Health ministry to amend Rule 66 of D&C Rules to authorise state DCs to issue stop sale order for non-compliance
The Union
health ministry will soon amend Rule 66 of Drugs and Cosmetics (D&C) Rules,
1940 to empower state drug controllers to issue stop sale order to drug
wholesalers and retailers for non-compliance.
Under Rule 66, currently state drug controllers cannot issue stop sale order on drug wholesalers and retailers for non-compliance as in the case of drug manufacturers on which the stop sale can be issued by the licensing authority without issuing show cause notice (SCN). As per Rule 66 currently, licensing authority can only suspend or cancel license after SCN has been served.
The licensing authority for manufacturing, as per Rule 85(2) of D&C Rules, are empowered to stop manufacturing, sale or distribution of the drug if in his/her opinion the licensee has failed to comply with any of the conditions of the license or with any provisions of the act or rules made thereunder.
Therefore, the Union health ministry has considered the proposal floated at the 55th Drug Consultative Committee (DCC) meeting held recently that similar provision should be made for licensing authority for sale by amending Rule 66 accordingly.
The matter was deliberated at the DCC meet and it was recommended to incorporate a provision under Rule 66 providing that the licensing authority to stop sale or distribution of the drugs, if, in his/her opinion, the licensee has failed to comply with any of the conditions of the license or any provisions of the act or rules made thereunder.
The Drug Technical Advisory Board (DTAB) of the ministry had also deliberated the matter and agreed to amend Rule 66 of the D&C Rules, 1945 for incorporating a provision to authorize the licensing authority to issue stop sale order of drugs.
The Drug Controller General of India (DCGI) had mandated risk-based inspections for all the Schedule M units in the country following notification for grant of licenses till perpetuity. The notification which is effective from October 27, 2017 says manufacturing and sale of licenses, once issued, shall remain valid forever unless suspended or cancelled by the licensing authority.
Union health ministry had notified D&C (Tenth Amendment) Rules, 2017 doing away with renewal of licenses for the manufacture, sale and distribution of pharmaceutical products every five years.
A proposal was also considered at DTAB to incorporate the provision for name of competent person-in-charge in form 20D under schedule A of the D&C Rules, 1945
DTAB was apprised that, in the D&C Rules, 1945, there is a provision in Form 20C i.e. ‘license to sell, stock or exhibit or offer for sale, or distribute homoeopathic medicines by retail’ and Form 20E i.e. ‘certificate of renewal of license 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. ‘license 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 incorporation of the provision for mentioning the name of competent person-incharge in Form 20D.
The matter was also 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 D&C rules to have provision to mention the name of the competent person-incharge in Form 20D.
Under Rule 66, currently state drug controllers cannot issue stop sale order on drug wholesalers and retailers for non-compliance as in the case of drug manufacturers on which the stop sale can be issued by the licensing authority without issuing show cause notice (SCN). As per Rule 66 currently, licensing authority can only suspend or cancel license after SCN has been served.
The licensing authority for manufacturing, as per Rule 85(2) of D&C Rules, are empowered to stop manufacturing, sale or distribution of the drug if in his/her opinion the licensee has failed to comply with any of the conditions of the license or with any provisions of the act or rules made thereunder.
Therefore, the Union health ministry has considered the proposal floated at the 55th Drug Consultative Committee (DCC) meeting held recently that similar provision should be made for licensing authority for sale by amending Rule 66 accordingly.
The matter was deliberated at the DCC meet and it was recommended to incorporate a provision under Rule 66 providing that the licensing authority to stop sale or distribution of the drugs, if, in his/her opinion, the licensee has failed to comply with any of the conditions of the license or any provisions of the act or rules made thereunder.
The Drug Technical Advisory Board (DTAB) of the ministry had also deliberated the matter and agreed to amend Rule 66 of the D&C Rules, 1945 for incorporating a provision to authorize the licensing authority to issue stop sale order of drugs.
The Drug Controller General of India (DCGI) had mandated risk-based inspections for all the Schedule M units in the country following notification for grant of licenses till perpetuity. The notification which is effective from October 27, 2017 says manufacturing and sale of licenses, once issued, shall remain valid forever unless suspended or cancelled by the licensing authority.
Union health ministry had notified D&C (Tenth Amendment) Rules, 2017 doing away with renewal of licenses for the manufacture, sale and distribution of pharmaceutical products every five years.
A proposal was also considered at DTAB to incorporate the provision for name of competent person-in-charge in form 20D under schedule A of the D&C Rules, 1945
DTAB was apprised that, in the D&C Rules, 1945, there is a provision in Form 20C i.e. ‘license to sell, stock or exhibit or offer for sale, or distribute homoeopathic medicines by retail’ and Form 20E i.e. ‘certificate of renewal of license 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. ‘license 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 incorporation of the provision for mentioning the name of competent person-incharge in Form 20D.
The matter was also 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 D&C rules to have provision to mention the name of the competent person-incharge in Form 20D.
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