Nobody is entitled to manufacture cosmetics for distribution or sale by himself or on behalf of anyone else without a license obtained from the Drug Inspector. Manufacturing cosmetics refers to the process of synthesis of pharmaceutical drugs on the industrial scale in a pharmaceutical factory. Manufacturing drugs involve several processes like milling, coating, granulation and tablet pressing.
In connection to any drug, the term ‘Manufacture’ refers to the process of altering, making, breaking up, packing, labeling, finishing, ornamenting, adopting or treating a drug with the objective of distributing or selling it. The process does not include the dispensing or compounding of the drug, or the packaging of any cosmetic or drug for retail business.
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.
Follow these steps to obtain your manufacturing license for Cosmetics:
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.