DCC: Insights from the Drugs Consultative Committee on NSQ Drugs

One of the key agendas discussed in the 63rd DCC meeting was the identification and blacklisting of manufacturers consistently producing NSQ drugs

The Health Master

March 21, 2024

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Last Updated on April 5, 2024 by The Health Master

DCC

In recent years, the Drugs Consultative Committee (DCC), established by the Central government, has been playing a pivotal role in advising both the Central and state governments on crucial matters pertaining to drug regulations in India.

The latest developments from the 63rd meeting of the DCC underscore the pressing need for concerted efforts to tackle issues related to the quality, procurement, and regulation of pharmaceuticals across the nation.

Download minutes of meeting of 63rd DCC

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Formation and Functioning of the DCC

The DCC serves as an advisory body, composed of experts and officials from the pharmaceutical sector, entrusted with the task of advising governmental agencies on matters related to drug regulation.

Chaired by the Drugs Controller General (India), the committee convenes periodically to deliberate on critical issues affecting the pharmaceutical landscape.

Addressing Quality Concerns: Blacklisting Manufacturers of NSQ Drugs

One of the key agendas discussed in the 63rd DCC meeting was the identification and blacklisting of manufacturers consistently producing not of standard quality (NSQ) drugs.

Read and Download minutes of all meetings of DCC

Improving Data Sharing Mechanisms Among States

The committee expressed concerns over the inadequate sharing of NSQ data by several states with the central authority.

Recognizing the importance of timely and comprehensive data sharing, the DCC urged all states to enhance their reporting mechanisms to facilitate the publication of crucial information on NSQ drugs on a centralized platform.

Strengthening State Drugs Testing Laboratories

Acknowledging the strain on Central Drugs Laboratories due to the influx of samples, the DCC emphasized the urgent need to upgrade and reinforce State Drugs Testing Laboratories.

With financial support from the central government, state authorities are encouraged to modernize their testing facilities to ensure efficient drug quality assessment.

Transition to Online Licensing Systems: The Role of ONDLS

In a significant move towards digitization, the DCGI mandated the transition to the Online National Drugs Licensing System (ONDLS) for processing license applications.

This shift aims to streamline the licensing process, eliminate paperwork, and enhance transparency in the issuance of licenses for blood centers and pharmaceutical establishments.

Ensuring Uniformity in Drug Enforcement: RBI

The DCC deliberated on the proposal to implement Risk-Based Inspection (RBI) of drug manufacturing sites, aiming to standardize enforcement practices across states.

By adopting a risk-based approach, regulatory authorities can prioritize inspections based on potential hazards, thus optimizing resource allocation and enhancing regulatory efficiency.

Regulation of Medical Devices

Recognizing the burgeoning importance of medical device regulation, the DCGI underscored the necessity of bolstering infrastructure and manpower in state regulatory bodies.

With medical devices emerging as a critical component of healthcare delivery, adequate regulatory oversight is imperative to ensure patient safety and efficacy.

Focus on Uniform Implementation of Drugs and Cosmetics Act and Rules

The 63rd DCC meeting reaffirmed the commitment to uniform implementation of the Drugs and Cosmetics Act and Rules across the country.

By fostering collaboration between central and state regulatory bodies, the committee aims to plug regulatory gaps, streamline enforcement mechanisms, and uphold the highest standards of drug quality and safety.

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