Disposal/Rejection of Long Pending Applications on SUGAM Portal Awaiting Query Response

Posted by: Hitesh Gupta May 6, 2026

What's New 2?

Regulation/Guidelines

AI/ML-Based Medical Devices — Emerging Regulatory Questions

Traditional Medical Device regulation assumes a fixed product: what’s approved is what ships, indefinitely, until a formal change is filed and reviewed. Adaptive AI and machine learning algorithms break that...

24th August, 2026

Regulation/Guidelines

Post-Market Surveillance for Cosmetics in India: What CDSCO Expects After Launch

Getting a Cosmetic product registered and onto shelves in India is only half the job. Once a product is in the market, the Cosmetics Rules, 2020 place ongoing duties on...

19th August, 2026

Regulation/Guidelines

Software as a Medical Device (SaMD) – India’s Regulatory Stance

Although software intended for Medical purposes has been regulated in India since the implementation of MDR, 2017 Rules. CDSCO's Guidance Document on Medical Device Software (Doc No. CDSCO/MD/GD/MDSW/01/2026), issued on...

18th August, 2026

Regulation/Guidelines

The Future of Biological Regulation in India: Biosimilars, CAR-T, AI & Advanced Therapies

India's Biological Regulatory landscape is at an inflection point. The country that pioneered affordable Biosimilar access, built one of the world's largest vaccine manufacturing ecosystems, and established the framework for...

14th August, 2026

Biological

Biological

Establishment of a TGSAFE (Telangana Standards Authority for Food and Essential drugs) through merger of the Food Safety and the Drugs Control Department under Health, Medical & Family Welfare (G) Department (HM&FW)

Submission of Post Approval Changes Applications of Registration Certificate and Import Licence of Human Vaccines and Anti-sera through SUGAM Portal

2026.06.18 G.S.R. 496(E)_Notification of Chaudhary Charan Singh National Institute of Animal Health, Baghpat, UP, as a CDL for testing viral and bacterial veterinary vaccines under the D and C Act

Implementation of Pharmacovigilance (PV) System as per the requirement of Schedule M of Drugs & Cosmetics Act 1940 and the Rules made there under

Revised Regulatory Guidelines For Sampling Of Drugs, Cosmetics & Medical Devices By Drugs Inspectors Of Central & State Drug Authorities

Disposal/Rejection of Long Pending Applications on SUGAM Portal Awaiting Query Response

Press Note – 23-04-2026 – Special Enforcement Drive – Weight Loss Drugs

2026.04.21 G.S.R. 299(E)_ Draft Notification for amendment under Rule 89 of Drugs Rules 1945, for obtaining licence under Form 29 for different categories falling under Form 25A, 25F, 28A, 28B, 28D, 28DA, 28E, 28F

For Importers To India

Drug

Biologicals

Food Supplements

Medical Device

IVD

Food

Cosmetic

Other

For Manufacturer in India

Drug

Biologicals

Food Supplements

Food

Medical Device

IVD

Cosmetic

Other