The Central Drugs Standard Control Organization (CDSCO) has established a new unit — the “Coordination Division” — as India broadens the mandate of its drug regulatory authority beyond just quality testing. With multiple tasks ranging from approval and regulation of drugs, vaccines, cosmetics, and medical devices, CDSCO is running risk-based

To strengthen medical device regulatory compliance in India, the Central Licensing Authority has upgraded the existing online application system. This introduces a new workflow for the auto-generation of Market Standing Certificate (MSC) and Non-Conviction Certificate (NCC) for licensed medical devices (Reference File No.: MEDI52/2024-eoffice). The Market Standing Certificate (MSC) and

In a significant move under the Indian medical device regulation framework, the Ministry of Chemicals and Fertilizers, through its Department of Pharmaceuticals, has revised the ceiling prices of coronary stents. This directive, which impacts all stakeholders involved in medical device import in India and domestic manufacturing, will come into effect

New Delhi, February 24, 2025: The Ministry of Environment, Forest, and Climate Change (MoEFCC) has updated the Battery Waste Management Rules 2025 with the 2025 amendments. The 2025 amendments remove some packaging requirements, require QR code tracking for batteries, mandate quarterly EPR compliance updates by the Central Pollution Control Board

New Delhi, May 16, 2024 – The Directorate General of Health Services (DGHS) and the Central Drugs Standard Control Organization (CDSCO) are taking steps to regulating antibiotic use in India. On April 25, 2023, an expert group at the Indian Council of Medical Research (ICMR) recommended banning Inappropriate antibiotic combinations

The Ministry of Environment, Forest, and Climate Change (MoEF & CC) has extended the deadline for filing quarterly and annual returns under the E-Waste (Management) Rules, 2024. The new deadline is 31st August 2024, instead of 30th June 2024. Registered producers and recyclers must submit their returns for the 2023-24

Extension for registration of PIBOs and PWPs – May 2024 , the CPCB updated the Plastic Waste Management (PWM) rules, reference number is CPCB [CP-20/28/2023-UPC-II-HO-CPCB-HO-Part (1)] to introducing mandatory fees, streamlined processes, and new deadlines. You can find a detailed step-by-step guide at the link below.   On 18th June, 2024,

Medical textile products, including sanitary napkins, baby diapers, reusable sanitary pads, sanitary napkins, period panties, dental bibs, napkins, bedsheets, pillow covers, and shoe covers, are subject to quality regulation in India in accordance with the Medical Textiles (Quality Control) Order, 2023. The Order requires all manufacturers and importers of these

New Delhi, June 12, 2024 – The Directorate General of Foreign Trade (DGFT) under the Ministry of Commerce and Industry has issued Trade Notice No. 05/2024-25, mandating a significant update regarding the Registration-Cum-Membership Certificate (RCMC) for medical devices. This directive is important for medical device manufacturers and importers, ensuring streamlined

In a recent development, the Department of Pharmaceuticals under the Ministry of Chemicals and Fertilizers, Government of India, has issued two critical circulars concerning the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) 2024. These circulars detail the mandatory self-declaration requirements for pharmaceutical and medical device associations for the fiscal year