DCGI Issues Draft Guidance For Drugs Imports In Bulk For Non-Medicinal Use.

The office of the Drug Controller General of India (DCGI) has issued fresh draft guidance for the grant of permission for drugs imported in bulk for non-medicinal use as per Rule 43 of the Drugs and Cosmetics Rules with a view to ensure uniform implementation.

The draft, for which comments have been invited from the stakeholders, also lays down specific requirements to be fulfilled by the importer for grant of such permissions. Efforts are also made to identify the list of drugs intended for non-medicinal use with the help of stakeholders.

The guidance will cover all medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes.

“Such substances (other than food) intended to affect the structure or any function of the human body or intended to be  used for the destruction of [vermin] or insects which cause disease in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette. All substances intended for use as components of a drug including empty gelatin capsules and such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the  Central Government by notification in the Official Gazette, after consultation with the Board,” the draft said.

“The drugs specified in Schedule D shall be exempt from the provisions of Chapter III of the Act and of the Rules made there under to the extent, and subject to the conditions specified in that Schedule. All provisions of Chapter III of the Act and rules there under subject to the condition that if the substance is imported in bulk, the importer shall certify that the substance is imported for non-medicinal uses, and if imported otherwise than in bulk, each container shall bear a label indicating that the substance is not intended for medicinal use or is of commercial quality,” it said.

Source : pharmabiz.com