Drug License

Overview of Drug License

Section 3(b) of the Drugs and Cosmetics Act of 1940 defines the term “drug” to include. All drugs and devices intended for internal/external use by humans/animals. As well as all substances used for/in the diagnosis, mitigation, treatment/prevention of any disorder/disease in animals/humans. Including preparations applied to the human body intended to repel insects such as mosquitoes. It also includes all substances that can be used to kill insects and all ingredients of medicines. Such as empty gelatin capsules. The definition was revised in 1964 to include Ayurvedic and Unani medicines.

What is Drug License for Drug License in India?

Access to drugs and pharmaceuticals must be Restricted and regulated to ensure that these goods are not abused or misused by individuals. All pharmacists – wholesalers, retailers, manufacturers, sellers, dealers and importers of medicines, cosmetics, Ayurvedic, Siddha and Unani medicines must have a license to practice pharmacy as per Dharma. Pharmaceuticals and Cosmetics Act of 1940.

The purpose of a pharmaceutical license is to license companies or individuals engaged in activities related to drugs and cosmetics. No company or individual can operate the business of drugs or cosmetics without a pharmaceutical license in India. In addition to a pharmaceutical business license, they must also have a business license and store and establishment registration.

The Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945 help the government regulate. And monitor the quality of drugs sold in India. The government exercises control over drugs from the raw material stage. Through manufacturing, sale, distribution and until they are sold by a pharmacist to a patient or consumer in a retail pharmacy, hospital or dispensary. .

The government also exercises control over aspects related to import and export of drugs, sale of drugs to minors, consumption of drugs on the H&X list, etc., which require strict supervision and careful implementation. Pharmaceutical licenses are issued by the Drug Controller under the Drugs and Cosmetics Act, 1940.

What are the following types of Drug License ?

In India, the following types of drug licenses are required, depending on the nature of the drug business:

1. Manufacturing License – License issued to a business that manufactures drugs inclusive of allopathic/homoeopathy medicines.
2. Sale License – License issued for the sale of drugs. It has the following bifurcations: – Wholesale Drug License, Retail Drug License
   1. Wholesale License – A drug wholesaler must obtain a wholesale licence. Wholesale means the sale of the drug to a person/retailer to further sell it.
   2. Retail License – A retail license is required for the retail sale of drugs. A retail sale means the sale of drugs or cosmetics for the consumption of the end consumer. Retailers can sell it to a dispensary, hospital, educational, medical, or research institute. Retailers engaged in pharmaceuticals, cosmetics, stand-alone pharmacists, ayurvedic shops, etc need this license.
3. Loan License – License issued to a business that does not own the manufacturing unit. But uses the manufacturing facilities of another licensee to manufacture drugs.
4. Import License – License issued to any dealer importing the products for the manufacturing of drugs. Or is engaged in the business of importing drugs in India.
5. Multi-Drug License – License issued to businesses that own pharmacies in multiple states with the same name.

Eligibility criteria for Drug License in India

1. Pharmacist/ Competent Individual: The pharmacist must be qualified in the case of a retail business. In the case of a wholesale business. The individual must be a graduate with 1-year experience or an undergraduate with 4 years of experience.
2. Space Requirement: The other important requirement is space, that is the area of the pharmacy/unit. For both wholesale and retail licenses the area of the pharmacy/unit should be 15 square meters. In the case of a retail and medical shop, it should be 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.
3. Storage Facility : The other important requirement is storage facility since some drugs require to be stored in low temperatures, refrigerators and air conditioners.
4. Technical Staff : The retail pharmacy staff must be experienced with in-depth knowledge. The staff of the wholesale pharmacy must be a graduate with a minimum of one year experience or an undergraduate having four years of experience.

Documents required to obtain an Drug License

1. Constitution of the entity, Memorandum of Association (MOA), Articles of Association
2. (AOA) for a company, partnership deed, LLP agreement in case of partnership and LLP.
3. ID proof of partner/director/proprietor.
4. Documents related to premises – Copy of ownership documents of property or rental agreement. NOC (No Objection Certificate) from the owner of the rented premises as the case may be.
5. Site plan and key plan of the premises.
6. Copy of Board resolution permitting obtaining of a license.
7. Proof of availability of storage space as cold storage, refrigerator, etc.
8. Copy of challan as proof of depositing fee.
9. Affidavit regarding non-conviction of proprietor/partner/director and the firm.
10. The affidavit from the registered pharmacist/competent person.
11. Cover letter with name and designation of the applicant
12. Declaration form in a prescribed format
13. Applicant’s qualification certificate
14. For a pharmacist at a retail sale:
    1. Proof of qualification
    2. Registration of local pharmacy council
    3. Appointment letter
15. For a pharmacist at a wholesale sale:
    1. Proof of qualification
    2. Experience certificate
    3. Appointment letter

List of Application Forms

FAQs About Drug License ?

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