What is Drug License?
Drug License is a permission granted by the authority under the Drugs and Cosmetic Act in order to carry out a business of drugs/medicines or cosmetics. The Drug License is issued by the State Drugs Standard Control Organization or the Central Drug Standard Control Organization.
The drugs are used in the medicines, in a medically defined ratio to cure our health. Drugs come in use on a need basis, to ensure our well being. However such medicines are manufactured with very restricted and correct amount of the drugs and it does not harm the body.
However, any violation of the medically defined limits may have a very serious effect on the health of the person using it. Therefore it requires to be regulated by the government via imposing stringent law and regulations in the process of manufacturing and distribution of drugs and medicines in India. Once you have Drug License from the government, you can deal with drugs otherwise not.
Drugs License Registration
Drug License registration and everything related to drugs is regulated by the Drugs and Cosmetics Act 1940. The Act regulates every step related to the drugs, from the raw material procurement stage during manufacture to sale including distribution, until it reaches the customer/patient. Drug License is required to be taken for all types of drugs or cosmetics business including Allopathic, Homeopathic, Ayurvedic or Unani drugs etc. The Act even covers the Pharmacist conduct, hospital or a dispensary usage of drugs. The Act covers the Ayurvedic and Unani drugs also in it.
Drugs License for Pharmaceuticals
The requirement of medicines is a never-ending thing which makes pharmacy business as the most ideal business. It does not get affected by the monetary cycles. In recent years, there has been a considerably very high level of developments in the hospitals has also lead to the increasing demand for pharmacies. The pharmacies are set up in hospitals, shopping areas, residential buildings, housing townships; the pharmacies in the residential building are built in form of the firms. E-commerce companies and e-health companies are the main participants due to their market reach with the easy availability of medicines to customers and by providing same-day delivery, cost saving.
Types of Drug License issued
Retail Drug License
It is issued to persons/agencies involved in Standalone/ chemist pharmacy shops
Wholesale Drug License
It is issued to persons/agencies involved in wholesale distribution of drugs
Types of Drug License
There are mainly two kinds of Drug License for drug distribution or sale in India. This License is issued subject to certain conditions attached to premises and competent person who shall be dealing with drugs.
Other types of License are:
- Manufacturing License
- Loan License
- Restricted License for general store basis the type of sale which will be made
Swarit Advisors provides professional assistance in obtaining Drug License in India.
Forms for Drug Licenses for sale and wholesale of drugs
Drugs have various categories and for different categories, the different License is required to be obtained by filing different forms as given below:
- FORM 20: For the sale of Allopathic drugs
In case a retailer is willing to obtain Drugs License to sell Allopathic drugs, he/she has to apply by filling FORM 20 for drugs license. Note that Form 20 is to be filed for drugs to be sold by retail other than those specified in Schedule C, C(1) and X (Form-19A).
- FORM 20-A: For the sale of Restricted Allopathic drugs
In case a retailer is willing to obtain Drugs License to sell restricted Allopathic drugs, he/she has to apply by filling FORM 20-A for drugs license. Note that Form 20-A is to be filed for drugs to be sold by retail other than those specified in Schedule C, C(1) and X (Form-19A).
- FORM-20-B For wholesale of Allopathic drugs
Drug License for wholesale of Allopathic drugs is to be applied in Form 20-B, however not for the categories specified in Sch C, C(1) and X. (Form-19).
- Form 20-C – For the sale of Homoeopathic medicines by retail
Fill in Form 20-C in case you are a retailer of Homoeopathic medicines.
- Form 21-For Sale of Allopathic drugs specified in Sch C & C (1).
To sell the Allopathic drugs, first apply for Drug License by filing Form 21.
- Form 21-B-For wholesale of Allopathic drugs specified in Sch C & C(1).
In order to deal in the wholesale business of Allopathic drugs, obtain a License by filing Form 21-B.
- Form 21-A- For the retail sale of restricted Allopathic drugs specified in Schedule C (I).
Obtain Drug License for retail of sale of the restricted Allopathic drugs, which are specified in Schedule C (I).
- Form 20-F-For retail sale of drugs specified in Sch. 'X'.
