What is Drug license?
The potential of the pharmacy business in India cannot be underestimated. The economic cycles have the least impact on the business of drugs and medicines. The rapidly growing state- of- the -art medicinal and surgical developments are further adding the spark to the scope of entrepreneurs involved in the business of pharmacy.
Being considered as one of the essential element required for the survival of mankind from the ancient times, the pharmacy business holds an integral position in the overall consumers market. The scope of medicines has changed rapidly from Ayurveda to Modern medicines such as allopath and homeopathy.
Type of Pharmacy Business
Hospital Pharmacy :- It is the one which you find to be present in a hospital satisfying the in-house medicinal requirements of the concern.
Standalone Pharmacy :- This is the one set-up in a residential area, in the neighborhood market which the residents have easy access to.
Chain Pharmacy :- A number of shops set up under the same brand, mostly located in a shopping mall and having similar branches in other places.
Township Pharmacy :- It is the era of modern townships built by the big realtors which facilitate almost every need of the residing individuals. These kind of pharmacy are the one which is set up in a planned township along with other shops looking after every daily need.
Documents Required for Drug License
Once you have made your mind in respect of setting up the pharmacy business in India, you have to be assured that the following points of importance are satisfied before applying for the drug license in order to start the business operations:
1. A form of business: Only an entity registered in the eyes of the law can proceed with obtaining the drug license. The form of registration you want to have for your pharmacy business is to be decided after considering the pros and cons of various forms of entities, be it a sole proprietorship, a company or an LLP.
2. Registration with the tax authorities: Now when you have registered your entity in the legally identifiable manner and have a physical place of business in India, the next step is to register yourself with the taxation department. The advent of 'Goods and Service Tax' under the framework of 'One Nation One Taxation' will also cover the pharmacy business. So, at this stage, you need to get a GST Registration, the moment your turnover exceeds 20 lacs per annum (in some states, the registration is mandatory on exceeding the threshold turnover of 10 lacs per annum).
The manner is compulsory for a food business to get a food license, in the same way, a pharmacy business is compulsorily required to get a drug license before initiating its operations.
Obtaining a drug license
The grant of the drug license to the desirous entities is controlled by The Central Drugs Standard Control Organization and State Drugs Standard Control Organization.
The above-stated entities issues licenses in two forms:
1. Retail Drug License :- these are the general chemist shops located in your neighborhood primarily involved in the retail sale of the medicines and cosmetics.
2. Wholesale Drug license :- If you are involved or want to be involved in the wholesale activity of drugs and medicines, then you are required to apply for the wholesale drug license.
Basic features of Drug License in India
The following characteristics are associated with the Drug License granted to a Pharmacy Business in India:
- It is mandatory for every pharmacy running in the state;
- Such license is granted in the commercial premises or any other premises independent of residence;
- Every drug and cosmetic business is to comply with the requirements of the license;
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 pre-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.
After being assured about the fulfillment of the minimum requirements for setting up of the pharmacy business, an application shall be made in the prescribed format with the appropriate authority for obtaining the drug license along with following mandatory documents:
- Covering letter of the application clearly stating the objects.
- Challan of fees paid during the application.
- Declaration form as per the prescribed format.
- Site plan of the premises or set up.
- Ownership proof of the premises.
- Rent agreement of the premises, if rented.
- Proof of the constitution of business like incorporation certificate, Partnership deed etc.
- Affidavit declaring non-conviction of directors/promoters/partners under Drugs and Cosmetics Act, 1940.
- Appointment letter of Registered Pharmacist/Competent person employed.
- Affidavit of Registered Pharmacist/Competent person regarding full time working with the firm duly attested by Notary.
- Bio-data form.
The applicants should ensure, before making applications for the grant of licenses, that they submit the correct details in the application form prescribed for Drug License and attach all the required documents as listed above, also mentioned in the booklet "guidelines for obtaining licenses" under Drugs and Cosmetics rules or listed under the check list of document on the online portals for making applications for such licenses.
With the rise in the phase of "Digital India", the department of Food and Drug Administration is also not left untouched. The process for obtaining the Drug License in India has become seamless and quick. The applicants are no longer required to make physical visits to the department. Everything has been made available online, ranging from making application to the payment of fees to submission of documents.
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 timeframe of 30 days, if they fulfill all the required eligibility criteria. The intention is to make the whole process of drug licensing transparent and user-friendly.