How to Apply for a Drug License in India | Complete Guide by Corpzo

 How to Apply for a Drug License in India | Complete Guide by Corpzo

Ensuring everyone has equal and fair access to drugs and medicine is the primary concern of any government. But the right to manufacture and sell drugs and medicines has to be given cautiously. Hence, the government has stringent rules for granting licenses for the manufacturing and selling of drugs and medicines. The Act that governs the end-to-end process from manufacture to the sale of drugs in India is the Drugs and Cosmetics Act, 1940 ('Act').

Meaning of Drugs

Section 3(b) of the Drugs and Cosmetics Act,1940 defines “drug” to include all medicines and devices for the use of human beings or animals internally or externally, and all substances planned to be used for or in the diagnosis, mitigation, treatment, or prevention of any disorder or disease in animals or human beings, including preparations applied on the human body for the purpose of repelling insects like mosquitoes; it also includes all substances that can be used for the destruction of insects and all components of a drug – like empty gelatin capsules. The definition was amended in 1964 to include Ayurvedic and Unani Drugs.

Purpose of Drug Licence

Access to medicines and drugs must be restricted and regulated to ensure that such goods are not abused or misused by individuals. Thus, all pharmacists, wholesalers, retailers, manufacturers, sellers, dealers, and importers of drugs, cosmetics, ayurvedic, Siddha, and Unani drugs have to mandatorily obtain a drug license under the Drugs and Cosmetics Act, 1940.

The purpose of the drug license is to grant permission to allow enterprises or individuals to engage in businesses related to drugs and cosmetics. No enterprise or individual can operate a business dealing in drugs, medicines, or cosmetics without obtaining a drug license in India. In addition to a drug license, they must also obtain a trade license and a shop and establishment registration.

The Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945, help the government regulate and monitor the quality of drugs sold in India. The government exercises control over drugs from the raw material stage during manufacture, sale, distribution, and till it is sold on to a patient or consumer by a pharmacist in a retail pharmacy, hospital, or dispensary.

The government also exercises control in the aspects related to import and export of medicines, sale of the drug to a minor, consumption of schedule H & X drugs, etc., which require thorough monitoring and cautious execution. The drug license is granted by the drug controlling authority under the Drugs and Cosmetics Act, 1940.

Types of Drug License

In India, the following types of drug licenses are required, depending on the nature of the drug business:

Manufacturing License– License issued to a business that manufactures drugs, inclusive of allopathic/homoeopathy medicines.

Sale License – License issued for the sale of drugs. It has the following bifurcations: – Wholesale Drug License – Retail Drug License.

Wholesale License – A drug wholesaler must obtain a wholesale licence. Wholesale means the sale of the drug to a person/retailer to further sell it.

Retail License – A retail license is required for the retail sale of drugs. A retail sale means the sale of drugs or cosmetics for the consumption of the end consumer. Retailers can sell it to a dispensary, hospital, educational, medical, or research institute. Retailers engaged in pharmaceuticals, cosmetics, stand-alone pharmacists, ayurvedic shops, etc, need this license.

Loan License – License issued to a business that does not own the manufacturing unit but uses the manufacturing facilities of another licensee to manufacture drugs.

Import License – License issued to any dealer importing the products for the manufacturing of drugs or is engaged in the business of importing drugs in India.

Multi-Drug License – License issued to businesses that own pharmacies in multiple states with the same name.

Drug Controlling Authority or Regulatory Authority

The drug controlling authority, as known as the drugs controller, specified under the Drugs and Cosmetics Act, is responsible for issuing different drug licences. The drug controlling authorities (licensing authorities) are as follows:

State Drugs Standard Control Organisation (SDSCO) – Issues licenses for the sales, distribution, and manufacture of drugs regulated by the state authorities.

Central Drugs Standard Control Organisation (CDSCO) – Responsible for approving and issuing licenses for newly made drugs and clinical trials of drugs. It also controls the quality of the imported drugs and coordinates with the SDSCO.

State Drug Controlling Authority, with approval by the Central License Approving Authority – Issues licenses for establishing blood banks and their components and products like Vaccines, Sera, etc.

Department of Ayush – Issues licenses for ayurvedic, Unani, Siddha, homoeopathic, and herbal products for cosmetic and medical use.

Prerequisites For Obtaining a License

Pharmacist/ Competent Individual: The pharmacist must be qualified in the case of a retail business. In the case of a wholesale business, the individual must be a graduate with 1 year of experience or an undergraduate with 4 years of experience.

Space Requirement: The other important requirement is space, that is the area of the pharmacy/unit. For both wholesale and retail licenses the area of the pharmacy/unit should be 15 square meters. In the case of a retail and medical shop, it should be 10 square meters. The clear height of the sales premises shall be as per the guidelines laid down under the National Building Code of India, 2005.

Storage Facility: The other important requirement is storage facility since some drugs require to be stored in low temperatures, refrigerators and air conditioners.

