Search
Sharan Murugan
Sep 25, 20242 min read
India CDSCO Guidance: Pharmacovigilance Document for Marketing Authorization Holders of Pharmaceutical Products
India's CDSCO Pharmacovigilance released an updated guidance " Pharmacovigilance Guidance Document for Marketing Authorization Holders of...
29 views0 comments
Sharan Murugan
Aug 27, 20242 min read
India's: Newly Launched Indian Pharmacopoeia (IP) Online Portal and Adverse Drug Monitoring System (ADRMS) Online Portal
India has recently made significant advancements in its healthcare regulatory landscape by launching two new online portals " Adverse...
56 views0 comments
Sharan Murugan
Aug 20, 20242 min read
India CDSCO Guidance: Draft Pharmaceutical Good Distribution Practices (GDP)
The Central Drugs Standard Control Organisation (CDSCO) in India has issued a draft guideline on Good Distribution Practices (GDP) for...
41 views0 comments
Sharan Murugan
Jun 5, 20242 min read
India CDSCO: Guidance for Industry on Pharmacovigilance Requirements for Human Vaccines
The Central Drugs Standard Control Organisation (CDSCO) has issued comprehensive guidance on (29 May, 2024) "Guidance for Industry on...
13 views0 comments
Sharan Murugan
Mar 5, 20242 min read
India CDSCO: Draft Guidance on Post Approval Changes (PAC’s) for Biologicals for consulataion
India's Central Drugs Standard Control Organization (CDSCO) has published draft guidance "Post Approval Changes in Biological Products:...
74 views0 comments
Sharan Murugan
Jan 2, 20241 min read
India CDSCO: Launching of National Single Window System (NSWS) Portal
To address the challenges in the management of medical devices, India's Central Drugs Standard Control Organization (CDSCO) has...
42 views0 comments
Sharan Murugan
Jul 27, 20221 min read
India CDSCO Guidance: 3 IVD Draft Guidances for Consultation
Recently the Indian Central Drugs Standard Control Organization (CDSCO) released three draft guidance documents, where the In vitro...
47 views0 comments
Sharan Murugan
Jun 24, 20221 min read
India MoH's - Draft Proposal for adding QR Codes for important SCHEDULE H2 Drugs
India's Ministry of Health and Human Welfare has released a draft proposal on 14th June, 2022 which suggests to add barcodes or quick...
53 views0 comments
Sharan Murugan
Jan 23, 20221 min read
India's National Pharmaceutical Pricing Authority (NPPA) -Study on global drug pricing policies
National Pharmaceutical Pricing Authority (NPPA) was established through a Government of India Resolution dated 29th August, 1997 as an...
23 views0 comments
Sharan Murugan
Dec 18, 20211 min read
Unannounced Inspections in India And China to be Resumed Soon: USFDA
Senior US Senator Chuck Grassley has urged to "reinstate unannounced" inspections of prescription drug manufacturing facilities in...
12 views0 comments
Sharan Murugan
Sep 29, 20211 min read
India CDSCO -Guide for Manufacturers/Importers for Registration of Non-Notified Medical Devices
India’s Central Drugs Standard Control Organization (CDSCO) has published the steps that need to be followed by the manufacturers and...
25 views0 comments