NPPA Approves 50% Increase in Ceiling Prices of 11 Formulations
Overview
The National Pharmaceutical Pricing Authority (NPPA) has approved a 50 per cent increase in ceiling prices of 11 formulations of eight drugs, invoking extraordinary powers in public interest to ensure availability of essential drugs.
Drugs Use
These drugs are used for treatment of asthma, glaucoma, thalassemia, tuberculosis, mental health disorders, etc and are part of first-line of treatment crucial to the public health programmes of the country.
Revised Price Formulations
Formulations for which ceiling prices have been revised include: Benzyl penicillin 10 lakh IU injection; atropine injection 06.mg/ml; streptomycin powder for injection 750 mg and 1000 mg; salbutamol tablet 2 mg and 4 mg and respirator solution 5 mg/ml; pilocarpine 2% drops; cefadroxil tablet 500 mg, desferrioxamine 500 mg for injection; and lithium tablets 300 mg.
Behind this Action
The action was following requests from the manufacturers for upward revision owing to increase in cost of raw materials, cost of production and other expenses resulting in unviability in sustainable production and marketing of these drugs.
Companies have also applied for discontinuation of some of the formulations on account of their unviability, said the Authority.
Govt committee- An Inter-Ministerial Committee formed by the Authority a few years back on April 5, 2024 recommended price revision for the formulations.
The Recommendations by Authority
The Authority noted that the formulations recommended by the Committee for upward price revision are mostly low-priced scheduled formulations and have been under repeated price control, but are generally used as first line of treatment and are important to address the public health needs of the country.
"Further, the mandate of NPPA is to ensure availability of drugs at affordable prices. While ensuring affordability, access cannot be jeopardised and the life-saving essential drugs must remain available to the general public at all times," observed the Authority.
"Therefore, unviability of these formulations should not lead to a situation where these drugs become unavailable in the market and the public is forced to switch to expensive alternatives," said the Authority.
Order for Fixing the Drug Price
The order has been issued invoking the Para 19 of Drugs Prices Control Order, 2013, which gives powers to the Centre to fix the ceiling price or retail price of a drug in case of extraordinary circumstances, if it considers necessary to do so in public interest.
Applications to NPPA
NPPA has been receiving applications from the manufacturers for upward revision of prices citing various reasons like increased cost of active pharmaceutical ingredients (APIs); increase in the cost of production; change in exchange rate etc.; resulting in unviability in sustainable production and marketing of drugs.
Companies have also applied for discontinuation of some of the formulations on account of their unviability.
Total Considered Applications
The Inter-Ministerial Committee has, in fact, considered applications for 76 formulations of 28 APIs and recommended price revision for 14 formulations and rejected application for price increase for 46 formulations and deferred 16 formulations for further examination.
The Committee in meetings held on March 14 and April 4, 2024, considered the applications on different parameters including essentiality of these formulations, market share of companies requesting for price revision, the period since when the formulation is under price control, concern regarding possible shortages, request, if any for discontinuation received from the companies and the trend of API prices during the last three years from 2020 to 2023 as reported by the Office of the Drugs Controller General (India).
Authority to NPPA for Examination
The Authority has in 2019, referred the issue to the Committee on Affordable Medicines and Health Products (CAMHP), NITI Aayog, Government of India, for guidance on the modalities and methodology to be followed and the Committee recommended an increase of 50 per cent in ceiling prices and also authorised NPPA to examine additional formulations or molecules experiencing similar issues.
Invoked Powers
Earlier such extraordinary powers have been invoked by NPPA in 2019 and in 2021 whereby price of 21 formulations for 12 drugs and 9 formulations of three drugs, respectively, were increased by 50% so as to ensure continued availability of essential drugs for the public.