What is a Drug License?
Drugs helps in curing diseases which directly ensure the well-being of human being. For forming medicines, drugs are used in a medically prescribed ratio. Hence, standards are made by the government for using the drugs in the correct amount so that it does not harm the body by overdose. In India, the business which deals in drugs, medicines, or cosmetics must mandatorily obtain Drug License from the appropriate authority.
As per the Drugs and Cosmetics Act, 1940, a Drug License is granted either by the Central or State Drug Standard Control Organization. Obtaining Drug License Registration is mandatory before starting any business dealing in drugs, whether it is Ayurvedic Medicine, Allopathic Drugs, Homeopathy or Unani, to manufacture, distribute or sell the drugs.
If in case a business has an operating unit in two states or more states, it has to obtain a drug license for each state in which the business is being carried on. Registration for Drug license is location-specific. It means if the drugs are stocked or sold for sale and distribution at more than one place, then the application shall be made to every state, and license shall be issued, regarding each such place except for migrant vendors.
What are the Types of Drug License issued India?
Following are the different types of licenses issued depending upon the type of business for which the license is obtained:
- Manufacturing Drug License
All the manufacturers dealing with ayurvedic, allopathic, cosmetics, or any other medications or drugs, as mentioned under the Drugs and Cosmetics Act, 1940, are required to obtain Manufacturing Drug License. This is the state license that is granted by the respective state government where the unit is located.
- Loan Drug License
The Drug Manufacturer who do not possess any land on his own, but is willing to manufacture drugs by using his brand name on the land to which license is already granted.
- Import Drug License
Any dealer who is importing the products for manufacturing drugs or is involved in the business of importing drugs in India shall mandatorily obtain this specific license.
- Multi Drug License
Multi Drug License is obtained by entities operating in more than one state or having multiple units.
- Sale Drug License
Sale drug license is obtained by entities engaged in either retail or wholesale business for the sale or distribution of drugs in India.
- Wholesale Drug License
Wholesalers who are engaged in the business of pharmaceuticals shall mandatorily acquire wholesale drug license from the CDSCO (Central Drugs Standard Control Organization). This license prescribes certain minimum conditions on the person applying for it. The following listed are those conditions:
- Degree and diploma in pharmacy
- Minimum one-year experience required in Drug dealing
- Retail Drug License
This license is acquired by the retailers engaged in either in pharmaceuticals business, or stand-alone pharmacists, etc. The same is acquired by applying to the State Pharmacy Council.
What are Key Requirements for obtaining Drug License Registration in India?
The following are the essential key factors to be taken into consideration while applying for Drug License:
- Premise Area
A minimum area of 10 sq meters is needed for setting up a retail pharmacy or a medical shop. However, in the case of Retail cum wholesale Drug business, the required minimum area shall increase to 15 sq meters.
- Storage Facility
Proper storage facilities must be ensured by implementing the refrigerator, cold storage facility, or other similar places for the storage of drugs and medicines as they shall be restored in cool places.
- Technical and Expert Staff
A Retail pharmacy must have an experienced, and technical staff with in-depth knowledge of the same. A qualified pharmacist is a must for obtaining a Drug License. However, in the case of Wholesale Drug License, the said staff must either be a graduate with minimum one-year experience or an undergraduate having four years’ experience.
- Inspection by the Drug Inspector
Before the issuance of a Drug License, the Drug Inspector who is having jurisdiction of the area will visit the premises for which the drug license has been applied and will verify all the particulars furnished with the application. If in case needed, he may also take the premise’s measurement, and may also interview the competent person.
What are the Different Forms of Drug License?
The different forms needed for obtaining various types of Drug License is mentioned below:
Types of Drugs
Restricted Allopathic Drugs
Wholesale of Allopathic Medicines
Retail of Homoeopathic Medicines
Allopathic drugs mentioned in the Schedule C & C (1)
Wholesale of Allopathic Medicines specified in the Schedule C & C (1)
Retail sale of the Restricted Allopathic Medicines specified in the Schedule C (I)
Retail Sale of Drugs specified in the Schedule ‘X.’
Wholesale of Drugs Specified in the Schedule ‘X.’
Who can issue Drug License?
Drug license acts as an authority given by the Government of India to the owner of the drugstore or pharmacy. The Drugs and the Cosmetics Act, 1940, is the governing force for the issuance of Drug License in India. This act provides the provisions for carrying out the business of medicines, drugs, or cosmetics in India.
In India, the Drug license is granted by the following listed authorities:
- State Drugs Standard Control Organization (SDSCO)
As per the provisions of Drugs and Cosmetics Act, 1940, the sales, distribution, and manufacture of drugs are regulated by the state authorities.
- Central Drugs Standard Control Organization (CDSCO)
According to the Drugs and Cosmetics Act of 1940, the CDSCO is responsible for approving the newly made drugs and clinical trials of the said drugs. It also controls the quality of the drugs imported and coordinates with the SDSCO.
