DCC to set deadline for adding details on Sugam portal

DCC advocates for the expedited verification and approval of drug formulation details by respective State Drugs Control Authorities

The Health Master

April 1, 2024

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Last Updated on April 11, 2024 by The Health Master

DCC

The Drugs Consultative Committee (DCC) serves as the advisory arm of the Central government, offering guidance to both Central and state governments on the uniform implementation of drug laws across the nation.

In its latest move, the DCC has advocated for a crucial recommendation aimed at enhancing transparency and efficiency within the pharmaceutical sector.

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Background of the Sugam Portal

The Sugam portal, a cornerstone in the regulatory framework, was established to facilitate the seamless submission and management of crucial formulation details by pharmaceutical manufacturers.

Its inception marked a significant stride towards ensuring compliance with regulatory standards and streamlining the oversight process.

DCC’s Call to Action

Acknowledging the imperative need for up-to-date information, the DCC has urged all States to enforce a deadline for pharmaceutical companies to upload formulation details onto the Sugam portal.

This directive, following extensive consultations with industry stakeholders, underscores the commitment to fostering transparency and accountability.

Read and Download minutes of all meetings of DCC

Insights from the CDSCO’s Committee Report

On November 30, 2023, the Central Drugs Standard Control Organisation (CDSCO) presented a pivotal report advocating for the establishment of a comprehensive National Drugs Database.

This initiative aims to centralize information pertaining to drug formulations manufactured and marketed across the country, laying the foundation for enhanced regulatory oversight.

An Assessment by DCC

Despite the passage of nearly five years since the mandate to update formulation details on the Sugam portal, the DCC’s observation reveals a concerning gap in compliance.

Of the total drug formulations uploaded, a significant portion awaits verification and approval by State Licensing Authorities (SLA), raising pertinent questions regarding data integrity and regulatory adherence.

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Recommendations for Enhancing Data Verification

To address the prevailing challenges, the DCC advocates for the expedited verification and approval of drug formulation details by respective State Drugs Control Authorities.

Additionally, the committee underscores the importance of engaging appropriate agencies to facilitate the verification of legacy data, thus ensuring the integrity of the database.

Urgency of Establishing a Comprehensive Drug Database

The establishment of a comprehensive drug database holds multifaceted benefits, ranging from empowering consumers to bolstering regulatory efficacy.

By centralizing crucial information, such a database facilitates informed decision-making, strengthens monitoring mechanisms, and enhances overall drug quality and safety standards.

Government Initiatives

In alignment with the broader objective of promoting Ease of Doing Business, the government has initiated measures to consolidate regulatory activities through a unified IT platform.

This endeavor aims to harmonize disparate regulatory responsibilities and streamline data management processes, fostering a conducive environment for pharmaceutical innovation.

Unified IT Platform

Recognizing the inherent challenges posed by regulatory fragmentation, the government’s push for a unified IT platform signifies a pivotal step towards standardization and efficiency.

By integrating diverse datasets and streamlining regulatory workflows, this platform promises to revolutionize regulatory oversight and enhance transparency across the board.

Significance of a National Drug Database

A national drug database stands as a beacon of transparency and accountability, empowering stakeholders with comprehensive and real-time insights into the pharmaceutical landscape.

Beyond regulatory compliance, such a database serves as a cornerstone for fostering innovation, promoting public health, and safeguarding consumer interests.

Regulatory Provisions

Rule 84AB, a pivotal regulatory provision, mandates manufacturers to register and upload formulation details onto the Sugam portal.

This stipulation, coupled with stringent verification mechanisms, underscores the government’s commitment to upholding regulatory standards and ensuring accountability within the pharmaceutical ecosystem.

Realizing the Vision

The integration of real-time data holds transformative potential, enabling regulatory authorities to make informed decisions promptly.

By harnessing the power of technology, stakeholders can preemptively identify potential risks, streamline compliance processes, and uphold the highest standards of drug safety and efficacy.

Implications of Rule 84AB

Rule 84AB serves as a cornerstone in the regulatory framework, setting forth clear guidelines for manufacturers to adhere to.

Its implementation underscores the government’s unwavering commitment to fostering transparency, accountability, and regulatory compliance within the pharmaceutical sector.

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