REGULATORY REQUIREMENTS OF BIOLOGICAL MEDICAL PRODUCTS USING CELLS AND TISSUES IN INDIA UNDER CENTRAL DRUG STANDARD CONTROL ORGANISATION IN COMPARISON WITH ETHIOPIA

Dr. Ashok Kumar P.*, Afifa Misba, Ameena Banu, Chethan L., Nizam Pasha and Noor Neha

ABSTRACT

The regulatory frameworks for biological products in India and Ethiopia differ significantly in their intricacy and scope. In India, the Central Drugs Standard Control Organization (CDSCO) supervises biological products under the Drugs and Cosmetics Act, 1940. Manufacturers must comply with Good Manufacturing Practices (GMP), and clinical trials follow the stringent guidelines of Schedule Y. Import of biological products requires a license (Form 40) and a Registration Certificate (Form 41) through the SUGAM portal, with post-marketing surveillance conducted under the Pharmacovigilance Programme of India (PvPI). India also has robust regulatory guidelines for biosimilars, with more humongous requirements for comparability studies. In Ethiopia, biological products are regulated by the Ethiopian Food and Drug Authority (EFDA), under Proclamation No. 1112/2019. Manufacturers must supervene GMP guidelines, and clinical trials are audited and approved by EFDA before marketing. Import licenses are indispensable, with documentation requirements such as GMP certificates. Post-marketing surveillance is also required, but with a less structured framework compared to India. Although Ethiopia’s regulatory framework aligns with international standards, India’s system is more developed, especially in biosimilar approvals and post-marketing surveillance.

Keywords: CDSCO, EFDA, Drugs and Cosmetics Act, 1940, Good Manufacturing Practices (GMP), Pharmacovigilance Programme of India (PvPI), Biological Products.