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Drug License Registration
A Drug license is a document/certificate issued under the Drugs and Cosmetic Act of 1940 that gives the permission to the applicant for carrying out businesses related to drug, medicines and cosmetics. It is mandatory to obtain Drug License before launching a drug business.
As per Drugs and Cosmetic Act of 1940, the term drug includes:
– All medicines and devices/ substances used for or in the treatment, diagnosis, prevention or mitigation of any disorder or disease in human beings or animals internally or externally, including preparations applied on the human body to repel insects like mosquitoes.
– All substances used for destruction of insects and all components of the drug like empty gelatine capsules
– Medical devices
ComplianceIndia can help you obtain your Drug license Registration quickly and hassle-free.
Types of Drug License Registration
Manufacturing License: License issued to a business that manufactures drugs inclusive of allopathic/ homeopathy medicines.
Sale License: License issued for the sale of drugs. It has the following bifurcations: – Wholesale Drug License – Retail Drug License – Restricted Drugs
Loan License: License issued to a business that does not own the manufacturing unit but uses the manufacturing facilities of another licensee.
Import License: License issued for the import of drugs.
Multi-Drug License: License issued to businesses that own pharmacies in multiple states with the same name.
Advantages of Drug license Registration
Avert unfair Pricing Policy
Compliance with legal regulators
Increase Goodwill and reputation in the Public
Ensure Quality in vaccination
Eliminates Prohibited Drugs
Eligibility for Drug License Registration
The first requirement for a pharmaceutical business is to have a competent person or a qualified and registered pharmacist. The qualification or eligibility of a Competent Person for Retail and Wholesale Drug License is as under:
|For Retail Drug License||For Wholesale License|
|B Pharma/D-Pharma Degree holder Registration with State Pharmacy Council No Prior Experience Required||B Pharma/D-Pharma Degree holder Registered with State Pharmacy Council or A graduate with one year of experience of dealing in drugs or An undergraduate having four years experience of dealing in drugs|
The Second requirement is related to space within which the Pharmacy Unit will operate. It must be as prescribed under the Guidelines issued and the other requirement is Storage Facility since some drugs requires to be kept in low temperatures.
How we Work?
Documents required for Drug License Registration
C. Premises Related
D. Technical person documents
D. Technical person documents
Frequently Asked Questions
1. What is a drug license issued for?
A drug license is issued by the government to carry out the process of manufacturing drugs, distributing and selling of drugs. All pharmacies require this form of license to carry out different processes.
2. What are the basic necessities of securing this form of license?
Some of the basic requirements for securing a drug license are:
– Sufficient Storage Space
– Sufficient Refrigeration Facilities for Storing Medicines
– Technical Staff.
3. Is the drug license a mandatory requirement for my business?
Yes drug license is a mandatory requirement if the business carried out is dealing with pharmaceutical materials and other forms of drugs. If a drug license is not taken out by the business then there can be penalties levied under the Indian Penal Code, 1860 and the Drugs and Cosmetics Act, 1940.
4. Is it possible to renew the drug license?
Yes it is possible to renew the drug license. The applicant has to provide requisite documents for renewing the drug license. Such documents have to be uploaded on the website where the shop or premises is established. After this step, the authority will issue the license for a particular period of time.
5. What is the time frame taken for securing a drug license?
Once the applicant provides the particulars for the drug license, the same will be provided within a period of one month to the applicant.
6. Is it possible to import drugs into India?
As per the Drugs and Cosmetics Act, 1940 all the works related to manufacturing drugs, distributing and selling of drugs have to be regulated. It is possible to import drugs into the country only after securing the specific import license.
7. What are the types of licenses that are provided?
The following are the types of licenses provided:
– Export License
– Import License
– Manufacturing License
– Sale License
– Loan License
– Multi Drug License.
8. What type of premises will the drug license be granted for?
Usually drug licenses would only be granted for a shop or establishment in commercial premises.
9. Is a drug Licence compulsory to do a pharmacy business?
No one can deal with drugs without a licence in any manner. So, a drug licence is compulsory to do pharmacy business.
10. Who provides a drug Licence?
Drug controlling authority specified under Drugs and Cosmetic Act,1940 and rules made thereunder provides the drug Licence.
11. What is the Drug and Cosmetics 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.
12. 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.
13. 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.
14. 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.
15. How to Run a 24X7 medical store? Is there a provision of a separate licence to run 24X&7 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.
16. What is the minimum area required to open a wholesale or Retail sale 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
17. Do a wholesaler or retailer of drugs mandatorily require a refrigerator?
The wholesaler or retailer of drugs compulsorily requires a refrigerator at his medical Store.
18. Can the fridge be switched off after the working hours of the medical shop/store?
No, as we all know, some medicine must be stored between 2ºC and 8ºCparticularly vaccines, insulins, sera, eye drops, etc. Thus the pharmacy store cannot switch off the fridge at any point in time. It should be on & in working conditions even after working hours at a medical shop/store.
19. Do you require a special licence for veterinary drugs?
No, Drug dealers do not have a separate license for veterinary drugs. Still, he needs to make a separate provision for storage in the medical Store marked as VETERINARY DRUGS, NOT FOR HUMAN.
20. Can the licenced premises store drugs and general items Eg: cosmetics, chocolates, mineral water etc.?
Yes, A medical store can store and sell general items like cosmetics, chocolate, mineral water etc.
21. What happens to the drug licence if there is a change in premises?
The applicant has to surrender the drug licence granted for the old premises and apply for a new licence if there is any change in the firm’s premises.
22. Do we require to inform if there is any change in the competent person/registered pharmacist?
Licensee needs to report any change in the competent person / registered pharmacist and submit relevant documents of the newly appointed competent person / registered pharmacist to the concerned licensing authority. The licencing authority does the necessary endorsement on the license after verification of the document to its satisfaction.
23. Do importers of drugs need a wholesale license?
Yes, the importer of a drug must possess both an import License and a wholesale licence to sell imported drugs within the country.