Nobody is entitled to manufacture drugs for distribution or sale on behalf of other individuals or by himself or herself without a license, that the Drug Inspector issues. Manufacturing of drugs refers to the process of synthesizing pharmaceutical drugs on an industrial scale. The mechanism of manufacturing drugs can be segmented into a series of operations. This includes granulation, milling, tablet pressing, coating and others.
The term ‘manufacture’ in connection to any drug refers to the mechanism, or a part of the mechanism for altering, making, packing, finishing, ornamenting, breaking up, labelling, treating or adopting a drug in order to sell or distribute the same. However, the process does not involve the process of dispensing or compounding any drug. Neither does it include the packing of any cosmetic or drug in general retail business.
Follow these steps to obtain your manufacturing license for drugs:
Submit the entire application in the form of a hard copy to the respective office of Assistant Drugs Controller. Then, this is forwarded to the office of the Drugs Controller. (For biological and notified medical devices, the application has to be dispatched to CDSCO in Delhi or Chennai.
Authentication of the documents by the respective Drug Inspector (Senior or Regional).
After the documents are verified, the concerned Senior or Regional Drug Inspector will inspect the premises. For notified medical devices, the inspection will be jointly carried out by the State Drugs Controller & CDSCO.
Then the Drugs Controller issues the license for drug manufacturing. This depends on the inspection report’s recommendations. The State and Central Licensing Authorities issue the license, if you have notified biological and medical devices.
1. Application in the respective form (24/24A/24B/24C/27/27A)
2. Receipt of online registration fee payment of INR 7500
3. Premise plans
4. Technical staff’s declaration on testing and manufacturing
5. Necessary documents to prove their experience and qualification
6. Product details, along with their SOPs and records of master formulas (For renewal too, you have to submit approved product details)
7. For renewing licenses, you need to attach the original copy of the previous drug license
8. By paying INR 7500 as the license fee and the allopathic drug application (forms 25 and 27), you can obtain a maximum approval of ten products. The applicant has to pay INR 300 extra for more than 10 products.