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.

IndiaFilings 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, IndiaFilings 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.

Meaning of Drugs

A drug licence is an authorisation issued by regulatory bodies that allows a business to engage in drug-related activities. Obtaining a drug licence is a prerequisite for initiating any drug-related business operations. The definition of a "drug" is provided in section 3(b) of The Drugs And Cosmetics Act, 1940, and encompasses.

• All medications and treatments used for diagnosing, preventing, treating, or alleviating diseases or disorders in humans or animals. This also covers substances applied to the human body to deter insects such as mosquitoes.
• Every component constitutes a drug, including empty gelatin capsules.
• Various medical devices.

Therefore, the term "drug" encompasses all forms of medicines, including Allopathic, Homeopathic, Ayurvedic, Siddha, and Unani. For licensing purposes for pharma licence, these medicines can be categorised into two main groups.

The objective of Obtaining a Drug Licence

The issuance of a drug licence serves as a regulatory measure to control and restrict access to medicines and drugs, ensuring they are not subjected to misuse or abuse. Drug licence verification done for the same purpose to ensure compliance and safety.

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.

Entities Required to Obtain a Drug License Registration

The following groups are typically required to secure a drug licence to operate legally within the pharmaceutical and healthcare sectors:

• Pharmacists: Professionals authorised to prepare, dispense, and advise on pharmaceutical drugs, ensuring their safe and effective use by having pharma license.
• Wholesale Distributors: Businesses involved in bulk purchasing and distributing drugs to various retail outlets or other organisations.
• Retailers: Businesses that sell drugs directly to consumers, providing the final link in the supply chain between the manufacturer and the end-user. These entities must obtain drug license along with medical store licence.
• Manufacturers: Companies or individuals producing pharmaceuticals and cosmetics, including formulation, compounding, packaging, and labelling.
• Drug Sellers and Dealers: Individuals or entities engaged in the commercial trading of pharmaceuticals and cosmetic products. They must have both drug and pharmacy license to carry out the operations legally. 
• Importers: Companies or individuals who import drugs, cosmetics, and traditional medicines from abroad, ensuring these imported items comply with the local regulatory requirements.
• Ayurvedic, Siddha, and Unani Drug Providers: Entities dealing in traditional Indian medicinal products, also regulated under the Drugs and Cosmetics Act need to have pharma licence.

Types of Drug Licenses

In India, the kind of drug licence required varies based on the specific activities of the drug business.

• Manufacturing License: For businesses that produce drugs, including allopathic and homoeopathic medicines. This manufacturing pharma licence is mandatory for any entity creating and producing pharmaceutical products.
• Sale License: This is required to sell drugs and has two main categories:
• Wholesale Drug Licence: This is needed by businesses that sell drugs in bulk to retailers or other entities rather than directly to consumers.
• Retail Drug Licence: Necessary for businesses selling drugs directly to consumers. This includes stand-alone pharmacies, ayurvedic shops, and any retailer providing drugs to end-users, such as hospitals and dispensaries. Selling products without a drug and pharmacy license leads to legal problems. 
• Loan License: This type of pharma licence For businesses that don't own a manufacturing facility but utilise the manufacturing premises of another licensed manufacturer to produce drugs. This arrangement allows for flexibility in production without the need to own a manufacturing unit.
• Import License: Required for businesses importing drugs into India, whether for further manufacturing or direct sale. This pharma licence ensures that imported drugs meet the same standards as domestically produced.
• Multi-Drug Licence: For businesses operating pharmacies under the same name across multiple states. This pharma licence facilitates the management of a pharmacy chain by standardising licensing across various locations.

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.

Adequate Premises:

• The premises must meet specific size and infrastructure requirements, such as minimum area, proper storage facilities, and adherence to safety standards.

Compliance with Legal and Regulatory Requirements:

• Applicants must ensure that their business complies with the local laws, regulations, and guidelines set forth by the drug control authorities.

Documentation and Records:

• Proper documentation, including educational certificates, identity proofs, and professional registrations, must be maintained and provided during the application process.

Good Storage Practices:

• The premises should be equipped to store drugs under the required conditions to ensure their efficacy and safety.

Ethical Practices:

• The business must commit to ethical practices, including the responsible sale and dispensing of drugs.

No Criminal Record:

• Typically, the applicant (proprietor, pharmacist, or competent person) should not have any criminal record related to drug offences or other serious crimes.

