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Drug & Cosmetic License

Get your drug license without much hassle.

DCGI/ CDSCO compliances support, filling and documentation done

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.

There are two types of drug licenses:

  • Retail
  • Wholesale

A retail drug license is required to run a chemist shop. In contrast, a wholesale drug license is required to sell drugs and pharmaceutical products.

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

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.

  • ncorporation 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

List of Important Rules

  • Drugs and Cosmetics Rules, 1945: These rules regulate the import, manufacture, distribution, sale, and storage of drugs and cosmetics in India. They also specify the classification of drugs, guidelines for their storage, sale, display, and prescription, and the procedures, forms, and fees involved in obtaining a license to manufacture or sell drugs and cosmetics.
  • Medical Devices Rules, 2017: These rules regulate the manufacture, import, sale, and distribution of medical devices in India. They define medical devices, specify their registration and licensing requirements, and set standards for their quality and safety.
  • New Drugs and Clinical Trials Rules, 2019: These rules regulate the developing and testing of new drugs in India. They specify the requirements for conducting clinical trials, the ethical considerations involved, and the procedures for obtaining a clinical trial license.
  • Cosmetics Rules, 2020: These rules regulate the manufacture, import, sale, and distribution of cosmetics in India. They specify the requirements for the registration and licensing of cosmetics, their quality and safety standards, and the labelling requirements.
  • National Pharmaceutical Pricing Policy 2012: This policy aims to ensure the availability of essential medicines at reasonable prices. It specifies the methodology for setting the prices of essential medicines and the procedures for their procurement by the government.
  • Drugs (Prices Control) Order, 2013: This order specifies certain essential drugs' maximum retail price (MRP). It requires manufacturers to display the MRP on the label of the drug container.

Drug & Cosmatic Registration FAQS

Drug and Cosmetic registration refers to the process of obtaining approval from regulatory authorities for the manufacture, import, sale, or distribution of drugs and cosmetic products to ensure their safety, efficacy, and quality.

The form used to apply for a license to manufacture new drugs is Form 44. The form must be submitted to the Drugs Controller General of India (DCGI).

The form used to grant a license to manufacture new drugs is Form 46. The form is issued by the DCGI.

The concerned applicant for a license to manufacture new drugs is the manufacturer of the new drug.

The purpose of a license to manufacture new drugs is to ensure that the drugs are manufactured in a safe and controlled environment. The license also ensures that the drugs meet the required standards of quality and efficacy.

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