DTAB recommends Stricter Qualifications for Wholesale Drug Licenses

Second proviso of sub-rule (2) defines the qualifications needed for a "competent person" eligible to hold a Form 20B or 21B wholesale drug license.

The Health Master

October 23, 2024

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Last Updated on November 8, 2024 by The Health Master

Wholesale

The Drugs Technical Advisory Board (DTAB), India’s highest body on technical drug matters, has reignited efforts to strengthen the drug supply chain by proposing stricter qualifications for wholesale drug licenses.

This move aims to enhance the safety and efficacy of medications reaching patients.

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Current Licensing Requirements under Rule 64

Rule 64 of the Drugs Rules, 1945, outlines the conditions for obtaining and renewing licenses for drug sales under various forms (20, 20B, 20F, 20G, 21, and 21B).

Specifically, the second proviso of sub-rule (2) defines the qualifications needed for a “competent person” eligible to hold a Form 20B or 21B wholesale drug license.

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Currently, the rules allow for three possible qualifications:

Registered Pharmacist: This is the most stringent qualification, ensuring the competent person possesses in-depth pharmaceutical knowledge.
Matriculation with Experience: Individuals with a matriculation certificate (equivalent to 10th grade) and four years of experience in drug sales are also eligible.
University Degree with Experience: Those holding a degree from a recognized university with one year of drug sales experience can qualify.

Read and Download Minutes of all meetings of DTAB

Proposed Changes: Focus on Pharmacy Background

The DTAB proposes amending the rule to restrict eligibility for a “competent person” to individuals with a pharmacy background only.

This includes qualifications like:

Diploma in Pharmacy (D.Pharm)
Bachelor of Pharmacy (B.Pharm)
Master of Pharmacy (M.Pharm)
Doctor of Pharmacy (Pharm.D)

By eliminating clauses (b) and (c) of the current rule, the amendment aims to ensure those in charge of wholesale drug operations possess a strong foundation in pharmaceutical sciences.

Previous Attempts and Stakeholder Concerns

This proposal isn’t entirely new.

In 2015, the DTAB made a similar recommendation, leading to a draft notification in December 2016.

However, stakeholders raised concerns about:

Desirability: Some questioned the need for such a significant change.
Accessibility: Others worried about the availability of qualified personnel, potentially hindering business operations.

These concerns resulted in the draft notification being shelved.

Re-examination and Path Forward

Following stakeholder feedback, the Central Government requested the DTAB’s renewed input.

After reviewing the matter, the DTAB has reiterated its recommendation for finalizing the amendment to Rule 64.

This move aligns with the ongoing efforts of the Central Drugs Standard Control Organisation (CDSCO) to revisit Rule 64.

A dedicated committee is examining the regulations “with regards to the present scenario” to ensure they remain effective in today’s drug market.

The Drugs Consultative Committee (DCC), which advises the central and state governments on drug regulations, has also requested the CDSCO committee to specifically address Rule 64.

Read and Download minutes of all meetings of DCC

These combined efforts highlight a growing focus on fortifying the drug supply chain in India, prioritizing the safety and efficacy of medications reaching consumers.

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