India’s pharmaceutical exports crossed USD 31 billion in FY26, and with the government targeting USD 50 billion by 2030 as part of Bharat’s broader ambitions, regulatory strategy in this sector has become inseparable from commercial strategy.

Pharmaceutical and biotechnology companies operate under overlapping regulatory regimes drug licensing, clinical trial approvals, import and export controls, and patent law specific to biotech innovation. We advise companies in this sector on regulatory approvals from bodies such as the CDSCO, as well as on IP protection and commercial agreements. Given how tightly regulated drug development and distribution are in India, regulatory strategy in this sector is often inseparable from commercial strategy.