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 Co...