Drugs Controller Proposes ‘Single-window Online Portal’ to Regulate Medicines, Cosmetics, Medical Devices
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India’s apex health regulatory agency, the Central Drugs Standard Control Organisation (CDSCO), has proposed a groundbreaking initiative to create a single-window online portal for the regulation of medicines, cosmetics, and medical devices in the country. The idea was conceived during a ‘chintan shivir’ organized by the health ministry in February, and it aims to digitize and streamline the regulatory processes for these essential products.
Drugs Controller General of India (DCGI), Rajeev Raghuvanshi, who heads the CDSCO, has reached out to all stakeholders across states and union territories, urging them to support this initiative. The proposed online portal is envisioned as a “single window” and “single sign-on” system to address the challenges faced by stakeholders involved in regulatory activities.
The digital regulatory system (DRS) will serve as a comprehensive database, encompassing manufacturers, excipients, intermediate suppliers, marketers, and primary packing material suppliers, among others. It will also facilitate the registration and tracking of all vendors and stakeholders in the supply chain.
The system is expected to establish a master registration of drugs, creating an online database of all licensed entities and permitted products manufactured and sold in India. Additionally, the portal will gather extensive data on drug consumption concerning categories, quantities, regions, and seasons.
One of the primary objectives of the online portal is to maintain a database of substandard, spurious, adulterated, or misbranded products in the public domain. It will enhance interstate coordination to address issues related to non-standard quality medicines and combat the circulation of counterfeit drugs, facilitating investigations and prosecutions.
The proposal aims to measure and monitor the outcomes of vigilance and enforcement actions. The collected data will prove invaluable during emergency situations, including pandemics. Moreover, the system will feature a dedicated online ticket system to address complaints effectively.
An essential aspect of bringing the regulatory processes online is the integration of multiple government agencies responsible for drug licensing and permissions. This includes all state licensing authorities, the National Institute of Biologicals (NIB), Indian Council of Medical Research (ICMR), Atomic Energy Regulatory Board, Bureau of Indian Standards, and the Department of Consumer Affairs.
The shift from offline to online regulatory processes is driven by the central government’s commitment to ensuring the safety, efficacy, and quality of drugs available in the country. By digitizing the drug regulatory system, India aims to strengthen public health protection and safeguard the well-being of its citizens.
As the proposal moves forward, it presents a significant leap toward creating a more efficient, transparent, and unified regulatory environment for medicines, cosmetics, and medical devices in India.
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