Drug License In India
Application Drafting & Filing
About Drug License
Drug license is a permission granted by the authority under the Drugs and Cosmetic Act in order to carry out a business of drugs/medicines or cosmetics. The Drug license is issued by the State Drugs Standard Control Organization or the Central Drug Standard Control Organization.
The drugs are used in the medicines, in a medically defined ratio to cure our health. Drugs come in use on a need basis, to ensure our well being. However such medicines are manufactured with very restricted and correct amount of the drugs and it does not harm the body.
However, any violation of the medically defined limits may have a very serious effect on the health of the person using it. Therefore it requires to be regulated by the government via imposing stringent law and regulations in the process of manufacturing and distribution of drugs and medicines in India. Once you have Drug License from the government, you can deal with drugs otherwise not.
Competent Person/ Pharmacist
The medicines need to be handled with by a specialist, and for that matter, there is a requirement of a qualified pharmacist in case of retail drug license and in case of wholesale a graduate with 1 years experience or undergraduate having four years experience is must
Area of Pharmacy Shop
For opening a pharmacy business, the carpet area of the pharmacy must be a minimum of 10 square meters, and in case the application is for both retail and wholesale pharmacy the minimum area prescribed in 15 square meters. The premises must be adequately ventilated.
Storage Facility of Drugs
Medicines need to be stored at a clean, ventilated and cool storage facility, since some drugs, in particular, the vaccines need to be stored in a low-temperature freezing zone. Hence, facility of a refrigerator and air conditioner is essential for grant of a drug license in India.
Inspection by Drug Inspector
Before the grant of a drug license, the drug inspector having jurisdiction of the area visits the premises where drug license is required and verify the particulars furnished with the application and if required take measurement of the premises and also interview the competent person.
Retail drug license
It is Issued to Persons/agencies involved in Standalone/ chemist pharmacy shops
Wholesale drug license
It is issued to Persons/agencies involved in wholesale distribution of drugs
1. Application forms.
2. Chalan of fee deposited.
3. Declaration form.
4. Key plan (Blue print)
5. Site plan (Blue print)
6. Basis of possession of the premises.
7. Proof of ownership of the premises, if rented.
8. Proof of constitution of the firm (Certified copy)
9. Affidavit of non-conviction of Proprietor/Partners/Directors under Drugs & Cosmetics Act, 1940.
10. Certified copy of Regn. Certificate of Delhi Pharmacy Council/Experience Certificate of the Registered Pharmacist/Competent person and qualification certificates.
11. Bio-data form.
12. Affidavit of Registered Pharmacist/Competent person regarding fulltime working with the firm duly attested by Notary.
13. Appointment letter of Registered Pharmacist/Competent person in charge, if employed person.
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 FILLING
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.
- Drug license application.
- Drugs license approval.
- Drugs license name tracking.
- Drug License renewal.
- Drug license manufacturing set up plan and compliance.
- Legal advisory and legal documentation and formats on a need basis.
Frequently Asked Questions
Is it necessary to obtain drug license prior to commencement of the drug business?
My shop is not located at a commercial premises, can i still get the drug license to sell/manufacture drugs?
No, in order to obtain the licenses for the sale of drugs commercial premises or other premises independent of residence, also known as mixed land use should be your premise.
How many types of licenses are issued for the pharmaceutical business?
Basis the needs of the applicant he/she may apply for following types of license
- Drug Manufacturing License
- Retail Drug License,
- Wholesale Drug License,
- Import of Drugs or Cosmetics
- Import of Medical Equipment
- Export of Medicines etc.
Who is liable to maintain the drugs quality in pharmacy?
It is the responsibility of all persons dealing with drugs to maintain the quality of drugs in the medicines. If any person consuming or using a drug or cosmetic suffers any harm due to the negligence on the part of the manufacturer or seller, it amounts to an offense of grievous hurt under India Penal Code.
How to import Drugs or Cosmetics ?
Visit Us On
501,Rishabh corporate Tower
Kakardooma Community Centre,