Need for a Unified Licensing and Drug Approval System in India

This move aimed to streamline and digitize drug approval processes, creating a more efficient and transparent system.

March 12, 2024

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Last Updated on October 9, 2024 by The Health Master

Drug Approval

In the realm of healthcare regulation, the Drugs Technical Advisory Board (DTAB) has recently proposed a significant change—advocating for a single licensing and drug approval authority in India.

This move is aimed at addressing various concerns related to medication safety, patient rights, and the standardization of drug regulatory mechanisms across the country.

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Historical Context

Past Discussions on Centralized Drug Regulation

The call for a centralized drug regulatory mechanism is not a new conversation.

Over the years, incidents involving adverse reactions to Indian-made medicines, particularly cough syrups causing harm to children abroad, prompted discussions on the need for a more robust and uniform drug approval system.

Government Initiatives

As of February 2024, the central government explored options, including the creation of a centralized drug registration and quality checking system.

Industry leaders joined the discourse, proposing the merger of all State drug regulatory mechanisms with the Central Drugs Standard Control Organisation (CDSCO) to establish a single quality standard nationwide.

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Digital Transformation in Drug Approval Processes

The government’s initiatives extended to the digital realm, with the launch of the National Single Window System (NSWS) portal by the CDSCO earlier this year.

This move aimed to streamline and digitize drug approval processes, creating a more efficient and transparent system.

DTAB’s Recommendations

During a recent hybrid meeting, the DTAB put forward several recommendations to enhance medication safety and patient rights.

Centralized Online Register

The proposal included the creation of a central online register for all drugs and formulations available in the country.

This comprehensive database would facilitate better tracking and monitoring of pharmaceuticals.

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Patient-Friendly Medicine Names

Recognizing the importance of patient-friendly medicine names, the DTAB suggested the central online registration of drug (brand) names.

This step aims to simplify drug identification for consumers.

Stringent Regulatory Enforcement

To ensure the availability of high-quality medicines, the DTAB proposed strict enforcement of existing regulations, including Schedule H1, child-proof packaging, and adherence to labeling and packaging regulations.

Regulating Off-Label Use and Online Pharmacies

The proposal also emphasized the need to regulate off-label use of medicines and online pharmacies (e-pharmacies).

With the increasing prevalence of self-medication, these measures seek to safeguard patient health and prevent misuse of prescription drugs.

Patient Safety Rights

“Medication safety is increasingly being considered as a fundamental patient right and not as an option.

Every patient has the right to receive effective medication in the safest possible manner,” emphasized the DTAB during the meeting.

Addressing Self-Medication

The Board discussed the issue of self-medication and recommended that the Director General of Health Services’ (DGHS) office issue an advisory to the public.

This advisory would highlight the harmful and detrimental effects of self-medicating with prescription drugs, emphasizing the need for caution.

Same Brand Name Dilemma

The meeting delved into the intricate issue of different drugs sharing the same brand name, including those that look and sound alike.

The DTAB expressed concerns about patient safety and suggested that the matter be thoroughly deliberated during the Drugs Consultative Committee (DCC) meeting.

DGHS’s Role in Brand Name Implementation

The Board recommended the DGHS office to write a letter to the Trademark authority, stressing the strict implementation of brand names, especially concerning medicines.

This proactive step aims to avoid confusion and uphold patient safety.

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