Regulation/Guidelines

How To Get Wholesale Drug Licenses In India?

  • 8th March, 2022

Wholesale Drug License – Overview

The pharmacy business in India is booming. To ensure consumer safety, the Government keeps changing guidelines that aid streamlining of the processes as well. To start manufacturing drugs, the main procedure is to obtain a drug license from the respected authorities.

The Drugs and Cosmetics Act, 1940 governs obtaining the license for manufacturing drugs in India. Any person who is interested in obtaining a license from the Food Safety and Drug Administration needs to file respective forms to the State Licensing Authority.

The schedule C of the Drugs and Cosmetics Act, 1945 contains the application and licensing of wholesale drug license. The overall process of licensing requires 1 month for approval. The approval depends on the review of Drug Inspector and the report which he sends to the Licensing Authority.

The license is distributed based on the type of business, for example, retail chemist shop require Forms 20 and 21 (Allopathic) whereas ayurvedic chemist shop requires Form 20C. For the wholesale license, Form 20B and 21B should be acquired and for Schedule X drugs Form 20G is required.

Need Of Wholesale Drug License in India

A wholesale drug license is required for manufacturing pharmaceuticals, distribution, sale, or store of the medication. The license proves that you are an authorized person with an authorized business for manufacturing or distributing pharmaceuticals. Without registration, it is illegal to manufacture drugs in India.

Criteria For Applying A Wholesale Drug Manufacture License in India

To obtain the Wholesale drug license in India, the manufacturer has to meet the criteria given below:

  • The business premises should be at least 15 square meters
  • The business premises should have an air conditioner for pharmaceuticals and a refrigerator for products which required to be stored in a cool place
  • A registered pharmacist who will supervise the business is a must to apply for the license.
  • The person must hold a degree or diploma from a recognized university or institution and should have at least 1 year of experience working with drugs or can be an SSLC holder with 4 years experience working with drugs
  • Any organization or company/ LLP / partnership firm can apply for the license
  • A registered state pharmacist with experience and authorized degree can apply for the wholesale drug license

Required Documents for Wholesale Drug License in India

Documents Filling: The applicant must have all the required documents and certifications according to the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rule, 1945 for successful approval of the application.

Required Documents:  Following documents are required generally for processing the application:

  • Filled Form 19
  • Challan fees i.e., 3000/-Rs
  • Affidavit of proprietor on stamp paper of 20 Rs.
  • Educational certificate copies of proprietor (Self attested)
  • Self-attested copies of Identity proof of proprietor (Domicile/Driving License/ Voter Id Card)
  • Affidavit of Regd. Pharmacist
  • Educational certificate copies of Regd. Pharmacist (Self attested)
  • Blue print of Plan layout of proposed area /premises
  • Copy of Refrigerator bill
  • Rent agreement (50 Rs. Stamp paper)
  • Ownership document of the premises including the copy of tax receipt of proposed area / premises
  • Covering letter
  • Photo 5-5 each of Regd. Pharmacist and proprietor
  • All documents should be in PDF scanned format in GRAY SCALE

Also Read – What Are The Benefits Of Having A Wholesale Drug License In Form 20B & 21B?

Process For Applying A Wholesale Drug License

wholesale drug license process
  1. Start applying from the website depending on your state (For Delhi: http://xlnindia.gov.in/). 
  2. Login and create your user id and password. 
  3. Start the online application by using Prepare/Edit application; you need to select a storage type (CP in Retail/CP in wholesale) and submit your Aadhar details. 
  4. Add every detail, photograph and certificate of pharmacists and save the application. 
  5. After saving the application, print out a self-declaration, and take all the signs of the pharmacist and the proprietor. 
  6. Upload these documents and keep the form. Print out form 19/19A/19B/19C and sign by the proprietor and the pharmacist (it can be done by e-sign format). 
  7. The pharmacist, also if required, get Schedule X license approval by submitting the application Form 19C for sales and distribution of Schedule X drugs, 
  8. After uploading the scanned copies of completed form, pay the fees through FRAS payment and upload the scanned copy of the challan. 
  9. Submit your application after all the uploads, which will send this application to the Licensing Authority. 
  10. The Drug Inspector will review the application, and if everything is in order, the approval of the application will be done. 
  11. The licensing authority will send the application to the Drug Inspector within five days, and the Drug Inspector will approve or reject the application within ten days. The license is given in Form 20B/21B/20C.
  12. The printing of the license will take 15 days, and the authorized personnel should print it within three days of approval, hanging it on the Wholesale premises.

Validity of the Wholesale Drug License

The drug license is valid perpetually until suspended by the Drug Inspector due to any reason; however, retainer fee is required to be submitted every Five years.

Conclusion

The wholesale drug license governs distribution and sale of pharmaceuticals in the country. It is the responsibility of the proprietor, the pharmacist and the authorized management to conduct the wholesale business as per the laid down rules and schedules. The application process is purely online and can be easily done with the required documents and certifications in place.