The National Pharmaceutical Pricing Authority (NPPA), in a decisive move to regulate the cost of essential medicines, has officially fixed the retail prices for nine new drug formulations. This order, issued on September 15, 2025, sets the maximum prices for a range of new medicines, including advanced combination therapies for pain management, diabetes, and cardiovascular conditions. The action is in line with the objectives of the Drugs (Prices Control) Order, 2013 (DPCO, 2013).
This latest intervention by the NPPA is a part of a continuous process to monitor and regulate the pharmaceutical market. By exercising its powers under paragraphs 5, 11, and 15 of the DPCO, 2013, the Authority aims to strike a balance between fostering a vibrant and innovative pharmaceutical industry and protecting public interest from market-driven price volatility. The NPPA’s mandate is to establish fair and reasonable prices for drugs, ensuring that they remain within the financial reach of the common person, thereby strengthening the nation’s public health infrastructure.
The nine formulations, deemed “new drugs” under the DPCO, 2013, represent significant advances in their respective therapeutic areas. The fixed prices, which are exclusive of Goods and Services Tax (GST), are applicable to the specific manufacturers and marketing companies that applied for these price fixations. This ensures that the benefits of price regulation are targeted and clear for both industry and consumers.
A Closer Look at the Fixed Prices
The NPPA’s order covers a diverse range of medicines, reflecting the evolving landscape of medical treatments and the need to regulate new, often more complex, drug combinations.
Pain and Anti-Inflammatory Management
Two formulations for pain and anti-inflammatory management have had their prices fixed.
- Aceclofenac, Paracetamol & Thiocolchicoside Tablets (8 mg): This combination therapy has a retail price of Rs. 27.49 per tablet.
- Aceclofenac, Paracetamol & Thiocolchicoside Tablets (4 mg): A lower-strength variant of the same combination has been priced at Rs. 18.43 per tablet. These drugs, widely used for their anti-inflammatory and muscle relaxant properties, are critical for managing chronic pain and musculoskeletal conditions. The price fixation ensures that these modern formulations are available at a controlled and reasonable cost, preventing potential overpricing that could burden patients with long-term treatment needs.
Diabetes Management
The increasing prevalence of diabetes in India has made advanced diabetic drugs a top priority for price regulation. The NPPA’s order includes several key formulations that combine multiple active ingredients to offer comprehensive management in a single tablet.
- Dapagliflozin, Glimepiride & Metformin Hydrochloride (ER) Tablets: Two strengths of this extended-release combination, designed for more effective blood sugar control, have been priced at Rs. 10.80 and Rs. 11.70 per tablet.
- Sitagliptin, Glimepiride & Metformin Hydrochloride Tablets: This triple combination, which is critical for managing advanced stages of diabetes, is now available at Rs. 13.24 and Rs. 15.00 per tablet, depending on the strength.
- Sitagliptin, Empagliflozin & Metformin Hydrochloride (ER) Tablets: This new, advanced combination therapy for diabetes, also in an extended-release form, has been priced at Rs. 30.00 and Rs. 34.50 per tablet. These price fixations are particularly significant given that combination therapies, while often more effective, can be prohibitively expensive. By regulating their prices, the government ensures that a wider segment of the population can afford these life-saving treatments, thus improving public health outcomes and reducing the economic burden of chronic disease.
Other Essential Formulations
The order also covers other crucial medicines, including a pain-relief suspension.
Ibuprofen & Paracetamol Suspension: A popular combination for pediatric and general use, this suspension has been priced at Rs. 0.55 per ml. This price regulation extends the government’s commitment to ensuring that even widely used, basic drug formulations are available at affordable prices.
Ensuring Compliance and Accountability
The NPPA’s notification is not merely a price list; it is a legally binding directive that outlines the responsibilities of every stakeholder in the supply chain, from manufacturers to retailers.
Manufacturer’s Responsibility
The manufacturer must sell the drug at or below the fixed retail price. They are permitted to add GST only if it has been actually paid or is payable to the government. A price list in Form-V must be issued to the NPPA, the State Drug Controller, and all dealers to ensure the new prices are disseminated throughout the market.
Retailer’s Obligation
As per paragraph 24(4) of the DPCO, 2013, every retailer and dealer is legally required to display this price list in a conspicuous part of their premises, making it easily accessible to consumers. This provision promotes transparency and empowers consumers to verify that they are being charged the correct price.
Penalties for Non-Compliance
The notification issues a stern warning that any manufacturer or marketing company found to be non-compliant with the fixed prices will be liable to deposit the overcharged amount, along with interest. This penalty is enforced under the provisions of the DPCO, 2013, read with the Essential Commodities Act, 1955, underscoring the serious consequences of overcharging.
By regulating the prices of new and important drug formulations, the NPPA is helping to ensure that the economic benefits of pharmaceutical innovation are shared with the patients who need them most, thereby strengthening the foundation of a healthy and prosperous nation.