Drug License Overview
To guarantee the quality and safety of medications, the Indian pharmaceutical industry is governed by strict laws. Any company that distributes and sells medications must obtain the required permits, such as Form 20 for retail drug licenses and Form 21 for wholesale drug licenses.
Understanding Form 20 & 21:
- Form 20: This form is used to obtain a drug license for the retail sale of drugs. It covers various establishments, including pharmacies, medical, and drug stores.
- Form 21: This form is required for obtaining a wholesale drug license. Wholesale drug licensees are responsible for storing, distributing, and supplying drugs to retailers, hospitals, and other healthcare institutions.
Key Requirements for Obtaining Forms 20 & 21:
- Registration: Businesses must be registered with the appropriate authorities, such as the State Drug Control Department.
- Qualification: Those working in the administration and running of the drug establishment might need to meet certain requirements.
- Infrastructure: The premises must meet specific requirements related to space, storage facilities, temperature control, and hygiene.
- Security Measures: Adequate security measures must be in place to prevent theft and misuse of drugs.
- Personnel: Trained and qualified personnel are required to handle and dispense drugs.
Application Process For Drug License:
- Obtain Application Forms: Obtain the necessary application forms (Form 20 or Form 21) from the designated authorities.
- Fill out the Application: Complete the application forms accurately and completely, providing all the required information and documents.
- Submit Application: Submit the completed application forms, required fees, and supporting documents to the concerned authority.
- Inspection: The authorities may inspect the premises to ensure compliance with the prescribed standards.
- License Issuance: The relevant drug license will be issued upon successful completion of the application process and inspection.
Factors Affecting Drug License Costs:
- Type of License: Generally speaking, getting a wholesale drug licence will cost more than getting a retail drug licence.
- Location: License fees may vary depending on the location and size of the establishment.
- Type of Drugs: The cost may also vary depending on the type of drugs handled by the business.
- Government Fees: Government fees for processing the application and issuing the license will be applicable.
Wholesale Drug License Fees:
Depending on several variables, wholesale drug licence fees can vary greatly. For the most precise and current information on fees and other requirements, it is essential to refer to the official guidelines of the relevant state drug control department.
Documents Required for Wholesale Drug License
The documents required for obtaining a wholesale drug license (Form 21) in India may vary slightly depending on the specific state and local regulations. However, some common documents typically include:
- Application Form (Form 21): Duly filled and signed a wholesale drug license application form.
- Proof of Identity and Address:
- For Proprietorship: Identity proof (Aadhaar Card, PAN Card, Voter ID) and address proof (Aadhaar Card, Driving License, Passport) of the proprietor.
- For Partnership: Partnership deed, identity and address proof of all partners.
- For the company, the certificate of incorporation, a memorandum, articles of association (MOA & AOA), and details of directors are required.
- Qualification and Experience:
- Educational and professional qualifications of the proprietor/partners/directors.
- Experience in the pharmaceutical sector (if applicable).
- Premises Details:
- Ownership/Lease agreement of the premises.
- Blueprint/Layout plan of the premises.
- Photographs of the premises.
- Electricity and water bills.
- Storage Facilities:
- Information on storage facilities includes air conditioners, refrigerators, and other appliances.
Final Thoughts:
Getting Form 20 and Form 21 drug licenses is essential for companies in India's pharmaceutical industry. Businesses may guarantee compliance and help create a safe and efficient healthcare system by being aware of the standards and following the guidelines.
