Drug Licence Meaning
Drug Licence grants permission under the Drugs and Cosmetic Act to carry out a drug/medicine or cosmetic business. As per the Drugs and Cosmetics Act, 1940, the Central or State Drug Standard Control Organization grants such License.
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 may be in use for the destruction of insects and all components of a drug like empty gelatin capsules. An amendment to the definition of ‘Drugs’ in 1964 to include Ayurvedic and Unani Drugs.
Types of Drug Licence
The pharmaceutical business in India requires the following types of licenses:
- Manufacturing Drug License
- All the manufacturers dealing with ayurvedic, allopathic, cosmetics, or any other medications or drugs require a Manufacturing Drug License. This state license shall be granted by the respective state government where the unit is located.
- Loan Drug License
- License issued to a business that does not own the manufacturing unit but uses the manufacturing facilities of another licensee.
- Import Drug License
- Any dealer who is importing the products for manufacturing drugs or is in the business that involves importing drugs in India shall mandatorily obtain this specific license.
- Multi Drug License
- Business require a Multi Drug License when operating in more than one state or having multiple units.
- Sale Drug License
- Sale drug license is a requirement for entities who engage in either retail or wholesale business for the sale or distribution of drugs
- Wholesale Drug License
- Wholesalers who engage in the business of pharmaceuticals shall mandatorily acquire wholesale drug license from the CDSCO. This license prescribes certain minimum conditions on the person applying for it.
- Retail Drug License
- This license is a requirement for retailers who engage in either in pharmaceuticals business, or stand-alone pharmacists, etc. You can also acquire the same by applying to the State Pharmacy Council.
Who can issue Drug Licence?
Drug license acts as an authority given by the Government of India to the owner of the drugstore or pharmacy. The Drugs and the Cosmetics Act, 1940, is the governing force for the issuance of Drug License in India. This act provides the provisions for carrying out the business of medicines, drugs, or cosmetics in India.
In India, the Drug license is granted by the following listed authorities:
- State Drugs Standard Control Organization (SDSCO)
- As per the provisions of Drugs and Cosmetics Act, 1940, the sales, distribution, and manufacture of drugs shall be regulated by the state authorities.
- Central Drugs Standard Control Organization (CDSCO)
- According to the Drugs and Cosmetics Act of 1940, the CDSCO is responsible for approving the newly made drugs and clinical trials of the said drugs. It also controls the quality of the drugs imported and coordinates with the SDSCO.
Pre-requisites 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.
- Technical and Expert Staff: Additionally, A Retail pharmacy must have an experienced, and technical staff with in-depth knowledge of the same. A qualified pharmacist is a must for obtaining a Drug License.
FAQs
Yes, before you start any business dealing in drugs, whether it is Allopathic Drugs, Ayurvedic Medicine, Homeopathy or Unani, to manufacture, distribute or sell the drugs It is mandatory to obtain a license as per the nature of business by applying to the controller of the drugs and cosmetics.
In case a business is operating in more than two states, it has to obtain drug license in every state in which business is being carried on. Drug licence is location specific, and hence within state application, all site must be included.
Any person/company/partnership firm/LLP/OPC can apply for Drug License at Drug Controlling Authority.
Drugs and Cosmetic Act aims at ensuring safety, effectiveness and conformity of the drugs and cosmetics sold in India to the state quality standards. Drugs or cosmetics of schedule X can be imported into India only after a License is obtained.
Trade License is a license or permission issued by a municipal corporation granting permission to carry on a particular business at a particular address. It ensures that the citizens are not adversely affected by health hazard and nuisance by the improper carrying of trade.