To ensure a healthy condition when you are sick, you need to consume medicines or drugs. But how can you be so sure that the medication you are purchasing from a Medical Store is genuine? The first and foremost thing that any person should check while buying medicines from the pharmacy/drugstore is that whether it is Drug Licensed or not. With a perspective to give this an edge, the Indian Government has laid down strict laws and regulations for the manufacturing and distribution of drugs and medicines across the drugstores and pharmacies in our country. In this article, we will have a look at how can you obtain a Drug License in India.
What is Drug License?
Drug license is the permission given by the Government to the owner of the pharmacy or a drugstore. The Drugs and the Cosmetics Act, 1940 governs the licensing of the drugs in India under which provisions are made to carry out the business of drugs, medicines or cosmetics.
The Drug license is issued by the authorities at the following two levels:
- State Drugs Standard Control Organization (SDSCO) – According to the Drugs and Cosmetics Act, sales and distribution and the regulation of manufacture are looked by the state authorities.
- Central Drugs Standard Control Organization (CDSCO) – under the Drugs and Cosmetics Act, the CDSCO is responsible for the approval of newly made drugs, clinical trials of the drugs in the country, control over the quality of imported drugs and coordinating with the SDSCO.
But many of us are not aware that there is a difference between pharmacy and drugstore. In this article, we will briefly discuss the drug license in India.
Prerequisites for Obtaining a License
- Pharmacist/ Competent Individual: The pharmacist is required to be eligible in the cases of retail business. Whereas, in wholesale business, the individual ought to be a graduate with an experience of one year or an undergraduate having 4 years experience.
- Space Requirement: The other significant requirement is space, which is the vicinity of the pharmacy or the unit for both the retail and wholesale license – 15 square meters.
- 10 square meters – In all other cases.
- The apparent height of the premises of sales shall be in accordance with the guidelines given down under the National Building Code of India, 2005.
- Storage Facility: The further imperative obligation is the storage facility in view of the fact that a few drugs needs to be stored in refrigerators, low temperatures and air conditioners.
A brief about Drug License and Drug License Registration
Drugs are used in the formation of the medicine in a medically defined ratio to cure the health of an individual. So, specific standards have been set up by the State and Central Drug Standard Organization for using the correct amount of drugs that do not harm the body.
Therefore, any violation in the medically defined limits can have a severe effect on the health of the person using that medicine.
What is the difference between a pharmacy and a Drugstore?
|Pharmacy or Dispensary||Drugstore|
|A place where prescription drugs are dispensed||A retail store where both prescription and non-prescription drugs are sold along with other first aid and similar products.|
|The only source of income is the prescribed medicines of individuals.||These drugstores earn a majority of their revenue from these products, which includes health and beauty products.|
What are the types of Drug License issued in India?
Retail Drug License
Retail Drug license is issued to the persons involved in chemist shops.
Wholesale Drug License
Wholesale drug license is issued to the persons or agencies who are involved in the wholesale distribution of drugs.
Forms for Drug Licenses for sale and wholesale of Drugs
Different licenses are required for obtaining different kinds of licenses which can be obtained by filing various forms:
|FORM||Types of Drugs|
|FORM 20||Allopathic Drugs|
|FORM 20-A||Restricted Allopathic Drugs|
|FORM 20-B||Wholesale of Allopathic Drugs|
|FORM 20-C||Homoeopathic medicines by retail|
|FORM 21||Allopathic drugs specified in Sch C & C (1).|
|FORM 21-B||Wholesale of Allopathic drugs specified in Sch C & C(1).|
|FORM 21-A||Retail sale of restricted Allopathic drugs specified in Schedule C (I).|
|FORM 20-F||Retail sale of drugs specified in Sch. ‘X’.|
|FORM 20-G||Wholesale of drugs Specified in Sch. ‘X’.|
Read our article:How to get a Manufacturing License of Drugs in India?
What are the Documents required for Drug License Registration?
The documents required for the Drug License Registration in India are as follow:
- Application form in the prescribed format duly signed by the concerned authority.
- Copy of Challan which will act as evidence that you have deposited the requisite fee.
- Id proofs such as PAN, Voter Id, Driving license, Passport, etc. in case an applicant is a proprietor
- Id proof of every partner along with the copy of partnership deed – for the partnership firm.
- Copy of MOA, AOA, and COI in case of private/public/OPC
- CTC of Board Resolution for authorizing the company for obtaining the license.
- Appointment letter of the person who is being authorized by the company
- Proof of availability of storage space such as cold storage, refrigerator, etc.
Additional documents if the applicant is registered, pharmacist:
- Registration certificate issued by pharmacy council
- Diploma pharmacy
- Appointment letter
- Affidavit of pharmacist
- Education qualification certificates such as high school & intermediary mark sheets, graduation certificate, post-graduation degree, etc.
- Minimum, one year of experience, is mandatory in drug sales and marketing of any pharmaceutical company.
- Plan the layout of the premise for which the license is applied
- There shall be an area of minimum of 10 square meters in case the license is applied for the wholesale or retail sale of drugs.
- A minimum of 15 square meters of area in case the license is applied for both wholesale and retail sales of drugs.
- Electricity availability and related installation in the premise.
What is the Procedure for applying for Drug License?
The Food Safety and Drug Administration of the concerned state Government governs the rules and regulations related to the Drug License:
Following steps need to be followed for obtaining the Drug License –
Visit the site
For issuance of every drug license, the particular authority has been provided to the respective state authorities.
Visit the site which connects to the state of yours, for example, a person who wishes to start the drugstore in UP needs to visit the government portal of the UP – http://fsdaup.gov.in/online-licensing.htm
Filing of Application
Fill the online application form online and upload the scanned copy of all the documents.
A visit by Drug Inspector
After receiving the application form, the Drug Inspector will personally visit the shop or the drugstore for the verification of documents.
Grant of the license
After successful inspection by the Drug Inspector, the Controller of the Drugs will issue the drug license.
What if you violate the law?
Under Section 18(C) of the Drugs and Cosmetics Act, 1940, any person who violates the law and sells drugs without a valid license is liable for the punishment. The punishment can be a term not less than one year and it may extend to three years or a fine not less than Five Thousand Rupees.
Well to conclude, one can say that if someone wishes to open a drugstore in India, needs to obtain Drug license before commencing the Business. Government of India, at its state and Central level, has set some basic standards and Norms which must be followed by every drugstore in India. After all, health is wealth is the main motto of every individual.
Read our article:Drug Distribution, Sale and Manufacture under Drugs and Cosmetics Act