NPPA Approves Separate Price for GSK's New Paracetamol-Phenylephrine Sachet

As per the official order, the formulation qualifies as a new drug under Para 2(1)(u) of the Drugs (Prices Control) Order, 2013 (DPCO 2013).

The NPPA had received a price application from GSK Asia for the sachet-based fixed-dose combination formulation. The application was placed before the Multidisciplinary Committee of Experts during its 65th meeting (January 23, 2025), 66th meeting (March 3, 2025), and 68th meeting (June 3, 2025).

During the 66th meeting, GSK Asia gave a detailed presentation outlining key benefits of the product, including, “faster solubility, faster disintegration hence better safety and efficacy, better AUC level, absorption in intestine, useful in patients who have difficulty in swallowing and claimed lower price compared to other companies.”

Based on these deliberations, the expert panel recommended fixing a separate price for the formulation under Para 11(3) of the DPCO 2013, considering the availability of similar products in the market.

Subsequently, in its 134th authority meeting held on June 26, 2025, the NPPA accepted the committee’s recommendation and approved the price of Rs 6.96 per sachet, exclusive of Goods and Services Tax (GST), if applicable.

In exercise of powers, conferred by paragraph 11(3) of the Drugs (Prices Control) Order, 2013 read with S.O. No. 1394(E) dated the 30th May, 2013 issued by the Government of India in the Ministry of Chemicals and Fertilizers, the NPPA, fixed the price as specified in column (5) of the table herein below as the price exclusive of goods and services tax, if any, for the formulation specified in the corresponding entry in column (2) of the said Table with the strength, unit, as specified in the corresponding entries in columns (3), and (4) thereof for M/s GlaxoSmithKline Asia Private Limited based on the market data;