Domestic medical device makers wary of India-EU FTA
'Country of origin' is not a requirement in EU and marketing companies are permitted to label packaging as 'legal manufacturer'.
'Country of origin' is not a requirement in EU and marketing companies are permitted to label packaging as 'legal manufacturer'.
Investments rise but companies ask for more hand-holding and incentives to make India a manufacturing base.
The Bill seeks to repeal the 80-year-old Drugs and Cosmetics Act, 1940 and introduce a new law.
Over 500 applications for manufacturing licences of high-risk Class D and moderately high-risk Class C medicines are pending with the regulator
733 applications for PLI have been approved in 14 sectors, with an expected investment of ₹3.65 lakh crore
Currently, medical devices are regulated by the drug authorities as the rules concerning these products are covered under the Drugs and Cosmetics Act.
Council will have special panels to promote specific categories of medical devices like disposables, consumables, orthopaedic implants, IVD equipment, and surgical instruments.
India’s top 5 medical device import sources -- China, USA, Germany, Singapore and the Netherlands – together account for ₹37,519 crore, or 68%, of the total value of imports
The medical devices sector is 70-80% import dependent in India.
The health ministry will amend the Medical Device Rules 2017 to empower the drug licensing authorities to issue such registration certificates.