India Import Licence

In India import, manufacturing, sale and distribution of Active Pharmaceutical Ingredients and finished dosage formulations is regulated under Drugs and Cosmetics Act 1940 and Rules 1945. Any substance falling within the definition of drug under the act, need to be registered before import into the country. The manufacturing site also has to be registered for import.

It includes all types of drugs which can be classified as under:

• Prescription drugs: It means the drugs for which prescription from the doctor is required. It includes both patented (branded) and non-patented drugs (generic).
• Prescription drugs: It means the drugs for which prescription from the doctor is required. It includes both patented (branded) and non-patented drugs (generic).

It includes all drugs providing symptomatic treatment or curing disease. These drugs may be oral, topical, subcutaneous, intramuscular & intravenous. These are drugs proposed to be used for the diagnosis, treatment, alleviation or avoidance of any disease or ailment. It includes drugs, both for human and veterinary use & all other substances which are considered as part of a drug such as empty gelatin capsules.

Information provided by Chemxpert for India Import licence :

• Product Name: It provides product name or the name of the active ingredient
• Import Licence Number: It provides licence or registration number of the importer.
• Importer Name: It provides the name of the Indian importing company
• Foreign Manufacturer: It provides the name of the foreign manufacturer/supplier from whom the importing company is buying the product.
• Import Licence Valid From: It provides the beginning date of the import licence.
• Import Licence Valid up to: It provides the beginning date of the import licence.

For example:

There are 5 registered suppliers with India Import licence for Paracetamol in our database. Information regarding one of them has been provided as under:

• Product Name: Folic Acid - Metamizole
• Import Licence Number: BD-628-15979
• Importer Name: Aarti Drugs Ltd.
• Foreign Manufacturer: Hebei Jiheng group
• Import Licence Valid From: 2010-01-25
• Import Licence Valid up to: 2012-10-31