Common License Types for Pharmaceutical Business in India

Based on the product or services of a Pharmaceutical business you can determine the kind of licence your business needs. Given below is the list of some common licenses in India for the trading or manufacturing of drugs. For any sort of for the discussion regarding your business please don’t hesitate in contacting us so that our expert can advise you appropriately.

RETAIL SALE DRUG LICENCE

Retail Sale Drug Licence: An applicant applies for a Retail Sale drug licence for the retail sale of any sort of drugs. The term “Retail Sale” means a purchase to the consumption of the end consumer. In addition, it is not meant for resale by the purchaser. Thus the purchaser isn’t required to possess a drug licence. The drug retailers could sell it to a dispensary, hospital, medical, educational or research institute, or any other person.

WHOLESALE DRUG LICENCE

Wholesale Drug Licence:It is a licence which a wholesaler of the Drug must possess. Wholesale means sale to an individual to further sell it; thus, the purchaser of these drugs must have either a wholesale or retail sale drug Licence. Wholesale may opt for Third party manufacturing. Third-party manufacturing implies the drugs manufactured as per the needs of a licenced manufacturer’s client, i.e. Wholesaler.

Moreover, such a manufacturer will require a brand affidavit before manufacturing any type of medicine under the brand name of Wholesaler. The product package will bear the manufacturer( Marketed by) and also the Wholesaler (Marketed by-). If a client places a requirement that needs the approval of the Drug controlling authority, the manufacturer is to actually take such approval before manufacturing those drugs.

MANUFACTURING LICENCE FOR DRUG

Manufacturing Licence for Drug: For manufacturing of Drug this license is required. Manufacture in Drugs implies any process or part of a process for labelling, making, altering, ornamenting, finishing, packing, breaking up, or otherwise treating or adopting any type of drug with the complete view to its sale or distribution.

LOAN LICENCE

Loan Licence: A licence for manufacturing the drug using the facility as well as premises of other manufactures is referred to as Loan Licence. A valid drug licence and surplus production capacity should be in possession of the manufacturer who provides its facility for the production of the drug.

IMPORT LICENCE

Import Licence: This is a licence that is required to import drugs in India. Import licence for drugs granted by CDSCO (Central Drug Standard Control Organisation).

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