Core Viewpoint - India's apex drug regulator plans to overhaul the Drugs and Cosmetics Act to increase punishments and fines for illegal diversion of pharmaceutical opioids, aiming to tighten oversight in the $50 billion pharmaceuticals market [1][2]. Regulatory Changes - The proposal includes increasing imprisonment duration from two years to a minimum of seven years and raising financial penalties from ₹20,000 to at least ₹5 lakh, aligning it with the stricter NDPS Act [2][4]. - The new regulations will make these offences cognizable and non-bailable, addressing the inadequacies of the current enforcement under the Drugs and Cosmetics Act [3][4]. Drug Categories and Misuse - The focus is on highly-regulated schedule H, H1, and X drugs, which account for 30% of high-value prescription antibiotics, psychotropics, and analgesics [5]. - Commonly misused drugs include codeine-based syrups, Alprazolam, Tramadol, and Zolpidem, which are often prescribed for anxiety, insomnia, and severe pain management [6]. Supply Chain and Compliance - A mandatory real-time tracking system for purchase orders will be implemented to secure the supply chain and prevent misuse [7][8]. - Drug manufacturers will be required to provide formal purchase orders and notify authorities upon dispatch of medicine batches [8]. Industry Concerns - Industry stakeholders express caution regarding the proposed regulations, arguing that they may lead to over-regulation and discourage compliance among manufacturers [19][22]. - The Indian Drugs Manufacturing Association (IDMA) claims that the additional monitoring provisions are unnecessary and could create regulatory confusion [20][21]. Market Impact - India's pharmaceutical sector is projected to grow to $130 billion by 2030 and $450 billion by 2047, highlighting the importance of balancing regulation with industry growth [23]. - Concerns have been raised that stringent regulations could reduce stock availability and affect patient access to essential medications [24].