Published on: 16th April, 2025

The Central Drugs Standard Control Organization (CDSCO) has released a crucial directive dated 11th April, 2025, addressing the unauthorized manufacture and marketing of Fixed Dose Combinations (FDCs) by pharmaceutical manufacturers in India. The notification highlights the growing concern over the approval of “New Drugs” by State Licensing Authorities (SLAs) without the required prior approval from the Drugs Controller General of India (DCG(I)), as mandated by the New Drugs and Clinical Trial Rules (NDCT), 2019.

⚠️ What’s the Regulatory Concern?

As per the NDCT Rules, 2019, any product classified as a “New Drug”—including:

  • New chemical entities (NCEs),
  • Drugs with new claims or new dosage forms,
  • Modified release formulations,
  • Combinations of already approved drugs (i.e., FDCs),
  • And specialized drugs like vaccines and recombinant products—

must receive prior approval from DCG(I) before being manufactured or marketed in India. This regulatory process ensures a robust assessment of safety, efficacy, and quality.

However, it has come to light that many FDCs have received manufacturing licenses directly from SLAs, by passing the central approval requirement. This is a direct violation of the Drugs & Cosmetics Act, 1940 and the Rules, 1945.

📋 CDSCO’s Key Observations:

  • A list of Such unapproved FDCs has been compiled and annexed in the official order.
  • Manufacturers often justify their operations by presenting valid state licenses—yet this does not absolve them from the requirement of DCG(I) approval under NDCT Rules.
  • CDSCO emphasizes that this directive is not limited to the listed drugs—any product manufactured without DCG(I) approval will be subject to regulatory action.

🔍 Action Points for Manufacturers

In view of the directive, all pharma manufacturers are advised to take the following immediate actions:

  1. Review all existing FDC licenses granted by SLAs.
  2. Verify whether the product qualifies as a “New Drug” under NDCT Rules.
  3. Check for DCG(I) approval and assess compliance gaps.
  4. Stop manufacture and marketing of unapproved FDCs immediately.
  5. Report compliance and corrective actions to CDSCO.

🛡️ How Vaayath Can Support You

At Vaayath Consulting Services, we understand the complexity and implications of this directive. Our team of regulatory experts is here to support your organization with:

  • ✅ Regulatory Product Portfolio Review to identify at-risk or non-compliant FDCs.
  • ✅ Gap Analysis & Risk Assessment under NDCT Rules.
  • ✅ Strategic Roadmap for obtaining DCG(I) approval.
  • ✅ Regulatory Representation & Filing Support.
  • ✅ Clinical & Scientific Advisory for FDC development.
  • ✅ Documentation Preparation & Review.
  • ✅ Customized Training for QA, RA, and manufacturing teams.

📢 Final Word

This is a critical time for Indian pharmaceutical companies to ensure regulatory compliance. With increasing scrutiny from CDSCO, it’s essential to align all products and processes with the NDCT Rules, 2019 to avoid regulatory action, product recalls, or reputational damage.

📞 Need assistance with compliance or product review?
We’re just a call away

Stay Compliant. Stay Ahead.
– Team Vaayath Consulting Services