1. Aditi 2018. Top generic pharma companies in India. Pharma Adda. https://www.pharmaadda.in/top-generic-pharma-companies-in-india (accessed 10.03.20).
2. Pharmaceutical regulations in India, history of drug regulation in India;Agarwal,2018
3. Regulatory requirements for marketing authorization of different categories of drugs in India;Ahmad;Int. J. Pharm. Pharm. Res.,2017
4. APEC, 2015. Drug approval system of Japan. Available from: https://www.nifds.go.kr/brd/m_95/down.do?brd_id=board_mfds_411&seq=21651&data_tp=A&file_seq=1 (accessed 11.05.20).
5. Japanese regulation of biosimilar products: past experience and current challenges;Arato;Br. J. Clin. Pharmacol.,2016