India Pharma Outlook Team | Thursday, 15 May 2025
The Embassy of India in Santiago, Chile sent a formal communication request to the Pharmaceuticals Export Promotion Council of India (Pharmexcil) regarding the central supply of the national health system of Chile, looking for specific medicines from Indian manufacturers.
Pharmexcil was glad to inform its member companies of the requirement for approvals from Chilean authorities and CENABAST are encouraged to confirm their interest in fulfilling these medicine supplies.
The Embassy of India in Santiago has given its full backing in coordinating efforts between CENABAST, Pharmexcil, and other industry stakeholders to ensure efficient communication and delivery. Despite this opportunity, Indian authorities have labeled ongoing challenges within Chile’s regulatory environment regarding pharmaceutical registrations. In particular, India has observed that the Chilean Public Health Institute (ISP) has not approved any vaccine registrations over the last two to three years, even vaccines that are already approved by WHO.
In response, India has respectfully requested that ISP consider yielding expedited or automatic approval for WHO-approved vaccines to become available in markets and highlighted those regulatory hurdles such as complex report submissions, mandatory plant inspections, and bioequivalence studies substantially increase compliance costs, unintentionally becoming trade barriers.
Another main concern raised involves the mandatory inspection of Clinical Research Organizations (CROs) by Chile’s ISP, even when these facilities are already accredited by stringent international regulators. India has urged Chilean authorities to recognize such existing approvals to prevent duplication and unnecessary delays.
The Embassy sees this partnership as a dynamic step in enhancing healthcare collaboration with Chile and the wider Latin American and Caribbean region. Pharmexcil has requested that CENABAST share an inclusive list of required medicines, allowing Indian manufacturers to respond quickly. This initiative is expected to extend India-Chile pharmaceutical ties and support critical health outcomes for Chilean citizens.