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 Health & Family Welfare Drugs and Cosmetics Act, 1940

New Drugs and Clinical Trials (Amendment) Rules, 2026

20-Jan-2026 | 46(E)

This circular issued by the Central Government, after consultation with the Drugs Technical Advisory Board, notifies the New Drugs and Clinical Trials (Amendment) Rules, 2026, which amend the New Drugs and Clinical Trials Rules, 2019. These amendments introduce and operationalise the concept of permission or prior intimation for the manufacture of new drugs and investigational new drugs for purposes such as clinical trials, bioavailability and bioequivalence studies, and examination, test, and analysis. Manufacturers shall ensure that applications are submitted in the prescribed forms (CT-10, CT-12, CT-13, CT-14, and CT-15, as applicable) either for obtaining prior permission or for giving prior intimation to the Central Licensing Authority, in accordance with the revised provisions. Institutions shall comply with the revised timelines, noting that the processing period has been reduced from ninety working days to forty-five working days under the relevant rules. Manufacturers shall strictly restrict the use of drugs manufactured under permission or prior intimation to approved purposes only, shall not sell or supply such drugs in the market, and shall maintain complete records of manufacture, use, supply, disposal, and destruction in accordance with Good Manufacturing Practices. Further, institutions shall adhere to the revised provisions relating to inspection, labelling, suspension or cancellation of permission or acknowledgement of prior intimation, and appellate remedies as prescribed under the amended rules. Compliance with these amendments shall be mandatory upon their coming into force, i.e., forty-five days from the date of publication in the Official Gazette.

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 reiterate the circular issued by SEBI regarding IT Resilience Index for Market Infrastructure Institutions (MIIs)

27-Aug-2026 | NSDL/POLICY/2026/0127

NSDL reiterated the circular issued by SEBI regarding IT Resilience Index for Market Infrastructure Institutions (MIIs) Through this circul

Read More
Corporate Laws

NSDL issues circular regarding Updates for Implementation of Section 51A of UAPA, 1967 – Security Council 1267(1999) amends entries in ISIL (Da’esh) and Al-Qaida Sanctions List

26-Aug-2026 | NSDL/POLICY/2026/0126

NSDL has issued circular regarding Updates for Implementation of Section 51A of UAPA, 1967 – Security Council 1267(1999) amends entri

Read More
Corporate Laws

BSE reiterate the circular issued by SEBI regarding Alignment of SEBI’s Cyber Incident Reporting Portal with FIRE format

26-Aug-2026 | 20260826-30

BSE reiterated the circular issued by SEBI regarding Alignment of SEBI’s Cyber Incident Reporting Portal with FIRE format Through th

Read More
Corporate Laws

IFSCA requires FMEs to maintain a website or webpage

26-Aug-2026 | IFSCA-SOF/2/2026-Capital Markets

The International Financial Services Centres Authority has directed all Fund Management Entities registered under the Fund Management Regula

Read More

Recent Posts

Labour Laws

Draft Puducherry Occupational Safety, Health and Working Conditions Rules, 2026

24-Aug-2026 | 09/AIL /Lab16/2026

This notification introduces the Puducherry Occupational Safety, Health and Working Conditions Rules, 2026, which prescribe requirements rel

Read More
Property Related Laws

Tamil Nadu Real Estate Regulatory Authority has extended the registration validity and completion timelines of real estate projects affected by the West Asia situation

28-Aug-2026 | Circular No.TNRERA/A2/2552/2026

The Tamil Nadu Real Estate Regulatory Authority (TNRERA) has extended the validity of registration and corresponding completion timelines of

Read More
Industry Specific- Pharma

Government of Himachal Pradesh has notified the Second Amendment to the Himachal Pradesh Narcotic Drugs and Psychotropic Substances Rules, 1989

20-Aug-2026 | No. EXN-F-(10)-8/2021-Vol-II

The Government of Himachal Pradesh has notified the Himachal Pradesh Narcotic Drugs and Psychotropic Substances (Second Amendment) Rules, 20

Read More
Industry Specific- Pharma

Government of Himachal Pradesh has amended the Himachal Pradesh Narcotic Drugs and Psychotropic Substances Order, 2026

20-Aug-2026 | File No. EXN-F-(10)-8/2021-Vol-I I

The Government of Himachal Pradesh has notified the Himachal Pradesh Narcotic Drugs and Psychotropic Substances (Amendment) Order, 2026, ame

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.