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

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.

However, some of the common documents required include:

• 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

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.

However, some of the common documents required include:

• 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.

To obtain a manufacturing drug license, the applicant must meet the following requirements:

• 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.

Travelling agents of licensed manufacturers and importers of drugs involved in the free distribution of samples of medicines among members of the medical profession, hospitals, dispensaries, and medical institutions or research institutions are not required to obtain a manufacturing drug license.

This license is required for any person or entity that imports drugs into India. The DCGI or CDSCO issues the license.

To obtain an import drug license, the applicant must meet the following requirements:

• The premises where the imported drugs will be stored must be equipped with proper storage accommodations for preserving the properties of the drugs.
• Patent or proprietary medicines must be imported in containers intended for retail sale.
• All consignments of drugs imported must be accompanied by an invoice or other statement containing the name and address of the manufacturer and the name and quantities of the drugs.
• The importer must submit a declaration to the Drugs Controller before importing any drugs not covered under mandatory licensing. The declaration should be signed by or on behalf of the manufacturer or importer.

• This license is required for any person or entity operating in multiple states. If drugs are sold or stocked for sale at more than one place, a separate license is required for each such place.

This license is required for wholesalers and retailers who are engaged in the distribution of drugs.

There are three categories of drug licenses:

• Wholesale drug license: This license is required for wholesalers who sell drugs to retailers.
• Retail drug license: This license is required for retailers who sell drugs to the public.
• Restricted license for general stores: This license is required for general stores that sell a limited range of drugs.

• This license is required for persons who do not have manufacturing facilities but want to manufacture drugs on the premises of another licensed manufacturer. The licensee can then sell the drugs under their brand name.

The loan drug license is valid for one year and can be renewed for subsequent years.

• The applicant must have a valid manufacturing license from the Drugs Controller General of India (DCGI) or the Central Drugs Standard Control Organization (CDSCO).
• The applicant must have a written agreement with the licensed manufacturer that allows them to use their facilities for drug manufacturing.
• The applicant must have a competent technical staff capable of manufacturing drugs per the good manufacturing practices (GMP) prescribed by the DCGI.

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.

However, some of the most common documents include:

• 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

The following are some of the important rules governing the drugs and cosmetics sector in India:

• 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.

Labelling Requirements on Imported Cosmetic

The following are the labelling requirements for imported cosmetics in India:

• Registration certificate number: The registration certificate number of the brand must be displayed on the label. This number is issued by the Central Drugs Standard Control Organisation (CDSCO).
• Name and address of certificate holder: The name and address of the certificate holder must also be displayed on the label. This is the person or entity who is responsible for the safety and quality of the cosmetic.
• Name and address of manufacturer: The name and address of the manufacturer must also be displayed on the label. This is the company that produced the cosmetics.
• Name of the cosmetic: The name of the cosmetic must be displayed on the label in a clear and legible manner.
• Date of manufacture/expiry: The date of manufacture and the expiry date must be displayed on the label. This information is important for consumers to know how long the cosmetic can be used safely.
• List of ingredients: The list of ingredients must be displayed on the label in descending order of weight. This information is important for consumers to know what ingredients are in the cosmetics and whether or not they are allergic to any of them.
• Adequate directions for use: Adequate directions for use must be displayed on the label. This information should be clear and easy to understand so that consumers know how to use the cosmetics safely.
• Any warning, caution or special directions: Any warning, caution, or special directions must also be displayed on the label. This information is important for consumers to know so that they can use the cosmetics safely.

Why Vakilsearch?

At Vakilsearch, we understand that obtaining drug and cosmetic licenses is a critical step for businesses in the pharmaceutical and cosmetic industry. While we offer a wide range of legal and business services, we believe that specialised service providers can bring unique advantages to your licensing process.

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