Biological

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

Preparing for CDSCO Inspection: Documentation, Site Readiness, and Common Reasons for Delay

A CDSCO inspection is one of the most consequential events in a Medical Device company's regulatory journey in India. Whether you are a manufacturer or Importer, demonstrating compliance with the...

14th July, 2026

Regulation/Guidelines

Stem Cell Regulation in India: Separating Legitimate Therapy Development from Regulatory Risk

Introduction Stem cell therapy represents one of the most scientifically promising and regulatorily complex frontiers in modern medicine. India's stem cell regulatory landscape presents both genuine opportunity and significant compliance...

10th July, 2026

Regulation/Guidelines

Cosmetic Labelling in India: CDSCO, , and Legal Metrology — Three Bodies, One Label

Three Regulatory Bodies, One Physical Label A Cosmetic label entering India is reviewed — directly or through market surveillance — against the requirements of three separate regulatory frameworks: CDSCO's Cosmetics...

8th July, 2026

Regulation/Guidelines

New Medical Device in India: When MD-22, MD-23, MD-26, and MD-27 Apply

India's Medical Devices Rules, 2017 (MDR 2017) has a distinct regulatory pathway for Devices classified as New Medical Devices — a category that carries additional scrutiny, documentation requirements, and in...

7th July, 2026

Biological

Biological

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

COVID-19 vaccines approved in the country as on 22.04.2026

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