The government finally comes into act as the complaints over the pricing of medical devices such as cardiac stents, implants. There has been a recommendation on the creation of the National Medical Devices Authority (NDMA), an autonomous body for price control by bringing it under the Essential Commodities Act said an official. Presently, the drug prices are notified through the Drug Prices Control Order. The government may also announce a separate policy for the price control of identified medical devices.
The NMDA may have an head ranked with additional/joint secretory and will include a secretory, two medical practitioners, two medical device technologists or scientists and the secretary general of Quality Council of India (ex-officio). In India, 70 to 80% of medical devices are imported while the domestic industry manufactures medical supplies and disposables. The complaints for over pricing has relatively increased over the last few months, as the medical devices is sold at a price of three to four times higher than the landing cost.
Regulated Medical devices include spinal needles, cochlear implants, annuloplasty rings, trachestomy tubes, syringes and needle, dental implants (dental market overview), surgical sealants, heart valves, cardiac stents, orthopedic implants, spinal implants, endotracheal tubes, and catheters, among others. Diagnostic equipment, several IVDs, medical equipment require special considerations.
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