CDSCO

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

7
Comments Off on 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
27th April, 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

Circular on Implementation of Prior intimation System for Form CT-05 application (for export purpose only) w.e.f 21.04.2026 in pursuance of G.S.R 50(E) dated 21.01.2026

Posted by: Hitesh Gupta April 22, 2026

2026.04.10_ G.S.R. 270(E)_Draft Notification to amend certain provisions under Medical Devices Rules, 2017 EU

Posted by: Hitesh Gupta April 21, 2026

2026.04.10_G.S.R. 269(E)_Draft Notification to amend certain provisions w.r.t. Medical Device Testing Fee under MDR, 2017

Posted by: Prabhas Chakraborty April 21, 2026

Import, manufacturing, sale etc. of medical devices intended for InVitro Fertilization viz., IUI (Intrauterine Insemination) kits, centrifuge for sperm washing etc. used for Assisted Reproductive Technology related procedures

Posted by: Hitesh Gupta April 2, 2026

Advisory to all manufacturers, importers and marketing authorization holders

Posted by: Prabhas Chakraborty April 1, 2026

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1st April, 2026

Online Applications for Post Approval Changes (PAC) w.r.t Marketing Authorization (MA) for r-DNA products

Posted by: Prabhas Chakraborty April 1, 2026

What's New 2?

Regulation/Guidelines

Documents Required for Cosmetic Import License in India (Checklist 2026)

The Central Drugs Standard Control Organization (CDSCO) is responsible for issuing Cosmetic Import licenses in India. Importers must apply through the SUGAM portal using Form COS-1 for fresh products. After...

13th April, 2026

Regulation/Guidelines

Regulatory Due Diligence for Medical Devices in India: What Manufacturers Must Know Before Market Entry

Regulatory Due Diligence for Medical Devices in India is essential for manufacturers planning to enter the country’s rapidly growing healthcare market. Proper regulatory assessment ensures compliance with CDSCO guidelines, licensing...

31st March, 2026

Regulation/Guidelines

How to Apply for BIS Certification in India: Process, Documents & Timeline

Businesses planning to apply BIS certification India must understand the regulatory framework governed by the Bureau of Indian Standards. The BIS certification process ensures product quality, safety, and compliance with...

23rd March, 2026

Regulation/Guidelines

Regulatory Pathway for Biologicals in India: Approval Process & Key Requirements

The Regulatory Pathway for Biologicals in India is governed by strict guidelines to ensure the safety, efficacy, and quality of biological products. Manufacturers must follow regulatory frameworks established by CDSCO...

23rd March, 2026

CDSCO

CDSCO

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

Circular on Implementation of Prior intimation System for Form CT-05 application (for export purpose only) w.e.f 21.04.2026 in pursuance of G.S.R 50(E) dated 21.01.2026

2026.04.10_ G.S.R. 270(E)_Draft Notification to amend certain provisions under Medical Devices Rules, 2017 EU

2026.04.10_G.S.R. 269(E)_Draft Notification to amend certain provisions w.r.t. Medical Device Testing Fee under MDR, 2017

Import, manufacturing, sale etc. of medical devices intended for InVitro Fertilization viz., IUI (Intrauterine Insemination) kits, centrifuge for sperm washing etc. used for Assisted Reproductive Technology related procedures

Advisory to all manufacturers, importers and marketing authorization holders

Online Applications for Post Approval Changes (PAC) w.r.t Marketing Authorization (MA) for r-DNA products

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