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The objective of this paper is to provide guidelines to applicants to enable them to understand and comply with the regulatory
requirements for the authorization of similar biologics in India. The CDSCO is the national regulatory authority in India
that evaluates safety, efficacy and quality of drugs in the country. The DBT through Review Committee on Genetic Manipulation
(RCGM) is responsible for overseeing the development and preclinical evaluation of recombinant biologics. 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 an authorized reference biologic.
A similar biologic may require reduced preclinical and clinical data package as part of submission for market authorization. The
similar biologics are regulated as per the Drugs and Cosmetics Act, 1940, the Drugs and Cosmetics Rules, 1945 (as amended from
time to time) and Rules for the manufacture, use, import, export and storage of hazardous microorganisms/genetically engineered
organisms or cells, 1989 (Rules, 1989) notified under the Environment (Protection) Act, 1986. Various applicable guidelines are
Recombinant DNA safety guidelines, 1990 guidelines for generating preclinical and clinical data for rDNA vaccines, diagnostics
and other biological, 1999, cdsco guidance for industry.
Competent authorities involved in the approval process are Review committee on genetic manipulation (RCGM) genetic
engineering appraisal committee (GEAC) Central Drugs Standard control Organisation (CDSCO). Thus all the global
pharmaceutical companies should follow up the guidelines approved for biologics by CDSCO for marketing authorisation in India.
katla. sirisha pursuing m.pharm 1st year with specialisation in regulatory affairs in jss college of pharmacy, jss university Mysore, I have completed
my b.pharm degree in Siddhartha institute of pharmaceutical sciences, Guntur.
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