NPPA Revises Ceiling Prices of Azithromycin & Amoxicillin + Clavulanic Acid

The National Pharmaceutical Pricing Authority (NPPA) has announced revised ceiling prices for two scheduled formulations under the Drugs (Prices Control) Order, 2013 (DPCO, 2013). This order was published on February 7, 2025.

This revision follows a review order issued by the Department of Pharmaceuticals (DOP) and incorporates the Wholesale Price Index (WPI) impact of 0.00551% for 2024.

Revised Prices

The revised ceiling prices, effective immediately, are as follows:

Sl. No.MedicinesDosage form & StrengthUnitCeiling Price under NLEM, 2022 (Rs.)Revised Ceiling price based on Review Order & considering WPI @0.00551% (Rs.)
1.AzithromycinTablet 250 mg1 Tablet11.6511.67
2.Amoxicillin + Clavulanic acidPowder for Injection 1g + 200mg1 vial140.66141.65

Implementation Guidelines for Manufacturers

Manufacturers selling these formulations (branded or generic) above the revised ceiling price (plus applicable GST) must immediately revise their prices downwards to comply.

Manufacturers with existing MRPs lower than the revised ceiling price (plus applicable GST) can maintain their current MRPs. GST can only be added if it has been paid or is payable to the government.

Pack pricing must be calculated as per DPCO, 2013 guidelines. Manufacturers must issue a price list (Form-V) to NPPA (via IPDMS), State Drug Controllers, and dealers.

Retailers and dealers must prominently display the price list provided by the manufacturer.

Existing manufacturers launching a new drug (as per DPCO, 2013) with the specified dosage or strength must apply for prior price approval from the NPPA (Form I).

Manufacturers must submit quarterly returns (Form-III) regarding production/import and sale to the NPPA via IPDMS. Discontinuation of production/import must be reported (Form-IV) six months in advance.

Non-compliance with the ceiling price and these guidelines will result in the recovery of the overcharged amount with interest under the DPCO, 2013, read with the Essential Commodities Act, 1955.

Previous price orders for these formulations are superseded by this notification.

Impact

These price revisions, while seemingly small, can have a significant cumulative impact on patient costs. The NPPA’s active role in price control and review ensures that essential medicines remain affordable and accessible to the public. Manufacturers are advised to take immediate steps to comply with the revised prices and guidelines to avoid potential penalties.

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