[Answered] In the light of the recent controversy, highlight the shortcomings of the drug regulatory system of India.

Introduction:

Recent controversy regarding the manufacturing process of eye drops exported by Chennai-based Global Pharma has raised concerns about the drug regulatory system in India. The US FDA conducted a plant inspection and listed multiple negative observations, leading to a halt in imports of the eye drops. Independent inspections by Indian regulators, however, found that quality standards were met. The focus should be on the domestic evaluation process and the overall shortcomings of India’s drug regulatory system.

Shortcomings of the drug regulatory system of India:

• Fragmented regulatory framework: India’s regulatory system for licensing drug manufacture and quality control is split between the central government (GoI) and states, leading to a fragmented system.
• Varying quality supervision: The fragmented system provides arbitrage opportunities as the quality of supervision varies across states, affecting the overall consistency of regulatory norms.
• Inconsistent quality evaluation: The market for medicines in India is nationwide, but the quality evaluation process is not standardized. Different states employ different sampling methodologies, raising questions about the reliability of quality assessment.
• Lack of transparency: A study in 2016 revealed that apart from Kerala and Tamil Nadu, other states and the central government lacked satisfactory answers to Right to Information (RTI) questions on sampling, indicating a lack of transparency in the process.
• Shortage of drug inspectors: A 2020 report by Brookings India highlighted a nationwide shortage of drug inspectors, with their numbers failing to keep pace with the growth of the domestic pharmaceutical industry. This shortage hampers effective monitoring and regulation.

Way forward:

• Establish a unified regulatory system: The Indian government should work towards establishing a unified drug regulatory system that streamlines processes, eliminates arbitrage opportunities, and ensures consistent quality evaluation across all states.
• Strengthen transparency and accountability: Enhance transparency in the drug regulatory system by ensuring timely and accurate responses to RTI queries. This will promote accountability and build trust among consumers and stakeholders.
• Increase the number of drug inspectors: Address the shortage of drug inspectors by increasing their numbers to match the growth of the pharmaceutical industry. This will enable more effective monitoring and regulation of drug manufacturing processes.
• Enhance collaboration and coordination: Foster greater collaboration and coordination between the central government and state regulatory bodies to ensure a unified approach to drug regulation.

Conclusion:

In light of the recent controversy and the shortcomings of India’s drug regulatory system, comprehensive reforms are needed. A unified regulatory system, standardized sampling, transparency, more drug inspectors, and better collaboration are crucial for ensuring high-quality standards and protecting consumer health.