A drug license is required to start a pharmacy business in India. Pharmacy business in India is becoming popular with greater acceptance of modern medicines in the smaller part of the country. The increasing popularity of corporate hospitals and multispecialty hospitals has brought tremendous growth in pharmacy business in India. Moreover, the arrival of online pharmacy also transformed the drug business in India.
Indian pharma and the drug industry have been working in a controlled environment for the larger interest of the community. Apart from this, pharmaceutical companies follow stringent quality standards set by the 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 the 60% global vaccine production. On an average 3 pills consumed in India are produced by India’s generic manufacturer. In UK 25% of medicines used are made in India. Consequently, India’s exports of generic drugs have been growing at an impressive rate of 24 percent per year in the last four years.
The permission to hold a drug license in India is given under the Drug and Cosmetic Act 1940. The drug license in India is mandatory to carry out business concerning drug and cosmetic. In other words, no person can start a business dealing with drugs/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 medicines 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 in India-
Retail drug license- These are general pharma chemist stores primarily involved in the sale of medicines and cosmetics in India. This license is for the limited stock of the medicines.
Wholesale drug license- It is for the wholesale business of drugs and cosmetic. Wholesale license for big businesses and also for the import and export medicines.
Conditions for the drug license-:
The drug license is granted after certain requirements are completed by the firm. To obtain a drug license following conditions must be followed.
Qualified/Specialist pharmacist- The license holder should be a qualified person and medicines must be handled by a specialist. This the first and foremost requirement to get a pharma license. The person should be knowledgable about medicines and drugs to handle the business.
The area of the shop- The area of your pharmacy shop also decides your chances to get a pharma license. The area of your pharmacy must be 10 square meters for retail and wholesale outlets. In the case of the combined wholesale and retail, the area should be 15 square meters.
The storage facility of drugs- The storage facility of the pharma should be at clean and ventilated place. Medicines should be stored in a clean and ventilated place. Pharma store should also have a refrigerator since some drugs and vaccine in particular need to be stored in a low-temperature freezing zone. Hence the storage facility should be of high quality to get pharma 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 India-
Photo, ID and Address proof of the competent person
Application form in the prescribed format
Cover letter with the intent of application signed with the name designation of application
Challan of fee deposited for obtaining drug license
Copy of documents like purchase bill, refrigerator, air-conditioner, electricity bills, etc.
Ownership proof of the premises
Rent agreement of the premises if rented property.
Proof of the constitution of the business [incorporation certificate, MOA/COA, partnership deed]
Affidavit of non-conviction of the proprietor, partners, directors under Drug and Cosmetic Act 1940.
Affidavit of a registered pharmacist or competent person working full time
Appointment letter by a registered pharmacist
This the complete process to get a drug license in India. You have to go through this complete procedure to get the drug license. Taking drug license in India is mandatory because it involves public health and lives of people. And the rules and regulations related to drug license are strict in our country.
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