What are the Documents Required to Obtain Drug License in India?
The documents needed to obtain Drug License in India are explained below:
- A duly signed application form which has already been filed.
- A copy of the Challan as a proof of depositing the prescribed fee.
- Identity proof in the form of PAN Card, Driving License, Voter ID, Passport, etc. in case the applicant is a proprietor/ partner/ director.
- If in case the applicant is a partnership firm, the copy of Partnership Deed.
- Constitution of Firm (MOA/AOA) and the Certificate of Incorporation in the case of a Private/Public/OPC.
- A copy of the Site Plan and key plan of the premises.
- CTC of the Board Resolution for authorizing the company to obtain the license.
- Appointment letter of the person being authorized by the company.
- A copy of the Property paper (In the case of owned property).
- A copy of the Rent agreement or Lease Deed (In the case of rented property).
- Proof of availability of storage like the cold storage, refrigerator, etc. in the form invoices.
- Affidavit concerning the compliance of MPD 2021 (if the said premise is located in a DDA residential flat/ building or plot).
The following listed are the additional documents needed in the case of the Retail Sale
- Proof of Qualification, i.e., Certificate of Final degree or the Provisional Certificate along with mark sheets
- Registration of the Delhi Pharmacy Council
- A copy of the Bio-data and the Appointment Letter
The following listed are the additional documents needed in the case of the Wholesale License
- Proof of Qualification, i.e., Certificate of Final degree or the Provisional Certificate along with mark sheets
- A copy of the Bio-data and the Appointment Letter
- A copy of the Experience Certificate of minimum one year
Procedure for Obtaining Drug License in India
The steps involved in obtaining the Drug License in India are listed below:
- Obtain Login Credentials
The first and foremost step for the applicant is to obtain User ID and Password by giving a request letter in person along with the firm's details.
- Prepare Documents
The next step in getting a drug License is the preparation of documents which are comprised of both Key Plan and Site Plan, along with various affidavits and declarations specified by law.
- Filling of Application
Nowadays, the application of obtaining Drug License is filed online, including the payment of the prescribed government fee. All the documents required must be scanned in 100 DPI, black and white, and uploaded at the time of filing the Drug License application by using provided login details.
- Visit by the Drug Inspector
Once the application for issuance of Drug License is filed online, the same is then marked for inspection. The Drug Inspector personally visits the concerned shop to verify the documents filed, and also to check the correctness of the information.
- Issuance of License
After the completion of Inspection and verification of all the documents and information filed, and also the competent person clears the personal interview in a case called for, the Controller of Drugs, then issues the Drug License. It usually takes around 45 to 50 working days for the issuance of a Drug License.
What is the Time Frame for obtaining Drug License?
As per a recent report published in "The Times of India," the Drug Regulatory Authority has made it compulsory for all its officials to attend as well as issue all the licenses, whether wholesale or retail, in a time frame of 30 days, if all the required eligibility criteria are fulfilled. The main intention is to make the whole process of obtaining drug license transparent and user-friendly.
What is the difference between a Drugstore and Pharmacy?
Pharmacy or Dispensary
A Retail store where both the prescriptive and non-prescriptive drugs are sold together with other first aid and similar items.
A place where only prescriptive drugs are dispensed or provided
These drugstores earn a majority share of their revenue by way of the products, which includes both health and beauty products.
In this case, prescribed medicines act as the only source of income for individuals.
Frequently Asked Questions
The term “Drug License” denotes the permission granted by the government to deal with drugs and cosmetics. It is a must requirement for an individual who wants to engage in or want to do business in Wholesale, Manufacturing, Retail, and Distribution of Pharmaceuticals.
The authority to grant Drug License to the applicant is only with the State Government.
If an applicant wants to obtain a Drug License for his/her Medical Shop or a Chemist Shop, then he/she must have a minimum area of 10 sq. meters, Air Conditioners, and Refrigerators installed at the Store Medicines. Moreover, the shop owner must hire qualified and professional personnel as staff at the shop.
For the Renewal of Drug License, the applicant needs to fill out an application form and submit all the required documents along with the form. Further, after filing the application form, the applicant requires to submit the same to the Drug Control Department, along with the prescribed fees. After that, the authorities will review the application form submitted, and if satisfied, will issue a new certificate of Drug License to the applicant.
No, a pharmacist cannot open and run a clinic to diagnose disease and recommend medicines. The same had been notified and declared by the Pharmacy council of India. Also, there are no provisions prescribed in the Pharmacy Practice Regulation for a pharmacist to practice pharmacy.
The term “Licensed Drug” denotes a drug that undergoes a strictly regulated process. It includes both lab researches and trial tests. Once the drug had successfully completed all the tests and trials, it will be issued a license.
