NPPA exempts Torrent Pharma Tapentadol Nasal Spray from price cap for 5 years

This comes in response to the application filed by Torrent Pharma for exemption under para 32 (i) of DPCO 2013 for the formulation "Tapentadol Nasal Spray 225mg/ml" in which each spray (0.1ml) contains Tapentadol Hydrochloride 22.5mg and Benzalkonium Chloride (50%) 0.02%w/v.

The issue was raised at the 89th meeting of the Authority under DPCO 2013, which was held on June 28, 2021, and was presided over by Shubhra Singh, Chairman, NPPA.

The authorities noted at the meeting that the document submitted by Torrent Pharmaceuticals included:

"a. Patent No. 355890 granted on 15.01.2021 to Torrent Pharma for an invention entitled "Pharmaceutical invention of Tapentadol" for the term of 20 years from 19th July, 2012, issued by the Patent Office, Government of India.

New drug approval was granted to the drugmaker on 02.09.2020 from the Central Drugs Standard Control Organisation (CDSCO), in form CT-23, to manufacture the new drug 'Tapentadol Hydrochloride Nasal Spray 225 mg/ml Nasal Spray' in which "Each spray (0.1ml) contains Tapentadol Hyd ro chlo ri de 22.5mg + Benzalkonium Chloride (50%) 0.02%w/v (as a preservative)".

Tapentadol is a centrally acting analgesic having both m-opioid receptor agonist and noradrenalin (norepinephrine) reuptake inhibition activity with minimal serotonin reuptake inhibition. This dual mode of action makes tapentadol particularly useful in the treatment of both nociceptive pain and neuropathic pain.

Proceeding further, the Authority also noted that CDSCO, in its email dated 26.05.20 21, stated that "... the new drug approval granted to Torrent Pharma for Tapentadol Nasal spray is covered under the Patent granted by the Patent Office vide Patent No. 355890."

After detailed deliberation, the authority observed that Torrent Pharmaceuticals fulfills the conditions as per para 32(i) of DPCO 2013 with respect to 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).

As per para 32(i) of DPCO 2013, The provisions of Drug Prices Control Order shall not apply to, - (i) a manufacturer producing a new drug patented under the Indian Patent Act, 1970 (39 of 1970) (product patent) and not produced elsewhere, if developed through indigenous Research and Development, for a period of five years from the date of commencement of its commercial production in the country. Accordingly, the Authority decided that,

An exemption should be granted to Torrent Pharmaceuticals Ltd under Para 32 (i) of DPCO 2013 for the said formulation for a period of five years from the date of commencement of its commercial marketing by the manufacturer in the country, subject to it being co-terminus with the duration of the Indian Patent. The authority also directed Torrent Pharmaceuticals to seek retail price approval, if applicable, three months before the expiry of the exemption granted under Para 32 (i) of DPCO 2013.

In view of the foregoing reasons, a gazette was rolled out saying,

" In exercise of the powers delegated under para 32 of the Drugs (Prices Control) Order, 2013 vide S.O. 1394 (E) dated 30th May, 2013 issued by the Government of India in the Ministry of Chemicals and Fertilizers, M/s Torrent Pharmaceuticals Limited is exempted 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 a preservative) for a period of five years from the date of commencement of its commercial marketing by the manufacturer in the country. Further, the period of five years is co-terminus with the duration of the Indian Patent. "

The Gazette further added,

Torrent Pharmaceutical Ltd shall inform NPPA, the date of commercial marketing 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) in the country and the Price to Retailer (PTR) and Maximum Retail Price fixed by the company in respect of the above said formulation by issuing a price list in Form V under DPCO, 2013."

However, Torrent Pharma has been directed to 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 months before the expiry of the exemption granted under Para 32 (i) of DPCO 2013.