Section 160C in The Drugs and Cosmetics Rules, 1945
160C. Duration of approval.
- An approval granted in Form 47 or renewed in Form 49 unless sooner suspended or withdrawn, shall be valid for a period of three years from the date on which it is granted or renewed:Provided that if an application for the renewal of an approval in Form 40 is made before its expiry or if the application is made within six months of its expiry after the payment of the additional inspection fee, the approval shall continue to be in force until orders to the contrary are passed on the application and the approval shall be deemed to have expired if the application for renewal is not made within six months of expiry.
