Government's policy decision regarding local labeling of Medical Devices, a big relief to the sector

FICCI Medical Device Forum welcomes the Government of India's Gazette notification GSR 690 (E) dated 25th September, 2014 which comprehensively deals with a range of concerns long sought by Medical Device Industry.

It may be recollected that Medical Devices Industry had been inconvenienced following discontinuity of allowing India Specific Labelling after imports. Rather it was directed that all products should be labelled before imports.

This Comprehensive notification from Government of India was urgently needed since the Interim Relief granted in March 2014 by DCGI was to expire in September 2014 and was brought to the notice of Ministry of Health & Family welfare and to DCG(I) by FICCI Medical Device Forum members.

FICCI Medical Device Forum along with others particularly took up the issue of India specific labelling with the urgency for addressing the sector's needs comprehensively with MOH&FW as well as with DCG(I) which supported the current amendment of the Drug & Cosmetic Rules, to allow India specific labelling after imports of Medical Devices into India.

It comes as a big relief to the sector and ushers in a positive sentiment amongst the Industry. The new notification is well timed as it will enable affordability and continued supply of Medical Devices to needy patients and healthcare providers.

Mr. Sushobhan Dasgupta, Chairman, FICCI Medical Devices Forum and Managing Director, Johnson & Johnson Medical India said, CDSCO has been a strong pillar of support and guidance for the growth of the medical devices industry in India. Their decision on this import labelling issue is a great example of their continued encouragement and sound understanding of the issues faced by the industry. He also added, We strongly believe that the Indian drugs & devices regulatory agencies are doing a commendable job of effectively monitoring the quality of medical devices and in-vitro diagnostics products imported into or manufactured and sold in India.

FICCI comprises both Indian and multinational manufacturers of global repute, who, for many past years, worked in close collaboration with the Indian regulatory agencies. The Indian drugs and medical devices regulatory agencies have ensured that the medical devices and in-vitro diagnostic products which are manufactured or imported and sold in the country, continue to benefit the patients who need them and are used in the most appropriate, effective and safe way.

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