Drug Controller General of India (DCGI) with the approval of the
Ministry of Health and Family Welfare, vide Order no. F. No.
DCGI/Misc./2014(132) dated 05 September, 2014 directed all the
Sponsors/CROs/ Medical Institution and other Stakeholders involved
in the conduct of Clinical Trial in the country to include
following information in their Clinical Trial Application with
immediate effect i.e. (i) Assessment of risk versus benefit to the
patients, (ii) Innovations vis-ŕ-vis existing therapeutic
options, (iii) Unmet medical need in the country. The above said
direction of inclusion of these three parameters in the Clinical
Trial Application by DCGI is in furtherance of the Hon'ble
Supreme Court Order dated 21.10.2013 in the matter of W.P (C) No.
33/2012 of Swasthya Adhikar Manch, Indore & Anr. V. Ministry of
Health and Family Welfare & Ors. with W.P (C) No. 779/2012
regarding Clinical Trials, wherein it was directed that all the
Global Clinical Trials (GCTs)/ New Clinical Trials (NCEs) should be
evaluated having regard to the three parameters (as mentioned
above) in the Clinical Trial Application.
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The food processing industry one of the largest industries in India is widely recognized as a 'sunrise industry' in India having huge potential for uplifting the agricultural economy, creation of large scale processed food manufacturing and food chain facilities, and the resultant generation of employment and export earnings.
One of the potential threats for manufacturing and sale of food/health supplements such as "Dietary food supplement", "Food supplements", "Nutritional supplements", "Health supplements", is its categorization in the category of "Food" or "Drugs", as there is a very thin line between "drugs/ medicines" and "nutritional supplements".
In its Cabinet Note in December, 2014, the Government of India proposed significant amendments to the Consolidated Foreign Direct Investment Policy, 2014 (''FDI Policy'') with respect to India's medical device industry.
Although in countries like the United States of America and New Zealand, drugs to be prescribed by medical practitioners are allowed to be advertised directly to consumers/patients and are regulated by the respective department of the Government in charge of drugs in the country, the same practice is not followed or encouraged in India.
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