Import of the Registered Drugs
1. When any drug registered in India a Certificate of Registration in the prescribed Form 41 is issued by the appropriate authority of the Central Government. When any person wants to import the registered drug, it is required to have import licenses by the appropriate authorities of the Central Government.
2. As per Rules 24 and 27 of the Drugs and Cosmetics Rules 1945, the import license to import drugs that are not specified in Schedule X to these Rules will be issued in the prescribed Form 10.
3. It will also apply to import of drugs which are specified in Schedule X to the Drugs and Cosmetics Rules, 1945. The import license will be issued in the prescribed Form 10A.
4. In India the drugs which are specified in Schedule X to the Drugs and Cosmetics Rules cannot be purchased over the counter without the prescription of a qualified doctor. Not only that the retailer also has to preserve the prescription for a period of two years.
Labeling on the Imported Consignment
On every import consignment of the registered drugs a label should be affixed showing the name and address of the manufacturer, date of manufacturing, batch number, date of expiry of the drug, name and address of the importer, import license number and date. (Form 10 or 10A).
Testing on Imported Drugs
1. As a safeguard, the Drug Controller office is at the Nominated Port where the import consignment arrives draws sample from the imported drug for testing to verify. It is checked that the drug which is being imported in India as a registered drug is the same drug that is actually registered in India or not.
2. The samples are sent for testing at the Central Drug Testing Laboratory of the Government of India. If the result of the testing comes to the satisfaction of the Drug Controller office the import consignment is given to the importer.
3. Import of any drug for the purpose of examination, test, or analysis in India is allowed subject to the import should be made against Test License issued by the appropriate authorities in the prescribed Form 11.
Import of the Unregistered Drugs
1. Unregistered drug means the drug which is not registered in India hence, no import license is issued consequently. The import of unregistered drug in India is not possible. However, there are various Drug Manufacturers Associations which have granted exemption from registration requirement under the Drugs and Cosmetics Act.
2. The import of unregistered drug made under Advance Authorisation (Advance License). The Government of India Ministry of Commerce and Industries has by Policy Circulars made a provision that no registration is required if the unregistered drug imported under the Advance Authorisation.
Those are subjected to the following conditions:
A) The Advance Authorisation has to be issued against valid export orders and to the extent raw material (Imported Drug) required to manufacture the final product which has to be exported.
B) The final product which is to be exported must be manufactured from the unregistered drug which has been imported under the advance authorization.
C) The export has to be made within 12 months from the date of the First import made under the advance authorization.
D) The export of the final products made out of the drug so imported under the authorization to the same buyer against whose export order the advance authorization is issued.
E) If the raw material is not possible to be utilized for manufacturing the final products which are to be exported the imported material can be used in any other products which are to be exported.
F) If it is not possible to manufacture the final product from the imported materials the imported material should be re-exported.
G) If re-export of imported material is not possible the same should be destroyed in presence of Jurisdictional Excise Authority.
H) The advance authorization holder is required to submit documentary evidence regarding such destruction of the imported raw material or the final product manufactured from the imported material.
I) The advance authorization holder has to pay applicable customs duty on the imported material against such Export Obligation is not fulfilled along with applicable interest.
For availability of safe, effective, and quality drugs, medical devices based on the scientific excellence and best possible regulatory practices the imported material under the advance authorization which is unregistered in India is not allowed to be diverted for the domestic consumption within India.
Import of Excipient
1. Import of any drug some substance is used for coloring or as preservative or as filler or diluter. The substance is not active in the drug in which it is used but works as vehicle or medium for the drug or other active substances. This substance which is so used it is called excipient.
2. Excipient can be imported in India without any import license issued under the Drug and Cosmetics Act 1940. However, no objection certificate (NOC) issued by the Drug Controller Office in India is required for import of such excipient. A copy of the NOC is sent to the Drug Controller Office at the port where the imported cargo is to have arrived.
3. No testing is required of the material imported as an excipient. The NOC issuing authority will mention in the NOC name and address of the manufacturer, name and quantity of the item to be imported and an instruction that Not for Medicinal use.
For more information on this visit TAXAJ
Posted by Aashima
Team TaxaJ