In June 2025, the NPPA announced a review of the pricing structure for antidiabetic medications, including Gliclazide, to ensure affordability and accessibility. This review could impact domestic pricing strategies for Indian manufacturers.
In September 2025, the EMA updated its guidelines on bioequivalence studies for generic medicines, emphasizing stricter compliance requirements. This development is particularly relevant for Indian exporters targeting the EU market, necessitating adherence to enhanced regulatory standards.
In December 2025, the WHO released the 22nd edition of its Model List of Essential Medicines, reaffirming the inclusion of Gliclazide. This inclusion highlights the drug's continued significance in global health initiatives and may influence procurement policies in various countries.
In February 2026, the CDSCO issued a circular mandating periodic stability studies for all exported pharmaceuticals, including Gliclazide, to ensure product efficacy throughout its shelf life. This directive aims to bolster the quality assurance framework for Indian pharmaceutical exports.
In March 2026, the DGFT introduced an online portal for the streamlined issuance of export NOCs, reducing processing times and enhancing compliance tracking for pharmaceutical exports. This initiative is expected to facilitate smoother export operations for Indian manufacturers.
These developments reflect a dynamic regulatory environment, underscoring the need for Indian exporters to stay informed and compliant with evolving standards to maintain and expand their global market presence.
