All manufacturers/retailers/traders that are directly or indirectly related in sale/purchase/manufacturing of medicines or involved in pharmacy business in India are required to obtain a drug license from the concerned authority. In India Central drug standard control organisation (CDSCO) at the national level and State drug control organisations have the authority to issue drug license.
Drug license is a kind of permission from the authorities by all those who are operating in the pharmaceutical business or any other operation relating to the pharmaceutical industry.
Manufacturing drug license
All manufacturing hubs of Allopathic, Ayurvedic or any Cosmetics products or any other drug specified under the Drugs and Cosmetics Act, 1940. State Government grants this kind of drug License to the applicant.
Loan drug license
Those applicants who don’t have their own land to manufacture drugs but want to manufacture under their brand name but on the land of those who have the drug manufacturing license.
Import drug license
This Drug License must be acquired by those persons who are using imported products for manufacturing drugs or those who are engaging in the distribution of imported drugs in India.
Multi drug license
Multi-Drug License must be acquired by those entrepreneurs who are operating in more than one state. No one can sell drugs at more than one place without obtaining this Multi-Drug License.
Sale drug license
Wholesaler or retailer who are engage in the pharmacy business activity of selling drugs which are specified under the drugs & cosmetics act, 1940 are required to obtain drug license under this category. There are three (3) types:
· Wholesale drug license- The wholesale Drug License in India is issued by CDSCO (Central Drugs Standard Control Organization) to those wholesalers who are doing business in pharmaceuticals. The person who wants to obtain this License must have some degree or diploma in pharmacy from a recognized university and a minimum of one year experience in drug dealing.
· Retail drug license- Retail Drug License in India is issued by Licensing Authorities to retailers who are doing business in pharmaceuticals, stand-alone pharmacists, etc. The applicant should be registered pharmacist under the State Pharmacy Council.
· Restricted drug license- This License is issued under Forms 20A and 21A to dealers or persons, to sell drugs without the supervision of any qualified person.
· Passport size photograph
· Identity/address proof of owners
· Receipt of application fee deposit
· Application form duly filled and signed
· Self-attested copy of the registered plant layout
· Rent agreement (if applicable) & No-objection Certificate (NOC)
· Invoice of Refrigerator for business purpose
· Invoice of the purchase of Air-Conditioner
· Partnership deed
· Complete list of partners
· Other documents required in case of Private and Public Limited Company
· Certificate of Incorporation
· Memorandum of Association
· Article of Association
· Appointment of the concerned and authorized person who will be responsible for daily operations.
· Copy of the board resolution regarding the authorized person who will be responsible for the day to day operations.
· Copy for the diploma in pharmacy
· Registration Certificate from The Pharmacy Council
· Experience Letter, if any
· Affidavit of pharmacist
· Details of the educational certificate of a competent person
1. SIGN UP: Visit the state drug standards control organisation website and fill up the application form. Create your profile by filling your personal details and updating your login password. Firstly, the applicants need to visit the website of their respective State Drug Licensing authority and register themselves by filling the registration form. After that, the applicant has to fill his details, organization details, and contact details to generate OTP.
2. DOCUMENTS UPLOAD: After filling up the form, the applicant has to upload documents; the documents checklist is mentioned earlier depending on the formation of the Company.
3. PAYMENT OF FEES: After uploading all the documents, requisite fees of the form should be submitted and generate a challan for the same for further processing.
4. SCREENING OF DOCUMENTS: After submitting the form, the licensing authority will scrutinize the form, and the District Coordination Officer will inspect the organization and ensures that it complies with all the requirements. After the verification and inspection, the DCO will forward the report to the SDCO of the zone for granting the License.
5. DRUG LICENSE: The report of SDCO will be forwarded to the respective State Drug License Authority, and, if the authority finds no discrepancy in the report, then it will issue Drug License to that person. Approximately 30 days are required for the issuance of a Drug license
What is drug license?
Drug license is an official document which certifies that you are eligible for the manufacturing, sale, purchase of pharmaceutical products in the area specified in the license. There are certain restrictions which is attached in getting a drug license such as premises establishment and the person who shall be dealing with the product etc.
How do you get a drug license?
Getting a drug license is not that tough but still requires various formalities which need to be fulfilled before filling up the application form. Documents which are required to proceed with you drug application form and the complete process is explained in the earlier phase of the article.
Wholesale Drug License for sale or redistribution of drugs comes under Drugs and Cosmetics Rules in Form 20B & 21B & its renewal process is specified in Form 21C is issued to the manufacturer or any other who want to sell, stock, exhibit or offer for sale or distribute drugs, by the State Licensing Authority in India.
Drug & cosmetics act, 1940 and rules amended thereafter in 1945 are applicable on Wholesale Drug licence which is issued in Form 20B and Form 21B.
Documentation may vary with the type of drug license you are opting for. This may vary on the type of license an individual is opting for. For example if you are a pharmacist then the documents required are different as compared to the documents required in a partnership firm. You can access the complete list of documents required for a drug license in the initial paragraph of this article.