The Indian Ministry of Health and Family Welfare’s Central Government Health Scheme (CGHS) has issued a policy on bio-similar medicines for procurement and issuance to CGHS beneficiaries. The regulatory authority for drug approval in India, the Central Drug Standard Control Organization’s Biological Division, defines bio-similar medicines as similar in terms of quality, safety, and efficacy to an approved reference biological product based on comparability. The policy states that bio-similar medicines procured and issued to CGHS beneficiaries should be on par with the reference authorized biologic/original biologic molecule/formulation of biologic medicine in accordance with the CDSCO’s guidelines. The memorandum was approved by Dr. Anjana Rajkumar, the Director of CGHS, on 8th February 2023.
Policy on Bio-similar medicines in CGHS for purpose of procurement and issue to CGHS Beneficiaries
File No. 1-1/22-23/CGHS/MSDI/3570884/2023
स्वास्थ्य और परिवार कल्याण मंत्रालय
निर्माण भवन, मौलाना आजाद रोड, नई दिल्ली
545-ए निर्माण भवन, नई दिल्ली
कार्यालय ज्ञापन/ OFFICE MEMORANDUM
Subject: Policy on Bio-similar medicines in CGHS for purpose of procurement and issue to CGHS Beneficiaries
The Central Drug Standard Control Organization’s (CDSCO) Biological Division is the regulatory authority for approval of drugs in India, and issues guidelines of bio-similar medicine/drugs. The guidelines define biosimilar as “a similar biologic product which is similar in terms of quality, safety and efficacy to an approved Reference’ Biological product based on comparability”.
Therefore, it has been decided that, for the purpose of procurement & issue to CGHS beneficiaries, the bio-similar medicine shall be at par with the reference authorized biologic/original biologic molecule/formulation of biologic medicine on the lines of guideline issued by CDSCO in this regard.
Signed by Anjana Rajkumar
Date: 08-02-2023 14:40:01
(डा. अंंजना राजकुमार)
Tel No. 011-23062800