A drug license is required to start a pharmacy business in India. Pharmacy business in India is becoming popular with greater acceptance of
modern medicine in smaller parts of the country. The arrival of online pharmacy has also transformed the drug business in India. Further, increasing the popularity of corporate hospitals and multi-specialty hospitals have brought tremendous growth in pharmacy business in India.
Indian pharma and the drug industry have been working in a controlled environment for the larger the interest of the community. Apart from this Indian pharmaceutical companies follow stringent quality
standards set by a global regulatory agency.
The size of the Indian drug and pharma industry is around 100 billion. Topmost of the Indian generic-drug industry has been able to double its revenue in the last 5 years. Globally, the Indian pharma industry has performed very well, to improve public health. It accounts for 60 percent of global vaccine production. On average, every 3 pills consumed in America is produced by India’s generic manufacturer. In the UK approximately 25 percent of medicines used are made in India.
India’s exports of generic drugs have been growing at an impressive 24 percent per year in the last 4 years. The permission to hold a drug license is given under the Drugs and Cosmetic Act 1940. The drug license is mandatory to carry out business concerning drug and cosmetics. In other words, no person can start a business dealing with drug/medicines unless the appropriate license is obtained for the conduct of such activity. Under the Drugs and Cosmetic Act 1940, all types of drugs and cosmetics are covered including allopathic and homeopathic. This act was further amended in parliament to include Ayurvedic and Unani drugs.
There are two types of Drug license:-
- Retail Drug license—These are the general pharmacy chemist store primarily involved in the sale of medicines and cosmetics in India. This license is for the limited stock of the medications.
2. Whole Sale Drug license- It is for the wholesale business of drugs and cosmetics. The whole Sale license is required for big businesses and also for the import and export of medicines. The drug license is granted after certain requirements are completed by the firm.
To obtain the Drug license following condition is a must-
- The license holder should be a qualified person.
- The medicines must be handled by a specialist.
- The person should be graduate with one year of experience and undergraduate having four years of experience.
- This is the first requirement to get the pharma license. You should be knowledgeable about the medication and drugs to handle the business.
Area of your shop
The area of your pharma-shop also decides your chances to get a pharma license. The area of pharmacy must be 10 square meters for retail and wholesale outlets. In the case of combined wholesale and retail, the area should be 15 square meters.
The storage facility of drug
The storage facility of the pharma store should be clean and ventilated place. We must store Medicines in a clean and well-ventilated place. The store needs to have a refrigerator since some drugs in particular vaccine need to be stored in a low-temperature freezing zone. Hence, the storage facility should be of high quality to get a license.
- Apart from this the staff of your store also is another condition before getting a license. An inspection officer visits your store for verification. This officer checks the required condition regarding drug license and gives approval.
Documents required to get a drug license:
- Photo, ID and Address proof of competent
- Application form in the prescribed format.
- Covering letter with the intent of the application
signed with the name designation of application.
- Challan of fee deposited for obtaining a drug
- Copy of documents like purchase bill like electricity.
- Declaration form in the format prescribed.
- Ownership proof of the premises.
- Rent agreement of the premises, if rented.
- Proof of the constitution of the business.
Affidavit of non-conviction of the proprietor, partners, directors under Drug and Cosmetic Act 1940. Affidavit of a registered pharmacist or competent a person working full-time Appointment letter by a registered pharmacist.
So this is the process to get a drug a license in India. You have to go through this complete procedure to get a drug license. The drug license in mandatory because it involves the lives of people. The rules and regulations related to drug license are strict in our country. If you are looking to obtain a drug license our agency is here to help you. GSB Infotech Business Solutions LLP. We offer legal services such as online company registration, government license registration, tax return filing, and other business advisory services. We serve more than 100+ services and have been working for more than 10 years in India. Our team has completed 12 thousand+ projects from all over India and we are still spreading our branches in the country in order to assist our clients in the best way we can. To know more you can visit our website. www.gsbtaxation.com or can call: 8586806283