The Central Drugs Standard Control Organization (CDSCO) is currently undergoing several transformations to upgrade the regulatory systems for medical devices, drugs, in vitro diagnostics and cosmetic approval processes. The registration process is done with New Delhi as the Head Quarters. By linking the different offices with e-governance the CDSCO would improve the efficiency of the systems. This project has received a sanction of US$ 150 billion for the networking and other processes involved in it, informed Dr. G N Singh, Drug Controller General of India (DCGI).
The first phase in this set-up would be to understand the current e-governance followed by various states. Based on this audit, a central system would be developed and used to integrate all states into an umbrella system. Meetings with heads of SLAs from Gujarat, Maharashtra, Goa, Karnataka, Tamil Nadu, Orissa etc have been initated for this process. ”We are very keen to go ahead with this project at the earliest as it will not only strengthen our system but will also empower the citizens with power to get precise and prompt information from us,” pointed out Dr Singh.
To learn more about the process of regulatory approvals for the CDSCO you could visit our article Step by Step Process of Registration. Additionally, the CDSCO has expanded the list of notification devices to spinal needles, cochlear implants, annuloplasty rings, trachestomy tubes, syringes and needle, dental implants, surgical sealants, heart valves, cardiac stents, orthopedic implants, endotracheal tubes, and catheters, among others. The new e-governance systems will play a role in improving the turnaround time for these products.
Other News
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 […]
Read MoreImports 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 […]
Read MoreSEC Committee: Pioneering Medical Approvals
New important article released by Central Drugs Standard Control Organization (CDSCO) titled “SEC – Special Expert Committee, Medical Devices”. Key highlights include the streamlined processes for CDSCO application evaluations, preparation and significance of briefing materials, […]
Read More
ErlySign Oral Cancer Detection Technology Gets CDSCO Nod
ErlySign, a Nagpur-based biotech startup, has received approval from the Central Drugs Standard Control Organization (CDSCO) to conduct large-scale clinical trials for its novel oral cancer detection technology. The approval for ErlySign follows a rigorous […]
Read MoreAdditional Steps Announced by FDA to Modernize Clinical Trials
The U.S. Food and Drug Administration has made draft guidance available with updated recommendations for good clinical practices (GCPs), which are intended to modernize the clinical trial design and conduct while maintaining data integrity and […]
Read MoreAccreditation and Registration Numbers for Foreign Manufacturers Publication by PMDA
This article deals In accordance with the Pharmaceuticals and Medical Devices Act (PMD Act) of Japan, foreign businesses that wish to produce pharmaceuticals, quackery products, active pharmaceutical ingredients (APIs), or medical devices abroad and import […]
Read MoreBSI New Certification to Mitigate Antimicrobial Resistance Risk in Antibiotic Manufacturing
BSI, the business improvement and standards company, has developed a new certification to mitigate the risk of antimicrobial resistance (AMR) in antibiotic manufacturing. The certification, called the Minimized Risk of Antimicrobial Resistance (AMR) certification, will […]
Read More
TUV SUD Inspects IVD Medical Devices’ Cyber Security
The growing digital connectivity of medical infrastructure is resulting in complicated systems with a plethora of diverse interfaces that are potentially vulnerable to assault. The IVD requires producers to provide proof of cyber security before […]
Read More
