National Pharmaceutical Pricing Authority (NPPA) grants exemption from Drugs Price Control Order (DPCO) 2013 to Torrent Pharmaceuticals for their formulation of Tapentadol Nasal Spray.
NPPA at its 89th meeting dated 28.06.2021 noted that Torrent Pharmaceutical meets the requirement of Para 32(i) of DPCO 2013 and decided that exemption may be granted to Torrent Pharmaceutical for their formulation Tapentadol Nasal Spray 225 mg/ml in which each spray (0.1ml) contains Tapentadol Hydrochloride 22.5mg plus Benzalkonium Chloride As preservative.
Earlier, an application was received from Torrent Pharmaceutical for exemption from the provisions of DPCO, 2013 under para 32 (i) for formulation “Tapentadol Nasal Spray 225mg/ml” which was duly approved by the Office of Central Drugs Standard Control Organisation (India) as ‘new drug’ under the Drugs and Cosmetics Act, 1940 and Rules.
Further, the Patent Office, Government of India has granted Patent to Torrent Pharmaceutical for an invention entitled ‘Pharmaceutical invention of Tapentadol’ for the term of 20 years from 19th July 2012 in accordance with the provisions of the Patents Act, 1970.
Torrent Pharmaceutical shall also seek retail price approval for the formulation Tapentadol Nasal Spray 225mg/ml, if applicable, three month before the expiry of the exemption granted under Para 32(i) of DPCO 2013.