For certain drugs specified in Sch. X of the Act, apply for Drug License in form 20-F.
- Form 20-G For wholesale of drugs Specified in Sch. 'X'.
To establish a wholesale business for drugs specified in Sch. X, apply for Drug License in form 20-G.
What are the services offered by Swarit Advisors for Drug License
Our comprehensive range of end-to-end solutions includes following:
- End to end services for Drug License for importers, manufacturers, sellers, wholesalers
- We also provide Drug License renewal services.
- We shall draft the Drug License application, review your business, and shall be responsible for end to end follow up with the Drug License department.
- We provide regular updates on developments on changes pursuant to the Drugs and Cosmetics Act via your registered mail.
- Free consultation on the Drug manufacturing plant set up and related matters.
To avail any of the above-stated services, kindly establish contact by posting a query at our site.
Documents required for Drug License: In General
The right documents will save you from any kind of rejections, the documents to be submitted is the most important step in obtaining the Drug License and it includes preparation of key plan and site plan and various Affidavits and declaration pursuant to the applicable rules and regulation of the law.
The following documents would be required along with the application
- Receipt of the online fee deposit.
- Site plan and key plan of premises as required in the respective state as per applicable rules.
- Incorporation proof like Incorporation Certificate.
- ID proof of proprietor/partner/director as the case may be.
- A valid affidavit stating about the non-conviction of proprietor/partner/director/ the firm under the Drugs & Cosmetics Act, 1940.
- An affidavit from the competent person or registered pharmacist.
- In case of retail sale registered pharmacist
- Proof of qualification of the pharmacist
- Registration under the Local Pharmacy Council
- Appointment letter in this regard
- For wholesale license competent person
- Proof of qualification of such competent person
- Experience certificate of the person dealing into it
- Appointment letter of such competent person
- Address proof- Either the Rent Agreement/Sale Deed
Checklist/Pre-requisites for Drug License
Certain preplanning is required to be done before setting up the business pertaining to the Drugs and obtaining Drug License
For competent person / Pharmacist
- The medicines are required to be handled by a specialist.
- A qualified Pharmacist in case of retail Drug License is a must.
- In case of wholesale, a graduate with 1 years experience or undergraduate having four years experience is a must.
For area of Pharmacy Shop
- The carpet area of the Pharmacy must be a minimum of 10 square meters.
- When you have applied for both retail and wholesale pharmacy the minimum area should be 15 square meters.
- The premises are required to be adequately ventilated.
For storage facility of drugs
- Medicines need to be stored at a clean, ventilated and cool storage facility.
- When in certain drugs cases and certain vaccines need to be stored in a low-temperature freezing zone or as required, it must be stored that way.
- A refrigerator and air conditioner by default are essential for grant of a Drug License in India.
Procedure for Drug License Application
The rules and regulations pertaining to Drug License are governed by the Food Safety and Drug Administration Department of the concerned State Government.
Well, the procedure to obtain Drug License is quite simple and with proper documentation, it is assured to get the Drug License.
Step1: Application Filling
Application for the Drug License is completely online, along with the payment of government fee. The scanned copy of all documents is uploaded at the time of filing the application.
Step2: Visit by the Inspector
On receipt of the application, the Drug Inspector shall personally visit the shop to verify the documents and correctness of provided information.
Step3: Grant of License
On successful completion of the inspection, Personal Interview is conducted by the Inspector or such competent person and upon verification of all information and documents furnished is correct, the Controller of drugs issues the Drug License.
Documents required for issue of Retail or Wholesale Drug License
Documents of an applicant for Drug License
- The Certificate of Incorporation or Registration
- MOA & AOA or Partnership Deed/ LLP Agreement
- Pan Card and Cancelled Cheque.
- List of Directors and Major Shareholders
- Photo, ID and Address Proof of Director
- Affidavit from Directors
- Board Resolution on the letterhead
Documents of Pharmacist or competent person
- Bio-data of Competent Person as per Proforma
- Appointment Letter of Competent Person
- Proof of Qualification
- Experience Certificate
- Photo, ID and Address proof of Competent Person
- Affidavit of the competent person
Documents for Shop for Drug License
For self-owned premises
- The registered Sale Deed
- Registered GPA
- Conveyance Deed in the name of owner or
- For unregistered Sale Deed / unregistered GPA, it must be supported with Electricity Bill / Water Bill/property tax receipt.
