In another effort towards a developing India and safe
conduct of clinical trials, the Indian Government has announced
another major initiative to help the biotech industry by
formulating the revised guidelines for biosimilars that has become
effective from August 15, 2016.
The new Biosimilar Policy, called the "Guidelines on
Similar Biologics" is prepared by the Central Drugs
Standard Control Organization (hereinafter referred to as
'CDSCO') and the Department of Biotechnology (hereinafter
referred to as 'DBT'), and it lays down the regulatory
pathway for a Similar Biologic claiming to be Similar to an already
authorized Reference Biologic.
A Similar Biologic product is that which is similar in terms of
quality, safety and efficacy to an approved Reference Biological
product based on comparability.
These guidelines address the regulatory pathway regarding
manufacturing process and safety, efficacy and quality aspects for
Similar Biologics. It also addresses the pre-market regulatory
requirements including comparability exercise for quality,
preclinical and clinical studies and post market regulatory
requirements for Similar Biologics.
However, these guidelines are for the general guidance of all
stakeholders and are not meant to substitute or rephrase the Rules
made under The Drugs and Cosmetics Act, 1940 or any other relevant
Acts and are subject to being in conformity with the Drugs and
Cosmetics Act and Rules as may be amended from time to time.
CDSCO is the national regulatory authority in India that
evaluates safety, efficacy and quality of drugs in the country. DBT
through its Review Committee on Genetic Manipulation (RCGM) is
responsible for overseeing the development and preclinical
evaluation of recombinant DNA derived products.
Presently, several organizations are actively engaged in
manufacturing and marketing Similar Biologics in India. So far,
these Similar Biologics were approved by RCGM and CDSCO using an
abbreviated version of the pathway applicable to new drugs on a
case by case basis. Since there are several such products under
development in India, both regulatory agencies considered the need
to publish a clear regulatory pathway outlining the requirements to
ensure comparable safety, efficacy and quality of a Similar
Biologic to the reference Biologic. Based on demonstration of
similarity in the comparative assessment, a Similar Biologic may
require reduced preclinical and clinical data package as part of
submission for market authorization.
Highlights of the Revised Guidelines
A reference biologic, not marketed in
India can be licensed in any ICH (International Council on
Harmonization) country, i.e., EU, Japan, US, Canada and
Primary and secondary endpoints to be
safety and immunogenicity;
immunogenicity studies not mandatory if immunogenicity has been
evaluated in clinical studies;
If a preapproval study includes more
than 100 patients on proposed similar Biologic drug, then the
number of patients in phase IV study can be reduced;
Similar Biologics can only be
developed against the Reference Biologic that has been approved
using a complete data package in India;
The guidelines are applicable on
Similar Biologics to be developed in India or imported to India for
The Similar Biologics manufacturer to
develop manufacturing process which yields a comparable quality
product in terms of identity, purity and potency to the Reference
The data requirements for review of
manufacturing process at preclinical submission stage, shall
include a complete description of the manufacturing process and
also its consequences on product characteristics.
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".
Biotechnology involves the modification of the basic genetic material in living things namely DNA , which imparts new properties and capabilities in organisms including plants, animals and micro organisms which can be harnessed for a number of useful applications.
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