New Delhi: The National Pharmaceutical Pricing Authority (NPPA) has fixed the retail price of 29 new drugs under the provisions of Drugs (Prices Control) Order, 2013 for fixing retail price of a new drug for existing manufacturers of scheduled formulations.
The Authority considered 30 applications seeking retail price fixation of 30 new drugs in its latest meeting and approved the prices for 29 drugs, while differing fixation of price for one formulation observing that necessary clarifications are required from the company before finalising the price.
The retail prices were fixed for new drug formulations based on company applications, including combination of paracetamol, phenylephrine hydrochloride, caffeine and diphenhydramine hydrochloride tablets marketed by Torrent Pharmaceuticals Ltd; Cilnidipine and telmisartan tablets marketed by Mankind Pharma; Ibuprofen solution for infusion 400 mg/100 ml marketed by Neon Laboratories; Phenylephrine hydrochloride and chlorpheniramine maleate drops IP marketed by Apex Laboratories; Ofloxacin and dexamethasone eye/ear drops marketed by Intas Pharmaceuticals; Montelukast and fexofenadine hydrochloride suspension marketed by Cipla Ltd, among others.
Application for retail price fixation of trastuzumab 150 mg manufactured by Hetero Biopharma and marketed by Mankind Pharma has been deferred by the Authority.
“The Authority deliberated on the agenda item and observed that further necessary clarifications are required from the company regarding per ml composition, pack size, etc. of the subject formulation. Hence agreed to defer the agenda item,” said NPPA.
According to the Department of Pharmaceuticals, the pricing authority has fixed the retail price of 184 new drugs during six months from April 1, 2023 to September 30, 2023. Of this, retail prices of 51 new drugs were fixed in the month of September, it added.
The Authority has fixed ceiling price of 40 scheduled formulations under the revised Schedule I of the DPCO, 2013, after the schedule was amended incorporating the National List of Essential Medicines (NLEM) 2022, in the first six months of the current fiscal year. It has also fixed ceiling price for two scheduled formulations with special features under the revised Schedule I, during the period, said DoP.
In its latest meeting, the NPPA also decided to grant exemption for Cadila Pharmaceuticals’ vitamin D3 injection from the price regulation under the DPCO, 2013 for a period of five years from the date of commercial marketing by the manufacturer in the country or expiry of Indian Patent, whichever is earlier. The exemption has been allowed based on the inputs from the Patent Office and recommendation from the Multi Disciplinary Committee (MDC) of Experts under the NPPA, stating that the company has a patent for the product from the Indian Patent Office.
The Authority directed that Cadila Pharmaceuticals shall intimate the date of commercial marketing of the said formulation in the country, the price to retailer and maximum retail price fixed by the company by issuing a price list in Form V under DPCO, 2013. Besides, the company also shall seek retail price approval for the formulation, if applicable, three months before the expiry of the exemption period of five years, it added.
Similarly, the Authority also granted exemption for Panacea Biotech’s EasyfourPol Vaccine containing adsorbed diphtheria, tetanus, pertussis, poliomyelitis (inactivated) and haemophilus influenzae typ b conjugate vaccine IP, as it fulfills the conditions for exemption under the Para 32(i) of DPCO, 2013. The decision was taken based on the inputs from the Patent Office and recommendation of the MDC, for five years.
It also decided to treat the matter related to Cipla’s request for a separate price for its asthma inhaler drug combination as closed. This is following the recommendation of the MDC to close the matter as it did not find merit in the claim of the company.
The Committee gave out its recommendation on the long pending issue after placing a complete point-wise examination on the issues raised by the Mumbai-based drug major for separate pricing of its combination of formoterol fumarate dihydrate 6mcg + beclomethasone dipropionate IP 100 mcg inhaler (MDI). Cipla has been fighting for a separate price for formulation and received a favourable order from the DoP in October, 2022, which stated that the matter requires remand for fresh orders on merits by MDC and NPPA after analysis of entire facts to avoid miscarriage of justice.
