News
DTAB Backs New Regulations to Curb Antibiotic Misuse in India
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
Extended Deadline for E-Waste Management Return Filing
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 Producers, Importers & Brand-Owners (PIBOs) and Plastic Waste Processors (PWPs) on Centralized Extended Producer Responsibily (EPR) Portal for Plastic Packaging
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,
India Extends Medical Textiles Quality Control Deadline
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
Issuance of RCMC for Medical Devices: New Directive from DGFT
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
Self Declaration Under UCPMP, India
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
CDSCO Compliance: New Order on Self Reporting of Adverse Events
New Delhi, 15 May 2024 – The Central Drugs Standard Control Organisation (CDSCO), under the Ministry of Health & Family Welfare, has issued a new circular (File No. MED-12/30/2024-eoffice) mandating strict compliance with post-market surveillance (PMS) requirements for all medical device license holders. This directive aims to enhance patient safety
CDSCO Issues Guidelines on Medical Device License Retention
New Delhi, May 15, 2024 — The Central Drugs Standard Control Organization (CDSCO) has released a circular (F. No. MED-15/35/2024-eOffice) on the retention of medical device licenses and certificates under the Medical Devices Rules, 2017. Effective immediately, licenses for manufacturing or importing medical devices, as well as registration certificates for
India Medical Device Pricing Strategy: Ensuring Growth & Affordability
India’s National Pharmaceutical Pricing Authority (NPPA) is developing a specialized India medical device pricing strategy for medical devices, transitioning away from the conventional drug-centric framework. This innovative strategy will incorporate international pricing tactics tailored to India’s unique market demands and serves as a response to previous policies on medical commodities
Imports of High-Value Medical Equipment
High-Value Medical Equipment The Central Drugs Standard Control Organization (CDSCO) and the Central Board of Indirect Taxes & Customs have released a new circular, “F.No.401/40/2021-Cus.III,” detailing updated policies on the import of used high-end medical equipment.The key highlights are that the guidelines streamline the import process for high-end medical equipment