Wholesaler Drug License Registration | Fees, Procedure and Documents Required

Updated on January 01, 2025 12:48:06 PM

Wholesale Drug license registration is a type of drug certification required for wholesalers of medicines and cosmetic products. Wholesalers are one who either sell or store such products in bulk. The Drug license is a mandatory compliance for all the wholesalers operating in the country. Objective of issuing drug licenses to wholesalers of drug and cosmetic products is to regulate the sale of generic and non generic medicines as well as cosmetic products in India and also to enhance trust of consumers in the existing market.

Drug license registration is an obligatory and mandatory compliance business dealing is to sell, store or manufacture medicines as well as for other traditional drug related businesses in India.

Let's dive into the legal framework governing the wholesale drug industry and highlight the government's initiatives to support and regulate this sector in India.

Wholesale Drug License Certificate Sample

  • Form-20B
  • Form-21B
Drug License Certificate Sample
Drug License Certificate Sample
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Wholesale Drug License Registration and its Importance?

Wholesale drug license certificate is a kind of authorization given to wholesalers of medicines and its allied products to sell and store and retail. It is an obligatory requirement by the government for the businesses that deal in the wholesale market. As per the guidelines prescribed under D&C act, applicants are needed to apply under form 19AA and other relative forms with central licensing authority to obtain drug license certification in India.

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Requirement to get wholesale drug license

  • Space is required for a physical shop
  • Must have a full-time qualified pharmacist or competent person
  • Proof of premises
  • Blueprint of premises
  • Invoice of all necessary types of equipment

These are the prerequisites that are required to start as a wholesaler in pharmaceutical business in India.

Classification of products under drug and controller act

Drugs are classified under the following categorie for sale in market

  • Medicines
  • Health Supplements
  • Nutraceuticals

Documents Required For wholesale Drug License Registration

These are the following documents that are needed to be attached for Wholesale drug license application.

  • General Documents
  • Documents required for Manufacturing License

General Documents

  1. Details of Applicant
  2. Copy of proprietorship/ Company Incorporation certificate
  3. Address proof and identity Proof of Proprietor/director

Documents required for wholesale License

  1. Key plan and site plan of the premises
  2. Affidavit of non-conviction regarding property respectively
  3. Affidavit from the registered pharmacist or competent person
  4. Proof of qualification is required
  5. Experience certificate is required
  6. Appointment letter and biodata of the competent person
  7. Proof of premises such as sale deed, utility bills, or rent agreement if rented
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Fee For Drug License Registration for wholesalers

The professional fee for a Wholesale drug license with Professional Utilities is INR 24,999/- only. Applicants are required to pay a government fee during the registration process.

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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 retail 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 the central licensing authority for registration.

Step 3 - Filing Application

Once documentation is completed a formal application will be filled under form 19A for Wholesale drug license 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 Wholesaler license. 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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At Professional Utilities, we leverage our industry knowledge and expertise to help businesses navigate complex regulations, minimize risks, and optimize operations for maximum efficiency and profitability.

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Conclusion

Wholesale Drug License is an important certification to have for the aggregator business model of drug and cosmetic products in India. As the drug industry is highly regulated and deals with public health and safety. It is mandatory for all the wholesalers of such products to get drug license certification from CLA for their business in India.

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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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