Drug and Cosmetic Amendment Bill in India: A Promising Hope for Healthy Medical Device Regulatory Environment

Author(s): Dimple Chaudhary, Swagat Tripathy, Harish Dureja.

Journal Name: Applied Clinical Research, Clinical Trials and Regulatory Affairs

Volume 2 , Issue 3 , 2015

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Abstract:

Background: Medical devices are the prevailing part of modern medical care. The quality of medical devices is depended largely on how effectively they’re regulated. In India, before 2005, there were no regulations on medical devices. Even though now in India, medical devices are regulated under the regulation of the Drugs and Cosmetics Act and Rules. Recently floated “draft medical device policy” (June 2015) have brought a promising scope for the formation of an autonomous National Medical Device Authority (NDMA). The draft changes have been publicly released for review comments.

Objective: The aim of this manuscript is to give a thorough analysis of draft medical device policy, its impact and how this praiseworthy initiatives are separating the regulation of drugs, cosmetics and devices.

Conclusion: This has become a ray of hope to improve so called unorganized medicinal devices regulatory environment efficiently and appropriately in India. India is always import driven and one of the largest medical device markets in Asia, so the formation of the country's first agency especially dedicated to the regulation of medical devices will catalyze the growth of medical device market of India.

Keywords: Drug and cosmetic act, medical device, NDMA, regulation.

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Article Details

VOLUME: 2
ISSUE: 3
Year: 2015
Page: [133 - 136]
Pages: 4
DOI: 10.2174/2213476X02666150908210025
Price: $58

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