Medical Devices

Parliamentary panel highlights gaps in medical radiation device testing

A parliamentary committee on Monday raised serious concerns about the country's capability to test and regulate radiation-emitting medical devices, urging immediate reforms in the national testing infrastructure. The Standing Committee on Consumer Affairs, Food and Public Distribution revealed significant gaps in the testing framework for critical medical equipment like X-ray and MRI machines in its fifth report submitted to Parliament. The National Testing House (NTH) currently lacks the expertise and capacity to comprehensively test and certify radiation-emitting medical devices, despite existing regulatory oversight from the Atomic Energy Regulatory Board (AERB) and the Central Drugs Standard Control Organization (CDSCO). The committee recommended establishing a collaborative framework between NTH, AERB, and CDSCO to address the identified regulatory shortcomings. Key recommendations include developing specialised testing capabilities at NTH, investing in advanced testing ...

CDMO player OneSource expands GLP-1 drug-device capacity as demand soars

OneSource Specialty Pharma recently raised Rs 801 crore through equity issuance

Dr Morepen launches weight management product, forays into wellness biz

Company eyes Rs 30 crore revenue in first year, Rs 200 crore by 2030

CII body calls for expansion of PLI for medical devices to more products

CII's medtech group to ask govt for strict policy on import of refurbished devices, incentives in R&D, and enhanced rebate on export duties

BIS to prioritise development of standards for 214 critical medical devices

The Bureau of Indian Standards (BIS) on Monday said it is prioritising development of standards for 214 critical medical devices, which are set for phased completion by December 2025. These devices, which include septal closure devices, plasma sterilizers, and phototherapy machines, are in line with the National Medical Device Policy, 2023 and have been identified in consultation with Department of Pharmaceuticals. BIS, in a statement, said the national standards body is developing standards for innovative products such as therapeutic footwear, portable ramps, braille displays, and fall detectors, which support individuals with disabilities. BIS has published over 1,700 standards for the medical sector, covering specialities such as cardiology, neurology, orthopaedics, ophthalmology, and more. Of these, around 1,200 standards specifically focus on medical devices critical to healthcare. BIS standards in this sector ensure that Indian medical devices are safe, effective, and globall

Demand for super top-up health insurance plans rises after Covid pandemic

A super top-up health insurance plan pays the policyholder for medical expenses that exceed the coverage limit of their base health insurance policy

Govt launches Rs 500 crore scheme to strengthen medical devices industry

This initial outlay of Rs 500 crore will be for three years, up to financial year 2026-27 (FY27), according to a government communication

Medical device makers claim import of refurbished devices can harm industry

Manufacturing associations added that recent government orders permitting such imports threaten the efforts of Indian manufacturers to meet the vision of Aatmanirbhar Bharat

CDSCO flags 4 drugs as spurious and 48 as not of standard quality

The apex drug regulatory body also listed 48 drugs and formulations, manufactured by 40 companies, as not of standard quality (NSQ)

Glucometer maker Morepen Labs to hive off medical devices business

Expanding capacities, backward integrating production and eyeing US market for exports

India becomes affiliate member of global medical device regulator IMDRF

India has become an affiliate member of the International Medical Device Regulators Forum, which will open doors to invaluable opportunities for reliance and collaboration with regulatory authorities worldwide, the Union health ministry said on Thursday. The IMDRF, which was established in 2011, is a group of global medical device regulators whose aim is to speed up the adoption of international medical device regulatory harmonisation and convergence. Its members include national regulatory authorities of the US, Australia, Canada, the European Union, Japan, the UK, Brazil, Russia, China, South Korea, Singapore and the World Health Organisation (WHO). "To achieve global alignment in its medical device regulatory system, enhance the competitiveness of the domestic industry and boost transnational prominence, the Central Drugs Standard Control Organisation (CDSCO), under the Ministry of Health and Family Welfare, applied for Affiliate Membership in the International Medical Device ...

