Government's Vision for a Unified Drug Regulatory Framework:

• The Health Ministry is considering the development of standardised regulations for drug regulators at both central and state levels. The plan also involves setting up a central database to improve the monitoring of pharmaceutical production, sales, and distribution.
• There is a concerted effort to ensure uniformity in the assessment and approval of drugs by aligning regulatory requirements, procedures, and databases across all states.

Current Regulatory Landscape:

• Under the existing system, the responsibility of issuing manufacturing licenses and regulating the drug sector is shared between central and state governments.
• The current system is fragmented, with 38 distinct regulators, each maintaining their own database.

Recent Concerns:

• There have been several instances where children have lost their lives after consuming drugs produced by Indian pharmaceutical companies.
• The World Health Organization (WHO) issued a medical product alert for four cough syrups manufactured and exported by an Indian pharmaceutical company, Maiden Pharma. The cough syrups are suspected to have caused the deaths of at least 70 children in The Gambia.

The Imperative for a New System:

• Currently, India does not have a unified public database that records violations by companies licensed under the Drugs And Cosmetics Act.
• Despite having 38 drug regulators, only three states – Gujarat, Maharashtra, and Kerala – maintain a consolidated database of their laboratory results.
• If a pharmaceutical company breaches regulations in one state, this information may not be communicated to other state or national regulatory bodies, such as the Central Drugs Standard Control Organization (CDSCO).
• In light of these issues, it is critical to ensure all manufacturing in the country, whether by MSMEs or larger pharmaceutical companies, adheres to Good Manufacturing Practices (GMP).

Anticipated System:

• The Ministry of Health and Family Welfare recently held a two-day “Chintan Shivir”, focusing on enhancing drug quality, regulation, and enforcement. The session facilitated the identification of challenges faced by the pharmaceutical industry and other stakeholders, setting the stage for a more effective regulatory system.
• India is in the process of developing a single-window portal, designed to serve as a hub for all key participants in the process, including regulators, manufacturers, distributors, state-run entities, and procurement agencies.
• The proposed integration of stakeholders like Central Drug Laboratories, state drug controllers, manufacturers, and others will be achieved by linking the existing IT portal of the Central Drugs Standard Control Organisation (CDSCO), the Sugam portal, with the new portal.

Potential Advantages:

• The new system will establish a common set of standards and regulations applicable across the nation.
• It will empower drug regulators across India to readily access information about the credentials of pharmaceutical companies and drugs.

Possible Obstacles:

• The proposal may face resistance due to India’s federal structure and the fact that healthcare is a state subject. The success of the initiative depends on the active cooperation of all stakeholders, including both central and state governments.
• Maintaining a central database could prove challenging if states do not provide accurate and timely data. Generating awareness and ensuring active participation from all states will require considerable time and effort.
• Despite these challenges, the implementation of the proposed system is crucial as it promises to significantly improve the regulatory landscape.