NPPA Caps Prices Of 42 New Drug Formulations, Including Diabetes, BP And Women’s Health Medicines

In a move aimed at keeping essential medicines affordable, the National Pharmaceutical Pricing Authority (NPPA) has fixed the retail prices of 42 new drug formulations under the provisions of the Drugs (Prices Control) Order (DPCO), 2013. The newly notified medicines include treatments for hypertension, diabetes, respiratory illnesses, high cholesterol, depression, parasitic infections, and heavy menstrual bleeding.

The decision was taken during the Authority’s meeting held on April 30, where applications submitted by pharmaceutical companies seeking retail price approval for new drugs were reviewed. While 43 applications came up for consideration, one proposal by Zydus Lifesciences related to an immunosuppressant medicine was deferred after the company raised objections to the draft pricing calculations.

Among the notable approvals were six formulations of a combination therapy containing relugolix, oestradiol, and norethindrone acetate—a once-daily oral medicine used for treating heavy menstrual bleeding and pain associated with uterine fibroids.

The formulation has been approved at different retail prices for multiple companies. Alembic Pharmaceuticals received approval for a price of ₹120.62 per tablet, while Zydus Healthcare secured a price of ₹116 per tablet. Intas Pharmaceuticals was allowed to market the medicine at ₹110 per tablet, whereas Emcure Pharmaceuticals, Jagsonpal Pharmaceuticals, and Aristo Pharmaceuticals received approval at ₹107.22 per tablet.

The same drug combination had earlier received price approval for Dr. Reddy's Laboratories. Internationally, the therapy is marketed by Sumitomo Pharma under the brand names Myfembree and Ryeqo.

Apart from women’s health medicines, the latest list also includes several commonly used therapies for chronic diseases. These include an anti-parasitic tablet combining ivermectin and albendazole from Wockhardt Ltd, a respiratory solution containing levosalbutamol and ipratropium bromide for chronic obstructive pulmonary disease (COPD) from Mankind Pharma, and an anti-diabetic formulation containing lobeglitazone sulphate and metformin hydrochloride from Zuventus Healthcare.

The regulator also fixed prices for an antidepressant combination of olanzapine and fluoxetine marketed by Cadila Pharmaceuticals, along with cholesterol-lowering medicines such as atorvastatin and ezetimibe tablets from Aristo Pharmaceuticals and atorvastatin with clopidogrel capsules from Corona Remedies.

The latest notification reflects the steady pace at which the NPPA has been clearing applications for new drug price fixation this year. In earlier meetings held in January, February, and March, the Authority had already fixed prices for 37, 20, and 31 new drugs, respectively.

Under the DPCO, 2013, “new drugs” include modified versions of medicines listed in the National List of Essential Medicines (NLEM), such as formulations with altered strengths, dosage forms, or combinations with other drugs. Existing manufacturers launching such modified formulations are required to seek price approval from the NPPA before marketing them.

The regulator follows a specific pricing methodology laid down under Paragraphs 5 and 15 of the DPCO while calculating retail prices. These calculations are based on data and applications submitted by pharmaceutical companies.

According to government officials, the price control mechanism plays an important role in preventing unreasonable pricing of medicines, particularly for chronic diseases such as diabetes, hypertension, and respiratory disorders, where long-term treatment often imposes a financial burden on patients.

The NPPA has also reiterated that pharmaceutical companies are legally bound to comply with the notified prices. In cases where manufacturers charge more than the approved ceiling price, they may be directed to deposit the overcharged amount along with applicable interest under the provisions of the DPCO and the Essential Commodities Act, 1955.

The latest round of price notifications comes amid continuing concerns over rising healthcare expenditure in the country. While the government has expanded insurance coverage through schemes such as Ayushman Bharat and strengthened public health programmes, out-of-pocket spending on healthcare continues to remain high for many families.

According to the latest National Statistical Office (NSO) health survey, the average cost of hospitalisation in private hospitals remains substantially higher than in public facilities, highlighting a persistent affordability gap in healthcare access.

The survey showed that the average out-of-pocket expenditure on hospitalisation across all types of hospitals stood at ₹34,064. However, the average cost in government hospitals was ₹6,631, compared to ₹50,508 in private hospitals.

Activists in the sector said that while initiatives such as drug price regulation have helped reduce the burden of medicine costs, expenses related to diagnostics, procedures, and private hospitalisation continue to place considerable financial strain on patients, particularly those managing chronic illnesses requiring long-term treatment.