Drug License
Drug License - For Trading Wholesale or Retail Drug Business All India Fastest Service
Online Drug License in India Starting at just Rs. 2999/-
The competent authority grants a drug license under the Drugs and Cosmetic Act of 1940 to carry out a business concerning drugs/medicines or cosmetics. In other words, no person can start or carry out a business dealing with drugs or cosmetics in India without a licence from the concerned authority. All types of drugs or cosmetics business fall under the Drugs and Cosmetics Act, 1940, including allopathic, homoeopathic, ayurvedic or unani drugs. To maintain the quality of medicines and cosmetics is the responsibility of all persons dealing with it.Suppose any person consuming or using a drug or cosmetic suffers any harm due to the negligence of the manufacturer or seller. In that case, the same is an offence, which is triable as an offence of grievous hurt under IPC. Hence it is essential to comply with conditions imposed on licence.
Types of Drug Licenses Issued in India
Manufacturing Drug License:
All the manufacturers of allopathic, cosmetics, ayurvedic products or any other medications or drugs as specified under the Drugs and Cosmetics Act 1940. This is the state license that is issued by the particular state government where the unit is situated.
Loan Drug License:
The manufacturer of drugs who don't possess land on his own rather willing to manufacture using his brand name on the land to which license is already issued.
Import Drug License:
Any dealer importing the products for the manufacturing of drugs or is engaged in the business of importing drugs in India shall obtain this license.
Multi-Drug License:
Multi-Drug license is acquired by the entity operating in more than one state having multiple units.
Sale Drug License:
Sale drug license is acquired by the entity engaged in whether wholesale or retail business for distribution of drugs in India.
Wholesale Drug License:
Wholesalers doing the business of pharmaceuticals shall obtain wholesale drug license from the central drugs standard control organization. Wholesale drug license specifies certain minimum requirement on the person applying for this license such as:
1. Degree and diploma in pharmacy
2. Minimum 1-year experience in drug dealing
Retail Drug License:
This license is obtained by retailers engaged in the business of pharmaceuticals, stand-alone pharmacists, etc. by applying to the State Pharmacy Council.
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Documents Required for Drug Licenses
- Application form duly signed which has already been filed
- Copy of Challan as proof of depositing the requisite fee
- Identity proof such as PAN, Voter Id, Driving license, Passport, etc. in case an applicant is a proprietor
- In case the applicant is a partnership firm, Id proof of every partner along with the copy of partnership deed
- Copy of MOA, AOA, and COI in case of private/public/OPC
- CTC of Board Resolution for authorizing the company for obtaining the license.
- Appointment letter of the person who is being authorized by the company
- Proof of availability of storage space such as cold storage, refrigerator, etc.
Additional documents if the applicant is registered pharmacist:
- Diploma pharmacy
- Registration certificate issued by pharmacy council
- Appointment letter
- Affidavit of pharmacist
- Education qualification certificates such as high school & intermediary mark sheets, graduation certificate, post-graduation degree, etc.
- Minimum, one year of experience, is mandatory in drug sales and marketing of any pharmaceutical company.
- Plan the layout of the premise for which the license is applied
- There shall be an area of minimum of 10 square meters in case the license is applied for the wholesale or retail sale of drugs.
- There shall be an area of a minimum of 15 square meters in case the license is applied for both wholesale and retail sales of drugs.
- Necessary Electricity availability and related installation in the premise
Step - 1: Documentation
Documentation is a crucial element in the whole licensing process. Correct documentation makes the process hassle-free and leads to a successful grant of licence. The list of documents required for the Wholesale /Retail sale drug Licence depends on the applicant's type and business activity.
Step - 2: Generation of User ID and Password
The applicant is to register for user ID and password. Once The User ID and password once generated is sent to the registered mail ID of the applicant. The applicant can apply to the generation of user ID and password.
Step - 3: Application Filing
The applicant applies for the grant of a Drug licence to the respective Drug Controlling Authority of the state. For each type of licence, a separate application is filed via different forms prescribed for it. There is no provision for one central certificate/license covering all states. The applicant is to file separate applications for each store.
Step - 4: Inspection of the premises
Before the grant of a drug license, the drug inspector having jurisdiction of the area visits the premises where the drug license is required and verifies the particulars furnished with the application and takes a measurement of the premises. He also checks the area of the premises, whether it is on mixed land use or in a commercial.
Step - 5: Scrutinization of Application
The concerned Drug Inspector verifies the details and the documents uploaded in the online application with his observations on his visit. He may raise a clarification in the application. The applicant must reply to the clarification within 3days of it. Non-furnishing a satisfactory reply may lead to the cancellation of the application.
Step - 6: Issue of License
After satisfactory verification of the documents and the details, the Drug Control department issues the Drug License. The issued licence is valid for five years and is valid after that, subject to its renewal.
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1. Is a drug Licence compulsory to do a pharmacy business?
Yes, no one can deal with drugs without a licence in any manner. So, a drug licence is compulsory to do pharmacy business. -
2. Who provides a drug Licence?
Drug controlling authority specified under Drugs and Cosmetic Act,1940 and rules made thereunder provides the drug Licence. -
3. What is the Drug and Cosmetic Act?
Drug and Cosmetic Act is an Act to regulate the pharma sector, be it sale, distribution, transport, storage, import, export, manufacturer of drugs in India. This act was passed in 1940 with the primary objective to ensure the provision of safe, effective and quality drugs to the people of India. -
4. Is it a requirement to display the original license?
Yes, the licensee should display the original license s in a prominent place in a medical store. The medical store should display the Registration Certificate of the registered pharmacist and the licence. -
5. Whether a license is required for the sale of cosmetics?
No, A cosmetic trader does not require any licence from the drug controlling authority. Cosmetic manufacturers require a licence from the drug department, but if they are manufacturing ayurvedic/herbal cosmetic products, they need an Ayurvedic cosmetic manufacturing licence from AYUSH. -
6. Whether a separate license is required for the sale of drugs through a motor vehicle?
Yes, a separate licence is required for the sale of drugs through motor vehicles. At the time of applying, applicants need to opt for it. -
7. How to Run a 24X7 medical store? Is there a provision of a separate licence to run 24X& medical Store?
Pharmacy stores running 24X 7 do not require any special licence. They need to get the retail sale licence, but they have to appoint three pharmacists to operate three shifts continuously. Each pharmacist will do a shift of 8 hours. -
8. What is the minimum area required to open a wholesale or Rtailsale medical store?
The minimum area required to sell drugs are as under:-
Retail sale Pharmacy Store- 10 sq.m
Wholesale Pharmacy store- 10 sq.m.
Retail & Wholesale Pharmacy Store at a single premise- 15 sq. m
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