To start a Pharmacy business you will need to choose or create a business idea. While this is a...
A company/ distributor/independent agent, in order to be an authorized Indian agent to deal with the local/foreign drugs and cosmetic, should have a drug manufacturing license from the Central Drugs Standards Control Organizations. The application for such license is made as per Rule 27 to the State Drug Licensing Authority, Central Drugs Standards Control Organizations and Drugs Controller General of India.
Drug license for sale or distribution of drugs is granted by the Central License Approving Authority. In case of other drugs, application for grant or for license renewal to manufacture for sale or for distribution should be made to the licensing authority, appointed by the state government.
Drugs can also be manufactured after obtaining a loan license under the Act and rules framed. As per Rule 69A, a loan license refers to a license which is issued by the licensing authority to an applicant who seeks to avail the manufacturing facilities owned by a licensee under Form 25A. The license to manufacture for sale, or distribution of drugs is valid for 5 years unless suspended or cancelled by the licensing authority.
We have discussed some types of manufacturing licenses, and forms in the table made below:
|LICENSE NAME||DESCRIPTION||LICENSING AUTHORITY||TIMELINE|
|Test License for manufacturing||Form-29 is a license for manufacturing drugs for examination and analysis purpose. The applicant cannot manufacture anything apart from examination, testing and analysis purpose in the manufacturing site proposed.||DGCI||Between 3 to 6 months period|
|License to manufacture post successful clinical trial||The license is granted under Form 46 when an application is made to permit manufacturing for sale of the medical devices that are new in the market without conducting clinical trials.||DGCI||6 months|
|License to manufacture notified Medical devices||This is required for the manufacturing of Disposable Hypodermic Syringes, Needles etc.||DGCI and also state drug licensing authority||Between 3 to 6 months period|
|Loan License||For manufacturing of notified devices in the third party site requires loan license.||DGCI and also state drug licensing authority||Between 3 to 6 months period|
The procedure is as follows:
The following documents are required-
The following conditions should be noted:
Due diligence should be undertaken by companies and entities before entering into the Pharmaceutical Industry of India. Further, timelines for renewal of license is also crucial. If an application for the renewal of drug manufacturing license is made before its expiry or if the application is made in 6 months of its expiry, the license continues to be in force.
Read our article: Do You Want to Start a Pharmacy Business in India? Obtain Drug License!