Request a Demo

By clicking Submit, you acknowledge that you have read and agree with the Privacy Policy
Contact Info
Unit 266, 267 & 268, Tower B1, Spaze Itech Park Sohna Road Gurugram, Haryana 122018 connect@complinity.com +91 8181 900 600
Follow Us

A Multi-Concept Theme for Digital Agencies and Startups

8181 900 600 Request a Demo Login
logo dark logo light logo
  • Products
    • Compliance Management Software
    • Contract Management Software
    • Secretarial Compliance Software
    • Litigation Management Software
    • Audit Management Software
    • Internal Financial Control Software
    • Enterprise Risk Management Software
  • Pricing
  • Industries
    • Pharmaceutical
    • Hospitality
    • BFSI
    • Manufacturing
    • NBFC
    • Renewable Energy
    • Agriculture
    • ITeS
    • Real Estate
    • Automobile
  • Legal Updates
  • Blogs
  • Videos
  • Downloads
  • Careers
Contact Sales
logo dark logo light logo
  • Products
    • Compliance Management Software
    • Contract Management Software
    • Secretarial Compliance Software
    • Litigation Management Software
    • Audit Management Software
    • Internal Financial Control Software
    • Enterprise Risk Management Software
  • Pricing
  • Industries
    • Pharmaceutical
    • Hospitality
    • BFSI
    • Manufacturing
    • NBFC
    • Renewable Energy
    • Agriculture
    • ITeS
    • Real Estate
    • Automobile
  • Legal Updates
  • Blogs
  • Videos
  • Downloads
  • Careers
Contact Sales
Mobile Logo
  • Products
    • Compliance Management Software
    • Contract Management Software
    • Secretarial Compliance Software
    • Litigation Management Software
    • Audit Management Software
    • Internal Financial Control Software
    • Enterprise Risk Management Software
  • Pricing
  • Industries
    • Pharmaceutical
    • Hospitality
    • BFSI
    • Manufacturing
    • NBFC
    • Renewable Energy
    • Agriculture
    • ITeS
    • Real Estate
    • Automobile
  • Legal Updates
  • Blogs
  • Videos
  • Downloads
  • Careers
Industry specific-Medical Central Ministry of Consumer Affairs, Food and Public Distribution Drugs and Cosmetics Act, 1940

Implementation of Gastro-resistant and Delayed-release Dosage Forms as "New Drugs"

24-Feb-2025 | File No. ND-13020/2/2024-eoffice

Central Drugs Standard Control Organization has issued a notification regarding the classification of 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. According to the rule, modified or sustained release forms of any drug, including novel drug delivery systems, are always considered new drugs by the Central Licensing Authority.

By virtue of the notice, it was discussed at the 64th meeting of the Drugs Consultative Committee (DCC) on 19-06-2024 that there was a need for uniform implementation of this rule for Gastro-resistant and Delayed-release Dosage forms (Enteric Coated Tablets/Capsules) across the country. The committee recommended issuing a circular to all States/UTs for consistent enforcement of the rule. Therefore, all State/UT Drugs Controllers are now instructed to ensure that modified or sustained release forms, including Gastro-resistant and Delayed-release Tablets/Capsules, are treated as new drugs as per the provisions of the New Drugs and Clinical Trials Rules, 2019 under the Drugs and Cosmetics Act, 1940

Please refer the attached documents for more information.

Upgrade to paid version to access the Notification, Circular & Rules along with the checklist

Get Legal Updates in your email

Request a Demo

Recent Posts in Corporate Laws

Corporate Laws

NSDL has reiterated the SEBI circular on Relaxation from SEBI Regulations on non-compliance with the MPS requirements

09-Apr-2026 | Circular No.: NSDL/CIR/II/20/2026

NSDL has reiterated the SEBI circular on the Reiteration of SEBI circular on Relaxation from SEBI Regulations on non-compliance with the MP

Read More
Corporate Laws

BSE reiterates the SEBI circular on Relaxation from SEBI Regulations on non-compliance with the MPS requirements

09-Apr-2026 | 20260409-3

BSE has reiterated the SEBI circular on the Reiteration of SEBI circular on Relaxation from SEBI Regulations on non-compliance with the MPS

Read More
Corporate Laws

NSE- Reiteration of SEBI Circular on Relaxation from the applicability of SEBI Master Circular for compliance of regulations on non-compliance with the Minimum Public Shareholding (MPS) requirements

07-Apr-2026 | NSE/CML/2026/06

NSE has reiterated the SEBI circular on the Relaxation from the applicability of the SEBI Master Circular for compliance with regulations on

Read More
Corporate Laws

RBI issues amendment in Reserve Bank of India (Non-resident Investment in Debt Instruments) Directions, 2025

10-Apr-2026 | RBI/2026-27/10 A.P. (DIR Series) Circular No. 06

RBI has issued an amendment in Reserve Bank of India (Non-resident Investment in Debt Instruments) Directions, 2025. Through this, the R

Read More

Recent Posts

Corporate Laws

NSDL has reiterated the SEBI circular on Relaxation from SEBI Regulations on non-compliance with the MPS requirements

09-Apr-2026 | Circular No.: NSDL/CIR/II/20/2026

NSDL has reiterated the SEBI circular on the Reiteration of SEBI circular on Relaxation from SEBI Regulations on non-compliance with the MP

Read More
Corporate Laws

BSE reiterates the SEBI circular on Relaxation from SEBI Regulations on non-compliance with the MPS requirements

09-Apr-2026 | 20260409-3

BSE has reiterated the SEBI circular on the Reiteration of SEBI circular on Relaxation from SEBI Regulations on non-compliance with the MPS

Read More
Corporate Laws

NSE- Reiteration of SEBI Circular on Relaxation from the applicability of SEBI Master Circular for compliance of regulations on non-compliance with the Minimum Public Shareholding (MPS) requirements

07-Apr-2026 | NSE/CML/2026/06

NSE has reiterated the SEBI circular on the Relaxation from the applicability of the SEBI Master Circular for compliance with regulations on

Read More
Corporate Laws

RBI issues amendment in Reserve Bank of India (Non-resident Investment in Debt Instruments) Directions, 2025

10-Apr-2026 | RBI/2026-27/10 A.P. (DIR Series) Circular No. 06

RBI has issued an amendment in Reserve Bank of India (Non-resident Investment in Debt Instruments) Directions, 2025. Through this, the R

Read More
Request a Demo

Request a Demo

By clicking Submit, you acknowledge that you have read and agree with the Privacy Policy

Complinity Logo Transparent

Complinity is a comprehensive cloud-based Compliance Management Software that helps track and monitor statutory and regulatory compliances.

Quick Links
  • Compliance Software
  • Regulatory Compliance Software
  • Statutory Compliance Software
  • Compliance Tracking Software
  • Legal Updates
Contact Info
Unit 266, 267 & 268, Tower B1
Spaze Itech Park, Sohna Road
Gurugram, Haryana 122018
connect@complinity.com
+91 8181 900 600

Request a Demo

© 2026 Complinity Technologies Private Limited. | Privacy Policy | Data Processing Addendum

Design & Developed By  Infinite IT Solutions

Request a Demo

By clicking Submit, you acknowledge that you have read and agree with the Privacy Policy
Powered by EssentialPlugin

Request a Demo

By clicking Submit, you acknowledge that you have read and agree with the Privacy Policy

Thank You for your interest in Complinity. Your CV has been forwarded to HR.
In case your profile is shortlisted, HR shall contact you.