Availabel Free CS Software
Enroll Now

Set up a sole Drug License

  • Compliance Gurukul offers comprehensive assistance in obtaining Drug Licenses for manufacturing, sale, and distribution of pharmaceuticals. Our experts ensure compliance with regulatory requirements, enabling businesses to operate legally and efficiently.

35,000+ Shop and Establishment registered since 2011

proprietorship

Register Drug License Firm Online through Compliance Gurukul

You can easily complete Drug License firm registration online through Compliance Gurukul. For a sole Drug License registration, only the PAN & Aadhaar card of the business owner is required. We can help you obtain the following registrations in less than 15 days:

  • GST Registration
  • Zero-Balance Business Current Account with Compliance Gurukul Software

Once, you have registered for the Drug License firm registration online on Compliance Gurukul, please follow the steps below and upload the following documents by logging into Compliance Gurukul Software.

  • Step 1: Login to Compliance Gurukul Software using the email address for payment.
  • Step 2: Go to Services Tab & Select Drug License Engagement
  • Step 3: Upload your PAN & Aadhar Card Copy
  • Step 4: An Compliance Gurukul Registration Expert will file the registration application with GST Department and Bank for Current Account.
  • Step 5: Access to Compliance Gurukul Software is for GST invoicing, GST filing and other services.

Drug License

Securing a drug licence is a fundamental step for entities wishing to engage in the pharmaceutical industry within India, encompassing activities from manufacturing to selling drugs and cosmetics. This license is a safeguard, ensuring that all pharmaceutical practices adhere to the rigorous quality and safety standards set forth by the Drugs and Cosmetics Act. Given the complexity of the application process and the importance of adherence to these regulations, navigating the intricacies of obtaining a drug license can be daunting.

Compliance Gurukul offers expert guidance and support for the Drug License registration Process and obtaining the licence. With our deep understanding of the regulatory landscape and a comprehensive approach to handling applications, Compliance Gurukul helps demystify the process, ensuring that businesses and individuals can secure their pharma licence efficiently while fully complying with the legal mandates.

What is a Drug Licence?

In India, businesses must have the right licenses for their operations, including those dealing drugs and cosmetics. A drug licence issued by the government requires firms to legally manufacture, distribute, or sell pharmaceutical and cosmetic products. These licenses are specific to each region, meaning a separate permit is needed for operations in different states. Moreover, a distinct pharma license is required for each location if a business operates in multiple locations within a single state. Selling pharmaceutical products which do not have proper drug licenses leads to the cancellation of a pharmacy license. Drug licence verification can be done by the officials to ensure the safety. However, there's an exception for mobile vendors.

Show More

Importance of Drug Licence

The drug license is a prerequisite for businesses or individuals to legally operate in India's trading, manufacturing, or distribution of drugs and cosmetics. It ensures that all entities adhere to the stringent guidelines and standards outlined in the Drugs and Cosmetics Act 1940 to maintain the safety, efficacy, and quality of pharmaceutical and cosmetic products.

Additionally, obtaining a license and drug licence renewal is just one part of regulatory compliance; entities must secure a trade license and register under the Shop and Establishment Act to fully comply with the legal requirements for operating a business in this sector.

Eligibility Criteria for Obtaining a Drug License

The eligibility criteria for obtaining a drug license typically involve a combination of educational qualifications, professional registrations, and specific requirements related to the premises where the drugs will be stored and sold. Some general criteria apply to most jurisdictions:

Qualified Personnel:

  • Retail Drug License: Requires a qualified and registered pharmacist with a B.Pharm or D.Pharm degree. A medical store licence must also be obtained to sell drug-based products.
  • Wholesale Drug License: Requires either a qualified pharmacist or a competent person with relevant experience in drug dealing (a graduate with one year of experience or an undergraduate with four years of experience).

