The Central Drugs Standard Control Organization (CDSCO) has issued a new directive that classifies Gastro-Resistant Tablets/Capsules and Delayed-Release Tablets/Capsules as ‘New Drugs’ under Rule 2(1)(w) of the New Drugs and Clinical Trials Rules, 2019. This decision was made to ensure uniform regulation and patient safety across India.
What Does This Mean?
Previously, there was inconsistent implementation of this rule across different states, allowing some pharmaceutical companies to bypass regulatory approvals. However, during the 64th Drugs Consultative Committee (DCC) meeting on June 19, 2024, the committee decided that all enteric-coated, gastro-resistant, and delayed-release formulations must follow the same approval process as new drugs.
Key Changes Under the New Classification:
✔️ Stricter Approval Process: Pharmaceutical companies must now conduct clinical trials, provide bioequivalence studies, and get fresh approval from the Central Licensing Authority (CLA) before selling these formulations.
✔️ Increased Safety & Efficacy Checks: This ensures that modified-release drugs meet quality, safety, and efficacy standards before reaching the market.
✔️ Uniform Implementation: All State and UT drug controllers must now enforce this rule uniformly, preventing companies from skipping regulatory steps.
Why is This Important?
Gastro-resistant and delayed-release drugs are commonly used for treating conditions like acid reflux, ulcers, and gastrointestinal disorders. These formulations allow medicines to be released slowly or in a specific part of the gut, improving their effectiveness. However, without proper regulatory checks, there is a risk of substandard or unsafe formulations reaching patients. This new directive ensures better drug quality and patient safety.
How Will This Affect Doctors and Patients?
🔹 Doctors prescribing delayed-release or gastro-resistant drugs must ensure they are CDSCO-approved under the new regulations.
🔹 Patients can expect better quality medicines with proper safety and efficacy tests.
🔹 Pharma companies will need to follow stricter rules before launching new modified-release formulations.
What’s Next?
CDSCO has also instructed its zonal and sub-zonal offices to monitor compliance and ensure pharmaceutical companies follow the updated rules. This move will improve drug safety standards and prevent unapproved modified formulations from entering the market.
✅ Doctors: Stay updated on the latest drug regulations to ensure you prescribe CDSCO-approved medicines.
✅ Patients: Always check with your doctor or pharmacist about the approval status of any delayed-release or gastro-resistant medication.
✅ Healthcare Professionals: Spread awareness about the new CDSCO guidelines to ensure safer medication practices in India.
Stay informed. Stay safe. Prioritize patient health with regulated, high-quality medicines!
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