This is the eligibility criteria required on how to get drug licence. Ensure to properly engage in the process, check drug licence status, and obtain the certificate.

Premises Specifications & Conditions

The specifications and conditions of the premises are crucial for obtaining a pharma licence.

Additional Notes:

• Combined Retail and Wholesale Premises: If applying for retail and wholesale pharma licences at the same premises, the minimum area should be 15 square meters.
• Measuring Carpet Area: The carpet area excludes open areas, pantry, and washroom, considering only the area used for drug dealings.
• Mixed Land Use Definition: It allows for non-residential activities in residential areas, with mixed-use shops permissible only on the ground floor up to the maximum floor coverage. Such regions require the unconditional surrender of the front setback for parking, with no boundaries, and must have approval from the local authority and payment of conversion charges.
• Commercial Place Definition: A location designated solely for commercial activities. Before renting for a wholesale pharma licence, it's important to confirm the commercial status of the premises by checking the conversion charge receipt and parking fee receipt.

Validity of Drug License

A drug license, upon issuance, remains valid for five years, subject to its continued compliance with regulations. It can, however, be suspended or cancelled by the Drug Department if it fails to adhere to the required standards and regulations within this timeframe.

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
• Electricity Bill for the Proposed Premises
• Refrigerator Purchase Receipt
• Lease Agreement (On Rs. 50 Stamp Paper)
• Ownership Documents for the Premises, Including Tax Receipt
• Cover Letter for the Application
• Photographs (Five Each) of the Registered Pharmacist and Proprietor

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.

All the documents are required before engaging in the process, check drug licence status and obtaining the drug licence. And also ensure to have the required documents for drug licence renewal for compliance.

How to Apply for Drug Licence?

The Procedure to obtain a Drug License involves several key steps, each critical to ensuring compliance with regulatory standards. Here are the step by step process on how to apply for drug license:

Preparation of Documentation

Documentation is the foundation of the licensing process. Proper documentation streamlines the process and facilitates the successful issuance of a license. The required documents vary depending on the type of application, whether for wholesale or retail drug sales, and the specific business activities involved.

Creation of User ID and Password

Applicants must register to obtain a user ID and password. These credentials are sent to the applicant's registered email address, allowing them to proceed with the application process for user ID and password creation.

Filing the Application

Applicants must submit their application for a drug license to the relevant state's Drug Controlling Authority. Each license type necessitates a distinct application form. Unlike some other regulatory areas, there isn't a single centralised license that covers all states; applicants need to submit separate applications for each location they operate in.

Premises Inspection

A drug inspector responsible for the area inspects the premises where the drug license is sought. This inspection involves verifying the application's details, measuring the premises, and ensuring the location is suitable based on zoning laws (e.g., commercial or mixed-use land).

Application Scrutiny

The Drug Inspector reviews the application and accompanying documents against observations made during the site visit. If any clarifications are needed, they will be requested from the applicant, who must respond within three days. Failure to provide a satisfactory response can result in the application being denied.

License Issuance

Following a thorough drug licence verification process and assuming all criteria are met, the Drug Control Department will issue the Drug License. Frequently, you can check drug licence status.

The experts at IndiaFilings can guide you through the process of successfully completing the process, check drug licence status and obtaining the license.

Process of Drug Licence Download

To proceed with drug licence download, visit the official website of the State Drugs Control Department. Log in using your credentials and navigate to the license section. Enter the required details, such as the application number or license number, and submit the request. Once verified, you can complete the drug licence download process and get the list in the prescribed format. Ensure that the license remains valid by regularly checking for renewal requirements and compliance updates.

Drug License Renewal

The drug license usually has a validity period of five years, after which it needs an drug licence renewal to continue its legal effectiveness.

Simplify Your Drug License Process with IndiaFilings

Securing a drug license can be a straightforward and hassle-free process when you choose IndiaFilings. With our expertise in navigating the complex regulatory framework of the pharmaceutical industry, IndiaFilings offers comprehensive support, from preparing your application to ensuring compliance with all legal requirements. Our knowledgeable team provides personalised guidance, making the entire process efficient including registration, check drug licence status, obtaining the certificate and minimising potential errors or delays. Whether you're new to the pharmaceutical sector or looking to expand your existing operations, IndiaFilings can help streamline your journey to obtaining a drug license.

Contact our experts today for personalised assistance!