Medical Device Industry

Drug regulator mandates CDSCO licensing on medical device procurement

The regulator told states not to demand USFDA or EU approvals in tenders after complaints that Indian-made devices were being sidelined

Poly Medicure to acquire Netherlands-based PendraCare for ₹188.5 crore

Poly Medicure has signed agreements to acquire 90 per cent of Netherlands-based PendraCare Group for Rs 188.5 crore, expanding its cardiology business in Europe and the US

Govt panel starts drafting rules for refurbished medical device imports

A high-level inter-departmental committee has begun discussions on regulating refurbished medical devices, balancing patient safety concerns with affordable healthcare access

Govt, industry hold talk on issues over marketing code for medical devices

Medical device companies raise issues with the DoP over UDMPMD norms related to disclosure of training expenses and restrictions on overseas training approvals

EU votes to curb Chinese medical devices, cites procurement bias

The move comes after the EU, in its investigation, found that Beijing discriminated against foreign firms in procurement of medical devices

Centre to aid development of indigenous thrombectomy device for stroke

Technology Development Board to fund S3V Vascular Technologies for manufacturing India's first thrombectomy device, aiming to reduce import dependency and boost stroke care

India's medtech industry goes local to develop high-end equipment

According to the Department of Pharmaceuticals' annual report for 2024-25, India imported medical devices worth $8.1 billion, while exports stood at $3.7 billion in the financial year 2023-24 (FY24)

Indian medical devices industry calls USA's 27% tariff challenge for growth

The new tariffs may impact India's medical devices exports, said Rajiv Nath, forum coordinator for the Association of Indian Medical Device Industry (AiMeD)

MedTech industry divided over move to stop imports of refurbished devices

Domestic manufacturers added that the order will also stop the unregulated influx of second hand medical devices which could have been detrimental to the patient safety in India

CDSCO to disallow import of pre-owned, refurbished med devices into India

Health Ministry to constitute expert committee, import suspended until policy framework is finalised

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

Cancer cases rising, prices of essential drugs kept in check: Nadda

The government makes all efforts to ensure affordable and accessible treatment is available for cancer patients amid a rise in cases in India, Health Minister JP Nadda said on Friday. Replying to supplementary questions during Question Hour in the Lok Sabha, Nadda said the government made all efforts to ensure that affordable and accessible treatment was available to the patients. "The number of cancer cases is going up, it is increasing by almost 2.5 per cent every year," Nadda said. In men, cases of oral and lung cancer are on the up while more women are getting breast cancer, he added. More than 15.5 lakh cancer cases are being registered every year, Nadda said. "There is a list of 131 essential cancer medicines, which are in Schedule 1, (that) are monitored and (their) pricing is decided by the government. These are the commonly used medicines," Nadda said. He said patients cumulatively saved around Rs 294 crore due to this price control. "There are 28 combinations, which ar

Alembic gets USFDA nod for generic injection to treat hereditary angioedema

Alembic Pharmaceuticals Ltd on Monday said it has received final approval from the US health regulator for its generic Icatibant injection indicated for the treatment of acute attacks of hereditary angioedema in adults. The approval by the US Food & Drug Administration (USFDA) is for the Abbreviated New Drug Application (ANDA) for Icatibant injection of strengths 30 mg/3 mL (10 mg/mL) single-dose prefilled syringe, Alembic Pharmaceuticals said in a regulatory filing. This is the first peptide product approval from the USFDA received by the company, Alembic Pharma said. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Firazyr Injection, 30 mg/3 mL (10 mg/mL), of Takeda Pharmaceuticals USA, Inc, it added. Icatibant injection is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. Hereditary angioedema is a disorder characterised by recurrent episodes of severe swelling (angioedema)

BHU study on Covaxin side effects poorly designed: ICMR director Bahl

The Indian Council of Medical Research Director General Dr Rajiv Bahl on Monday criticised a recently published study on the long-term safety analysis of the Covaxin in adults and adolescents for its poor methodology and design, and clarified the article misleadingly and erroneously "acknowledges" ICMR. Dr Bahl said the study had no control arm of unvaccinated individuals for comparing the rates of events between the vaccinated and unvaccinated groups. Hence, the reported events in the study cannot be linked or attributed to COVID-19 vaccination. The ICMR is not associated with the study and has not provided any financial or technical support for the research, Dr Bahl said. The ICMR DG has written a letter to the authors of the paper and Editor of the journal to immediately remove the acknowledgement to ICMR and publish an erratum. A research paper, titled 'Long-Term Safety Analysis of the BBVl52 Coronavirus Vaccine in Adolescents and Adults: Findings from a l-Year Prospective Stud

KKR acquires Bengaluru-based medical devices company Healthium MedTech

According to sources close to the deal, the value of the acquisition is Rs 6,500-7,000 crore

Hindustan Syringes launches Dispojekt to reduce needle stick injuries

Company aims to capture 60-70% of disposable syringes market in India

Arcatron Partners with OrbiMed to Accelerate Growth

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Imports of medical devices rise 21% till October to Rs 61,262.84 cr

Imports from the US grew by 33 per cent, followed by Germany at 27 per cent and the Netherlands at 20 per cent