The application for Registration and import can be made to the Licensing Authority under the Act i.e. to the Drugs Controller General at CDSCO. Drug and Cosmetic Act 1945: It Contains provisions for classification of drugs under given schedules. Guidelines for the storage,sale,display and prescription of each schedule.

1. IMPORT OF DRUGS: AN OVERVIEWS
Submitted by - Prachi Pandey*, Rahul Pal
M. Pharm (Pharmaceautics)
Department of Pharmaceutics, NIMS Institute of Pharmacy, NIMS University, Jaipur, Rajasthan, 303121

2. IMPORT OF DRUGS MEANS TO BRING DRUGS INTO
INDIA

3. CLASSES OF DRUGS WHICH ARE
PROHIBITED TO IMPORT
 Drugs which are:-
 Misbranded
 Spurious
 Adulterated
 Claim to cure or prevent any disease or ailment any disease (mentioned in schedule J)
 Whose import is prohibited by the rules

4. DRUGS AND COSMETICS WHOSE IMPORT IS
PERMITTED UNDER LICENSE
 Drugs mentioned in schedule C & C1
 Drugs mentioned in schedule X
 Drugs for test or analysis
 Drugs for personal use
 Drug which is new

5. CONDITIONS FOR GETTING LICENSE FOR THE
IMPORT OF SCHEDULE C & C1 DRUGS
 Licensee must have appropriate storage conditions for the import of drugs under schedule C &C1.
 Licensee must maintain the records for import of drugs.
 Licensee must allow the inspector to inspect the premises where imported drugs are stored.
 Licensee shall supply the samples of drugs for the examination / test or analysis.
 Licensee must comply with the undertaking given in form 9.

6. IMPORT OF SCHEDULE X DRUGS
 The license of import of schedule X drugs is granted under following conditions-
 Storage of imported drugs
 Storing conditions
 Note:
 The licensing authority may refuse to grant the license to the applicant if previously
granted license was cancelled or suspended
OR
 The applicant failed to comply with any provision of Drug and Cosmetics act

7. IMPORT OF SMALL QUANTITIES OF DRUG FOR TEST /
ANALYSIS
 Licensee must maintain records for the imported drugs.
 Licensee must use imported drug only for the purpose for which they are imported.
 Licensee must comply with the conditions as specified.
 Licensee must allow the inspector to inspect the storage area where the imported drugs are been kept.

8. IMPORT OF DRUGS FOR PERSONAL USE
 Small quantities of drugs are required to import for the personal use under following conditions:
 The drug should be exclusively for the personal use.
 The drug should be declared to the custom authority.
 The quantity of single drug should not exceed the limits as specified by the licensing authority.

9. IMPORT OF NEW DRUG
 No new drugs are allowed to import until the approval of licensing authority, or the import of new
drugs following documentary evidence are required.
 Evidence related to :
 Strength
 Purity
 Quality
 Clinical trials
 Safety

10. OFFENCES AND PENALITIES RELATED TO IMPORT OF
DRUG/COSMETIC
 In case of importing adulterated/ spurious drug or cosmetics
 Imprisonment up to 3 years or fine up to 5000 rupees or both on first conviction.
 Imprisonment up to 5 years or fine up to 10,000 rupees or both on subsequent conviction.

11. THE DRUG AND COSMETICS WHOSE IMPORT IS PROHIBITED
UNDER SECTION 10
 Punishable with imprisonment up to six month or fine up to 500 rupees or both
on first conviction.
 Punishable with imprisonment up to one year or fine up to 1000 rupees or both
on subsequent conviction.
SAMPLE FOOTER TEXT 20XX 11