Health Ministry Proposes Easier Drug Import Test Process with Prior Intimation Instead of Form 11 Licence Written By Susmita Roy29 Jun 2026 10:29 PM ISTNew Delhi: The Ministry of Health and Family Welfare (MoHFW) has issued a draft notification proposing amendments to the Drugs Rules, 1945 to simplify...
CDSCO Makes SUGAM Portal Mandatory for Imported Vaccine, Anti-sera Approval Changes from July 1 Written By Susmita Roy27 Jun 2026 8:42 PM ISTNew Delhi: In a move aimed at streamlining the regulatory submission process for imported biological products, the Central Drugs Standard Control...
CDSCO Announces Interim Import Approval Process for BA/BE Export Studies Written By Susmita Roy31 May 2026 4:00 PM ISTNew Delhi: The Central Drugs Standard Control Organisation (CDSCO) has issued a notice outlining the interim procedure for obtaining Form CT-16...
Pharma Companies to Count PSUR Timeline from Market Launch, Not Approval Date: CDSCO Written By Susmita Roy11 May 2026 11:15 PM ISTNew Delhi: The Central Drugs Standard Control Organization (CDSCO), under the Directorate General of Health Services (DGHS), has issued a new advisory...
Reply Within 30 Days or SUGAM Applications Will Be Rejected, CDSCO Warns Applicants Written By Susmita Roy8 May 2026 5:30 PM ISTNew Delhi: In a major regulatory move aimed at reducing backlog and improving efficiency, the Central Drugs Standard Control Organisation (CDSCO),...
CDSCO Mandates Online Submission of PAC Applications for r-DNA Products via SUGAM Portal Written By Susmita Roy11 March 2026 1:15 PM ISTNew Delhi: The Central Drugs Standard Control Organization (CDSCO) has announced that all applications related to Post Approval Changes (PAC) for...
CDSCO to Reject Long-Pending SUGAM Applications After 30 Days for Non-Response to Queries Written By Susmita Roy18 Jan 2026 5:58 PM ISTNew Delhi: The Central Drugs Standard Control Organisation (CDSCO) has announced that it will dispose of and reject long-pending applications...
No More Offline Filings: CDSCO Mandates Submission of Post-Approval Changes for Cell and Gene Therapy Trial via SUGAM Portal Written By Susmita Roy30 Oct 2025 1:18 PM ISTNew Delhi: In a major regulatory development aimed at strengthening transparency and efficiency in India's clinical trial oversight, the Central Drugs...
CDSCO Launches One-Year Online Dual Use NOC System for Bulk Drug Imports Parthika Patel13 Aug 2025 6:07 PM ISTNew Delhi: The Central Drugs Standard Control Organisation (CDSCO) has introduced a new online Dual Use No Objection Certificate (NOC) system on its...
CDSCO Introduces Tooltips on SUGAM and Medical Device Portals to Enhance Application Accuracy Written By Dr. Divya Colin19 May 2025 6:00 PM ISTNew Delhi: In order to improve the user experience and facilitate submission of data in the applications, through a recent notice, the Central Drug...
CDSCO Introduces Online Export NOC System on SUGAM Portal Dr. Divya Colin10 March 2025 6:00 PM IST New Delhi: Enhancing the ease of doing business, the Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health...
CDSCO Introduces Online CRO Registration Mandate from April 1, 2025, sets fee at Rs 5 lakh Written By Dr. Divya Colin8 March 2025 6:00 PM ISTNew Delhi: With the mandated registration of clinical research organizations (CROs) effective from April 1, 2025, the Central Drug Regulator has...