Technical Staff: The retail pharmacy staff must be experienced with in-depth knowledge. The staff of the wholesale pharmacy must be a graduate with a minimum of 1-year experience or an undergraduate having four years of experience.

Application for a Drug License

The drug controlling authority or the regulatory authority is responsible for issuing the drug license. The applicant must apply to the respective drug controlling authority based on the license he/she requires as each drug controlling authority is responsible to issue different licenses (as stated above). The following is the process for obtaining the drug license:

Visit the respective drug controlling authority website

The applicant must visit the respective drug controlling authority (SDSCO, CDSCO or Ayush) depending on the type of license he/she is applying for since each drug controlling authority is responsible for the issue of different types of drug licenses. 

Filing of application

The applicant must file the drug license application online on the respective drug controlling authority website. The applicant must fill all the details asked in the application form.

Upload documents

After filling in the details on the application form, the next step is to upload the documents and submit the form along with the applicable fees. The applicant must keep all the documents updated before filing the application.

Visit by drug inspector

After receiving the application form, the drug Inspector will personally visit the company premises, shop or the drugstore for the verification of documents and correctness of facts stated in the application.

Grant of the drug license

After inspection and verification by the drug inspector, the drugs controller will issue the drug license.

List of Essential Documents For Obtaining a License

The documents essential for obtaining a sale license are:

Constitution of the entity, Memorandum of Association (MOA), Articles of Association (AOA) for a company, partnership deed, LLP agreement in case of partnership and LLP.

ID proof of partner/director/proprietor.

Documents related to premises – Copy of ownership documents of property or rental agreement and NOC (No Objection Certificate) from the owner of the rented premises as the case may be.

Site plan and key plan of the premises.

Copy of Board resolution permitting obtaining of a license.

Proof of availability of storage space as cold storage, refrigerator, etc.

Copy of challan as proof of depositing fee.

Affidavit regarding non-conviction of proprietor/partner/director and the firm.

The affidavit from the registered pharmacist/competent person.

Cover letter with name and designation of the applicant

Declaration form in a prescribed format

Applicant’s qualification certificate

For a pharmacist at a retail sale:

Proof of qualification

Registration of local pharmacy council

Appointment letter

For a pharmacist at a wholesale sale:

Proof of qualification

Experience certificate

Appointment letter

List of Application Forms

Sr. No Form No Purpose

1 Form 8 Application for licence to import drugs apart from those specified in Schedule X of the Drugs and Cosmetics Rules, 1945 ('Rules')

2 Form 8A Application for licence to import drugs specified in Schedule X of the Rules

3 Form 9 Undertaking accompanying an application for an import licence

4 Form 12 Application for licence to import drugs for purpose of examination, test or analysis 

5 Form 12A Application for the issue of a permit to import small quantities of drugs for personal use 

6 Form 12AA Application for licence to import small quantities of new drugs by a government hospital or

autonomous medical institution for the treatment of patients

7 Form 14A Application from a purchaser for test or analysis of a drug

8 Form 19 Application for grant or renewal of a license to sell, stock, exhibit or offer for sale, or distribute drugs apart from those specified in Schedule X

9 Form 19A Application for grant or renewal of a license to sell, stock, exhibit or offer for sale, or distribute drugs by retail via dealers who don't engage the services of a registered pharmacist

10 Form 19AA Application for grant or renewal of a licence to sell, stock or exhibit or offer for sale by wholesale or distribute drugs from a motor vehicle

11 Form 19B Application for license to sell, stock or exhibit or offer for sale, or distribute Homoeopathic Medicines

12 Form 19C Application for grant or renewal of a license to sell, stock, exhibit or offer for sale, or distribute drugs specified in Schedule X of the Rules

13 Form 24 Application for the grant of or renewal of a licence to manufacture for sale or for distribution of drugs other than those specified in Schedules C and C (1) and X of the Rules

14 Form 24A Application for grant of a loan license or renewal of a loan license to manufacture for sale or distribution of drugs other than those specified in Schedule C, C (1) and X of the Rules

15 Form 24B Application for grant or renewal of a license to repack for sale or distribution of drugs, being drugs other than those specified in Schedule C and C (1) excluding those specified in Schedule X of the Rules

16 Form 24C Application for the grant or renewal of a license to manufacture for sale or for distribution of Homoeopathic medicines or a license to manufacture potentised preparations from back potencies by licensees holding a license in Form 20 C

17 Form 24D Application for the grant or renewal of a licence to manufacture for sale of Ayurvedic, Siddha or Unani drugs

18 Form 24E Application for grant or renewal of a loan licence to manufacture for sale of Ayurvedic (including Siddha) or Unani Drugs

19 Form 24F Application for grant or renewal of a license to manufacture for sale or for distribution of drugs specified in Schedule X and not specified in Schedule C and C (1) of the Rules

