The clinical trial on new drugs is regulated under the provision
of D&C rule 1945 as amended from time to time. The rule
provides that no clinical trial can be initiated without the
grant of permission by the licensing authority and the
condition prescribed there in. The detailed requirements and
guidelines for undertaking the clinical trial are specified
under schedule Y of said rule. Similarly, for import/manufacture of
new drugs, the Union Health Ministry will soon amend the Note
regarding the authenticity of the data or documents to be submitted
by the applicant under Schedule Y of the Drugs and Cosmetics Rules,
1945 ("Note"). The Note shall provide
that only authentic data should be submitted in the application for
permission to import and/or manufacture new drugs for sale or to
undertake clinical trials. The data will have to be self certified.
Note will also provide that the licensing authority reserves the
right to reject any data or any document(s) if such data or content
of such document are found to be of doubtful integrity.
Therefore, the Drugs Technical Advisory Board has proposed that
the Note be amended to read as under-
"The data requirements stated in this Schedule are
expected to provide adequate information to evaluate the efficacy,
safety and therapeutic rationale of new drugs (as defined under
Rule 122-E) prior to the permission for sale. Depending upon the
nature of new drugs and disease(s), additional information may be
required by the Licensing Authority. The applicant shall certify
the authenticity of the data and documents submitted in support of
an application for new drug. The Licensing Authority reserves the
right to reject any data or application or debar the applicant for
a specific period to make any application to the office of Drugs
Controller General (I) as the case may be if such data or contents
of such documents are found to be of doubtful
PSA view - It is good to see that the Drugs
Technical Advisory Board has filled up the legislative vacuum.
Looking at the sensitiveness of the matter, be it import of
drugs or clinical trial, this is a welcome move.
2. Regulation Specific to
Medical Device Sector in the Pipeline
The Task Force on the Medical Devices Sector in India,
constituted by the DoP, pursuant to the Prime Minister's Make
in India campaign, has recommended enacting the Medical Device
Regulatory Act ("ProposedAct") to lay down globally recognized
and transparent regulations that specifically cater to medical
The Proposed Act shall primarily focus on these concerns
(i) simplify procedure relating to import,
manufacture and sale of medical devices; (ii)
formulate procedure for clinical trial of medical devices at par
with international standards; (iii) re-classify
the medical devices based on the risk factor upon its usage on
humans; (iv) integrate within MDR Act the
regulations pertaining to radiation emitting medical devices;
(v) ensure that the standards for safety, efficacy
and adverse reaction reporting must be in consultation with Bureau
of Indian Standards and National Health Systems Resource Centre;
and (vi) set-up and implement single window model
for obtaining regulatory clearances for operations pertaining to
medical device sector.
PSA view - Implementation of Proposed Act shall
aid in setting up a definite guideline for medical device sector
ensuring that it is regulated by device relevant laws and not those
relevant to drugs. Considering the interest of stakeholders, it is
recommended that the new legislations must facilitate transforming
the industry from an import dependant sector to a export oriented
sector by promoting domestic manufacturers of medical devices and
pharmaceutical equipments. Therefore, in our view, an initiative to
formulate a industry specific legislation is commendable and it
will be interesting to see its impact on the industry upon once
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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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