India's drug regulatory agency, the Drugs Controller General of India (DCGI), has recently ordered a crackdown on marketers found to be associated with pharmaceutical manufacturers that are producing substandard or non-compliant drugs. This directive raises concerns about potential medicine shortages and the overall safety and reliability of pharmaceutical products in the Indian market.

The DCGI's order, issued on September 12, 2025, instructs state regulators to take strict action against marketers who are linked to manufacturers that have failed recent inspections. These inspections revealed significant violations and a lack of essential marketer information on medicine labels. The core message is that marketers can no longer avoid responsibility for drug quality; they will be held legally accountable.

This action follows increased scrutiny of India's pharmaceutical industry, with the DCGI having flagged numerous instances of substandard drugs, devices, and vaccines in recent months. These instances involved popular brands and treatments for common ailments, implicating major companies.

The DCGI's recent actions highlight the ongoing challenges within India's pharmaceutical regulatory framework. A study by the Max Institute of Healthcare Management at the Indian School of Business indicates that weak oversight has hampered India's success as a global drug manufacturer. While India produces a significant portion of the world's generic drugs, its regulatory system has been slow to catch up, with essential safeguards like good manufacturing practices and post-marketing surveillance only recently introduced.

The complexity of India's drug regulatory system also contributes to the problem. The Central Drugs Standard Control Organisation (CDSCO), the national regulatory body, lacks independence and is under the authority of the Health Ministry. State authorities also possess licensing powers, leading to overlapping jurisdictions and coordination issues.

The crackdown on non-compliant drug manufacturers and their marketers could lead to potential medicine shortages. Moreover, recent regulations restricting the export of pharmaceuticals labeled "For sale in India only" have already caused losses for exporters and limited access to affordable medicines for patients abroad. The Federation of Pharmaceutical and Allied Products Merchant Exporters (FPME) estimates losses of $500 million due to this rule and has asked for it to be repealed.

The Retail Distribution Chemist Alliance (RDCA) has also warned of potential medicine shortages across Delhi due to recent Goods and Services Tax (GST) reforms. These reforms have created financial challenges for distributors and small pharmacies, potentially disrupting the medicine supply chain.

To prevent medicine shortages and ensure drug quality, several measures can be considered. These include:

• Strengthening regulatory oversight: Improving inspection processes, increasing the number of qualified inspectors, and ensuring stricter enforcement of regulations are essential.
• Streamlining the regulatory framework: Addressing the complexity and fragmentation of the drug regulatory system by clarifying the roles and responsibilities of different agencies.
• Promoting good manufacturing practices: Ensuring that all pharmaceutical manufacturers adhere to good manufacturing practices (GMP) to maintain product quality.
• Enhancing post-marketing surveillance: Strengthening post-marketing surveillance to detect substandard drugs and take appropriate action.
• Addressing tax-related challenges: Implementing measures to ease the transition to the new GST regime and prevent financial distress for pharmacies and distributors.

The recent actions by the DCGI signal a commitment to improving drug quality and safety in India. However, addressing the underlying issues within the pharmaceutical regulatory framework and ensuring a smooth transition to new policies are crucial to prevent medicine shortages and protect public health.