- In the case of a village, Khasra Khatauni will suffice.
For Rented Premises
- Registered Rent Agreement along with Rent Receipt or,
- For Unregistered rent, the agreement provides the owner document.
- No Objection Certificate provided by the owner of the premises
- Key Plan and Site Plan of the premises (duly attested by an approved architect or mapmaker of the municipality).
How to apply for Manufacturing License of Drugs and Cosmetics
Step 1: Form selection
Choose the Form of License as per product, you propose to be manufactured.
Step 2: Application
Go to http://fsdaup.gov.in and click on online registration for Drugs/Cosmetics Manufacturing icon. Fill online Form, upload required documents and submit.
Step 3: Submission
Submit one hard copy of an Application Form along with complete set of documents in the office of Food Safety and Drug Administration.
Step 4: Inspection
The Drugs Control Authorities will carry a joint inspection of proposed premises as pre-scheduled and intimated to the applicant.
Step 5: Rectification
The applicant shall be given an opportunity to rectify the defects in case any discrepancies have been observed.
Step 6: Final issuance of License
The License is finally issued by the Licensing Authority on satisfaction and proper submission of the documents along with the Application.
For cases when you are operating in more than two states, following rules are to be adhered and kept in mind:
- Obtain Drug License in every state in which business is being carried on.
- Drug License is a location specific License.
- For cases where the drugs are sold or stocked for sale at more than one place, the license should be issued, in respect of each such place. However migrant vendors are an exception to this rule.
- After the grant of Drug License, the licensee must ensure that all the condition provided under the act at all the time during the course of the business.
- To maintain all the records /registers /Forms in the manner specified by the Licensing Authorities.
- Keep the authorities informed for all the changes or modification in the business activities.
Import Drug Licence
How to obtain Import Drug License pertaining to the Drugs import?
To obtain the Drugs Import License, one needs to file following Forms at the CDSCO’S SUGAM portal:
What is the fees for Import Drug License?
- The above-stated forms should be accompanied by a license fee of one thousand rupees for a single drug.
- In case of an additional license, an additional fee at the rate of one hundred rupees for each such additional drug license is required to be obtained.
- An undertaking in Form 9 duly signed by or on behalf of the manufacturer is also required to submit stating his/her additional requirement reason.
Who can apply for the Import License for Drugs License?
- The manufacturer has a valid Wholesale License for sale or distribution of drugs, or
- The manufacturer‘s agent in India having a valid License, or
- The manufacturer has a valid Wholesale License for sale or distribution of drugs
Frequently Asked Questions on Drugs License
No, you are not allowed to start any drug business or sell the drugs without obtaining a License as per the nature of business from the Controller of the drugs and cosmetics.
No, in order to obtain Licenses for the sale of drugs commercial premises or other premises independent of residence, also known as mixed land use should be your premise.
Basis the needs of the applicant, he/she may apply for following types of License
- Drug Manufacturing License
- Retail Drug License,
- Wholesale Drug License,
- Import of Drugs or Cosmetics
- Import of Medical Equipment
- Export of Medicines etc.
Yes, for cases where a person is operating in more than two states, it has to obtain a Drug License in each state. The Drug License is issued as per the location and hence, within state application, all sites must be included.
It is the responsibility of all persons dealing with the drugs to maintain the quality of drugs in the medicines. If any person consuming or using a drug or cosmetic suffers any harm due to the negligence on the part of the manufacturer or seller, it amounts to an offense of grievous hurt under India Penal Code.
No, you need not to apply, but you need to submit the application copy to the Zonal Office of Central Drugs Standard and Control Organization (CDSCO) also.
Well, Swarit Advisors has set a benchmark for all kinds of Drug License and related services in India, with its in-house expert team of professionals from different academic excellence.
The main purpose of the Drugs and Cosmetic Act is to ensure the safety, effectiveness and conformity of the drugs and cosmetics sold in India to the state quality standards for which certain prohibitions have been provided under the Act.