Page 3 - Medical Devices

CDSCO gives 6-month extension to medical device manufacturers for imports

Under the new regulation, medical devices under' class C' and 'class D' cannot be sold without a manufacturing licence after October 1

Medical devices lobby seeks 6-mth extension to come under licencing regime

Medical devices are divided into four classes, based on the level of risk they pose

We approved investment of Rs 6,000 cr under PLI scheme for pharma: Shah

The Centre has approved investment of Rs 6000 crore to 74 industries in the pharmaceutical and medical device manufacturing sectors under the production linked incentive (PLI) scheme, Union Home Minister Amit Shah said here on Saturday. Shah was addressing a gathering after dedicating the newly built campus of the National Institute of Pharmaceutical Education and Research (NIPER) at Gandhinagar. "The Union government has taken a holistic approach and begun the process for the development of a cost-effective, sustainable and affordable process for 16 APIs (active pharmaceutical ingredient) and two KSMs (key starting material)," he said. In the next one decade, India will not just become self-reliant but also be in a position to export them (APIs and KSMs), Shah added. "The Narendra Modi government has given permission for the investment of Rs 4000 crore to about 48 small and big industries in the sector of pharmaceutical manufacturing under the PLI scheme," Shah said. The PLI sche

HC upholds Centre's decision to include all medical devices as drugs

The Delhi High Court has upheld the Centre's decision to include all medical devices within the ambit of "drug" under the law regulating drugs and cosmetics. A bench headed by Justice Rajiv Shakdher rejected petitions by the Surgical Manufacturers and Traders Association challenging the central government's 2018 and 2020 notifications first declaring four medical devices as drugs under the Drugs and Cosmetics Act, and then spreading the net to cover all medical devices. The court said the decision to include all medical devices as drugs was a policy matter and no case for interference was made out as there was no arbitrariness or unreasonableness. MHFW (Ministry of Health and Family Welfare), in its wisdom, thought it fit to bring all medical devices within the ambit of the expression 'drug '. This is clearly a policy matter, the bench, also comprising Justice Tara Vitasta Ganju, said in a recent order dated September 1. To our minds, there is no manifest arbitrariness or ...

Planning to open manufacturing facility in Russia soon: Trivitron Group CEO

Apart from our joint venture in Russia, we are investing heavily in the US, where we already have infrastructure, including factories and R&D setups, said Ganjoo

Health ministry proposes separate post for medical devices controller

Specific provision for recall of drugs and devices; penal provisions for substandard drugs

Parliamentary committee recommends a separate medical devices Bill

According to sources, DCGI has convened a meeting in Delhi on August 10 to discuss matters related to the draft New Drugs, Medical Devices and Cosmetics Bill, 2023

Industry, patient groups want draft drugs and medical devices Bill recalled

Seek a separate 'Medical Devices Act' distinct from the drug regulations Bill

Abbott beats quarterly profit estimates on demand for medical devices

Abbott's diagnostic sales came in at $2.3 billion in the quarter, in line with analysts' average estimates.

J&J raises profit forecast as it bets on cancer drugs, medical devices

Shares of J&J, which recently spun off its consumer health unit to focus on drugs and medical devices, rose about 2% in premarket trading

All provisions of medical devices rules to come into force from Oct 1: DCGI

Medical devices of all four categories (A, B, C, and D) will be brought under the regulation by October 1 and as of now only two groups (A and B) are being regulated, Drugs Controller General of India (DCGI) Rajeev Singh Raghuvanshi said on Wednesday. Speaking to reporters on the sidelines of the 9th International Pharmaceutical Exhibition (iPHEX) being organised by the Pharmaceuticals Exports Promotion Council (Pharmexcil) here, Raghuvanshi said the regulations would ensure quality in the production of medical devices. "In the medical devices, we are categorising into four groups. Two groups (A and B) are already notified. C and D are left which will happen from October 1," he said. The Union Cabinet on April 26 approved the National Medical Devices Policy, 2023 to give a thrust to the sector with quality controls. The market size of the medical devices sector in India is estimated to be USD 11 billion (approximately Rs 90,000 crore) in 2020 and its share in the global medical devi

