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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…
📌 Introduction In today’s rapidly evolving pharmaceutical landscape, staying updated with drug approvals, regulatory changes, and compliance requirements is no longer optional—it’s critical. Yet, professionals across the industry—regulatory experts, manufacturers, consultants, and marketers—face a common challenge: 👉 Fragmented information spread…
[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…