A License required for manufacturing drugs as per the Drugs and Cosmetics Act, 1940, is known as Drug Manufacturing License. Further, the applicant can apply online for obtaining Drug Manufacturing License from the State Drugs Controller cum Licensing Authority.
To obtain a Drug Distribution Licence, the applicant needs to file an application 19 and the prescribed documents such as the Identity Proof, Ownership Documents of the Premises, Affidavit of Registered Pharmacist, etc. with the authorities.
In India, opening an Independent Pharmacy needs a high-level investment. The term “Investment” includes the form of furniture and fitting, legal paperwork, and any other investment that will cost an individual around Rs 60000 approx.
The drugs that are classified and bifurcated as per the Drugs and Cosmetic Rules, 1945, are known as the Schedule C Drugs. Further, various biological products are included in the category of Schedule C Drugs. It also includes Toxins, Sera, Antigen, Antitoxins, etc.
The term “Form 21C” means a license to stock, sell, exhibit, or offer for sale or distribute retail drugs mentioned in Schedule C and C1. Moreover, a manufacturer who wants to sell, stock, etc. also need this license.
The applicant who wants to obtain a Retail Drug License must have an adequate area of not less than 10 sq. metres. Further, the area should be equipped with all the proper storage facilities for preserving and conserving the properties of drugs. Lastly, the applicant (Competent Person) must mandatorily be registered as a Registered Pharmacist with the Pharmacy Council.
Essentials for obtaining a Wholesale Drug License is the same as the Retail Drug License. However, in this case, the applicant must have passed Matriculation or is has equivalent four years of experience in dealing with the Drugs or is holding a degree, together with one of year experience in dealing with Drugs.
The applicant’s Chemist or Medical shop must have an adequate area of not less than 15sqr.mtrs.
A Written complaint about the questionable quality of Drugs can be filed at the Drugs Control Department, Govt. of N.C.T. of Delhi, at F-17, Karkardooma, Shahdara, Delhi-32. Further, the complaint made must be indicating the Name and Address of the complainant, Name, and other particulars of the concerned drug and the nature of the complaint.
Several provisions dealing with the Drug license are provided under the Drugs and Cosmetics Act, 1940, and the rules thereunder. Moreover, the information and details can also be obtained in person from the drug inspectors placed in the Drugs Control Department.
The basic features of a Drug License include obtaining Drug License for drugs, medicine, or cosmetics business; the Drug License shall be issued for a commercial premise; Drugs and Cosmetics business needs to mandatorily comply with the requirement and conditions prescribed by the law and issuing authorities; Lastly, the Holder of Drug License must display the license issued all the time in the place of business.
Yes, an individual needs to obtain different a Drug License for each unit operating in any part of India. For example: For example, if a drug business has its unit operating in two separate states, it shall obtain the drug License for both the operational unit.
The books of accounts, forms, registers, and other related documents shall be maintained in such a way as may be prescribed by the licensing authority at the time of issuance of such license. Moreover, it is the duty of the license holder to intimate about every change and modification that happened in his business.
Form 20B and Form 21B are required by the applicant got for obtaining the wholesale Drug License for the sale and redistribution of Allopathic Drugs under the Drugs and Cosmetics Rules.
A Drug License for the sale of drugs can only be granted for those premises that are commercial premises or any other premise independent of residence. Before starting a business of drugs, it is always advisable to take guidance from the guidelines issued by the state drug office for this purpose.
Yes, obtaining Drug License is mandatory before starting any business dealing in drugs, whether it is Ayurvedic Medicine, Allopathic Drugs, Homeopathy or Unani, to manufacture, distribute or sell the drugs.
If in case a business dealing in drugs is operating in more than two states, then there is a need for the owner to obtain a drug license in every state in which the said business is being carried on. Further, the Drug license is a location-specific license, and hence within a state application, all sites must be included.
The Drugs and Cosmetics Act, 1940, acts as the governing and regulating force for the business dealing with drugs.
In India, the Drugs and Cosmetic Act, 1940, aims at ensuring the effectiveness, safety, and conformity of the drugs and cosmetics sold to the state quality standards. Moreover, the drugs or cosmetics mentioned under schedule X are eligible to be imported only after obtaining Drug License.
The main two advantages of a Drug License include freedom from the fear of being caught from selling drugs without acquiring a Drug License. Secondly, it assists in the expansion and growth of the wholesale drug selling business, as retailers would never hesitate in dealing with a person who has obtained the license from the concerned authority.
Licenses in the Form 20-A and 21-A are needed for the sale of Restricted Drugs, commonly known as Household Remedies or Medicines. Further, for the sale of such drugs, services of a registered pharmacist and prescription of a Doctor (RMP) are not needed.
According to Rule 33 of the Drugs and Cosmetics Acts, 1940, and Rules, Form 11 is granted for the purpose of allowing import of the small quantities of drugs that are used for examination testing or analysis.