What is Drug License?

Drug License is permission from the government to deal with drugs. There are two kinds of license, the retail license and wholesale license of for drug distribution or sale in India. This license is issued subject to certain conditions attached to premises and the competent person who shall be dealing with drugs.

Drug license is a permission granted by the competent authority under Drugs and Cosmetic Act, 1940 to carry out a business concerning drugs/medicines or cosmetics. In other words, no person can start or continue a business dealing with drugs or cosmetics in India, unless an appropriate license is obtained for the conduct of such activity. Under the purview of Drugs and Cosmetics Act, 1940 all types of drugs or cosmetics business is covered including allopathic, homeopathic, ayurvedic or unani drugs. To maintain the quality of drugs and cosmetics is the responsibility of all persons dealing with it. If any person consuming or using a drug or cosmetic suffers any harm from the negligence on the part of the manufacturer or seller the same is an offence, which is triable as an offence of grievous hurt under IPC.

Rietway Consultants Drug License Package

The Services which are included in our package are as Follows:
✅ Consultation for Type of license required
✅ Preparation of Documents
✅Application Filing
✅Paying Government Fees
✅ Drug License

Documents required to obtain Drug License

Following documents are required with application form:
1. Constitution of the firm (MOA/AOA)
2. Photo ID proof of proprietor/partner/director
3. Copy of Property paper (If owned property)
4. Copy of Rent agreement (If rented property)
5. Site Plan and key plan of the premises
6. Refrigerator invoice and details
7. Affidavit regarding compliance of MPD 2021 (if premises are located on DDA residential flat/ plot/ building)

Additional document for Retail Sale Registered Pharmacist
1. Proof of qualification i.e. final degree certificate/provisional certificate with mark sheets
2. Registration of Delhi Pharmacy Council
3. Appointment Letter and Bio-data

Additional document for Wholesale Licence Competent person
1. Proof of qualification i.e. final degree certificate/provisional certificate with mark sheets
2. Experience Certificate
3. Appointment Letter and Bio-data

Drug License procedure

Step 1: Documentation: The most important step in obtaining the drug License is the preparation of documents which includes, preparation of key plan and site plan and various affidavits and declaration as prescribed under law.
Step 2: Application Filing: The Drug License applications are filed online, these days including the payment of government fee. All documents are scanned and uploaded at the time of filing the application. However, filed documents are verified by the inspector.
Step 3: Inspector: Visit After the application for grant of drug license is filed, the same is marked for inspection and thereafter the drug inspector personally visits the shop to verify the documents and correctness of information.
Step-4: Grant Of License: After the Inspection is complete and in case personal interview is called for is cleared by the competent person and upon verification all information and documents furnished is correct the controller of drugs issues the Drug License.

Conditions for obtaining Drug License

The applicant has to provide an independent shop with the adequate area for grant of retail/wholesale licences as per details given below:
For grant of a licence in Form 20 or Form 21 or both, the premises are of an area of not less than 10 square metres.

For grant of a licence in form 20-B or form 21-B or both, the premises are of an area of not less than 10 square metres.
For grant of licences :
In Form 20 or Form 21 or both,
In Form 20-B or Form 21-B or both, the premises should be of an area of not less than 15 square metres.

The clear height of the sales premises should be in accordance with the National Building Code of India, 2005 as amended from Time to Time.

No drug licence is granted in a premises situated on a DDA allotted residential plot/land or flat unless it meets with the requirements of MPD-2021.

FAQ on Drug License

Is it necessary to obtain a drug license prior to commencement of the drug business?
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.

Is it true that for grant of a drug license my shop must be located at a commercial premise?
Licenses for the sale of drugs can be granted only at premises which is commercial premises or other premises independent of residence, also known as mixed land use. For this purpose, state drug office issues guidance which may be referred to.

What are different types of Licenses Issued for the Pharmaceutical Business?
i. rug Manufacturing License,
ii. Wholesale Drug License,
iii. Retail Drug License,
iv. Import of Drugs or Cosmetics,
v. Import of Medical Equipment,
vi. Export of Medicine

Do I have to apply and seek separate drug license for Branches of My Pharmaceutical Business?
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.

How to import Drugs or Cosmetics ?
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 can be imported into India only after obtaining a License.