The Drug License is granting a permission by the component authority under the act of drugs and cosmetics for carrying out the businesses related to pharmaceutical industries that deal with drugs, medications and cosmetics. Without a Drug License no person can do pharmacy business or even start to associate with any dealings. Doing so is a cognizable offence. Hence one must obtain an appropriate Drug License for conducting such activities under the drug and cosmetics act of 1940 under which all types of drugs and cosmetics businesses are covered which includes allopathic drugs, homeopathic drugs and even the Ayurveda or unani drugs. The quantity of the drugs used and produced and packed in a dose is the responsibility of all the persons involved in the whole line of work. In case any consumer of these products suffers from any unmentioned harm, these persons will be held responsible and answerable to the event and is an offence of grievance which can go under trial under IPC. Hence vigilance is important.
A particular business entity could need different types of Drug License based on their business. In case a business is being operated in more than two states, it will require a Drug License in every state where it is placed and operating. A Drug License is region specific. If the drugs are stocked and sold at more than one place than one needs to put an application, made with regard to each of such places and Drug license should be issued except for migrant vendors. Once a Drug License is obtained for the business, make sure that the license is compiled at all times with the rules and regulations for Drug License or it could get cancelled. All the records, its registration and forms must be maintained in a specified way by drug License authority and the Drug Licenseauthority must be informed of any changes and modifications to the business activities.
• Application Drafting
• Review about the Business
• Application filing
• End to end follow-up with Department
• The firm's constitution (AOA/MOA)
• The photograph identity proof of sole proprietor, partner or their director.
• The papers of the owned property where the business will be conducted.
• In case it’s rented property, then the copy of rent agreement will be required.
• The key plan and the site plan of the respective premises.
• Drugs storage sometimes need to be in the cold chain, hence the details and invoice of the refrigerator in use.
• An affidavit with regard to compliance with MPD 2021 and if premises are located on DDA flat or building or a plot then their affidavit.
• An additionally detailed document will be required for a registered pharmacist.
• Qualification proof in form of degrees and certificates or mark sheets.
• The certificate of registration with Delhi pharmacy council. Or other state council depending on the region.
• An appointment letter along with bio data.
• Any other additional wholesale documents for wholesale Drug License competent person.
• Any kind of experience certificate.
For obtaining a Drug License, there are certain conditions that applicant will have to follow.
The applicant will have to provide with an independent shop with an adequate amount of area to get permission for retail or wholesale Drug License as per the given details below:-
• To get a drug license in form 20 or form 21 individually or both, the premises of an area must not be less than 10 square meters.
• To get a drug license in the form 20-B or 21-B or both, the premises are supposed to be of an area of not less than 15 square meters.
• The height of the premises where the sales will be conducted must be according to the national building code of India.
If the premises of sales are situated on a DDA allotted land then the Drug License will not be granted but then it can in some cases if it meets the requirements of MPD-2021.
The Drug License is classified by different categories.
These are the –
• Manufacturing license
• Loan license
• Sales license
The sales license is then further divided and classified as the –
• Retail license
• Wholesale license
• Restricted license for general store depending on the kind of sales are done.