Whalesbook
India is set to implement a new licensing framework for bulk drugs, active pharmaceutical ingredients (APIs), and key starting materials (KSMs). The significant overhaul aims to bolster drug safety and enhance accountability across the nation's pharmaceutical supply chain.
Addressing Safety Concerns
The move comes amid mounting scrutiny over drug safety lapses, including child deaths linked to Indian cough syrups in several countries. Over 70% of India's pharmaceutical raw material imports originate from China, a dependency the new regime seeks to monitor more closely. The country's $50 billion pharmaceutical market will see a dismantling of the current umbrella licensing approach.
Enhancing Traceability
Government officials confirmed that a draft notification is in preparation for this separate licensing regime. This will create a registry of approximately 1.2 million bulk drug traders, a database long sought by the Drugs Controller General of India (DCGI). The current system often lumps raw material licensing with finished medicine licensing, obscuring accountability for specific dealers.
Regulatory Overhaul Details
India's global standing has been affected by fatalities linked to cough syrups manufactured by domestic firms in countries like Uzbekistan and Gambia. The new licensing regime is designed to prevent such tragedies by improving oversight of the entire supply chain, including high-risk solvents used in drug formulations.
The current regulatory structure does not adequately distinguish between bulk drug dealers, who handle chemical processes for manufacturers, and formulation sellers, who interact with retailers and the public. Separate licenses will allow regulators to enforce stricter storage and handling protocols, making it easier to assign responsibility when quality issues arise.
Industry Perspective
Industry stakeholders, such as Namit Joshi of Pharmexcil, have highlighted the need for better supply chain intelligence. He emphasized that API quality is fundamental to formulation integrity. Experts like Akash Karmakar, a regulatory advisory partner, view the move positively, stating it addresses a critical gap and could improve ease of doing business for compliant entities, including foreign API manufacturers. R.K. Agrawal of BDMAI anticipates better accountability and reduced issues like pilferage of medicines in transit.