    • Registration with Pharmacy Council:

  • The pharmacist or competent person must be registered with the State Pharmacy Council or equivalent regulatory body.
  • The premises must meet specific size and infrastructure requirements, such as minimum area, proper storage facilities, and adherence to safety standards.
  • Applicants must ensure that their business complies with the local laws, regulations, and guidelines set forth by the drug control authorities.
  • Proper documentation, including educational certificates, identity proofs, and professional registrations, must be maintained and provided during the application process.
  • The premises should be equipped to store drugs under the required conditions to ensure their efficacy and safety.
  • The business must commit to ethical practices, including the responsible sale and dispensing of drugs.
  • Typically, the applicant (proprietor, pharmacist, or competent person) should not have any criminal record related to drug offences or other serious crimes.

Documents Required for Drug License

The documents required for obtaining a New Retail Drug License and a New Wholesale Drug License share several similarities but also differ, particularly in the personnel involved. These documents are essential on how to get drug licence. Here's a comparative overview:

    Required Documentation for Obtaining a New Retail Drug License

  • Application Form (Form No. 19)
  • Application Fee Receipt (Challan of Rs. 3000/-)
  • Proprietor's Affidavit (On Rs. 20 Stamp Paper)
  • Proprietor's Educational Certificates (Self-Attested)
  • Proprietor's Identity Proof (Self-Attested Copies of Domicile/Driving License/Voter ID Card)
  • Registered Pharmacist's Affidavit
  • Registered Pharmacist's Educational Certificates (Self-Attested)
  • Registered Pharmacist's Identity Proof (Self-Attested Copies of Domicile/Driving License/Voter ID Card)
  • Blueprint of the Proposed Premises' Layout
  • Refrigerator Purchase Receipt
  • Lease Agreement (On Rs. 50 Stamp Paper)
  • Ownership Documents for the Premises, Including Tax Receipt
  • Cover Letter for the Application

    • Required Documents for New Wholesale Drug License

  • Form No. 19: Official application form.
  • Challan of Rs. 3000/-: Proof of application fee payment.
  • Proprietor's Affidavit: On Rs. 20 stamp paper.
  • Educational Certificates of Proprietor: Self-attested copies.
  • Identity Proof of Proprietor: Self-attested copies (Domicile, Driving License, Voter ID Card).
  • Competent Person's Affidavit.
  • Educational Certificates of Competent Person: Self-attested copies.
  • Identity Proof of Competent Person: Self-attested copies (Domicile, Driving License, Voter ID Card).
  • Experience Certificate of Competent Person: Original certificate showing four years of experience post-12th or two years post-graduation.
  • Blueprint of Proposed Premises Layout.
  • Electricity Bill for Proposed Premises.
  • Refrigerator Purchase Receipt: Required for storing certain drugs.
  • Lease Agreement: On Rs. 50 stamp paper.
  • Ownership Documents for Premises: Including tax receipts.
  • Cover Letter: Introducing the application.
  • Photographs: 5 each of the Competent Person and Proprietor.

Timelines

A sole Drug License firm registration can normally be done in India through Compliance Gurukul in max 2 weeks. However, the timelines for registration will vary from case to case, depending on the government and bank processing timelines.

Drug License FAQ's

A Drug License is a legal permit issued by the government to businesses for manufacturing, distributing, or selling pharmaceutical and cosmetic products in India, ensuring compliance with safety and quality standards.

Compliance Gurukul can assist with various types of Drug Licenses, including Manufacturing, Wholesale, Retail, Loan, and Import Licenses, tailored to your business needs.

A Drug License is typically valid for five years, after which it must be renewed to continue legal operations.

Common documents include application forms, proprietor and pharmacist/competent person affidavits, educational and identity proofs, premises layout, rent agreement, and ownership documents, among others.

Yes, Compliance Gurukul offers services for the renewal of Drug Licenses, ensuring continuous compliance and operation of your business.

Operating without a valid Drug License is illegal and can result in severe penalties, including fines and imprisonment, besides endangering public health.

Start Company Registration