Drug & Cosmetic License

Overview Drug & Cosmetic License

The Central Drugs Standard Control Organisation (CDSCO) regulates the import, manufacture, distribution, and sale of drugs and cosmetics in India. This is done through a licensing system that ensures that all drugs and cosmetics meet the required quality standards. The CDSCO also has the power to issue notifications under Section 26B of the Drugs and Cosmetics Act, which allows them to control and regulate or restrict drug manufacture in the public interest.

Drug and Cosmetic License

Drug License

A drug license is required for any person or entity involved in selling, purchasing, or manufacturing drugs in India. This includes manufacturers, retailers, and traders. The Drugs Controller General of India (DCGI) or the Central Drugs Standard Control Organisation (CDSCO) issued the drug license.

Documents Required

The applicant must submit an application form to the DCGI or CDSCO and the required documents to obtain a drug license. The documents required may vary depending on the type of license being applied for.

• ➜ Proof of identity and address
• ➜ Proof of ownership or lease of the premises where the drugs will be sold or manufactured
• ➜ A certificate from a registered pharmacist
• ➜ A fee

Cosmetic License

A cosmetic license is required for any person or entity that manufactures or imports cosmetics in India. The CDSCO issues the cosmetic license. The applicant must submit an application form to the CDSCO and the required documents to obtain a cosmetic license. The documents required may vary depending on the type of cosmetics being manufactured or imported.

• ➜ Proof of identity and address
• ➜ Proof of ownership or lease of the premises where the cosmetics will be manufactured or stored
• ➜ A list of ingredients used in the cosmetics
• ➜ A stability test report
• ➜ A fee

Classification or Types of Drugs License

This license is required for any person or entity that manufactures drugs in India. The Drugs Controller General of India (DCGI) or the Central Drugs Standard Control Organisation (CDSCO) issued the license.

• ➜ The manufacturing unit must be located in a suitable place. It must have adequate space, plant, and equipment for the manufacturing operations.
• ➜ The manufacturing unit must comply with the good practices (GMP) the DCGI prescribes.
• ➜ The manufacturing unit must have a competent technical staff, including at least one who is a Pharmacy or Pharmaceutical Chemistry graduate with at least 18 months of practical experience in drug manufacturing.
• ➜ The manufacturing unit must have separate arrangements for tests for the drugs' strength, quality, and purity.
• ➜ Suppose a single manufacturer has two or more factories situated in different locations for manufacturing the same or different drugs. In that case, each such factory will require a separate license.

Documents Required for Drug & Cosmetic License

The documents required for a drug and cosmetic license vary depending on the type of business and the regulatory authority.

• ➜ Incorporation certificate of the company
• ➜ KYC documents of each director, partner, or proprietor
• ➜ Proof of premises, such as a rent agreement, electricity bill, or property tax receipt
• ➜ Site plan
• ➜ KYC details of the technical person
• ➜ List of cosmetics with product sheets in a specified format, including the composition formula
• ➜ Ownership details of the brand of cosmetic, whether it is registered or under a trademark
• ➜ Manufacturing process description with flow diagrams
• ➜ In-house specifications, where applicable
• ➜ Method of analysis of products
• ➜ Copies of BIS (Bureau of Indian Standards) certificates, where applicable