The Drugs Technical Advisory Board (DTAB) has once again recommended that a Registered Pharmacist should be the required qualification for a competent person for wholesale drug licences in Form 20B and Form 21B under Rule 64 of the Drugs Rules, 1945. The recommendation was recorded during the 94th meeting of the DTAB, following detailed re-deliberation on the proposal to amend the qualification requirements for competent persons responsible for wholesale drug licences.
The matter has been under consideration for several years. The Central Government had earlier published draft notification G.S.R. 1179(E) dated December 28, 2016, proposing an amendment to Rule 64 under which the competent person for wholesale licences in Form 20B and 21B would be required to be a Registered Pharmacist. However, the draft notification could not be finalised within the stipulated period because a large number of issues and representations were raised by stakeholders.
The proposal was subsequently considered again during the 91st DTAB meeting held on August 14, 2024. After deliberation, DTAB recommended finalisation of the draft G.S.R. 1179(E) to amend Rule 64, stating that the proposed change would help strengthen the drug supply chain and support the quality, safety and efficacy of medicines.
The matter was again taken up during the 93rd DTAB meeting held on February 16, 2026. At that meeting, DTAB had considered a broader qualification proposal under which a competent person could be a Registered Pharmacist or a person holding a Science degree with two years of experience in dealing with drugs, along with a six-month online certificate course recognised by bodies such as the Pharmacy Council of India (PCI), NIPER or a Skill Development Council. Following this recommendation, a large number of representations were received from stakeholders.
DTAB has now re-deliberated the proposal in detail. After considering the representations and the availability of pharmacists in the country, the Board recommended that the qualification of the competent person for wholesale drug licences should be a Registered Pharmacist. The Board accordingly recommended that the Drugs Rules, 1945, be amended suitably to incorporate the qualification and that the earlier draft notification G.S.R. 1179(E) dated December 28, 2016 may be finalised.
The recommendation is significant for pharmacists because it could establish the Registered Pharmacist qualification as the prescribed requirement for the competent person associated with wholesale drug licences in Form 20B and 21B, if the Government proceeds with the proposed amendment and issues the final notification.
It is important to note that the DTAB recommendation itself is not the final amendment to the Drugs Rules. The proposal would still need to go through the applicable government rule-making process, including finalisation and publication of the amendment in the Official Gazette, before the amended requirement becomes legally effective.
