25th February,2025

The pharmaceutical industry operates under strict regulations to ensure the safety, efficacy, and quality of drugs available in the market. One of the critical aspects of drug classification in India is the definition of a “New Drug” under the New Drugs and Clinical Trials (NDCT) Rules, 2019. A recent deliberation by the Drugs Consultative Committee (DCC) has reinforced the interpretation of Gastro-Resistant Tablets/Capsules and Delayed-Release Tablets/Capsules as “New Drugs.”

Key Takeaways from the 64th DCC Meeting (19-06-2024)

  1. Definition of “New Drug” as per NDCT Rules, 2019

According to Rule 2(1)(w), a modified or sustained release form of an approved drug, including those developed using a novel drug delivery system, shall always be considered a “New Drug.”

  1. Clarification on Gastro-Resistant & Delayed-Release Dosage Forms

  Gastro-resistant tablets/capsules and delayed-release tablets/capsules (enteric-coated formulations) fall under the category of modified-release formulations. As per the   New Drugs and Clinical Trials (NDCT) Rules, these formulations shall always be deemed as new drugs for a lifetime.

  1. Uniform Implementation Across States/UTs

All State/UT Drugs Controllers are requested to ensure the uniform implementation of Rule 2(1)(w) of the New Drugs and Clinical Trials Rules, 2019. This rule mandates that modified or sustained release forms of a drug, including Gastro-resistant Tablets/Capsules and Delayed-release Tablets/Capsules (Enteric Coated Tablets/Capsules), shall always be deemed “New Drugs” under the Drugs and Cosmetics Act, 1940.

Implications for the Pharmaceutical Industry

  • Regulatory Approval Requirement: Any company introducing Gastro-resistant or Delayed-release formulations must obtain approval from the Central Licensing Authority as per NDCT rules 2019,
  • Clinical Trial Considerations: Depending on regulatory requirements, additional bioequivalence or clinical studies may be mandated to establish safety and efficacy.

Conclusion

The reaffirmation of Gastro-Resistant and Delayed-Release dosage forms as “New Drugs” under NDCT Rules, 2019, highlights the importance of regulatory oversight in ensuring drug safety and efficacy. Pharmaceutical companies must align their regulatory strategies accordingly to ensure compliance with these provisions while planning product development and market authorization.

For More Details, Please click on Official Circular

How Vaayath Can Help? 

At Vaayath, we specialize in navigating India’s complex regulatory framework. Our services ensure compliance with the Drugs and Cosmetics Act, facilitate import/export approvals, and streamline the drug approval process. By partnering with us, marketers can mitigate risks, achieve timely drug launches, and maintain compliance throughout the product lifecycle.

List of Services Offered by Vaayath in the Drug Approval Process:

  • New Drug Approval
  • Investigational New Drug Approval
  • Subsequent New Drug Approval
  • Approval of Fixed Dose Combinations
  • NOC for Conducting Clinical Trials
  • NOC for Conducting BA-BE Studies
  • BE NOC for Export
  • Toxicity Studies
  • NOC for Test License
  • Form 29 for Test Batches

  Stay Informed, Stay Compliant!