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.

Some of the basic requirements for securing a drug license are:
– Sufficient Storage Space
– Sufficient Refrigeration Facilities for Storing Medicines
– Premises
– Technical Staff.

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.

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.

Once the applicant provides the particulars for the drug license, the same will be provided within a period of one month to the applicant.

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.

The following are the types of licenses provided:
– Export License
– Import License
– Manufacturing License
– Sale License
– Loan License
– Multi Drug License.

Usually drug licenses would only be granted for a shop or establishment in commercial premises.

No one can deal with drugs without a licence in any manner. So, a drug licence is compulsory to do pharmacy business.

Drug controlling authority specified under Drugs and Cosmetic Act,1940 and rules made thereunder provides the drug Licence.

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.

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.

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.

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.

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.

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

The wholesaler or retailer of drugs compulsorily requires a refrigerator at his medical 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.

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.

Yes, A medical store can store and sell general items like cosmetics, chocolate, mineral water etc.

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.

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.

Yes, the importer of a drug must possess both an import License and a wholesale licence to sell imported drugs within the country.