BY THE DIGITAL HEALTH LEADERS FOR THE DIGITAL HEALTH COMMUNITY
BY THE DIGITAL HEALTH LEADERS 
CDSCO to Develop Digital Drugs Regulatory System for Effective, Unified Infrastructure November 7, 2023 The CDSCO plans to build this DDRS using open-source technology and standards similar to successful Digital Public Infrastructure (DPI) models. It aims for DDRS to be India's DPI for healthcare product regulation.
High-Risk Medical Device Manufacturers Granted License Compliance Extension October 23, 2023 The extension applies exclusively to manufacturers and importers who had already submitted their license applications to the central licensing authority before September 30, 2023.
CDSCO Approves India's 1st Living Drug '˜CAR'to Fight Cancer October 17, 2023 Marking a significant milestone in the countrys cancer care landscape, the Central Drugs Standard Control Organisation (CDSCO), has approved the first living drug called CAR (Chimeric Antigen Receptor) T-cell therapy.
Govt Extends Deadline to Class C & D Medical Device Manufacturers Facing Licence Approval Delays October 13, 2023 The Indian government has announced a six-month extension for existing manufacturers and importers of high-risk medical devices who have applied for licences.
After a Long Hiatus, Govt Now Mulling Deadline Extension to Medical Device Manufacturers October 6, 2023 This potential extension is in response to delays in granting new licenses required to sustain production, reported the Economic Times.
Medical Devices Industry in Turmoil as New Law Restrains 200 Producers October 5, 2023 The medical devices industry is facing a crisis as more than 200 manufacturers have been compelled to halt the supply of their products due to the non-approval of their manufacturing licence applications under a recently implemented law before the cutoff date of October 1, 2023.
AstraZeneca India gets CDSCO Marketing Approval for Palivizumab, a Preventive Therapy for RSV October 4, 2023 AstraZeneca Pharma India, a leading biopharmaceutical company has received marketing approval from the Central Drugs Standard Control Organisation (CDSCO) to import and distribute €˜Palivizumab injection 100 mg/ml (r-DNA origin) in India.
High-Risk Medical Device Manufacturers Halt Production Facing Regulatory Hurdles October 4, 2023 The recent regulatory changes dictate that medical devices categorised as class C and D, encompassing items such as ventilators, imaging equipment, oxygen therapy equipment, nebulisers, x-ray equipment, surgical robots, and oncology treatment linear accelerators, are prohibited from being sold without a valid manufacturing licence from October 1 onwards.
AiMeD Urges Govt to Extend Deadline for Medical Device Manufacturing Licence Amid Resource Constraints September 29, 2023 The Association of Indian Medical Device Industry (AiMeD) has once again appealed to the central government for an extension of the deadline for mandating manufacturing licences for Class C and D medical devices beyond October 1.
CDSCO Approves 9 More Medical Device Testing Laboratories Across India September 22, 2023 As per CDSCO, these laboratories conduct assessments and testing of medical devices on behalf of manufacturers, adhering to the guidelines specified in Form MD-40 under the MDR, 2017.
HiMedia Receives CDSCO Approval for Influenza PCR Detection Kit August 25, 2023 In a deal with BlackSoil, a prominent investment firm, GenWorks Health has received $4 million in funding. Through this investment, GenWorks Health can provide quality healthcare in underserved areas.
