Drugs & Cosmetics Act, 1940 is a statue of Parliament of India. it is enforced to regulate the import of drugs, manufacturing & distribution of drugs in India. The main focus of this Act is to make sure the sale of drugs & cosmetics in India are safe , effective and are of good quality. Drugs & Cosmetic Rules, 1945 has all the related provisions and guidelines. Initially it was Drugs Act which was passed in 1940. Drugs Rules was passed in 1945. This Act of 1940 has undergone certain amendments and ends up in Drugs & Cosmetics Act, 1940. As per the Act, “Drug” includes a several substance, diagnostic and some medical device. “Cosmetic” means a product applied for the purpose of cleansing and beauty. This Act, also include Ayurveda and Unani Drugs.
Select a License Form according to the product. File an application based on same.
Visit the website and proceed through Online Registration for Drugs/ Cosmetics manufacturing.
Fill the form, and attach the necessary documents required for registration.
Also submit the hard copy of application form along with documents to Office of Food Safety and Drug Administration for the record.
If the application has made for the products which received approval under CLAA (Central Licence Approving Authority), then also submit the application form’s copy and documents to Zonal Office of Central Drugs Standard and Control Organization (CDSCO).
An inspection has to be conducted by Drugs Control Authorities on the scheduled date.
If any flaws, discrepancies are observed during inspection, applicant will be provided with one opportunity to remove the defects. The compliance report of same will be verified by Local Drugs Inspector.
If the authorities are satisfies will all the tests and reports, Licensing Authority will issue a License. Applicant may download it from Nivesh Mitra portal.
If the products has been approved by CLAA, a copy of license must be sent to Drugs Controller General (DCGI) for their approval. After getting this approval also, Licensing Authority will issue a License.
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