Table 1.

Various stakeholders involved in decision making of biosimilars

S. no.	Stakeholders	Role
1.	CDSCO	National Regulatory Authority in India that evaluates safety, efficacy, and quality of drugs in the country
2.	Ministry of Environment	Issued Biosafety Guidelines under Environment Protection Act (EPA)
3.	Review Committee on Genetic Manipulation (RCGM) under Department of Biotechnology (DBT), Ministry of Science and Technology	Is responsible for authorizing import/export for research and development and review of data up to preclinical evaluation.
4.	Genetic Engineering Appraisal Committee (GEAC) under the Ministry of Environment and Forests (MoEF)	Is responsible for review and approval of activities involving large-scale use of genetically engineered organisms (LMOs) and products thereof in R&D, industrial production, environmental release, and field applications
5.	State Licensing Authority	Works with CDSCO in each state and is responsible for issuance of license to manufacture r-DNA products in India.
6.	Ministry of Health & Family Welfare’s	Constituted New Drug Advisory Committee (NDAC) on March 31, 2012 to advise Drugs Controller General (India) in matters related to approval of New Drugs including biopharmaceutical products and Clinical Trials.

CDSCO = Central Drugs Standard Control Organisation, r-DNA = recombinant deoxyribonucleic acid