In vitro diagnostics is a technique used to identify many diseases and health conditions in a controlled artificial environment. The wide ranging of application in various diagnostics (biological and medical) industries provides a competitive edge to the IVD device and reagents manufacturers. In-Vitro Diagnostic(IVD) kits/reagents which are notified in India are regulated under Central Drugs Standard Control Organization (CDSCO). and the regulatory process deals with obtaining three key licenses – Form 11, Performance Evaluation Report(PER) and Form 41.
The Indian IVD industry is of important amount at present. Comparing IVD globally, matured markets are reaching a stage of saturation and most of these countries look at India as a future market because of industrial development. At present it is estimated to be around 700 million. Its growth in the next 5 years is supposed to be substantial and we will cross a billion dollar mark very soon.
India is going to be the future market. The main growth drivers are the changes in the market situations. There is a lot of consolidation of laboratories, pathology lab chains merging together, hospital setups coming into India and lot of foreign direct investment also putting in money into the Indian IVD industry. Emerging markets like India are the focus for many of the multinational companies, the biggest advantage that countries like India have is volumes and as the markets mature these volumes are going to be important bottom lines for the multinationals.
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 MoreErlySign 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 MoreTUV 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