In a significant move to regulate drug pricing, the National Pharmaceutical Pricing Authority (NPPA) has finalized retail prices for 84 new formulations during its recent meeting, chaired by P Krishnamurthy. These include essential medications in therapeutic categories such as antihypertensives, antidiabetics, and anti-inflammatories.

Among the approvals, 36 combinations containing empagliflozin—a molecule patented by Boehringer Ingelheim—were priced based on submissions by several pharmaceutical marketers, including Mankind Pharma, Alkem Laboratories, Lupin, Skymap, Zuventus, and Micro Labs.

Patent Dispute & Empagliflozin Pricing

The pricing process followed contentions from Boehringer Ingelheim India Pvt Ltd (BIIPL), which challenged the retail pricing recommendations by NPPA’s Multidisciplinary Committee (MDC). The company objected to the incorrect patent expiry date listed as March 10, 2025, instead of March 11, and also disputed Cipla's designation as licensee of the compound.

BIIPL urged the Authority to consider retail pricing based only on its own and its authorized co-marketers’ brands—Jardiance, Gibtulo, and Cospiaq. However, the NPPA upheld the MDC’s recommendations, stating the objections didn’t warrant a pricing revision.

Broader Drug Price Fixation

In addition to empagliflozin-based drugs, the Authority reviewed prices for several anti-diabetic combinations involving glimepiride, dapagliflozin, and sitagliptin, with applications from companies like USV Ltd and Mankind Pharma.

Retail prices were also set for blood pressure medications featuring combinations of telmisartan, cilnidipine, and extended-release metoprolol succinate.

Unapproved Launches and Price Adjustments

Prices were fixed for several formulations that were launched without prior NPPA approval, including:

• Paracetamol infusion (Hetero Healthcare)

• L-Carnitine with methylcobalamin and folic acid tablets (Ozone Pharmaceuticals)

• Rosuvastatin, aspirin, and clopidogrel combination (Unimed Technologies)

The Authority applied the lowest value among the launched price, calculated price, and claimed price for these cases.

Vitamin D3 Pricing Revisions

NPPA also revised the prices of cholecalciferol (Vitamin D3) 60,000 IU nano droplet oral solutions:

• German Remedies: Final retail price set at Rs 14.94/ml, after Pharmarack data reconfirmation.

• Cipla Ltd: Price revised to Rs 15.03/ml following corrections in Pharmarack's earlier data.

These changes follow earlier draft worksheets uploaded in February and March, which were later modified after NPPA directed a re-examination.