Biological

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

Posted by: Hitesh Gupta June 5, 2026

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

Posted by: Hitesh Gupta May 29, 2026

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

Posted by: Hitesh Gupta May 6, 2026

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

Posted by: Prabhas Chakraborty April 29, 2026

7
Comments Off on Press Note – 23-04-2026 – Special Enforcement Drive – Weight Loss Drugs
29th April, 2026

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

Posted by: Hitesh Gupta April 27, 2026

COVID-19 vaccines approved in the country as on 22.04.2026

Posted by: Hitesh Gupta April 27, 2026

7
Comments Off on COVID-19 vaccines approved in the country as on 22.04.2026
27th April, 2026

Guidance document on dossier based licensing of Drugs for uniform product licensing in the country

Posted by: Hitesh Gupta April 1, 2026

2026.03.09 G.S.R. 164(E)_Draft Notification regarding Blood product testing under Drugs Rules,1945

Posted by: Hitesh Gupta March 27, 2026

What's New 2?

Regulation/Guidelines

Loan License vs Own Manufacturing License in India: Which Route Is Right for Your Medical Device Business?

One of the most consequential decisions a Medical Device company faces when entering the Indian manufacturing landscape is whether to establish its own licensed manufacturing facility or to operate under...

23rd June, 2026

Regulation/Guidelines

Top 10 Reasons Biological Product Approvals Get Delayed in India — And How to Avoid Them

Time Is Money — And Preventable Delays Are Common India's Biological product approval timelines are frequently longer than companies anticipate. While CDSCO has made significant progress in recent years —...

19th June, 2026

Regulation/Guidelines

What Investors and PE Firms Actually Look for in Pharmaceutical Regulatory Due Diligence

Private equity investment in India's Pharmaceutical sector has accelerated substantially. The combination of a large domestic market, globally competitive manufacturing, and India's strategic position as a supplier of generic medicines...

18th June, 2026

Regulation/Guidelines

Manufacturing License for Sale or for Distribution of Medical Devices in India: MD-3, MD-5, MD-7, and MD-9 Made Simple

India's Medical Device manufacturing sector is growing rapidly, driven by a combination of government policy, the Make in India initiative, and increasing global demand for cost-effective, high-quality medical products. For...

17th June, 2026

Biological

Biological

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

Guidance document on dossier based licensing of Drugs for uniform product licensing in the country

2026.03.09 G.S.R. 164(E)_Draft Notification regarding Blood product testing under Drugs Rules,1945

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