Indian Regulators to Fast-Track WHO-Approved Combination Products for HIV, Hepatitis
India’s top drug regulatory body plans to fast-track approvals for combination products recommended by the World Health Organization to treat HIV and hepatitis B and C.
The Drugs Controller General of India may issue clinical trial waivers for certain products for concomitant use under the heading of “extreme urgency.” Manufacturers should apply for bioequivalence No Objection Certificates and new drug applications at once to make those products available as early as possible, DCGI said.
Bioequivalence NOC applications to export such combination products will be made for pilot studies on batches manufactured at pilot scale, followed by pivotal studies for batches produced at pivotal scale.
Drugmakers should adhere to international regulatory standards in producing the batches and ensure sufficient quality and clinical oversight during bioequivalence studies.