Drug License Registration For Cosmetic In Haryana | Fees, Procedure, & Documents

Updated on July 06, 2024 06:15:12 PM

The process of obtaining a drug license for cosmetic products involves categorization for manufacturers, importers, and retailers. Given the rapid growth of the cosmetic industry in the country, regulation becomes imperative. Therefore, in compliance with the Drug and Cosmetic Act of 1945 and D&C Rule of 1940, it is mandatory for manufacturers, importers, and retailers of cosmetic products in Haryana to acquire a compulsory drug license for cosmetics.

Now, let's explore the legal framework governing the drug certification for manufacturers and importers of cosmetic products in Haryana and shed light on the government's initiatives supporting and regulating the manufacturing sector in the city.

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 Cosmetic Drug License In Haryana

These are the list of documents for cosmetic drug license registration In Haryana

  • General Documents
  • Documents required for Cosmetic Drug License In Haryana:

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 Cosmetic Drug License In Haryana:

  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 a 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 for retailers and wholesalers

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Fee Structure For Drug License Registration For Cosmetic in Haryana

The fee for a cosmetic drug license varies as per the type of registration:

Particular Fees
Wholesaler ₹24,999
Retailer ₹34,999
Manufacturing ₹49,999

Note: The government fee for license certification is not included in the above charges.

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Procedure For Drug License Registration for Cosmetic in Haryana

Step 1 - Account Creation for users

Initiate the drug license registration process with the central licensing authority for drugs and cosmetics by creating an online login user ID and password.

Step 2 - Documentation

After creating user login credentials, our experts verify all required documents before filing a formal application with the central licensing authority for registration.

Step 3 - Filing Application

Once documentation is complete, a formal application is filled under respective forms along with other relevant forms in its entirety.

Step 4 - Issuance of Certification

Licensing authorities conduct a formal inspection for authorization of the drug license certificate. The registration process takes approximately 30 days to complete.

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Benefits of Drug license certification

  • Legal Compliance: Acquiring a drug license in Haryana ensures adherence to legal requirements. The Drugs and Cosmetics Act of 1940 mandates a valid drug license for those involved in manufacturing, distributing, or selling drugs and pharmaceutical products. Failure to comply can result in legal consequences, demonstrating your commitment to operating within the bounds of the law.
  • Quality Assurance: Drug license registration in Haryana involves a rigorous evaluation of products and facilities. This scrutiny ensures that manufactured drugs meet specific quality standards, instilling confidence in consumers regarding the safety and efficacy of purchased pharmaceuticals.
  • Consumer Trust: Products that are legally approved and regulated inspire more trust in consumers. Possessing a drug license reflects a commitment to quality and safety, significantly enhancing your brand's reputation and fostering trust with customers, especially in the pharmaceutical industry.
  • Market Access: Many government tenders, hospitals, and medical institutions require suppliers to hold a valid drug license. Obtaining one expands market reach, providing access to a broader customer base, including government and institutional buyers.
  • Export Opportunities: Aspiring to export pharmaceutical products often requires a drug license as a prerequisite. International markets demand strict compliance with quality and safety standards, and a drug license facilitates entry into global markets, enhancing competitiveness.
  • Regulatory Support: Obtaining a drug license makes you part of a regulated industry, providing 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: Credibility is paramount in a highly competitive industry like pharmaceuticals. A drug license adds a layer of credibility, assuring partners, investors, and stakeholders of your legitimacy in the market.
  • Risk Mitigation: Operating without a drug license poses risks such as product seizures, legal penalties, and damage to your business's reputation. Obtaining a license reduces these risks, ensuring 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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