India Pharma Outlook Team | Tuesday, 02 June 2026
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India’s drug pricing regulator, the National Pharmaceutical Pricing Authority (NPPA), has revised the ceiling price of a key long-acting antibiotic formulation manufactured by Pfizer, increasing the price to Rs 13.42 per vial from the earlier notified Rs 11.97 per vial.
The revision follows a directive from the Department of Pharmaceuticals (DoP) after a detailed review of pricing inputs submitted by the company.
The decision relates to benzathine benzylpenicillin powder for injection (6 lakh units), a widely used long-acting antibiotic administered for bacterial infections such as streptococcal upper respiratory infections and syphilis.
The price revision was initiated after Pfizer filed a review application, arguing that the Price to Retailer (PTR) considered earlier for its brand Penidure LA 6 was incorrect. The company submitted revised data through Form II in April 2023, requesting correction of pricing inputs.
Following the DoP’s review order dated March 20, 2026, the matter was referred back to NPPA for recalculation of the ceiling price under the Drugs Prices Control Order (DPCO), 2013. The regulator subsequently re-evaluated the pricing framework and issued updated working sheets reflecting corrected PTR values.
The earlier ceiling price was based on a PTR of Rs 10.31 per unit, later revised during the assessment process. The draft pricing exercise indicated a corrected PTR of Rs 12.89 per unit after adjustments, leading to recalibration of the final ceiling price.
The NPPA also applied monopoly correction provisions, noting that Pfizer holds a significant market share in the formulation segment. A reduction of Rs 1.60 was factored into the average PTR calculation in line with pricing regulations.
After incorporating all revisions, including Wholesale Price Index (WPI) adjustments for 2025 and 2026, the final notified ceiling price was fixed at Rs 13.42 per vial through a Gazette notification.
The pricing revision went through multiple stages, including draft notifications, stakeholder review, and internal recalculations. The final decision was taken after no objections were received following the revised draft worksheet issued in May.
The updated ceiling price replaces the earlier February 2024 notification, which had initially fixed the price at Rs 11.69 per vial before subsequent WPI-linked revisions.
The drug in question has a Moving Annual Turnover (MAT) of Rs 2.41 crore, indicating a relatively niche but essential therapeutic use in India’s antibiotic market.
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Penidure LA 6 is a long-acting intramuscular antibiotic administered as a sterile powder for reconstitution. It is used to treat a range of bacterial infections, including mild to moderate upper respiratory tract infections caused by susceptible streptococci and conditions such as syphilis.
The NPPA’s revised pricing decision highlights the dynamic nature of India’s pharmaceutical price control framework, where regulatory corrections, industry representations, and cost benchmarks jointly determine final drug pricing. The adjustment ensures both compliance with pricing norms and correction of input discrepancies flagged during review.
The National Pharmaceutical Pricing Authority (NPPA) is a government regulatory body under the Department of Pharmaceuticals, responsible for controlling and revising drug prices in India. It ensures affordable access to essential medicines while maintaining fair pricing in the pharmaceutical market.
Pfizer is a global biopharmaceutical company focused on developing innovative medicines and vaccines across key therapeutic areas. In India, it operates across prescription drugs and specialty therapies, contributing to advanced treatment access while working within the country’s regulatory and pricing framework.
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