Drug License Registration for Cosmetics Products | Fees, Procedure and Documents Required

Updated on January 01, 2025 11:03:54 AM

Drug license registration for cosmetic products can be classified into few categories, such as for manufacturer, importer and retailer of the cosmetic products. As the cosmetic industry is one of the finest growing industries in the country. It has become a necessity to regulate it. Therefore under the drug and cosmetic act 1945 and D&C rule 1940. It is mandatory for manufacturers of cosmetic products, importers and retailers of cosmetic products to get an obligatory drug license for cosmetics for their businesses in India.

Let's dive into the legal framework governing the drug certification for manufacturers and importers of cosmetic products in India and highlight the government's initiatives to support and regulate the manufacturing sector in India.

Cosmetics Products Drug License Certificate Sample

  • Form-20B
  • Form-21B
Drug License Certificate Sample
Drug License Certificate Sample
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What is Drug License Registration for Cosmetics?

Drug licenses for cosmetics can be classified into the following categories.

  • For manufacturer for cosmetic products
  • For Importers of Cosmetic Products
  • For Retails of medical and Cosmetic Products

Under the rules of Drugs and Cosmetics 1945 it is mandatory for such businesses to obtain a drug license for cosmetic products in India as per the requirement of their business.

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Requirement to establish Drug license Registration of Cosmetic Products

  • Blueprint of manufacturing unit or minimum 100 sq ft area in the case of a retailer
  • Must have a qualified or competent person
  • Proof of premises
  • Detail of machines
  • Invoice of all necessary types of equipment

These are the prerequisites that are required to start a drug manufacturing business in India.

Documents Required For Drug License

These are the following documents that are needed to be attached for manufacturer drug license registration for cosmetic products.

  • General Documents
  • Documents required for Manufacturing License

General Documents

  1. Cover letter stating the purpose of company registration
  2. List of directors of the company
  3. Copy of Memorandum of Association (MoA) and Articles of Association (AoA) of the company
  4. Address proof and identity proof of directors
  5. Copy of resolution passed by the board of directors

Documents required for wholesale License

  1. Key plan and site plan in blueprint
  2. Declaration form duly filled
  3. Proof of possession of property, rent agreement (if rented)
  4. Proof of ownership such as copy of regd. GPA/ Sale-deed/ property tax receipt/ POA
  5. Affidavit of non-conviction
  6. List of equipment & machineries provided for manufacturing
  7. List of equipment for testing
  8. List of technical staff for manufacturing along with their self-certified photocopies of educational qualification and experience
  9. List of technical staff for testing along with their self-certified photocopies of educational qualification and experience
  10. Affidavit from employer and technical staff for full-time working with the firm

Note: The list of documents may differ in case of retailers and wholesalers.

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Fee For Drug License Registration For Cosmetic Products

The fee for a cosmetic drug license varies based on the type of registration you are going for.

Particular Professional Charges
Manufacturer ₹49,999
Retailer ₹34,999
Importer ₹49,999

Note: The govt free for license certification is not mentioned above.

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Procedure For Drug License Registration for wholesalers

Given below is the complete registration process of One Person company in India:

Step 1 - Account Creation for users

An online login user ID and password is created on the portal to initiate drug license registration process with central licensing authority for drug and cosmetics.

Step 2 - Documentation

After the creation of user login credentials, all the required documents for drug license will be verified by our expert before filing a formal application with central licensing authority for registration.

Step 3 - Filing Application

Once documentation is completed a formal application will be filled under respective forms along with other relevant forms in its entirety.

Step 4 - Issuance of Certification

A formal inspection will be held by licensing authorities for authorization for drug license certificate. The registration process would take around 30 days to complete.

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Benefits of Drug license certification

There are several benefits of a registering One Person Company in India, which are discussed below:

  • Legal Compliance: One of the primary benefits of acquiring a drug license in India is that it ensures legal compliance. The Drugs and Cosmetics Act, 1940, mandates that anyone involved in the manufacturing, distribution, or sale of drugs and pharmaceutical products must hold a valid drug license. Failing to do so can result in legal consequences. By obtaining the necessary license, you demonstrate your commitment to operating within the bounds of the law.
  • Quality Assurance: A drug license registration in India involves a rigorous evaluation of the products and the facilities where they are manufactured or stored. This scrutiny ensures that the drugs being produced meet specific quality standards. As a result, consumers can have confidence in the safety and efficacy of the pharmaceuticals they purchase, which is vital for any healthcare-related business.
  • Consumer Trust: Consumers tend to have more trust in products that are legally approved and regulated. Having a drug license displays a commitment to quality and safety. It can significantly enhance your brand's reputation and help you build trust with your customers, which is especially important in the pharmaceutical industry.
  • Market Access: Many government tenders, hospitals, and medical institutions require suppliers to have a valid drug license. Without it, you may miss out on lucrative business opportunities. By obtaining a drug license, you can expand your market reach and access a broader customer base, including government and institutional buyers.
  • Export Opportunities: If you have aspirations to export pharmaceutical products, a drug license is often a prerequisite. International markets demand strict compliance with quality and safety standards. A drug license can facilitate your entry into global markets, making your business more competitive.
  • Regulatory Support: Obtaining a drug license means you are part of a regulated industry. This can provide you with access to regulatory support and updates on industry best practices. Staying informed about changing regulations is crucial in the pharmaceutical sector, and a drug license keeps you in the loop.
  • Business Credibility: In a highly competitive industry like pharmaceuticals, credibility is everything. Having a drug license adds a layer of credibility to your business. It assures partners, investors, and stakeholders that you are a legitimate player in the market.
  • Risk Mitigation: Operating without a drug license carries the risk of product seizures, legal penalties, and damage to your business's reputation. By obtaining a license, you reduce these risks and ensure the smooth operation of your pharmaceutical business.
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Frequently Asked Questions

What kind of drug license is required for wholesalers in India?

Applicants are required to get a wholesale drug license from the central licensing authority under drug and controller act 1940, for their business by filing a formal application under form 19A respectively.

What is the fee for wholesale drug license?

The professional fee for wholesale drug license is INR 24,999/-

How Much Time Does it Take to Get a Drug License in India?

It takes around 30 working days to get drug license registration in India

Is having a drug license mandatory?

Yes, as per the guidelines of D&C rules 1945 any entity dealing in list of scheduled drugs are required to have drug license in India.

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