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05th May, 2026 In a decisive move reinforcing India’s drug regulatory framework, the Delhi High Court has delivered a significant judgment that could reshape how pharmaceutical companies approach approvals—especially for Fixed Dose Combinations (FDCs) and other “new drugs.” The ruling…
[caption id="attachment_17292" align="aligncenter" width="550"] CDSCO on Rejection of Long-pending SUGAM Portal Applications due to Non-Submission of Regulatory Responses[/caption] Dated: 16th January 2026 The Central Drugs Standard Control Organisation (CDSCO), under the Directorate General of Health Services, Ministry of Health…
In a major regulatory move, the Government of India has banned oral Nimesulide formulations above 100 mg in immediate-release form. The decision was officially announced through Gazette Notification S.O. 6091(E) dated 29 December 2025. (Click Here) This ban…
The Central Drugs Standard Control Organisation (CDSCO) has issued a Public Notice regarding the Compounding of Offences under the Drugs and Cosmetics Act, 1940, based on the newly notified Drugs and Cosmetics (Compounding of Offences) Rules, 2025. This notice…
07th November 2025 The Central Drugs Standard Control Organisation (CDSCO) has issued a directive to all State Licensing Authorities (SLAs) to conduct inspections of pharmaceutical manufacturing firms in accordance with the Revised Schedule M requirements. As per the notice…