new delhi, Jan. 6 -- Facing mounting scrutiny over drug safety lapses, India is working to overhaul 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. A draft notification is in the works for a new licensing regime, the people cited above said on the condition of anonymity. This will dismantle the current common licensing system for raw materials andfinished medicines, give the Drugs Controller General of India (DCGI) a long-missing registry of nearly 1.2 million bulk drug traders, and significantly strengthen traceability and accountability in the country's pharmaceutical market. "The lack of transparency in the raw material supply chain was highlighted by recent reports of cough syrups contaminated with diethylene glycol, raising serious safety concerns. It is the need of the hour to monitor the supply chain and the quality of high-risk solvents, including propylene glycol used in formulations," said one of the three officials said on the condition of anonymity. 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 market for APIs, bulk drugs and advanced intermediates, was valued at approximately $3.5 billion in FY25. The government move comes in the backdrop of India's reputation as the 'Pharmacy of the World' taking a hit due to deaths of children in Uzbekistan, Gambia, Cameroon and India linked to cough syrups manufactured by Indian firms. While the total value for India's total pharmaceutical-related imports-including finished products-for FY24 was approximately $8.2 billion, bulk drugs remain the dominant share of this inflow data from the Directorate General of Commercial Intelligence and Statistics and commerce ministry shows. India's API market is projected to reach $38.13 billion by 2034, growing at a CAGR of 8.50% from 2025 to 2034, according to reports by research firms like Market Research Future....