Drug & Cosmetic License In India
- Obtain your Drug & Cosmetic License effortlessly with expert online filing and processing.
- Full DCGI/CDSCO compliance support, including documentation and form submission.
- Ensure smooth approvals to legally manufacture, distribute, or sell drugs and cosmetics.
Overview of Drug & Cosmetic License
The Central Drugs Standard Control Organisation (CDSCO) regulates the import, manufacture, distribution, and sale of drugs and cosmetics in India. The licensing system ensures that all drugs and cosmetic products meet the required quality and safety standards. Additionally, under Section 26B of the Drugs and Cosmetics Act, CDSCO has the authority to issue notifications to control, regulate, or restrict the manufacture of drugs in the public interest.
Drug and Cosmetic License
Drug License
A drug license is mandatory for any person or entity involved in the manufacture, sale, or distribution of drugs in India. This includes manufacturers, wholesalers, retailers, and traders. The license is issued by the Drugs Controller General of India (DCGI) or the Central Drugs Standard Control Organisation (CDSCO), ensuring compliance with the Drugs and Cosmetics Act, 1940.
Types of Drug Licenses:
Retail Drug License: Required for individuals or businesses selling drugs directly to consumers, such as pharmacies and chemist shops.
Wholesale Drug License: Required for entities involved in bulk trading, distribution, or supply of drugs to retailers or other businesses.
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 for Drug & Cosmetic License
Drug License
To obtain a drug license from the DCGI or CDSCO, applicants must submit the prescribed application form along with supporting documents. The required documents may vary depending on whether the license is for retail or wholesale. Commonly required documents include:
Proof of Identity and Address: For the applicant or business entity.
Proof of Premises: Ownership documents or a valid lease agreement for the place where drugs will be manufactured or sold.
Pharmacist Certificate: A certificate from a registered pharmacist, as applicable.
Fee: Payment of the prescribed license fee.
Cosmetic License
A cosmetic license is mandatory for any person or entity involved in manufacturing or importing cosmetics in India. This license is issued by the CDSCO. Applicants must submit the application form along with relevant documents. The exact requirements may vary depending on the type of cosmetic products, but commonly include:
Proof of Identity and Address: For the applicant or business entity.
Proof of Premises: Ownership documents or lease agreement for the place where cosmetics will be manufactured or stored.
Ingredient List: Detailed list of ingredients used in the cosmetics.
Stability Test Report: Demonstrating the safety and shelf-life of the product.
Fee: Payment of the prescribed license fee.
Classification / Types of Drug Licenses in India
Drug licenses in India are issued by the Drugs Controller General of India (DCGI) or the Central Drugs Standard Control Organisation (CDSCO). These licenses are required for various activities related to manufacturing, importing, distributing, or selling drugs. Below is a detailed classification:
1. Manufacturing Drug License
Required for any person or entity that manufactures drugs in India.
Key Requirements:
The manufacturing unit must be located in a suitable premises with adequate space, plant, and equipment.
Compliance with Good Manufacturing Practices (GMP) as prescribed by DCGI is mandatory.
The unit must employ competent technical staff, including at least one graduate in Pharmacy or Pharmaceutical Chemistry with a minimum of 18 months of practical experience in drug manufacturing.
The unit should have arrangements for testing drugs for strength, quality, and purity.
Separate licenses are required for each manufacturing unit if a company operates multiple factories at different locations.
Note: Traveling agents distributing free drug samples to medical professionals or institutions are not required to obtain a manufacturing license.
2. Import Drug License
Required for any person or entity that imports drugs into India.
Key Requirements:
Storage premises must have proper facilities to preserve the properties of imported drugs.
Patent or proprietary medicines must be imported in containers suitable for retail sale.
All consignments must be accompanied by an invoice detailing the manufacturer’s name, address, and quantity of drugs.
Importers must submit a declaration to the Drugs Controller for drugs not covered under mandatory licensing, signed by or on behalf of the manufacturer or importer.
3. Multi-Drug License
Required for businesses operating in multiple states or selling/storing drugs at more than one location.
Each place of sale or stock requires a separate license.
4. Sale Drug License
Required for wholesalers and retailers involved in drug distribution.
Categories:
Wholesale Drug License: For wholesalers selling drugs to retailers.
Retail Drug License: For retailers selling drugs directly to the public.
Restricted License for General Stores: For general stores selling a limited range of drugs.
