Rising Alarms Over Substandard Drugs NITI Aayog has initiated a review following alarming data from the Central Drugs Standard Control Organisation (CDSCO), which revealed that multiple micro, small, and medium enterprise (MSME) pharmaceutical firms in India are producing substandard medications, prompting calls for strengthened oversight and
· Beyfortus® (nirsevimab) is the first monoclonal antibody approved to protect all infants born during or entering their 1st Respiratory Syncytial Virus (RSV) season · Dr. Reddy’s receives exclusive rights from Sanofi to promote and distribute Beyfortus® in India · This announcement follows Dr. Reddy’s successful exclusive distribution partnership with Sanofi for their
Eyestem Research Pvt Ltd announced the completion of its phase one study for its investigational retinal pigment epithelium (RPE) cell therapy, Eyecyte-RPE. The clinical study report of the study has been submitted to the Central Drugs Standard Control Organisation (CDSCO) for permission to start the phase 2 study.The
In a significant regulatory overhaul aimed at streamlining administrative workflows and enhancing transparency, the Central Drugs Standard Control Organization (CDSCO) has announced the implementation of an automated re-application process for the issuance of Compliance Certificates (CoCs) for medical device manufacturers. This initiative is set to
Adults taking Mounjaro® with diet and exercise in a controlled clinical trial lost on average 21.8 kg. at the highest dose (15mg) and 15.4 kg at the lowest dose (5mg)over a period of 72 weeks.1,2 Individual results may varyMounjaro® delivered superior A1C reductions
The Medical Technology Association of India (MTaI), representing leading research-based medical technology companies, emphasizes the need for a balanced assessment of the Central Drugs Standard Control Organization's (CDSCO) role in regulating medical devices and drugs. MTaI acknowledges recent reforms aimed at enhancing operational efficiency and
In the pursuit of accessible and cost-effective healthcare, refurbished medical devices have emerged as a pivotal component in India's medical infrastructure. By providing high-quality equipment at reduced costs, these devices are instrumental in bridging the healthcare gap, particularly in underserved regions.The Role of Refurbished Medical
The Central Drugs Standard Control Organisation (CDSCO), India's apex regulatory authority for pharmaceuticals and medical devices, has officially prohibited the import of second-hand or refurbished medical devices. This decisive action aims to safeguard patient health and bolster the domestic medical device industry.Regulatory Framework and EnforcementIn
Entod Pharmaceuticals has announced that it has received final approval from the Drug Controller General of India (DCGI) for its groundbreaking PresVu eye drops. This approval, disclosed during a press conference held today in New Delhi, follows a favorable recommendation by the Subject Expert Committee
By Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AiMeD), New Delhi.The potential of the Indian medical devices industry is immense. With the implementation of enabling measures such as streamlining regulations, achieving self-reliance in domestic production and global competitiveness is very much within our
