New Delhi: The Drugs Technical Advisory Board (DTAB) has once again recommended the finalisation of the amendment of Rule 64 of the Drugs Rules, 1945, to restrict the qualification of the competent person eligible for holding the license for wholesale of drugs under Form 20B and 21B.
The Board, in its latest meeting held in August, observed that the amendment was issued through a draft notification in December, 2016, after an earlier recommendation, but has not been finalised.
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 licence in Form 20B and 21B.
The existing rules specifies that the competent person should be a registered pharmacist, or one who has passed the matriculation examination or its equivalent examination from a recognised Board with four years’ experience in dealing with sale of drugs, or one who holds a degree of a recognised university with one year’s experience in dealing with drugs.
The Board was considering a proposal to amend this proviso to restrict the qualification of the competent person to a person with pharmacy background only, such as D.Pharmacy, B.Pharmacy, M.Pharmacy and Pharm.D.
As per the proposal, clause (b) and (c), which are related to other qualifications such as matriculation examination or its equivalent examination from a recognised board with 4 years’ experience in dealing with sale of drugs, or degree of a recognised university with one year experience in dealing of drugs should be deleted from the Rules.
The matter was earlier considered in a meeting held by the Board in August, 2015, and recommended that the clause (b) and (c) of the second proviso may be deleted and a protection clause may also be provided that the academic qualification shall not apply to the persons already registered prior to the date of final notification.
A draft notification in this regard was published in December, 2016, but there were several issues raised from the stakeholders, due to which the said draft notification could not be finalised. The Board also said that “there was a concern about its desirability and accessibility.”
After examination of the stakeholders comments, the Central Government requested the Board to furnish comments and inputs in the matter.
The DTAB, after looking at the matter, “again recommended for the finalisation of the Draft” for amendment of the Rule 64, “to strengthen the supply chain for ensuring the quality, safety and efficacy of drugs.”
It may be noted that the Central Drugs Standard Control Organisation (CDSCO) has constituted a committee for revisiting the Rule 64, under Part VI of the Drugs Rules, pertaining to sale of drugs other than homoeopathic medicines “with regards to the present scenario”. The conditions of Rule 64 prescribes the conditions to be satisfied before a license in various forms related to sale of drugs is granted.
The Drugs Consultative Committee (DCC), which advises the Centre and the States on the matters that requires uniform implementation across the country, has also recently asked the committee formed by the CDSCO to revisit the Rule 64 of Drugs Rules, 1945, and place its report before the DCC for further discussion and consideration.
