CDSCO Allows Stickering of Revised MRP on Medical Devices based on 56th GST Council rate amendment

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Dated: 12.09.2025

CDSCO Allows Stickering of Revised MRP on Medical Devices based on 56th GST Council rate amendment

In a significant move aimed at making healthcare more affordable, the Government of India has announced a reduction in Goods & Services Tax (GST) rates on drugs and medical formulations. This decision, effective from 22nd September 2025, is expected to benefit millions of patients across the country by lowering the cost of essential medical products. To ensure smooth implementation of the revised GST rates, the Directorate General of Health Services (DGHS) has issued guidelines for manufacturers and importers of medical devices, as well as state drug controllers.

Key Highlights of the GST Rate Reduction

Effective Date: The revised GST rates will come into effect from 22nd September 2025.
Scope: The reduction applies to drugs, formulations, and medical devices classified under Class C and Class D categories.
Implementation Timeline: Manufacturers and importers are allowed to affix stickers reflecting the revised Maximum Retail Price (MRP) on medical products within three months from the date of the order (11th September 2025).

Guidelines for Manufacturers and Importers

The Central Licensing Authority (CLA), under the Drugs and Cosmetics Act, 1940, has granted permission to manufacturers and importers to affix stickers with the revised MRP on medical products. This ensures compliance with the new GST rates without requiring complete relabeling of products.

Steps for Manufacturers and Importers:

Affix Stickers: Update the MRP on medical products using stickers that reflect the revised GST rates.
Timeline: Ensure the stickering process is completed within three months from the issuance of the order.
Compliance: Adhere to the rules and regulations under the Drugs and Cosmetics Act, 1940, while implementing the changes.

Guidelines for State/UT Drug Controllers

State and Union Territory Drug Controllers have been requested to expedite the issuance of “No Objection Certificates” (NOCs) for manufacturers to alter product labels. This step is crucial for ensuring timely implementation of the revised GST rates.

Action Points for State/UT Drug Controllers:

Issue NOCs: Facilitate the process of granting permissions for label alterations.
Monitor Compliance: Ensure manufacturers adhere to the guidelines under the Drugs and Cosmetics Act, 1940.
Report Progress: Communicate the action taken to the Directorate General of Health Services.

Impact on Stakeholders

The GST rate reduction is expected to have a positive impact on various stakeholders, including:

Patients: Lower costs for essential drugs and medical devices.
Manufacturers and Importers: Simplified compliance through stickering instead of complete relabeling.
Healthcare Industry: Enhanced affordability and accessibility of medical products.

Role of Associations and Organizations

Leading industry associations such as IDMA, IPA, OPPI, FICCI, FOPE, CII, and AiMeD have been informed about the changes. These organizations are expected to play a key role in disseminating information and ensuring compliance among their members.

Conclusion

The reduction in GST rates on medical products is a welcome step towards making healthcare more affordable for the masses. With clear guidelines issued by the DGHS, manufacturers, importers, and state drug controllers are well-equipped to implement the changes effectively. Stakeholders are encouraged to act promptly to ensure compliance within the stipulated timeline.

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Source: CDSCO

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