PLI scheme: 50 units to be set up for pharma, medical device manufacturing

As many as 50 new greenfield plants are in the pipeline to come up in the next two years under the Production-linked Incentive (PLI) scheme for pharma and medical devices manufacturing, a senior government official said on Thursday. Speaking at the Annual Pharma Summit organised by industry body Assocham, Department of Pharmaceuticals Secretary Arunish Chawla said as the 'Make in India' initiative completes ten years, already 50 plants have been set up under the PLI schemes for the two sectors. "The PLI schemes in the pharma and meditech sectors have been a roaring success, 50 brand new greenfield pharma and medical device manufacturing plants have already become operational, and 50 more are in the pipeline," he said. When asked on the sidelines of the summit when the 50 new greenfield plants will come up, he said, "Everything will be completed in the next two years." Elaborating on the success of the PLI schemes, Chawla said, "In the last two years alone, the PLI plants have ...

Govt introduces risk-based model for testing imported medical devices, kits

The risk-based approach allows authorities to assess products by public health impact, with stricter measures for high-risk items like vaccines, diagnostic kits, and critical medical supplies

Medical gear makers up in arms against zero-duty imports under EU FTA

India is 70% import-dependent, and Germany and the Netherlands are among the top five countries

New code for medical devices mandates complaint decisions within 90 days

This comes as the central government on Friday notified the UCMPMD 2024 in a move to regulate unethical marketing practices in the medical devices industry

Govt notifies uniform marketing code for medical devices industry

The government has notified a uniform code for marketing practices for the medical device industry in order to curb unethical practices. In a notification, Department of Pharmaceuticals (DoP) has asked the medical devices association to prohibit organising workshops abroad for healthcare professionals, offering them hotel stays or monetary grants. "All associations should constitute an ethics committee for marketing practices in medical devices (ECMPMD), upload it on their websites along with a detailed procedure of complaints, which will be linked to the UCPMP portal of Department of Pharmaceuticals," the notification said. The DoP has also sought disclosures form medical devices firms for particulars related to distribution of evaluation samples and expenses incurred on conferences , workshops, seminars etc. As part of the code, a medical device must not be promoted prior to receipt of product approval by the regulatory authority, the notification said. "The word safe or safet

Medical device park in Himachal to provide 10,000 jobs, state Assembly told

The Medical Device Park being set up on 265 acres in Solan district would create 10,000 direct and indirect jobs, Himachal Pradesh Industries Minister Harshwardhan Chauhan told the state assembly on Tuesday. The upcoming park in Manjholi village panchayat under Nalagarh assembly constituency would provide direct and indirect employment to 10,000 persons, Chauhan said in response to a question. The minister said that the state government will bear the entire expenditure on the project which is expected to be completed by December 31, 2025. No technical sanction was pending and there is possibility of setting up 65 industrial units under the project, he added. Meanwhile, chief minister Sukhvinder Singh Sukhu informed the state assembly that 2,708 cases of forest fires were reported during six months of the current year ending June 2024, but there was no loss of human life. In reply to another question of BJP member Sukh Ram Chowdhary, the chief minister said that out of 55 hotels ru

Narayana Hrudalaya's consolidated revenue rises 8.7% to Rs 1,364.4 cr in Q1

The hospital chain reported a net profit of Rs 201.49 crore in Q1FY25 as compared to Rs 184.04 crore in Q1FY24

Veerhealth Care expects Rs 100 crore revenue in upcoming 2-3 years

Veerhealth Care on Monday said it is expecting to reach revenue of Rs 100 crore in the next 2 to 3 years. In a statement, the company said it has executed and delivered an export order valued at USD 50,000 (about Rs 41.50 lakh). Additionally, another export order valued at USD 197,793 (approximately Rs 165 lakh) is scheduled to be fully executed and delivered by the end of July. According to the statement, the company has also received an additional export order worth USD 106,673 (about Rs 89 lakh) from top US Institutional Supplier. The order will be executed within three months, as stipulated by the terms of the purchase agreement. Further, it stated that it is expecting monthly repeat orders from the same top US Institutional Supplier. In addition to this, the company said it is renovating its existing plant in Vapi, Gujarat, to set up a bigger plant which will be US FDA & WHO-compliant. In February 2024, the company has announced its expansion plans with a proposed investmen

Centre looks to standardise breath analyser equipment to ensure accuracy

The new set of rules provides for various types of tests to ensure the correctness of the instrument