1. No DCGI approval required for clinical trials for academic
The Ministry of Health and Family Welfare, vide its notification
No. G.S.R. 313(E) dated March 16, 2016, amended Rule 122DA of the
Rules to segregate procedures of approval for clinical trials of
drugs intended for academic and marketing purposes. As per the
amended Rule 122DA, no permission is required to conduct clinical
trials for academic research on drug formulations approved by the
Ethics Committee. This exception covers clinical trials for new
indications, routes of administration, dose or dosage forms of
drugs. Prior to this amendment, researchers had to seek approval
from DCGI for clinical trials for academic purposes, in the same
manner as pharmaceutical companies' application for approval of
new drugs. It included many stages and clearance from multiple
committees, and hence delayed research and development activities
related to drugs developed for treatment of cancer and other such
critical medical conditions.
PSA view: This move not only makes clinical
trials for academic research on drugs more cost effective and
efficient, but also promotes innovation in terms of treatment of
critical maladies like AIDS, cancer, etc. The exemption from DCGI
approval reduces timelines for research and development activities
in the country while maintaining vigilance through Ethics
2. Validity of free sale certificates for domestic medical
device manufacturers increased
The DCGI has requested state regulators to extend the validity
of free sale certificates required by domestic medical device
manufacturers for exports so that they expire only alongside the
manufacturing license. Free sale certificates which are issued to
medical device manufacturers by state licensing authorities were
initially valid for two years. In 2015, the DCGI has extended this
to five years, subject to validity of manufacturing license. In
order to export medical devices, manufacturers need to register
with the foreign country and obtain its regulatory approval. These
foreign regulators generally ask for a free sale certificate to
allow imports. Notified medical devices are regulated as
"drugs" under section 3(b )(iv) of the Drugs and
Cosmetics Act, 1940 ("Act"). As of now,
only 15 medical devices are notified and regulated for import,
manufacture and marketing in the country. This proposed extension
on free sale certificate validity will apply only to these 15
notified medical devices.
PSA view: This move comes in light of incessant
requests from medical device manufacturers with a view to promote
exports. The limited validity period of free sale certificates used
to restrict registration by domestic manufacturers and exporters
with overseas authorities. It also added to re-registration costs
of overseas importers. For medical devices not covered as drugs
under the Act, the certificates are issued by the Directorate
General of Foreign Trade (DGFT).
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
To print this article, all you need is to be registered on Mondaq.com.
Click to Login as an existing user or Register so you can print this article.
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.
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).