sitagliptin, and dapagliflozin for various manufacturers and marketing companies.

It may be noted that some of these drugs are manufactured and marketed by the Indian companies in recent times after the patent rights of the originator products expired. The NPPA has formulated a methodology to fix the prices of these drugs ensuring the prices to be more affordable compared to the prices of the patented products.

Some of the other drugs for which the prices were fixed in the latest meeting include blood pressure lowering drug combinations with compounds including metoprolol succinate and telmisartan.

The Authority also fixed the price of ophthalmic drug combination brinzolamide IP 10 mg+ brimonidine tartrate IP 2 mg + timolol maleate eq. to timolol IP 5 mg + benzalkonium chloride solution IP 0.2 mg, manufactured and marketed by Bengaluru-based Micro Labs Ltd, at Rs. 105.25 per unit of 1 ml.

It was discussing the price fixation of this combination, the Multi Disciplinary Committee (MDC) of Experts with the NPPA in its earlier meeting suggested that the applications for retail price fixation may not have to go through the scrutiny of the Committee if the basic methodology for the drug is the same and only the data of calculations changes.

The Committee, after recommending the retail price by calculating it through its methodology, observed that the retail price recommended in earlier meetings for a particular formulation for a specific company are being again placed before the MDC in case of a different applicant.

“Since, the basic methodology followed is the same and only the data of calculations changes, the Committee is of the view that for the formulations for which once the retail price is recommended by the MDC, other applications may be placed before the committee, when change in circumstances requires deliberations,” it said.

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