13th September,2025

The Government of India has just announced a significant change that will impact the pharmaceutical and medical devices industry, effective “22nd September 2025”. Yes, you read that right—GST rates on drugs, formulations, and medical devices are being reduced, and the result? Cheaper medicines and devices for consumers! 🎉

While this sounds fantastic for patients, but for manufacturers, importers, and marketers—who now need to comply with updated pricing regulations and navigate some serious paperwork.

But don’t worry. Let’s break down everything you need to know and how this change will unfold. 👇

🔑 What You Need to Know

  1. NPPA Directives (Order dated 12.09.2025)

The National Pharmaceutical Pricing Authority (NPPA) has issued detailed directions for implementation:

  • The benefit of GST reduction must be passed on to consumers/patients starting 22nd September 2025.
  • All manufacturers and marketing companies must revise the MRP of drugs, formulations, and medical devices accordingly.
  • Companies must issue revised price lists (Form V/VI) to dealers, retailers, State Drug Controllers, and the Government.
  • Immediate action should be taken to sensitize dealers, retailers, and consumers through electronic, print, and social media campaigns Advertisements in leading national and regional newspapers
  • Stocks released before 22nd September 2025 do not require mandatory re-labelling or re-stickering, provided price compliance is ensured at the retailer level.
  • Companies that wish to re-label or re-sticker may do so in a phased manner to avoid shortages. CDSCO has already issued necessary directions under Rule 104A of the Drugs and Cosmetics Rules, 1945.
  1. CDSCO Directives (Order dated 11.09.2025)

The Central Drugs Standard Control Organisation (CDSCO) has also released specific instructions for drugs and medical devices:

  1. For Medical Devices

Importers and manufacturers of Class C and D medical devices are permitted to affix stickers with the revised MRP under the Drugs and Cosmetics Act, 1940 and Rules, 1945.

All stickering/label alterations must be completed within 3 months from the date of order.

2. For Other Drugs

Manufacturers are permitted to alter labels/stickers to revise MRPs in line with the new GST rates, after obtaining a No Objection Certificate (NOC) under the Drugs and Cosmetics Act, 1940.

Direction to Regulators

All State/UT Drug Controllers have been directed to expedite the NOC process under the Drugs and Cosmetics Act, 1940, to ensure timely implementation of the revised GST rates by manufacturers.

📌 Why This Matters

This change isn’t just about lowering costs for consumers; it’s a step towards increased transparency in the pricing of medicines and medical devices. Here’s why it matters:

  • Affordable healthcare: The GST reduction directly benefits patients, making life-saving medicines and medical devices more affordable.
  • Industry accountability: It ensures that industry players stay transparent and comply with updated regulations, benefiting both the patient community and healthcare providers.
  • Regulatory oversight: It’s a win-win for patients and the government, as the NPPA and CDSCO are keeping a close eye on compliance to ensure that the reduced prices actually reach the end consumer.

For industry stakeholders, this is a clear call to act quickly and efficiently:

  • Revise MRPs without delay.
  • Update your official price lists and communicate the changes throughout the supply chain.
  • Ensure that all labelling and sticker updates are compliant with the new regulations.
  • Communicate the changes effectively to the market through advertising and media campaigns.

 

For More Detail Reach out to Vaayath today to ensure a seamless transition under the new GST guidelines and stay ahead in regulatory compliance.