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Drug License Registration for Manufacturers

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Manufacturing Drug License Certificate Sample

Drug License registration for manufacturers | Fees, Procedure and Documents Required.

Drug license registration is a type of certification required for manufacturers of Drug and cosmetic products in India. It is mandatory for all the drug manufacturers and producers of drugs. The objective of issuing a drug license for manufacturing of medicines and cosmetics is to regulate and quality control the production of the generic and non generic drugs in the country. and also to enhance trust of consumers in the market locally and in the international market.

Drug license registration is an obligatory and mandatory compliance for the manufacturers of medicines and cosmetics as well as for other traditional drug related businesses in India. India being the world’s pharmacy it’s become very important for authorities to regulate this sector to maintain quality and credibility of the Indian drug manufacturing sector globally. Hence Drug license certification is a crucial step for all the manufacturers of medicines.

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

Overview

What is manufacturers Drug License Registration?

Manufacturing Drug license certificate is a type of registration or permission granted to drug and cosmetic manufacturers in India by drug controller authorities to manufacture medicines in the country. Certification is a statutory obligation for all under the D&C act and rule. Manufacturers are required to file applications under form 24, 24A, 24B for manufacturing drug licenses.

Requirement to start establish drug manufacturing unit in India

  • 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.

Classification of products under drug and controller act

Drugs are classified under the following categories.

  • Medicines
  • Health Supplements
  • Nutraceuticals

Documents Required For Drug License for Manufacturer

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

General Documents

  1. Cover Letter Stating Purpose
  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 Manufacturing 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

Procedure For Drug License Registration for wholesalers

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 retail 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 form 19A for retail 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 retail license for medical shops. The registration process would take around 30 days to complete.

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.

Conclusion

Manufacturers of drug and cosmetic products are required to authorize the drug controller general of India to initiate their business in India. It is an obligatory procedure for drug and cosmetic manufacturers, which requires getting authorization from the central licensing authority.

Just fill up the form with your personal details and our team will contact you shortly to discuss further steps