NPPA Fixes Retail Prices Of 37 New Drug Formulations Under DPCO

The National Pharmaceutical Pricing Authority (NPPA) has fixed the retail prices of 37 new drug formulations under the provisions of the Drugs (Prices Control) Order (DPCO), 2013, covering a wide range of commonly used medicines, including those for hypertension, diabetes, respiratory disorders, allergies and mental health conditions.

The decision was taken at the Authority’s recent meeting as part of its mandate to ensure the availability of essential medicines at affordable prices, while maintaining a balance between consumer interests and the viability of pharmaceutical manufacturers.

Among the formulations for which prices have been fixed are bilastine and montelukast tablets manufactured by Cipla Ltd; bisoprolol fumarate and telmisartan tablets by Dr. Reddy’s Laboratories; and levocetirizine dihydrochloride with montelukast sodium syrup by German Remedies. The list also includes myo-inositol and sustained-release metformin hydrochloride tablets from companies such as Mankind Pharma, Emcure Pharmaceuticals and Torrent Pharmaceuticals.

Prices have also been notified for ophthalmic and injectable formulations, including moxifloxacin hydrochloride and ketorolac tromethamine eye drops from Torrent Pharmaceuticals, as well as multiple electrolytes and 5% dextrose injection (Type I USP) manufactured by Otsuka Pharmaceutical India.

In addition, the Authority has fixed prices for combination tablets containing paracetamol, phenylephrine hydrochloride and chlorpheniramine maleate, produced by firms such as Intas Pharmaceuticals, Stedman Pharmaceuticals and Macleods Pharmaceuticals. Psychotropic medicines, including paroxetine controlled-release and clonazepam capsules from Ipca Laboratories, are also part of the latest notification.

Several drugs used for managing diabetes, blood pressure and respiratory diseases have been included, such as dapagliflozin and telmisartan tablets, and inhalation formulations containing glycopyrronium, formoterol fumarate and budesonide from Glenmark Pharmaceuticals.

The NPPA noted that these formulations qualify as “new drugs” under Paragraph 2(1)(u) of the DPCO, 2013. Under this provision, a new drug refers to a formulation introduced by an existing manufacturer by either combining drugs listed in the National List of Essential Medicines (NLEM) with other drugs, or by altering the strength or dosage of a scheduled formulation already included in the NLEM.

According to the price regulator, the methodology for calculating and fixing the retail prices of such new drugs is clearly laid down in Paragraphs 5 and 15 of the DPCO, 2013. These provisions specify the formulae and principles to be followed while assessing price applications submitted by pharmaceutical companies, and the Authority adheres strictly to these guidelines while issuing price notifications.

The NPPA also referred to an earlier meeting held on November 27, 2025, during which the retail price of one additional new drug formulation was fixed under the same legal framework. That decision, too, covered medicines used for diabetes, hypertension and respiratory conditions.

Emphasising compliance, the Authority warned that manufacturers and marketing companies must strictly adhere to the notified retail prices. Any violation, including overcharging, would attract recovery of the excess amount along with applicable interest, as per the provisions of the DPCO, 2013, read with the Essential Commodities Act, 1955.

The NPPA reiterated that its pricing interventions are aimed at protecting public health interests by preventing unreasonable price escalation of essential and widely used medicines. With non-communicable diseases such as diabetes and hypertension on the rise, officials said timely price regulation remains crucial to ensure sustained access to affordable treatment across the country.