5. Loan Drug License
Required for individuals or entities that do not have their own manufacturing facilities but wish to manufacture drugs using another licensed manufacturer’s premises.
Key Requirements:
Valid manufacturing license of the contracted manufacturer.
A written agreement with the licensed manufacturer allowing the use of their facilities.
Competent technical staff to manufacture drugs in compliance with GMP.
The license is valid for one year and can be renewed annually.
Documents Required for Drug & Cosmetic License
- Incorporation certificate of the company
- KYC documents of each director, partner, or proprietor
- Proof of premises such as rent agreement, electricity bill, or property tax receipt
- Site plan of the business premises
- KYC details of the technical person
- List of cosmetics with product sheets in the prescribed format, including composition formula
- Ownership details of the cosmetic brand, whether registered or under 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
Important Rules Governing the Drugs & Cosmetics Sector in India
The pharmaceutical and cosmetics industry in India is regulated through a set of rules and policies that ensure quality, safety, and ethical practices. Key regulations include:
1. Drugs and Cosmetics Rules, 1945
Regulate the import, manufacture, distribution, sale, and storage of drugs and cosmetics.
Specify drug classifications, storage conditions, sale and display guidelines, and prescription norms.
Outline procedures, forms, and fees for obtaining licenses to manufacture or sell drugs and cosmetics.
2. Medical Devices Rules, 2017
Govern the manufacture, import, sale, and distribution of medical devices.
Define medical devices and establish standards for quality and safety.
Specify registration and licensing requirements for medical devices.
3. New Drugs and Clinical Trials Rules, 2019
Regulate the development and testing of new drugs in India.
Lay down requirements for conducting clinical trials, including ethical considerations.
Detail the procedures for obtaining a clinical trial license.
4. Cosmetics Rules, 2020
Govern the manufacture, import, sale, and distribution of cosmetics in India.
Specify requirements for registration and licensing, along with quality and safety standards.
Outline labelling requirements for cosmetics to ensure consumer safety.
5. National Pharmaceutical Pricing Policy, 2012
Ensures availability of essential medicines at reasonable prices.
Provides a methodology for setting prices of essential drugs.
Specifies procedures for government procurement of medicines.
6. Drugs (Prices Control) Order, 2013 (DPCO 2013)
Determines the Maximum Retail Price (MRP) for specified essential drugs.
Requires manufacturers to display MRP on drug labels.
Ensures affordability and transparency in drug pricing.
Labelling Requirements for Imported Cosmetics in India
All imported cosmetics in India must comply with the labelling guidelines specified by the Central Drugs Standard Control Organisation (CDSCO). The label must include the following details clearly and legibly:
Registration Certificate Number
Display the registration certificate number issued by CDSCO on the label.
This number verifies that the cosmetic is legally registered in India.
Name and Address of Certificate Holder
Include the full name and address of the certificate holder, i.e., the person or entity responsible for the safety and quality of the cosmetic.
Name and Address of Manufacturer
Mention the full details of the manufacturer who produced the cosmetic.
Name of the Cosmetic
Clearly display the product’s name in a legible font.
Date of Manufacture and Expiry Date
Include both the manufacture date and the expiry date to inform consumers about the product’s safe usage period.
List of Ingredients
Provide a complete list of ingredients in descending order of weight.
This helps consumers identify any allergens or substances they may want to avoid.
Directions for Use
Clearly mention how the cosmetic should be used.
Instructions should be easy to understand to ensure safe usage.
Warnings, Cautions, or Special Directions
Display any necessary warnings or precautions, such as “for external use only” or other safety information.
This ensures consumer safety and regulatory compliance.
Why Choose FilingIndia?
FilingIndia simplifies the process of obtaining drug and cosmetic licenses for businesses in the pharmaceutical and cosmetics sector. Our expert team ensures a hassle-free, compliant, and timely licensing process.
Advantages of FilingIndia:
Expert Guidance: In-depth knowledge of CDSCO/DCGI regulations and documentation.
End-to-End Support: Assistance with application submission, documentation, and approvals.
Quick & Efficient: Minimise delays with accurate and complete applications.
Regulatory Compliance: Ensure adherence to all legal requirements for manufacturing, selling, or distributing drugs and cosmetics.
Peace of Mind: Focus on your business while we handle the licensing process.
With FilingIndia, get a trusted partner to navigate the regulatory landscape and secure your license efficiently.
Start and grow your business in India with FilingIndia’s expert support.