Pocket-friendly health: Price caps on critical medical devices extended

The pricing policy is a part of the National Medical Device Policy 2023 launched by the government to facilitate the growth of the sector while also ensuring accessibility and affordability

10,000 Jan Aushadhi Kendras expected to be functional by year-end: Official

Applications have been invited for setting up more Jan Aushadhi Kendras as around 10,000 such centres are expected to be made functional by the year-end, a top official said on Friday. Ravi Dadhich, CEO of Pharmaceuticals and Medical Devices Bureau of India (PMBI) said, "10,000 Jan Aushadhi Kendras are expected to be functional across the country by the end of the year." He added that applications have been invited for the proposals to establish these centres. As on May 31, a total of 9,484 Jan Aushadhi Kendras are operational in the country. Dadhich made the comments in an interaction with media persons assembled at the central warehouse, Bilaspur, Gurugram. There are currently four warehouses in the country under Pradhan Mantri Bharatiya Jan Aushadhi Pariyojana (PMBJP), located at Gurugram (Haryana), Chennai, Guwahati and Surat, with the central warehouse at Gurugram being the largest. At present, PMBJP is providing 1,800 medicines, as well as 285 surgical devices at highly ...

Japanese medical devices major Omron to set up mfg unit in Tamil Nadu

Stalin's visit to Japan brings in investments worth Rs 1,300 crore

Omron to establish first Indian medical devices factory in Tamil Nadu

Omron will make devices including blood pressure monitors and will invest nearly 1.3 billion Indian rupees (about $15.7 million) to set up the plant, the sources said, declining to be identified ahead

Medical device's environmental impact can challenge innovation: Report

The report by GlobalData, a leading data and analytics company, shows that the industry finds itself at a crucial juncture, balancing technological advancements with sustainable practices

Medical devices must display essential information on packaging: Govt

The department of consumer affairs has mandated that pharmaceutical clearly display important information on their packaging so consumer can make informed decisions

Indian medical devices sector to emerge as global leader in innovation: MoS

Backed by growing healthcare needs and the government's commitment to facilitate growth, the Indian medical devices industry has the power to emerge as the global leader in manufacturing and innovation in the next 25 years, Union Health Minister Mansukh Mandaviya said on Tuesday. The medical devices sector is an essential and integral constituent of India's healthcare sector, he said during his interaction with representatives of Japanese medical devices companies in Tokyo. "The sector's contribution became even more prominent as India supported the domestic and global battle against COVID-19 pandemic through large scale production of medical devices and diagnostic kits," he said. Dr Mandaviya noted that the medical devices sector has the potential to grow from its current size of USD 11 billion to four times by 2030. He further stated that backed by growing health care needs and the government's commitment to facilitate growth, the Indian medical devices industry has the power to

Uttar Pradesh govt looking to tap domestic medical devices' market

Chief Minister Yogi Adityanath has reiterated his resolve to make the state a leading medical and pharmaceutical hub in the country

Healthium Medtech appoints Prashant Krishnan as global business head

Medical devices maker Healthium Medtech on Monday said it has appointed Prashant Krishnan as global business head for advanced wound care and surgery portfolio. The appointment of Krishnan, who was earlier with Medtronic, comes at a time when the company is strengthening its portfolio in advanced surgery, wound care, orthopaedics and post-surgical care through organic and inorganic routes, Healthium Medtech said in a statement. Krishnan brings more than 27 years of experience and has led businesses across India, South Asia and the US in various leadership positions across surgery, cardiology and orthopaedics medical devices sector. He has also previously worked with companies like Johnson & Johnson and Godrej & Boyce. He holds a master's degree in Business Administration from Xavier Institute of Management and an alumni of The Wharton School, University of Pennsylvania, the company said.