The Drugs and Cosmetics Act is governed by Central Drugs Standard Control Organization (CDSCO) to regulate the import, manufacture, distribution and sale of drugs and cosmetics through licensing and to prevent substandard in drugs. Recently Many notifications issued under Section 26B of the D&C Act which empowers the CDSCO to control and regulate or restrict the manufacture of a drug in public interest. CDSCO Licensing Service offered comprises services handled by experienced industry professionals who have with the rich service and process experience to successfully handle the in-hand project consultation demands. Having an understanding of developing medical device markets, we ensure the consultation regarding medical device regulations is up to the latest legislation requirements.
DRUG AND COSMETIC LICENSE
Drug License: All manufacturers/retailers/traders that are directly or indirectly related in sale/purchase/manufacturing of medicines or involved in pharmacy business in India are required to obtain a drug license from the Drugs Controller General (India) or Central Drugs Standard Control Organization (CDSCO).Retail drug license is required to run a chemist shop and wholesale drug license is required for those who are engaged in the activities of wholesale of drugs and pharmaceutical products.
Cosmetic License: Every manufacturer of Cosmetics or importer of cosmetic have to obtain this license. The regulatory authority or body for Cosmetic Registration in India is the Central Drug Standard Control Organization (CDSCO).
DOCUMENTS REQUIRED FOR DRUG & COSMETIC LICENSE
The list of documents required for the Wholesale /Retail or sale drug and cosmetic License depends on the applicant’s type and business activity. Few important documents are as following:
- Incorporation Certificate of the Company
- KYC documents of each Director/Partner/ or Proprietor
- Proof of premises such as rent agreement, electricity bill, property tax receipt etc
- Site plan
- KYC details of Technical Person
- List of Cosmetics with Product sheets in specified proforma for approval of products along with their composition formula
- Ownership details of the brand of cosmetic whether it is registered or under trademark, if any
- Manufacturing Process description with flow diagrams. In-house specifications, where applicable; method of analysis of products. Copies of BIS where applicable
STEPS AND PROCEDURE OF REGISTRATION
- As there are different types of Drug and Cosmetic license and the type of license required depends on goods, services, activities and the nature of business. The applicant has to make application online in the requisite Forms as per the category mentioned below with fees and required documents:
- Form COS- 1: Application to obtain registration certificate for import of cosmetics
- Form COS- 3: Permission to import or manufacture new cosmetics in India
- Form COS-5: License to manufacture cosmetics for sale or for distribution
- Form COS-6: Loan license to manufacture cosmetics for sale or for distribution
- Form 8 & Form 8A: License to import drugs
- Form 19 & 19A: License to sell, stock or exhibit or offer for sale, or distribute of drugs
- Form 24: License to manufacture or distribution of drugs for sale purpose
- Form 24A: Loan license for Drugs
- Documentation for obtaining drug and cosmetic license is a crucial element in the whole process of licensing in India
- The applicant has to apply separate applications for each type of prescribed license via different forms mentioned above
- Scrutiny of application and Inspection of Factory premises takes place. The Drug Inspector visits the premises and verifies the particulars of application. A query is raised in case of any shortcoming / discrepancy
- Products Scrutiny also takes place. The Drug Inspector verifies details of the products applied on online application and if they are found to comply with the norms, the application will be considered for grant of license. Inspector may raise any clarification in the application
- After satisfactory verification, Drug Controller Department issues the License
- The drug control administration also provides the approval for technical staff as per Drugs and Cosmetics Rules, 1945 framed under the legislation abiding by the WHO and GMP inspection norms.