India's health ministry released draft amendments to the Drugs Rules, 1945, proposing easier drug import procedures and relaxed shelf-life norms for imported medicines. The changes aim to promote pharmaceutical research and development and improve ease of doing business, according to livemint.com. Under the proposal, applicants will submit prior intimation through an online portal and can import drugs once an acknowledgement is generated.
The draft amendments simplify compliance requirements for pharmaceutical companies and researchers by reducing paperwork and streamlining inventory management. The government intends to facilitate faster access to imported drugs for R&D purposes by allowing imports after a prior intimation rather than waiting for formal approvals. This approach is expected to reduce delays and administrative burdens faced by the industry, the health ministry said in the draft notification reported by livemint.com.
These regulatory changes come amid growing efforts to boost India's pharmaceutical sector, which plays a critical role in global drug supply chains. By easing import rules and shelf-life restrictions, the government aims to enhance innovation and competitiveness in drug development. The move aligns with broader initiatives to support India's position as a major pharmaceutical hub, complementing ongoing reforms in manufacturing and export policies, as detailed by livemint.com.
The draft amendments were published on June 26, 2026, and are open for stakeholder consultation before finalization, according to livemint.com. The next step involves feedback from industry and researchers, which will shape the final rules to be implemented by the health ministry.