Drug License - Application, Documents, Registration & Forms
Ensuring everyone has equal and fair access to drugs and medicine is the primary concern of any government. But the right to manufacture and sell drugs and medicines has to be given cautiously. Hence the government has stringent rules for granting licenses for the manufacturing and selling of drugs and medicine. The Act that governs the end to end process from manufacture to the sale of drugs in India is the Drugs and Cosmetics Act, 1940 (‘Act’).
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.
Purpose of Drug Licence
The access to medicines and drugs must be restricted and regulated to ensure that such goods are not abused or misused by individuals. Thus, all pharmacists, wholesalers, retailers, manufacturers, sellers, dealers and importers of drugs, cosmetics, ayurvedic, Siddha and Unani drugs have to mandatorily obtain drug license under the Drugs and Cosmetics Act, 1940.
The purpose of the drug license is to grant permission to allow enterprises or individuals to engage in businesses related to drugs and cosmetics. No enterprise or individual can operate a business dealing in drugs, medicines or cosmetics without obtaining a drug license in India. In addition to a drug license, they must also obtain a trade license and a shop 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 during manufacture, sale, distribution and till it is sold on to a patient or consumer by a pharmacist in a retail pharmacy, hospital or dispensary.
The government also exercises control in the aspects related to import and export of medicines, sale of the drug to a minor, consumption of schedule H & X drugs, etc., that requires thorough monitoring and cautious execution. The drug license is granted by the drug controlling authority under the Drugs and Cosmetics Act, 1940.
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 during manufacture, sale, distribution and till it is sold on to a patient or consumer by a pharmacist in a retail pharmacy, hospital or dispensary.
The government also exercises control in the aspects related to import and export of medicines, sale of the drug to a minor, consumption of schedule H & X drugs, etc., that requires thorough monitoring and cautious execution. The drug license is granted by the drug controlling authority under the Drugs and Cosmetics Act, 1940.
Types of Drug License
In India, the following types of drug licenses are required, depending on the nature of the drug business:
- Manufacturing License– License issued to a business that manufactures drugs inclusive of allopathic/homoeopathy medicines.
- Sale License – License issued for the sale of drugs. It has the following bifurcations: – Wholesale Drug License – Retail Drug License
- 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.
- 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.
- 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.
- 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.
- Multi-Drug License – License issued to businesses that own pharmacies in multiple states with the same name.
List of Essential Documents For Obtaining a License
- 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.
- ID proof of partner/director/proprietor.
- Copy of ownership documents of property or rental agreement and NOC
- Site plan and key plan of the premises.
- Applicant’s qualification certificate