Wholesale Drug License
The function of pharmaceutical wholesalers is to act as an intermediary between the pharmaceutical industry and their customers (e.g., hospital and community pharmacies) by purchasing and distributing medicines to their customers. 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. The Ministry of Health and Family Affairs issued the Cosmetic Rules in December 2020, which states that a drug license is mandatory for importing cosmetics into India. For being an authorized agent of drugs and cosmetics in India, any company or individual must obtain a wholesale drug license.
To obtain the Wholesale drug license in India, the manufacturer must follow the following perquisites
- A wholesale pharmacy store only at a Commercial Place.
- The road/street on which it is located must be broad enough to facilitate loading and unloading of goods. It is suggestable to have a premises facing a minimum road width of 18 mitres or more.
- The carpet area of the wholesale pharmacy must be a minimum of 10 square meters and height of 2.75 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.
- Wholesale License Enhance Business - wholesale drug license shows your consumers that you are distributing drugs by stringent quality standards. The wholesalers’ compliance with the Drugs and Cosmetics Act, of 1940 would help them enhance the credibility that the market needs to succeed and create endless opportunities
- Visibility- After obtaining a wholesale drug license, the entity is not only able to meet its business goals, but they are also able to increase its market visibility. The pharmaceutical company may take advantage of the improved visibility as a brand and explore new opportunities that are available in the market to expand.
- The Authority Can Keep Track of The Working A wholesale drug license helps the authority keep track of the working and regulating the dealing of medicines in India, ultimately enhancing business reliability and trustworthiness.
- Certificate of Incorporation (COI), Memorandum of Association (MOA), Article of Association (AOA), Pan Card Copy of entity (in case of company)
- COI, LLP Agreement and PAN card copy of Entity (in case of LLP)
- Partnership deed and pan card copy of the entity (In case of Partnership)
- Any establishment proof in case of proprietorship
- Rental Agreement in the name of the entity.
- Ownership proof of the premises i.e., Latest electricity bill, property tax paid receipt and sale deed (property papers) of the premises
- Site plan and key plan of the premises with total area, dimensions, name of the firm, address mentioned on it.
- List or details of directors/proprietor/director.
- Board resolution or Authorization Letter
- Passport size Photograph of directors/proprietor/director.
- Affidavits for directors/proprietor/partners
- Pan Card, Aadhar card directors/proprietor/partners
- Affidavit from the pharmacist or the competent
The Eligibility & Qualification of Pharmacist / Competent Person –
The qualification or eligibility of a Competent Person for Wholesale Drug License is as under:
- B Pharma/D Pharma Degree holder Registered with State Pharmacy Council or
- A graduate with one year of experience of dealing in drugs or
- An undergraduate having four years’ experience of dealing in drugs.
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.