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DTAB Suggests Setting Up a Single Licensing & Approval Authority for Drugs in India

Written by : Jayati Dubey

March 12, 2024

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Calls for centralized regulation in India surged due to reported adverse effects and fatalities abroad due to India-made medicines.

The Drugs Technical Advisory Board (DTAB) of the Union Health Ministry has proposed exploring the possibility of establishing a single licensing and approval authority for drugs in India.

During a recent meeting conducted in a hybrid mode, the DTAB deliberated on various regulatory aspects to enhance medication safety under patient safety rights.

The discussions included considerations for a centralized drug regulatory mechanism, addressing issues such as uniform brand names, self-medication, and the regulation of e-pharmacies.

Single Licensing & Approval Authority

In the meeting, the DTAB directed the Drugs Consultative Committee (DCC) to seek states' opinions in upcoming meetings regarding setting up a single licensing and approving authority for drugs across the country.

The idea of a centralized regulatory mechanism has been under consideration, especially following instances where Indian-made medicines, such as cough syrups, reportedly had adverse effects and led to fatalities in children overseas.

Reportedly, in February 2024, the central government was exploring various options, including creating a centralized drug registration and quality checking system.

This initiative aimed to monitor drug quality issues arising from different manufacturing sites across the country. Some industry leaders also advocated merging state drug regulatory mechanisms with the Central Drugs Standard Control Organization (CDSCO) to establish a single quality standard nationwide.

Centralized Approvals through National Single Window System

Efforts have been initiated to digitize processes and consolidate them under a single portal. Following this, CDSCO launched the National Single Window System (NSWS) portal at the beginning of the year, streamlining approval processes.

The DTAB, in its recent meeting, also supported the proposal to strengthen various regulatory activities related to patient safety.

This includes the creation of a central online register for all drugs and formulations available in the country, online registration of drug (brand) names, patient-friendly medicine names, and the enforcement of labeling and packaging regulations.

Further, the DTAB recommended several patient safety measures, emphasizing the need for a central online register of drugs, strict enforcement of regulations like Schedule H1, child-proof packaging, and ensuring the availability of high-quality medicines in the market.

The proposal also emphasized the regulation of off-label use of medicines and the need to regulate e-pharmacies or online pharmacies. Medication safety was also highlighted as a fundamental patient right, and the board stressed the importance of every patient receiving effective medication in the safest possible manner.

Self-medication Advisory & Brand Name Regulations

Deliberating on the issue of self-medication, the DTAB recommended that the Director General of Health Services (DGHS) office issue an advisory to the public, emphasizing the harmful and detrimental effects of self-medication with prescription drugs.

The issue of different drugs having the same brand name was also addressed, with the board suggesting that the manufacturing and marketing of different drugs under the same brand name should not be allowed for patient safety. This recommendation is set to be further deliberated in the DCC meeting.

Additionally, the Board recommended that the DGHS office write a letter to the Trademark Authority, urging strict implementation of brand names, especially concerning medicines. This move aims to ensure clarity and avoid confusion, safeguarding patient safety.

The DTAB's recommendations to explore the establishment of a single licensing and approval authority reflect the ongoing efforts to enhance drug regulation in India. As discussions progress, stakeholders anticipate further developments in India's drug regulatory landscape, aligning with evolving global standards.


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