DTAB Recommends To Take Opinion From Ministry Of Ayush For Amendment Of Drugs Rules, 1945

New Delhi: The Drugs Technical Advisory Board (DTAB) has recommended to the regulator to take opinion of Ayush Ministry on amending the Drugs Rules, 1945 to incorporate provision for name of competent person-in-charge for homoeopathy wholesale sellers, in tune with the similar rules for manufacturers and retailers of the modern system of medicine.

The proposal is to amend the Drugs Rules for incorporating a provision in Form 20D for mentioning the name of competent person-in-charge as it is mentioned in Form 20C and Form 20E.

The Board, pursuant to its recommendation in its 82nd meeting on April 2, 2019 which supported the amendment, in its 90th meeting held earlier this year recommended to take opinion of the Ministry of Ayush for further consideration.

In the Drugs and Cosmetics Rules, 1945, there is a provision in Form 20C, that is, ‘Licence to sell, stock or exhibit or offer for sale, or distribute Homoeopathic medicines by retail’ and Form 20E, that is, ‘Certificate of Renewal of Licence to sell, stock or exhibit or offer for sale, or distribute Homoeopathic medicines’, to mention the name of competent person-in-charge.

However, the DTAB observed that no such provision is there in Form 20D i.e. ‘Licence to sell, stock or exhibit or offer for sale, or distribute Homoeopathic medicines by wholesale’. The Board received a representation from a State Drugs Controller for incorporation of the provision for mentioning the name of competent person-in-charge in Form 20D.

The matter was also deliberated in 55th Drugs Consultative Committee (DCC) meeting held on January 31, 2019 and February 1, 2019 and the DCC recommended for incorporating a provision in Form 20D for mentioning the name of competent person-in-charge in line with that in Form 20C and Form 20E.

The 82nd DTAB meeting agreed to amend the Drugs and Cosmetics Rules, 1945 to have provision.

The Board’s latest meeting was considering these proposals once again, as it was deliberating on certain proposals for which it had already shared recommendations to the concerned ministry for taking actions including publication of draft rules. The Ministry informed the Board that since several important notifications for amendments of rules under the Drugs and Cosmetics Act, 1940 have been issued after these recommendations, the DTAB recommendations may be critically reviewed and revised in the context of the updated rules and recent notifications.

Similarly, the meeting also agreed to the proposal to incorporate the provision for competent persons in Form 20B and Form 21B and for qualified person-in-charge in Form 20G under the Schedule A of the Drugs Rules, 1945.

The earlier DTAB meeting observed that licences to sell, stock or exhibit or offer for sale or distribute drugs by retail (in Form 20, Form 20F & Form 21) and wholesale (in Form 20B, Form 20G & Form 21B) are issued under the provisions of the Drugs and Cosmetics Rules,1945.

In the Drugs and Cosmetics Rules, 1945, there is a provision in Form 20, Form 20F & Form 21 to mention name of qualified person in-charge and in Form 21B to mention name of competent person. However such provision is not there in Form 20B and Form 20G, it added.

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