Of Tariffs Reform & Resilience

Despite being under the looming threat of higher US tariffs on medicine imports—possibly as steep as 200 per cent, the Indian pharmaceutical sector has reasons to stay optimistic.

- Dr Milind Kokje

One offers a potential escape route from US trade risks, and the other signals regulatory modernisation that could ease the way of doing business. The Central Drug Standards Control Organisation (CDSCO) is working on streamlining approval processes, setting fixed timelines, and exploring the use of Artificial Intelligence (AI) in regulatory functions. The goal is to make regulations lighter while strengthening enforcement—a much-needed shift, given India’s longstanding reputation as a country good at making laws but poor at implementing them. The intent was confirmed by none other than the Drugs Controller General of India (DCGI), Dr. Rajeev Raghuvanshi, in a recent media interview. While detailed plans are still awaited, even the prospect of simplified procedures and time-bound approvals may bring relief to the industry. India has repeatedly highlighted its commitment to improving the ease of doing business. Yet, in pharmaceuticals, regulatory bottlenecks remain a major hurdle. Strict oversight is essential considering the sector's sensitivity, but implementation challenges persist—particularly because regulatory enforcement lies with state-level Food and Drug Administrations (FDAs), many of which are severely understaffed.