Pharmaceutical Industry Blog

Last Updated: September 5, 2026 TL;DR: Trinidad and Tobago answers the question we always ask first — does the country keep a list of regulators it will rely on, and is India on it — with three layered lists, India on none of them, and Indian factories nonetheless the largest source of the medicines it registers and buys. The Food and Drugs Regulations of 1964 name Canada, the United States, the United Kingdom and Australia plus a ministerial-discretion clause; the Chemistry,

Last Updated: September 5, 2026 TL;DR: Bahrain answers the question we always ask first — does the country keep a list of regulators it will rely on, and is India on it — with a clear yes and a clear no. The National Health Regulatory Authority's Medicine Licensing Guideline of 20 October 2025 names six fast-track reference authorities (the Gulf Health Council's central registration, SFDA, US FDA, EMA, Swissmedic and MHRA), a second list on its application form, a third list

Last Updated: September 4, 2026 TL;DR: Equatorial Guinea answers the question we always ask first — does the country keep a list of regulators it will rely on, and is India on it — with no list at all, because its gate is a certificate test rather than an agency test. Ley del Medicamento 3/2003 requires every imported lot to be lodged with the Ministry of Health and Social Welfare with its invoices and a quality certificate under the WHO certification scheme, or failing that

Last Updated: September 4, 2026 TL;DR: Guinea-Bissau answers the question we always ask first — does the country keep a list of regulators it will rely on, and is India on it — with no published list and a national procedure we could not read. The law that binds it is not national at all: it is the West African Economic and Monetary Union's Règlement 04/2020/CM/UEMOA, which replaced the 2010 regulation and prescribes a five-module CTD dossier, a five-year marketing authorisat

Last Updated: September 4, 2026 TL;DR: Lesotho answers the question we always ask first — does the country keep a list of regulators it will rely on, and is India on it — with no list at all, and with a regulator that is still being built. The Lesotho Medicines and Medical Devices Control Authority Act of 2023 was brought into operation on 1 March 2026, replacing the 2008 framework, and the new authority is reported to be awaiting its regulations; no medicines register, guide

Last Updated: September 4, 2026 TL;DR: Botswana answers the question we always ask first — does the country keep a list of regulators it will rely on, and is India on it — with a reliance pathway that visibly exists and a list we could not read. The Botswana Medicines Regulatory Authority, BoMRA, created under the Medicines and Related Substances Act of 2013, opened a reliance-based expedited registration window for veterinary products in May 2026 and says it is building a Bo