(a) whether permission of the Union Government is likely to be made compulsory for importing medicines to conduct trials
on human beings by researchers;
(b) if so, the details thereof; and
(c) the time by which it is likely to be implemented?
(a) whether permission of the Union Government is likely to be made compulsory for importing medicines to conduct trials
on human beings by researchers;
(b) if so, the details thereof; and
(c) the time by which it is likely to be implemented?
THE MINISTER OF STATE IN THE MINISTRY OF HEALTH & FAMILY WELFARE ( SMT. PANABAKA LAKSHMI)
(a) to (c): Under Rule 33 of Drugs and Cosmetics Rules relating to Import of drug for examination, test or analysis,
small quantities of drugs, the import of which is otherwise prohibited under Section 10 of the Act, may be imported for
the purpose of examination, test or analysis. The aplicant is required to make an application in Form-12 alongwith
prescribed fee for import of small quantities of drugs/medicines for clinical trial purpose. Drugs can be imported for
such purpose only after licence for the same is issued in form 11 under the Drugs and Cosmetics Rules.