Troikaa's Paracetamol IM injection 250mg/ml Exempted from price control: NPPA
New Delhi: Noting that Troikaa Pharmaceutical's formulation "Paracetamol Injection Intramuscular (IM) 250mg/ml, 2ml" was duly approved by the Office of Central Drugs Standard Control Organisation (India) as ‘new drug’ under the Drugs and Cosmetics Act, 1940, the National Pharmaceutical Pricing Authority (NPPA) has exempted the formulation from price control for a period of five years from the date of commencement of its commercial marketing by the manufacturer in the country or expiry of the Indian Patent whichever may be earlier, under the Para 32 (i) to (iii) of DPCO 2013.
This came in line with the application presented by Troikaa Pharmaceuticals for exemption from the provisions of Drug Price Control Order 2013 under Para 32 (i) to (iii) for the formulations “Paracetamol Injection (Intramuscular) 250mg/ml”
At the 115th Meeting of Authority under DPCO, 2013 held on 31.07.2023, the authority noted that Troikaa Pharmaceutical's formulation “Paracetamol Injection (Intramuscular) 250mg/ml, 2ml” 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.
It was also observed that although there are commercially available injections of paracetamol, the formulation proposed by Troikaa Pharmaceutical can provide a higher strength in a smaller amount and deliver the proper dosage. Compared to other intramuscular Paracetamol injections, it has a benefit.
Regarding the above, the Authority also added the followings:
a. Paracetamol is covered under Schedule-1 of DPC0, 2013 and Paracetamol injection 150mg/ml is scheduled formulation. Troikaa Pharmaceuticals has submitted the patent issued by the Patent Office under Indian Patent Act, 1970 dated 09.11.2022 for “Novel Composition comprising Paracetamol and process for preparing the same” bearing registration no. 411067 along with the claim filed with Patent Office (Application No. 630/MUM/2010) dated 09.10.2010. Troikaa Pharmaceuticals has also submitted the Patent Status of this drug in other 76 Countries.
b. Troikaa Pharmaceutical has submitted DCGI approval No. MF/FF/SND/36/2022 dated 16.09.2022 for 'Paracetamol Injection Intramuscular, 2ml, and each ml contains Paracetamol 250mg, Absolute Alcohol IP 30% v/v, Water for injection IP q.s.
c. State Licensing permission was also granted on 26.09.2022 for the formulation as stated in DCGI approval.
Drug Price Control Orders (DPCO) are issued under Essential Commodities Act (ECA). The government of India is the issuer of such orders. The drug price control orders enable the government to declare a ceiling price for essential and life-saving medicines (as per a prescribed formula).
In accordance with the Drug Price Control Order 2013 under Para 32 (i) to (iii),
"The provisions of this 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.(ii) a manufacturer producing a new drug in the country by a new process developed through indigenous Research and Development and patented under the Indian Patent Act, 1970 (39 of 1970) (process patent) for a period of five years from the date of the commencement of its commercial production in the country.(iii) a manufacturer producing a new drug involving a new delivery system developed through indigenous Research and Development for a period of five years from the date of its market approval in India:Provided that the provision of this paragraph shall apply only when a document showing approval of such new drugs from the Drugs Controller General (India) is produced before the Government."
In view of the above, the Authority deliberated on the matter in detail and observed that Troikaa Pharmaceuticals Limited fulfills the conditions as per Para 32(i) of DPC0, 2013 with respect to (w.r.t) the formulation “Paracetamol Injection (Intramuscular) 250mg/ml”.
Accordingly, the Authority decided that exemption be granted to Troikaa Pharmaceuticals Limited under Para 32(i) of DPC0, 2013 w.r.t the formulation “Paracetamol Injection (Intramuscular) 250mg/ml” for a period of five years from the date of commencement of its commercial marketing by the manufacturer in the country or expiry of the Indian Patent whichever may be earlier.
In addition, the Authority further suggested, "Troikaa Pharmaceuticals Limited shall inform NPPA, of the date of commercial marketing of the formulation “Paracetamol Injection (Intramuscular) 250mg/ml” in the country and the Price to Retailer (PTR) and the Maximum Retail Price fixed by the company in respect of above said formulation by issuing a price list in Form V under DPCO, 2013."
Furthermore, the committee stated, "Troikaa Pharmaceuticals Limited shall also seek retail price approval for the formulation “Paracetamol Injection (Intramuscular) 250mg/ml”, if applicable, three months before the expiry of the exemption granted under Para 32(i) of DPCO 2013."
