Last Updated on December 31, 2023 by The Health Master
The National Pharmaceutical Pricing Authority (NPPA) has exempted Torrent Pharmaceuticals’ tapentadol nasal spray from price regulation for 5 years from the date of commencement of its commercial marketing by the manufacturer in the country under Para 32 of Drugs (Prices Control) Order, 2013 based on the decision of 89th authority meeting dated June 28, 2021 vide notification No. S.O. 2653(E) dated 01-07-2021.
NPPA noted that Torrent Pharmaceutical Limited meets the requirement of Para 32(i) of DPCO 2013 and decided that exemption may be granted to Torrent Pharmaceutical Limited under Para 32(i) of DPCO, 2013 for their formulation “Tapentadol nasal spray 225mg/ml” in which each spray (0.1ml) contains tapentadol hydrochloride 22.5mg + benzalkonium chloride (50%) 0.02%w/v (As preservative).
The application has received from Torrent Pharmaceutical Limited, for exemption from the provisions of DPCO, 2013 under Para 32 (i) of the said order in respect of the formulation “Tapentadol nasal spray 225mg/ml” in which each spray (0.1ml) contains tapentadol hydrochloride 22.5mg + benzalkonium chloride (50%) 0.02% w/v (As preservative) 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 there under.
Further, the Patent Office, Government of India has granted Patent to Torrent Pharmaceutical Limited for an invention entitled ‘Pharmaceutical invention of tapentadol’ for the term of 20 years from July 19, 2012 in accordance with the provisions of the Patents Act, 1970.
The Ministry of Chemicals and Fertilizers vide S.O.1394 (E) dated the 30th May, 2013, in exercise of the powers conferred by Section 3 and 5 of Essential Commodities Act, 1955 has delegated the powers in respect of specified paras of the DPCO, 2013, including para 32 of the said order to be exercised by the NPPA on behalf of the Central Government.
Torrent Pharmaceutical shall also seek retail price approval for the formulation “Tapentadol Nasal Spray 225mg/ml” in which each spray (0.1ml) contains tapentadol hydrochloride 22.5mg + benzalkonium chloride (50%) 0.02%w/v (As preservative), if applicable, three month before the expiry of the exemption granted under Para 32(i) of DPCO 2013.
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