India plans new bulk drug licence regime, supplier database to fix accountability

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 approach in the current common licensing system for raw materials and finished 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 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.As per the officials, a draft notification is in the works for this separate licensing regime for active pharmaceutical ingredients (APIs), including bulk drugs and advanced intermediates, which were valued at approximately $3.5 billion in FY25.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.“The lack of transparency in the raw material supply chain was highlighted by recent reports of cough syrups