Starting a business involving drugs or cosmetics requires obtaining a Drug License. Without this license, anyone who attempts to engage in the sale of drugs or cosmetics would be legally punished. The specifics regarding how to obtain a drug license and the qualifications necessary can be found in the Drugs and Cosmetics Act of 1940. This Act comprehensively governs all aspects concerning drugs, their sale, and manufacturing. Operating a pharmaceutical business without the requisite license would be considered a violation of the law. In this blog, we shall see what a wholesale drug license in India.
Advantages of Wholesale Drug License in India
There are many advantages of a wholesale drug license in India, which includes:
1. Regulatory Oversight and Accountability
Acquiring a Wholesale Drug License in India facilitates regulatory oversight by authorities, enabling them to monitor and regulate the distribution of medicines in India. This contributes to improved business reliability and trustworthiness as it ensures compliance with essential regulations.
2. Legal Admissibility
In the pharmaceutical trade in India, securing a Wholesale Drug License isn’t merely a preference but it’s an absolute legal necessity. Without this vital license, any involvement in drug-related business activities would be in direct violation of the law, highlighting its vital significance in the pharmaceutical sector.
3. Establishment of Authenticity
A Wholesale Drug License serves as a compelling proof of authenticity for a business. It substantiates the company’s commitment to operating within the law.
4. Expansion of Consumer Base
Possessing a drug license certificate signifies to consumers that the business is dedicated to maintaining rigorous quality control measures in the manufacturing of drugs.
Requirements for Obtaining a Wholesale Drug License in India
The basic requirements for getting a wholesale drug license in India are as follows:
1. Minimum Shop/Office Size Requirement
To acquire a wholesale drug license, it is essential that the shop or office designated for this purpose has a minimum floor area of 15 square meters.
2. Essential Equipment
The shop or office seeking a wholesale drug license must be equipped with an air-conditioning system and a refrigerator to maintain the integrity and safety of pharmaceutical products.
3. Educational Qualifications
In certain states, wholesale drug licenses are exclusively granted to companies or entities that have a qualified individual holding a degree or diploma from a recognized and reputable college or university. This educational requirement ensures a certain level of competence in the pharmaceutical field.
4. Supervision by Registered Pharmacist or Competent Person
When applying for a wholesale drug license, it is imperative that the license holder either works under the direct supervision of a registered pharmacist or a competent individual. The supervisor should possess a minimum of one year of relevant experience in the pharmaceutical domain. Alternatively, they should have completed SSLC (Secondary School Leaving Certificate) with a minimum of four years of experience in a field related to pharmaceuticals.
5. Display of License
Once the wholesale drug license has been obtained, it must be prominently displayed on the exterior of the shop or office. This display serves as a reference for future inquiries and demonstrates compliance with the necessary regulations.
Documents Required for Wholesale Drug License in India
Applying for a wholesale drug license in India entails providing a comprehensive set of documents to meet regulatory requirements. The essential documents are as follows:
- Business Structure Documents
- Memorandum and Articles of Association and Articles of Association for companies.
- Partnership Deed for partnerships.
- Limited Liability Partnership Agreement for LLPs.
- Identity Proof
Valid identity proof (e.g., Aadhar card, passport, voter ID) of the directors, partners, or proprietor.
- Property Documents
Copies of property-related documents, including proof of ownership or the rent agreement for the premises where the pharmaceutical business will be conducted.
- No Objection Certificate (NOC)
NOC from the owner of the property if the premises are rented.
- Site Plan and Key Plan
Detailed site plan and key plan of the premises, illustrating the layout and facilities.
- Board Resolution
Copy of the board resolution approving the application for the Manufacturing Drug License.
- Equipment Proof
Evidence of essential equipment such as refrigeration units, cold storage facilities, and air-conditioning systems.
- Fee Payment Proof
Copy of the fee payment challan as proof of payment for the license application.
- Affidavit of Non-Conviction
An affidavit stating that the directors, partners, or proprietor has never been convicted in any relevant legal matters.
- Affidavit from Pharmacist or Competent Person
An affidavit provided by the pharmacist or competent person involved in the operations, affirming their qualifications and compliance with regulations.
- Cover Letter
A cover letter that includes the name and designation of the applicant, addressing the licensing authority.
- Application Forms
Duly filled Application Form 19 along with the required declaration forms.
- Pharmacist or Competent Person Documentation
- Appointment letter of the pharmacist or competent person.
- Qualification certificates of the pharmacist or competent person.
- Experience certificate of the pharmacist or competent person.
- Applicant’s Qualification
Proof of the applicant’s qualifications and eligibility to operate in the pharmaceutical sector.
Registration Procedure for Obtaining a Wholesale Drug License in India
Obtaining a Wholesale Drug License in India involves a structured process. The following steps outline the registration procedure, which typically takes 30-60 days to complete:
Step 1: Creation of User ID and Password
- The applicant initiates the process by visiting the online state licensing portal or website of the relevant state.
- A formal request letter is submitted to create a user ID and password for the online application. This letter should include detailed information about the firm.
Step 2: Application Submission, Document Upload, and Fee Payment
- The applicant completes the application form (Form 19) available on the online portal, ensuring that all required fields are filled accurately.
- Supporting documents, as specified by the licensing authority, are uploaded in black and white scanned copies.
- The applicant pays the prescribed fees as determined by the government.
- It’s important to ensure that all information is complete and accurate, as fees paid will not be refunded in case of objections due to incomplete information.
Step 3: Premises Inspection
- After the director receives the application, he then assigns a drug inspector to conduct an inspection of the premises mentioned in the application, which involves a physical visit to the shop or office location.
- The drug inspector verifies and scrutinises the uploaded documents to ensure compliance with regulations.
Step 4: License Issuance
- Upon a satisfactory inspection of the premises and validation of the submitted documents, the director of the licensing authority proceeds to issue the wholesale drug license.
- The license, once issued, grants the applicant the legal authorisation to engage in wholesale drug distribution within the specified region or state.
Penalties for Non-Compliance with Drug Licensing Regulations
The following acts attract penalties under drug licensing regulations:
- Manufacturing for Sale: Manufacturing drugs for sale or distribution without the appropriate drug license.
- Selling Drugs: Selling drugs without the necessary drug license.
- Stocking Drugs: Stocking drugs for sale without the required drug license.
- Exhibiting Drugs for Sale: Displaying drugs for sale without holding the appropriate drug license.
Penalties:
The following penalties are provided as per the Drugs and Cosmetics Act:
- Imprisonment: A term of imprisonment for a minimum of one year, which may extend to three years.
- Fine: A fine of not less than Rs. 5,000.
Final Thoughts
Adherence to drug licensing regulations in India is paramount for the safe and legal operation of pharmaceutical businesses. To legally serve as an authorised agent for drugs and cosmetics in India, both individuals and companies must secure a wholesale drug license in India. This license is granted by the relevant state’s licensing authority and permits the wholesale distribution of drugs to individual retailers for further sale.
To avoid legal repercussions and ensure a trustworthy pharmaceutical industry, businesses must diligently obtain and maintain the necessary licenses, follow prescribed protocols, and remain informed about evolving regulatory requirements. Compliance is not just a legal obligation but a fundamental commitment to ensuring the well-being of consumers and the integrity of the pharmaceutical sector.
