Drug sale License

The Drug sale License is issued for both retail as well as wholesale purpose for the distribution of drug in India. The issuance of license for drug subjects to conditions attached with the competent person who deals with drugs and the premises (area of pharmacy shop and storage facility).

The applicant must apply online for the license as per the line of business, for which he/she must have a valid email id and contact number. The next step is to keep all the documents updated. Next is to upload the documents and the form along with the applicable fees.

1. Meaning of Drugs

Section 3(b) of the Drugs and Cosmetics Act,1940 defines “drug” to include all medicines and devices for the use of human beings or animals internally or externally, and all substances planned to be used for or in the diagnosis, mitigation, treatment, or prevention of any disorder or disease in animals or human beings, including preparations applied on the human body for the purpose of repelling insects like mosquitoes; it also includes all substances that can be used for the destruction of insects and all components of a drug – like empty gelatin capsules. The definition was amended in 1964, to include Ayurvedic and Unani Drugs.

2. Types of Drug License

Looking at the definition of “drug”, the pharmaceutical business in India requires the following types of licenses:
Manufacturing License– License issued to a business that manufactures drugs inclusive of allopathic/ homeopathy medicines.
Sale License – License issued for the sale of drugs. It has the following bifurcations: – Wholesale Drug License – Retail Drug License – Restricted Drugs
Loan License – License issued to a business that does not own the manufacturing unit but uses the manufacturing facilities of another licensee.
Import License – License issued for the import of drugs.
Multi-Drug License – License issued to businesses that own pharmacies in multiple states with the same name.

3. Prerequisites For Obtaining a License

Pharmacist/ Competent Individual: The pharmacist must be qualified in the case of a retail business. In case of a wholesale business, the individual must be a graduate with 1-year experience or an undergraduate with 4 years experience.
Space Requirement: The other important requirement is space, that is the area of the pharmacy/unit. – For both wholesale and retail license – 15 square meters. -In all other cases – 10 square meters. – The clear height of the sales premises shall be as per the guidelines laid down under the National Building Code of India, 2005.
Storage Facility: The other important requirement is storage facility since some drugs require to be stored in low temperatures, refrigerators and air conditioners are a must.

4. Application for a Drug License

The following are the steps to be taken for obtaining the drug license: The applicant must apply online for the license as per the line of business, for which he/she must have a valid email id and contact number.
The next step is to keep all the documents updated.
Next is to upload the documents and the form along with the applicable fees.
Upon completion of the online process, an inspector will visit the site and verify the validity of documents.
If all the above steps have been duly complied with, the authority will issue the drug license.

5. List of Application Forms

Sr. No	Form No	Purpose
1	Form 19	Application for grant or renewal of a license to sell, stock, exhibit or offer for sale, or distribute drugs apart from those specified in Schedule X.
2	Form 19A	Application for granting or renewing a restricted license to sell, stock, exhibit or offer for sale, or distribute drugs by retail via dealers who don’t engage the service of a qualified individual.
3	Form 19B	Application for license to sell, stock or exhibit or offer for sale, or distribute Homoeopathic Medicines.
4	Form 19C	Application for grant or renewal of a [license to sell, stock, exhibit or offer for sale, or distribute] drugs specified in Schedule X.
5	Form 24	Application for either the grant of a license or for the renewal of a license or to manufacture for sale or for distribution of drugs other than those which are specified in [Schedule C, C (1) and X].
6	Form 24A	Application for either the grant of a loan license or renewal of a loan license to manufacture for sale or distribution of drugs other than those specified in Schedule C, C (1) and X.
7	Form 24B	Application for grant or renewal of a licensee to repack for sale or distribution of drugs, being drugs other than those specified in Schedule C and C (1) excluding those specified in Schedule X.
8	Form 24C	Application for the grant or renewal of a license to manufacture for sale [or for distribution] of Homoeopathic medicines or a license to manufacture potentized preparations from back potencies by licensees holding a license in Form 20-C
9	Form 24F	Application for grant or renewal of a license to manufacture for sale or for distribution of drugs specified in Schedule X and not specified in Schedule C and C(1).
10	Form 27	Application for grant or renewal of a license to manufacture for sale or for distribution of drugs specified in Schedule C and C (1) excluding those specified in part XB and Schedule X

What are the Benefits of Obtaining the Manufacturing Drug License?

The Benefits Of Obtaining The Manufacturing Drug License Are-
Legality
A person must file a Manufacturing drug license application as it provides legality to the business and also it is illegal to engage in the manufacturing or sale of drugs in India without obtaining the license.
Proper Monitoring And Regulation By The Authority
Manufacturing drug license helps the authority in monitoring and regulating the sale of medicines in India that ultimately enhances business credibility and trustworthiness.
Proof Of Authenticity
A Manufacturing Drug license plays a vital role, as it works as a proof of authenticity and builds an image of the company.
Confidence In The Consumers
A drug license certificate proves to your consumers that the business is following strict quality measures while manufacturing drugs. Also, a valid license proves to the consumers that the medicines and drugs are safe and constitute no health hazards.

Documents Required:

List of Essential Documents For Obtaining a License

1. Constitution of the entity – Memorandum of Association (MOA), Articles of Association (AOA) for a company, partnership deed, LLP agreement in case of partnership and LLP.
2. ID proof of partner/director/proprietor.
3. Documents related to premises – Copy of ownership documents of property or rental agreement as the case may be.
4. Site plan and key plan of the premises.
5. Copy of Board resolution permitting obtaining of a license.
6. Proof of availability of storage space as cold storage, refrigerator, etc.
7. Copy of challan as proof of depositing fee.
8. Affidavit regarding non-conviction of proprietor/partner/director and the firm.
9. The affidavit from the registered pharmacist/competent person.
10. For a pharmacist at a retail sale: – Proof of qualification – Registration of local pharmacy council – Appointment letter
11. For a pharmacist at a wholesale sale: – Proof of qualification – Experience certificate – Appointment letter