Drug Licence and Registration is Mandatory for Drug Imports

[Ref: F.No. 450/11/2011-Cus.IV dated 25th February 2011]

Subject: Import of Vitamin ‘C’ and other bulk drugs by misdeclaration, in huge quantities, resulting into the loss to the National exchequer.

It has been brought to the notice of the Board by Ministry of Health & Family Welfare that mandatory requirements under Drugs & Cosmetic Act and Rules like drugs registration in Form 41 and Drugs Import Licence Form 10 are not being followed at the time of import of drugs/bulk drugs from unregistered sources in China and clearances of import consignments of drugs/bulk drugs are being allowed by Customs without obtaining NOC from the port offices of Central Drug Control Organisation (CDSCO)/Assistant Drugs Controller (ADC).

2. The Board has taken a serious note of this matter. Accordingly, it is decided that mandatory requirements under Drugs & Cosmetic Act and Rules like drugs registration in Form 41 and Drugs Import Licence Form 10 should be strictly complied with and NOC from CDSO/ADC port offices mandatorily obtained before allowing clearances of import consignments of drugs/bulk drugs.

3. These instructions may be brought to the notice of all the concerned officers by issuing suitable Standing orders/instructions. 

4. Difficulties faced, if any, in implementation of these instructions may please be brought to the notice of the Board.