Drug License: Meaning, Types, Requirements & Validity

Drug License: Meaning, Types, Requirements & Validity – To run a pharmaceutical business, it is very essential to get a Drug License. This license ensures that all the products manufactured are safe to use and are of good quality. Any individual who is interested in starting a pharmaceutical business firm must apply for this license.  Below we are going to discuss the whole procedure that is required to obtain a drug license in India. 

Why do we need a Drug License?

Having a drug license is very crucial for manufacturing, distributing, and selling medicinal drugs and cosmetics. This License is required for a business to run lawfully and avoid any trouble with the legal authorities. This License restricts and regulates the access to drugs and medications to ensure that these services are not misused by any individual. So, you must obtain a drug license before opening your pharmaceutical business.

The Drugs and Cosmetics Act, of 1940 was formed by the Government of India to ensure that quality medications are manufactured and sold in our nation. This act provides all the information regarding the manufacturing, storage, distribution, and selling of drugs and cosmetics including Ayurveda, Siddha, and Unani drugs. 

State Drugs Standards Control Organization or SDSCO works in State authority with CDSCO (Central Drugs Standard Controls Organization) under The Drug and Cosmetics Act, of 1940. This authority handles the granting of Licenses on the state level. A drug License is permission granted for the manufacturing, delivery, and selling of drugs by the Drug Controller. 

How many types of drug licenses are there?

There are different types of Drug License available depending upon the scale and nature of the Pharmaceutical Business. Let’s discuss some of them.

• Manufacturing Drug License – This license is granted to the manufacturer of medicinal drugs and cosmetics including Ayurvedic and Allopathic products.
• Sale Drug License – This license is issued for the selling of drugs. Sales drug licenses are divided into two categories.

1. Wholesale Drug License – Having a wholesale drug license allows you to sell and distribute your products to retailers, Pharmacists, and Doctors for further selling. It is issued by CDSCO.
2. Retail Drug License – This license is issued to retailers and chemists for selling the products to end consumers for instance patients. They can sell their products to health facilities, Hospitals, Dispensaries, educational facilities, and research facilities. This is issued by the state Government of India.

• Loan Drug License – As stated by The Drugs And Cosmetics Act, a loan license is granted to someone if they don’t own any manufacturing resources. So, they use the manufacturing unit, facilities, and resources of another licensee to manufacture their products.
• Import Drug License – This license is issued under Schedule X by the CDSCO for the import of drugs and cosmetics all over India.
• Multi-Drug License – A multi-drug license allows an individual to Operate multiple pharmaceutical businesses under the same name all over India.
• FDA License – This license deals with the selling of drugs, cosmetics, food, and related products in the United States of America. This license is issued by the FDA and ensures that all the products are safe to use.  So, if you want to increase your business in the USA you must get this license.

What are the basic requirements to obtain a Drug License?

• The applicant must possess enough space for factory premises and manufacturing units as stated by Schedule M.
• The person applying should submit a blueprint or layout. The applicant should follow the National Building Code Of India at all costs.
• The applicant should be a Registered Pharmacist and possess a license from the Pharmacy Council of India (PCI).
• The premises must be equipped with adequate laboratory equipmentThe applicant must ensure that there are enough storage arrangements including temperature-regulated storage.
• Most importantly, the premises should run on Good Manufacturing Practices (GMP) standards.

Which Documents are needed for a Drug License?

To obtain a drug license, you must fulfill all the document requirements mentioned below.

• The constitutions of firms( MOA & AOA along with partnership deeds and LLP).
• Valid Id proofs of partners/Proprietor/Director.
• Owners address proof.
• Copy of rent agreement or owned property papers.
• Blueprint and site plan of the premises.
• Copy of details and invoice of equipment like refrigerator/ air conditioner purchased for usage.
• Cover letter mentioning the purpose of the application.
• In the case of a sale license, an affidavit of a registered pharmacist is required.
• List of appointed technical staff along with their bio-data, id proofs, education qualification, and appointment letter. Experience letter, and 3 photographs.
• Affidavit from hired technical staff for full-time working with the firm.
• List of machinery and laboratory equipment.
• No Objection Certificate from the fire department and pollution control.

Process of Obtaining a Drug License in India

• Documentation – Complete and collect all the required documents to apply for a drug license. 
• Application – After making sure that you have all the required documents then the next step is to submit your application to the SDCA ( State Drug Control Authority) or CDSCO.
• Inspection by the Drug Inspector – SDCA or CDSCO appoints a drug inspector to audit and inspect the compliance of GMP standards ( Good Manufacturing practices).
• Approval – After the detailed inspection of the premises and documents. The drug department issues you the drug license if they are satisfied.

 Validity of drug License

The validity of a drug license is around 5 years unless it gets suspended by the drug department due to any valid and relevant reason. This license can be renewed before its expiry date by logging into the respective website, entering your drug license number, filling out the application, and submitting the required documents and fees.

Conclusion

In conclusion, a Drug License is crucial to do business in the pharmaceutical industry whether small-scale or large-scale. A drug license ensures the safe and secure manufacturing, distribution, and selling of products. So, that the customers receive high-quality products. To obtain the drug license you must fulfill all premises, documents, and legal requirements. 

FAQS related to “Drug License: Meaning, Types, Requirements & Validity”

Question 1. A drug license is valid for up to how many years?

Answer 1. A drug license is valid for up to 5 years unless and until it gets canceled by the drug department due to any valid circumstances.

Question 2. What educational qualification a person must possess to get a drug license?

Answer 2. The applicant must possess a valid degree or diploma from any reputed university

Question 3. What are the various types of drug licenses?

Answer 3.  Different types of drug licenses include-

• Manufacturing drug license
• Wholesale drug license
• Retailer drug license
• Loan drug license
• Import drug license
• FDA drug license
• Multi-drug license