NPPA Approves Separate Price for GSK's New Paracetamol-Phenylephrine Sachet
New Delhi: The National Pharmaceutical Pricing Authority (NPPA), under the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, has fixed the retail price of a new drug formulation, each sachet containing Paracetamol I.P. 500 mg and Phenylephrine HCl I.P. 10 mg, at Rs 6.96 for GlaxoSmithKline Asia Private Limited (GSK Asia).
The price notification was published in the Gazette of India on July 4, 2025.
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;
TABLE
S. No. | Medicines | Strength | Unit | Retail Price (in Rs.) |
(1) | (2) | (3) | (4) | (5) |
1 | Paracetamol and Phenylephrine Hydrochloride sachet | Each sachet containing Paracetamol I.P. 500 mg and Phenylephrine HCl I.P. 10 mg | 1 Sachet | 6.96 |
The official order further mandates that, “M/s GlaxoSmithKline Asia Private Limited shall issue a price list in Form–V from date of Notification as per paragraph 24 of the DPCO, 2013 to NPPA through IPDMS and submit a copy to State Drug Controller and dealers.”
Retailers and dealers are required to display the price list prominently under Para 24(4) of the DPCO. Non-compliance with the price notification may attract penal provisions; “In case the price of the formulation... is not complied as per the instant price notification... M/s GlaxoSmithKline Asia Private Limited shall be liable to deposit the overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the Essential Commodities Act, 1955.”
The notified price is applicable exclusively to GSK Asia, subject to fulfillment of statutory requirements and valid manufacturing permissions from the Central or State Licensing Authority. Retailers must display the price list prominently in their premises. Non-compliance with the price notification may lead to recovery of the overcharged amount with interest under the DPCO 2013 read with the Essential Commodities Act, 1955.
