As per regulatory requirements, biosimilar drugs must show high similarity to their reference product in both pre-clinical and clinical tests. It is by these means that biosimilars are considered to be safe and efficacious. In India, any major deviation(s) from science-based principles in the manufacturing of a recombinant DNA-derived biologic product leads to its classification as a ‘non-innovator’ biologic, which are approved ‘New Drugs’. According to the World Health Organization (WHO), these biologic products have uncertain safety and efficacy when compared to the reference biologic. They are therefore not recommended for use. Reasons for the development of non-innovator biologic products in India include the brief and not fully implemented guidelines on biologics, lack of expertise on biosimilars in various committees involved in drug regulation in India, lack of coordination among different departments/ministries working on biosimilars, poor quality accreditation for testing laboratories, and a lack of patent protection for many innovator drugs. There is an urgent need to identify the major gaps prevailing in the ministries responsible for biosimilars in India, which could be identified through a scientific audit. Such an audit could strengthen the Indian regulatory system and thus increase the provision of accessible and affordable quality biosimilars.
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