New Delhi, India – The Central Drugs Standard Control Organization (CDSCO), India’s national regulatory body for pharmaceuticals, has issued a critical clarification regarding the regulatory status of gastro-resistant (enteric-coated) and delayed-release tablets/capsules. According to a recent circular, these formulations are now officially classified as “New Drugs” under the New Drugs and Clinical Trials Rules, 2019.
This decision, stemming from the 64th Drugs Consultative Committee (DCC) meeting held on June 19, 2024, has significant implications for pharmaceutical manufacturers and regulatory professionals.
Key Points:
- New Drug Classification: The CDSCO has confirmed that gastro-resistant (enteric-coated) tablets/capsules, delayed-release tablets/capsules, and novel drug delivery systems of already approved drugs fall under the definition of “New Drugs” as per Rule 2(1)(w) of the New Drugs and Clinical Trials Rules, 2019.
- Regulatory Requirement: This classification mandates that these formulations require approval from the Central Licensing Authority before they can be marketed in India.
- Uniform Implementation: The CDSCO aims to ensure consistent implementation of this rule across all States and Union Territories (UTs) in India.
- Impact on Industry: This directive will directly affect pharmaceutical professionals, regulatory teams, and formulation scientists involved in the development and marketing of modified-release drug products.
Why This Matters:
The decision underscores the CDSCO’s focus on ensuring the safety and efficacy of modified-release drug formulations. By classifying these as “New Drugs,” the regulatory body aims to maintain stringent oversight over the development and introduction of advanced drug delivery systems.
Implications for Pharmacy Professionals:
- Pharmacists and regulatory professionals must stay updated on these regulatory changes to ensure compliance.
- Pharmaceutical companies will need to adhere to the “New Drug” approval process for these formulations.
- This clarification will drive greater scrutiny and documentation in the development and manufacturing of enteric-coated and delayed-release drugs.
This update is crucial for all stakeholders in the pharmaceutical industry to ensure adherence to the latest regulatory standards and promote innovation in drug delivery systems within the framework of regulatory compliance.
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