The Crucial Role of Responsible Person in Pharma: DCC

This sub-committee aims to deliberate and submit a comprehensive report, specifically focusing on defining the role of a Responsible Person in Pharma

The Health Master

December 4, 2023

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Last Updated on December 21, 2023 by Hitesh Goyal

Responsible Person

In its recent 62nd meeting in September 2023, the Drugs Consultative Committee (DCC) took a significant step to enhance regulatory efficiency in the pharmaceutical sector for defining the role of a Responsible Person.

Under the guidance of Drugs Controller General (India) Dr. Rajeev Singh Raghuvanshi, the committee recommended the formation of a sub-committee.

This sub-committee aims to deliberate and submit a comprehensive report, specifically focusing on defining the role of a Responsible Person (RP) within individual licensee companies.

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Understanding the Need for a Responsible Person (RP)

The pharmaceutical industry operates under the umbrella of various licenses, including proprietary, partnership, and private limited.

However, the lack of a designated responsible person for day-to-day affairs within these firms has posed challenges for regulatory authorities.

The State Licensing Authority (SLA) or the Central Licensing Authority (CLA) often needs to issue critical notices, letters, and circulars.

Unfortunately, the absence of information on the responsible person can lead to delays in obtaining essential replies or information from the firms.

Read and Download minutes of all meetings of DCC

Challenges in Information Retrieval for NSQ Drugs

The complexity amplifies in cases involving Not of Standard Quality drugs (NSQ drugs).

Obtaining necessary information regarding the recall of the drug, acknowledging notices from drugs inspectors, and understanding the constitution of the firm becomes a daunting task.

The DCC recognized the pressing need for a single point of contact – a Responsible Person (RP) – to streamline communication and ensure timely responses.

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The Proposed Solution: RP as the Single Point of Contact

The Drugs Consultative Committee emphasizes that having an RP will significantly reduce delays in obtaining crucial information.

The RP would serve as the focal point for all notices, letters, and data issued by authorities for various purposes.

This strategic move aims to enhance transparency and responsiveness within the pharmaceutical licensing process.

Streamlining Communication with Licensing Authorities

By designating an RP, the committee envisions a smoother communication process between licensing authorities and pharmaceutical firms.

This includes serving notices, providing data, and responding to queries promptly.

The RP becomes the linchpin, ensuring that all communication is directed through a singular, accountable channel.

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Forming a Sub-Committee for Deliberation

To delve deeper into this crucial matter, the DCC has proposed the formation of a sub-committee.

This sub-committee will comprise regulators from:

Delhi,
Karnataka,
Andhra Pradesh,
and Ranga Chandrashekhar, Deputy Drugs Controller, CDSCO Baddi Zone, as the convenor.

The committee’s mandate is to deliberate on the intricacies of defining the RP’s role and submit a comprehensive report with recommendations.

Additional Sub-Committee Initiatives

In addition to defining the RP, the committee has also recognized the need for a uniform system for quick actions.

The current system of drug alerts through the central drug regulator’s website has shown inefficiencies.

Therefore, a separate sub-committee will be formed to establish a uniform Standard Operating Procedure (SOP) for administrative actions related to critical, major, and minor violations under the Drugs and Cosmetics Act and Rules.

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Collaborative Data Sharing: A Step Towards Transparency

During the meeting, a consensus was reached among all states to share data related to NSQ products on a monthly basis.

Timely data sharing, preferably before the 10th of each month, is seen as a crucial step.

The DCC recommends sharing a standardized format with State Licensing Authorities (SLAs) for the submission of NSQ details to the Central Drugs Standard Control Organisation (CDSCO).

Challenges with Spurious Products

The committee also addressed the challenges posed by spurious products circulating in the market.

The current system of website alerts with the manufacturer’s name alone was deemed insufficient for creating awareness.

The DCC stressed the importance of a robust and uniform system for quick actions, including information circulation on NSQ and spurious results.

Conclusion

In conclusion, the Drugs Consultative Committee’s recommendation to define a Responsible Person (RP) marks a pivotal moment in streamlining regulatory processes in the pharmaceutical sector.

The formation of sub-committees to address not only RP-related matters but also issues with spurious products and administrative actions reflects the committee’s commitment to transparency and efficiency.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

FAQs

What is the role of the Responsible Person (RP) in pharmaceutical licensing?
- The RP serves as a single point of contact for regulatory purposes, streamlining communication between licensing authorities and pharmaceutical firms.
Why is there a need for a sub-committee to deliberate on defining the RP’s role?
- The sub-committee ensures a thorough examination of the complexities involved and provides comprehensive recommendations for the pharmaceutical industry.
How will data sharing among states enhance regulatory transparency?
- Timely data sharing on NSQ products enables a proactive approach in addressing pharmaceutical challenges, fostering a transparent regulatory environment.
What actions are being taken to combat the circulation of spurious products?
- The committee is working on establishing a robust system for quick actions, including information circulation and suspension or cancellation of licenses for sale of spurious products.
How does the committee address delays in obtaining information related to not of standard quality (NSQ) drugs?
- Designating an RP ensures a prompt and efficient channel for communication, reducing delays in obtaining crucial information related to NSQ drugs.