India is one of the largest drug market in the world. This is primarily due to the large population. Pharmacies in India are abundant and so are wholesale drug outlets. However, this thriving business opportunity comes with its fair share of complications. To enter the market, a business must have a drug license. In this article, we explain how to obtain wholesale drug license in India.
It is mandatory to have a license to undertake the business of drugs in India. The person/entity willing to undertake wholesale and retail sale of drug business must obtain a license from the Food Safety and Drug Administration. The applicant can file form 20B; form 21B; Form 20G for obtaining wholesale drug license. This is granted by the concerned state licensing authority. The business is governed by the provisions mentioned in the Drugs and Cosmetics Act, 1940. Drug licenses are of various types: Wholesale Drug license, Drug Manufacturing License, Retail Drug License, License for Import of Drugs or Cosmetics, etc.
Requirements for wholesale drug license
- The business premises must have an area of at least 15 square meters.
- It must have a refrigerator. (This is to store drugs and prevent them from damage)
- The application for the license can be made under the personal supervision of the registered pharmacist or a competent person having relevant experience in Wholesale Drug Licensing Business. In some states in the country, the wholesale drug license is issued only to people who have degree in pharmacy
- Educational requirements: (Must meet any one)
- The person concerned must be a graduate with at least an year of experience dealing in drugs
- The person concerned must have passed SSLC with 4 years of experience dealing in drugs
- Post obtaining the drug license, it should be clearly displayed on the premises for future inspection.
- Goods and Services Tax (GST) Registration number. (This is Optional)
- The business premises (warehouse) must be a closed and sanitized area. Open-ended or open roofed areas are not eligible.
- The premises must have the required furniture such as storage racks.
Documents required for wholesale drug license
The documents differ from state to state. Below we have prescribed generically the list of the documents required for wholesale drug license:
- Cover letter stating the application’s purpose.
- Two applications filed through form 19.
- Declaration form.
- Fee challan (Rs.3000).
- The blueprint of the business premises.
- Rent agreement (if the shop/office is rented) or the ownership documents of the business premises.
- Property tax receipt.
- Incorporation certificate/MoA/AoA (If the business entity is a Company or LLP).
- Partnership deed (If the entity is a partnership).
- Board resolution (if the entity is a private limited company).
- List of directors (if the entity is a private limited company).
- Affidavit (of the proprietor, if applicable).
- Affidavit (of the concerned pharmacist).
- Educational certificate (of the proprietor, if applicable).
- Biodata (of the concerned pharmacist or Competent person).
- Identity Proof (of the proprietor, if applicable).
- Degree certificate (of the concerned pharmacist or Competent person).
- Appointment letter (if applicable).
- Invoice receipt of the refrigerator.
- Photographs (of the concerned pharmacist).
- Photographs (of the proprietor, if applicable).
Process of obtaining Drug License
To obtain Drug License the process involved is as follows:
Filing Documents –
The person/entity must ensure that he possesses the list of documents that we mentioned above in the article. The former should also ensure that he meets the requirements prescribed. The documents will be filed online in the next step.
The application for drug license has to be filled online. While filling the application, the applicant has to upload scanned copies of the required documents. After the payment of the required fees, the application is accepted.
Inspection by a Drug Inspector
After the application is filed, a drug inspector reviews the documents in person. He physically comes to the store and ensures the business meets all the prescribed requirements. Post verification, he gives approval to go ahead.
Approval and Grant
After the documents are verified and the requirements are met, the application is approved by Drug Licensing Authority and the license is granted. However, this license has to be renewed.
Drugs are a necessity. They are essential products. Owing to their importance, the government has put a strict application process. This ensures that drug wholesalers comply with the provisions. These provisions, in turn, ensure that the business is undertaken by a competent person. They also ensure drugs do not risk the lives of the people. The process for Drug Licensing is long and requires the applicant to file lots of documents. If you want any assistance with regard to the licensing process, reach out to us at Registration Arena. We help make the process easier by filing the documents for you and take care of any hassle that you might encounter.