CDSCO Launches National Single Window System Portal

This portal has been designed to build a system that functions as a one-stop shop for all the approvals required by the investor and facilitates ease of doing business. The NSWS Portal for CDSCO will be independent of the SUGAM Portal or the cdscomdonline portal.

Clarification on Approval Process for TAVI/TAVR and IVL Procedures under CGHS

The OM reiterates that the approval from the Director, CGHS, in consultation with the Special Technical Committee (STC) is needed for Transcatheter Aortic Valve Implantation/Replacement (TAVI/TAVR) and Coronary Intra Vascular Lithotripsy (IVL) or Shock Wave Lithotripsy procedures under CGHS. This clarification aims to streamline the process of obtaining approval for TAVI/TAVR and IVL procedures, ensuring that the highest standards of patient care are maintained under the CGHS.

MedTech Mitra Launched To Empower Innovators in Healthcare

Acknowledging the import dependency of India’s MedTech sector, which stands at 80%, the Minister underscored the progress made through production-linked incentive schemes, investments in medical drug parks, and the implementation of the MedTech research policy and incentive scheme. The collaborative initiative of ‘MedTech Mitra’ is expected to drive indigenous development, making quality MedTech devices more affordable and reducing import dependence.

‘MedTech Mitra’: A Strategic Initiative to Empower MedTech Innovators and Advance Healthcare Solutions

To ensure that medical devices are supplied within the country, this sector has seen phenomenal progress with the implementation of production linked incentive schemes and investments for medical drug parks, MedTech research policy and MedTech research incentive scheme. This collaborative initiative will facilitate indigenous development of affordable, quality MedTech devices and diagnostics leading to considerable reduction in the import dependence of this sector.

Department of Atomic Energy (DAE) Advances Artificial Intelligence and Machine Learning Research

The integration of AI and ML research with high-performance computing has enabled the processing of vast data volumes, leading to the development of applications across various domains. Notably, advancements in Security and Cyber Security have been realized, with the initiation of AI-based video analytics and Cyber Security tools. Indigenous products, such as the Secured Network Access System (SNAS), have emerged as crucial components, forming the backbone of Cybersecurity.

India Witnesses Reduction in Drug-Resistant TB Cases

India has scaled up the availability of molecular diagnostic facilities. This effort has resulted in an increased proportion of TB patients being screened for the presence of drug resistance. Under the National TB Elimination Programme (NTEP), there has also been a consistent and regular supply of Anti-TB drugs to all states and union territories (UTs) throughout the year.

CDSCO Revises Drug Alert for May 2022

CDSCO has purported Omeprazole (Delayed-Release) and Domperidone (Sustained Release) Capsules as spurious. This drug is purported to be manufactured by Dr. Reddys Laboratories Ltd., Village Mauja Thana, Baddi173205, Dist. Solan, Himachal Pradesh. However, the actual manufacturer (as per label claim) has stated that the impugned batch of the product has not been manufactured by them and that it is a spurious drug.

Drug Alert List for November 2023

A total of 1197 samples were tested by the CDSCO. Based on the samples tested, CDSCO has found a total of 64 drugs, medical devices and cosmetics that are identified as being deficient.

CDSCO Streamlines Procedure for Evaluation of Applications

All copies of presentations before the SEC must be submitted through the e-vartalap (Sugam Portal). This submission must be made well in advance, upon receipt of the invitation letter from CDSCO. The submission must be made only to the concerned division.