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.
 ProprietorshipGST Software & Registration | 1 | ₹45.00 | |
ProprietorshipGST Filing & Registration - 6 Months | 1 | ₹55.00 | |
ProprietorshipGST Filing & Registration - 12 Months | 1 | ₹55.00 |
Already have an account? Sign in
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.
LegallensIndia 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, LegallensIndia helps demystify the process, ensuring that businesses and individuals can secure their pharma licence efficiently while fully complying with the legal mandates.
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.
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.
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.
| Drugs Regulated By Drug Controller | Drugs Regulated By Drug Controller |
|---|---|
Medicines are Licensed by the Drug Controlling Authority (Functioning Under the Ministry Of Health). Following are the examples
| Aayush Drug Control Cell is one of the verticals of the Central Drug Standard Control Organisation (CDSCO), regulated by the Ministry of Ayush. The following is covered under Aayush.
|
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.
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.
The following groups are typically required to secure a drug licence to operate legally within the pharmaceutical and healthcare sectors:
In India, the kind of drug licence required varies based on the specific activities of the drug business.
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:
Registration with Pharmacy Council:
Adequate Premises:
Compliance with Legal and Regulatory Requirements:
Documentation and Records:
Good Storage Practices:
Ethical Practices:
No Criminal Record:
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.
The specifications and conditions of the premises are crucial for obtaining a pharma licence.
| Eligibility Criteria | For Retail Drug License | For Wholesale Drug License |
|---|---|---|
| Type of Premises | May be located in a Mixed Land Use Area or a Commercial Place. | It must be located in a Commercial Place only. |
| Minimum Area | The minimum carpet area is 10 square meters with a height of 2.75 meters. | The minimum carpet area is 10 square meters with a height of 2.75 meters. |
| Approach Road | The road must face a minimum width as the local municipality prescribes for mixed land use. | Should be on a road/street broad enough for easy loading and unloading, ideally facing a road with a minimum width of 18 meters. |
| Furniture | Requires racks, almirah for storage, and a table and chair. | Requires racks, almirah for storage, and a table and chair. |
| Equipment | Computer systemPrinter for invoices Refrigerator (essential for storing certain drugs, especially vaccines, in a low-temperature zone) | Computer systemPrinter for invoicesRefrigerator (essential for storing certain drugs, especially vaccines, in a low-temperature zone) |
Additional Notes:
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.
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:
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.
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:
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.
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.
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.
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).
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.
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 LegallensIndia can guide you through the process of successfully completing the process, check drug licence status and obtaining the license.
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.
The drug license usually has a validity period of five years, after which it needs an drug licence renewal to continue its legal effectiveness.
Securing a drug license can be a straightforward and hassle-free process when you choose LegallensIndia. With our expertise in navigating the complex regulatory framework of the pharmaceutical industry, LegallensIndia 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, LegallensIndia can help streamline your journey to obtaining a drug license.
Contact our experts today for personalised assistance!
