Only D.Pharm, B.Pharm, M.Pharm, Pharm.D Holders Can Be Drug Wholesalers: DTAB
New Delhi: The Drugs Technical Advisory Board (DTAB) has reaffirmed its recommendation to finalize amendment to Rule 64 of the Drugs Rules, 1945, which governs the qualifications required for a ‘competent person’ to hold a wholesale drug license (Form 20B, 21B, and 20G).
The proposed amendment would restrict the qualification for this role to those with a pharmacy background, such as individuals holding a D.Pharm, B.Pharm, M.Pharm, Pharm.D, or registered pharmacists.
The Rule 64 specifies the conditions to be satisfied before a licence in Form 20, 20B, 20F, 20G, 21 or 21B is granted or renewed. The second proviso to sub-rule (2) of this Rule specifies the requirements of the area and the qualification of the competent person for grant of license in Form 20B and 21B.
Under the present rules, the qualifications for a competent person also include a matriculation exam with four years of experience in drug sales, or a degree from a recognized university with one year of experience in dealing with drugs. The amendment seeks to remove these qualifications, limiting eligibility to those with formal pharmacy education.
The DTAB initially discussed this proposal in its 70th meeting on August 18, 2015, where it recommended deleting the broader qualifications under clauses (b) and (c) of the second proviso of sub-rule 64(2). Additionally, it was recommended that a protection clause be added to exempt individuals registered as competent persons before the final notification date from the new educational requirements.
In December 2016, a draft notification (G.S.R. 1179(E)) was published to amend Rule 64. However, the proposal was met with widespread opposition, with concerns raised about its impact on accessibility and the practical implementation of the new requirements. Following stakeholder feedback, the Ministry has sought further comments and inputs to reassess the proposal's feasibility.
In its latest review, DTAB has reiterated the need for this amendment to be finalized, citing the importance of strengthening the pharmaceutical supply chain and ensuring the quality, safety, and efficacy of drugs. The Central Government has also sought further comments and inputs on the matter before proceeding with the final notification.
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