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Now State Drug Controllers to have authority to issue STOP SALE order of Medicines: CDSCO to amend to rule


Now State Drug Controllers to have authority to issue STOP SALE order of Medicines: CDSCO to amend to rule

New Delhi: Empowering State Drug Controllers, the Government will soon amend Rule 66 of Drugs and Cosmetics (D&C) Rules, 1940 thereby granting them the authority to issue stop sale order to drug wholesalers and retailers for non-compliance of the rules of the act. Drugs Consultative Committee (DCC), functional under the Central Drugs Standard Control Organisation (CDSCO) has considered the proposal regarding the same.

The matter was put forth in a DCC meeting held recently wherein DCC was apprised that, as per Rule 85(2) the Licensing Authority for manufacturing are empowered to stop manufacturing, sale or distribution of the drug if in his opinion the licensee has failed to comply with any of the condition of the licence or with any provisions of the Act or rules made thereunder.

Also Read: CDSCO expert committee suggests ban of yet another 324 FDCs

It was proposed that similar provision shall be made for Licencing Authority for sale by amending Rule 66 in the following manner.

DCC deliberated the proposal and recommended for incorporating a provision under Rule 66 providing that the Licensing Authority may direct the licensee to stop sale or distribution of the drugs, if, in his opinion, the licensee has failed to comply with any of the conditions of the licence or any provisions of the Act or Rules made thereunder.

A proposal was also considered at DTAB to incorporate the provision for the name of competent person-in-charge in form 20D under schedule A of the D&C Rules, 1945.

The Board was apprised that, in the Drugs and Cosmetics Rules, 1945, there is a provision in Form 20C i.e. ‘Licence to sell, stock or exhibit or offer for sale, or distribute Homoeopathic medicines by retail’ and Form 20E i.e. ‘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 but 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’.

Representation was received from one of the State Drugs Controllers for the incorporation of the provision for mentioning the name of the competent person in charge in Form 20D.

The matter was deliberated in 55th DCC meeting 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. DTAB also deliberated the matter and agreed to amend the Drugs and Cosmetics Rules, 1945 to have provision to mention the name of the competent person in charge in Form 20D.

Also Read: Adverse Reactions: Cefotaxime, Oflaxicin, Cefixime told to carry Warning by CDSCO



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