New Delhi, Jan. 6 -- Facing mounting scrutiny over drug safety lapses, India is preparing an overhaul of its pharmaceutical licensing framework by introducing a separate wholesale licensing regime for bulk drugs, active pharmaceutical ingredients (APIs) and key starting materials (KSMs), according to three government officials and documents reviewed by Mint.

The proposed change aims to build a comprehensive database of bulk drug traders, improve traceability of imported raw materials, over 70% of which come from China, and allow regulators to quickly identify and hold accountable specific dealers involved in the supply of substandard inputs in India's $50-billion pharmaceutical market.

The new mechanism would dismantle the umbrella appr...