1. Separate drug controller
under Ayush ministry on the cards
Department of Indian Systems of Medicine and Homoeopathy
(ISM&H) which was created in March, 1995 and re-named as
Department of Ayurveda, Yoga & Naturopathy, Unani, Siddha and
Homoeopathy ("AYUSH") in November, 2003 was constituted
with a view to providing focused attention to development of
Education & Research in Ayurveda, Yoga & Naturopathy,
Unani, Siddha and Homoeopathy systems. The Department will soon
witness upgradation on the regulatory front. We already know that
the new government had done a laudable job with the creation of a
separate portfolio for AYUSH. Now, the Union Ministry is proposing
to have a drug controller at the Centre for AYUSH. This will
put in place a separate regulatory regime for Ayurveda, Yoga &
Naturopathy, Unani, Siddha and Homoeopathy which were till now
governed by the drug controller of modern medicine. It has been
reported that the budgetry allocations for Ayush which were until
now very meagre at about Rs. 400 crore for fiscal 2014-15 will soon
be elevated to Rs. 2,700 crore for the next fiscal, beginning April
Union minister for Ayush, Shirpad Yesso Naik stated in a recent
public event, "The drug controller for AYUSH would be
provided with sufficient teeth to regulate the AYUSH as per new
policy prescription, who would also be provided with a mandate to
issue the Certificate of Pharmaceutical Products (CoPP) for export
of AYUSH products...Recruitment rules are being finalized for the
new drug controller and cabinet note being finalized for new
regulations of AYUSH products under the new AYUSH health policy
which would be unveiled very shortly",
PSA view – Ayurveda, Yoga &
Naturopathy, Unani, Siddha and Homoeopathy have been India's
forte and it's high time we take this stream of medicine
seriously. It is indeed great to see the government doing something
beyond just propagating this field in various conferences and
seminars. It will be interesting to see the new set of rules and
regulations for sale, manufacture, labeling, distribution, testing
and quality control of AYUSH drugs. We won't be wrong in
stating that the sector is still untapped and going forward, if we
take a well blended commercial-cum-welfare centric approach, the
Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy
segment of drugs will be highly beneficial for our pharma
2. AIMED Recommends
re-Drafting of Drugs and Cosmetics (Amendment) Bill, 2015
The Union Ministry of Health and Family Welfare (the
"Ministry") had released the draft Drugs
and Cosmetics (Amendment) Bill, 2015 (the
"Bill") to amend the Drugs &
Cosmetics Act, 1940. Early, this month, the Ministry had invited
suggestions on the Bill from all the stakeholders of the pharma
industry. In this context, the Association of Indian Medical Device
Industry (AIMED) has raised certain concerns regarding the scope
and effectiveness of the Bill for improving medical device industry
and urges the Ministry to re-draft the Bill according to their
The recommendations put forth by AIMED includes:
(i) the bill may be re-named as Medical Devices
& Patient Safety Bill, 2015; (ii) the
regulatory body may be called Indian Healthcare Products Regulatory
Authority with separate divisions for Drugs, Cosmetics, Medical
Devices & Diagnostics; (iii) revise the
definition of manufacturer which includes "manufacture through
another Person on his behalf" as it aides the foreign players
to claim their dominance in the Indian market and thus, contradicts
the goal of "Make in India"; (iv)
include a representative of the Medical Device Industry and
National Accreditation Board of Confirmatory Assessment Bodies in
the Drugs, Cosmetics & Medical Devices Consultative Committee;
(v) must provide for a transition period for the
implementation and compliance of the new regulatory provisions by
the manufacturers; (vi) power to impose commercial
punishments on registered and licensed manufacturers by regulatory
authority, and; (vii) clarity on procedure to
regulate notified category of medical devices under the Bill.
PSA view – The Bill aims to regulate the
import, manufacture, distribution and sale of drugs, cosmetics,
medical devices and conduct of clinical trials and for matters.
However, in reference to the AIMED's recommendation, necessary
steps must be taken by the Ministry to re-define the definition of
manufacturers, lay down effective procedure to regulate notified
category of medical devices and adopt manufacturing compliances
favorable for domestic manufacturers to ensure not only patient
safety but also promote competitiveness in the sector.
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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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