Torrent’s nasal spray exempted from price cap for five years

The country’s drug pricing regulator has granted a rare exemption to Torrent Pharmaceuticals’ tapendatol nasal spray from price caps, and approved a one-time price hike of 50% from the ceiling for key drugs carbamazepine, ranitidine and ibuprofen.

The National Pharmaceutical Pricing Authority (NPPA) gave its nod to price cap exemption for Torrent’s nasal spray used for pain relief under Para 32 of the Drug Price Control Order (DPCO) 2013, which is applicable when a new drug developed through a unique, indigenous process, is patented under the Indian Patent Act, 1970, and is not produced elsewhere.

NPPA experts approved the Ahmedabad-based company’s application at a meeting on June 28.

The regulator has also given its nod to a one-time price hike for carbamazepine, used in the treatment of stomach ulcers, ibuprofen, a pain reliever, and ranitidine, an antacid. As per the revision, depending upon the dosage form and strength, a tablet of carbamazepine would cost ₹1.02-4.61, ranitidine ₹1.10- 2.43, and ibuprofen ₹0.59-1.04 a tablet, excluding GST.

NPPA said it had been receiving requests from the manufacturers for upward price revision for more than two years citing various reasons including increase in cost of production and exchange rates that made sustainable production and marketing of the drugs unviable.

The authority had referred the issue to the Standing Committee on Affordable Medicines and Health Products (SCAMHP) of Niti Aayog and took the decision as per SCAMHP recommendation, considering these drugs are used as a first line of treatment and are important to the public health programme of the country, an NPPA notification said.

Accordingly, NPPA invoked “extra ordinary powers in public interest under para 19 of DPCO 2013 for upward revision of the ceiling prices of the nine scheduled formulations of 3 drugs by giving one time increase of 50% from the present ceiling price”, it said.

Manufacturers of these medicines include Sun Pharmaceuticals, Torrent, Zydus Cadila, Cadila Pharmaceuticals, Intas, Abbott, Cipla and J B Chemicals.