What is a Drug License in India?
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.
How to Do Drug License Registration?
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 License authority must be informed of any changes and modifications to the business activities.
What are the Documents Required for Getting a Drug License?
The following is the list of documents that are needed for Drug License.
- 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 residential 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.
What are the conditions for obtaining a Drug License?
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.
The steps for getting a Drug License
You may file for a Drug License application with the government directly, this process shall take as long as 30-60 days as it’s a long process.
Step 1 : The applicant must 1st obtain a user identity and a password by requesting a letter in person, with details of their firm.
Step2 : All of the documents must be then scanned in a 100ppi size and in black and white after that be uploaded using the same identity and password you received at space provided for the purpose.
All information should be precisely filled for the respective application then re-send it. However, the other authority involved in licensing could ask for other documents if needed.
Step 3 : Then you would require a follow up with the government for an update on your application. If the information is incomplete, then it’s rejected, and for this the paid fees will be fortified by the government.
Step 4 : The government Drug License department shall take upto 45 to 60 working days for completing the review of your application and approve it.
Check list for Drug License
The Capital and the proper place of business is a must for every new entity coming into the existence. The same holds true for obtaining the drug license also. There are certain minimum criteria prescribed by the Authority which need to be complied with before applying for the drug license. These are:
1. Area of the pharmacy set-up: In case it is a retail medical shop or a retail pharmacy, a minimum area of 10 square meters is required. If the retail outlet is working in combination with the wholesale one, a minimum area of 15 square meters is mandatory.
2. The Presence of proper storage facility: Certain medicines, most importantly, vaccines are required to be refrigerated while certain other drugs are required to be kept in low-temperature zones. Therefore, the facilities like refrigerators and air conditioners are the per-requisite for a pharmacy business seeking to obtain drug license.
3. Recruitment of technical staff: The presence of a registered pharmacist, having valid certification, is mandatory for every retail form of pharmacy.
However, In the case of a wholesale setup, every sale of a drug shall be supervised by either a registered pharmacist or a graduate with one year of experience in drug dealing or an SSLC passed individual with four years of experience in dealing with drugs.
Time-frame of Obtaining Drug License
According to a recent report stated in "The Times of India", the Drug Regulatory Body has made it mandatory for its officials to attend as well as grant all the licenses, whether retail or wholesale, in the time frame of 30 days, if they fulfill all the required eligibility criteria. The intention is to make the whole process of drug license transparent and user-friendly.