20 Form 27 Application for grant or renewal of a license to manufacture for sale or for distribution of drugs specified in Schedule C and C (1) excluding those specified in part XB and Schedule X of the Rules

21 Form 27A Application for grant or renewal of a loan licence to manufacture for sale or for distribution of drugs specified in Schedules C and C (1) excluding those specified in part XB and Schedule X of the Rules

22 Form 27B Application for grant or renewal of a licence to manufacture for sale or for distribution of drugs specified in Schedules C, C(I) and X of the Rules

23 Form 27C Application for grant or renewal of licence for the operation of a Blood Bank for processing of whole blood and/or preparation of blood components

24 Form 27D Application for grant or renewal of a licence to manufacture for sale or for distribution of Large Volume Parenterals/Sera and Vaccines/recombinant DNA (r-DNA) derived drugs excluding those specified in Schedule X of the Rules

25 Form 27DA Application for grant or renewal of a loan licence to manufacture for sale or for distribution of Large Volume Parenterals/Sera and Vaccines/recombinant DNA (r-DNA) derived drugs excluding those specified in Schedule X of the Rules

26 Form 27E Application for grant or renewal of licence to manufacture blood products for sale or distribution

27 Form 27F Application for grant or renewal of licence for collection, processing, testing, storage, banking and release of umblical cord blood stem cells

28 Form 30 Application for licence to manufacture drugs for purposes of examination, test or analysis

29 Form 40 Application for issue of registration certificate for import of drugs into India

30 Form 44 Application for grant of permission to import or manufacture a new drug or to undertake clinical trial

Frequently Asked Questions

What are the types of drug businesses that require a drug license?

All types of drugs or cosmetics businesses that fall under the Drugs and Cosmetics Act, 1940, are required to obtain a drug license before starting/establishing a drug or cosmetics business. The Drugs and Cosmetics Act covers all drugs businesses, including allopathic, homoeopathic, ayurvedic, Siddha or Unani drugs. 

What are the drugs included under the Drugs and Cosmetics Act, 1940?

The drugs included under the Drugs and Cosmetics Act are as follows:

All medicines for external or internal use of animals or human beings and all substances intended to be used for or in the treatment, diagnosis, prevention, or of any disease or disorder in animals or human beings, including preparations applied on the human body for repelling insects like mosquitoes.

Substances (other than food) intended to affect the function or structure of the human body or intended to be used to destroy insects that cause disease in human beings or animals, as may be specified by the Central Government by notification in the Official Gazette. 

All substances intended for use as components of a drug, including empty gelatin capsules.

Such devices intended for external or internal use in the treatment, diagnosis, prevention, or mitigation of disorder or disease in animals or human beings, as may be specified by the Central Government by notification in the Official Gazette.

Is the drug license and a pharmaceutical business license the same? 

Yes. The drug license is also known as a pharmaceutical license. A drug license is required for all businesses involved in distributing pharmaceutical and medicines supplements. 

I have a drug license in Bangalore. Do I need to obtain another drug license to sell my drugs in Chennai?

Yes. When a drug business has an operating unit in two or more states, it has to obtain a drug license separately for each state in which it carries the business. The drug license registration is location-specific. Thus, if the drugs are sold or stocked for sale and distribution at more than one place, the application should be made to every state, and a license will be issued regarding each place except for migrant vendors.

What is the validity of a drug license?

A drug licence is valid for five years unless cancelled and suspended by the drug department.  It can be renewed before its expiration period by logging into the respective drug controlling website, entering the drug licence number, filling up the renewal application and submitting the document along with the fee for the issue of renewal of the drug license. The drugs controller will issue a renewed drug license.

What happens to the drug licence if there is a change in premises?

When there is a change in premises, the drug license for the old premises has to be surrendered, and the drug business owner has to apply for a new licence for the new premises. 

Do importers of drugs need a wholesale license?

Yes, the importers of a drug(s) must obtain both an import license and a wholesale licence to sell imported drugs within India.

What are the qualifications required for obtaining a drug license?

The qualification or eligibility of a competent person for retail and wholesale drug license, technical staff of a company dealing in drug or pharmacist are as follows:

For retail drug license:

B Pharma/DPharma degree holder

Registration with State Pharmacy Council

No prior experience is required

For Wholesale drug license:

B Pharma/DPharma degree holder 

Registered with State Pharmacy Council 

A graduate with one year of experience of dealing in drugs or an undergraduate having four years experience of dealing in drugs

What is an FDA license?

A Food and Drug Administration (FDA) license is a license obtained under the  Federal Food and Drugs Act. The Food, Drug and Cosmetic Administration (FDA), established in 1906, is a government agency under the Federal Food, Drugs and Cosmetic Act for consumer protection. The FDA license or certification is mandatory for placing food, drug, cosmetics and medical products in the USA.

How can I get a drug license in India?

The following is the procedure to get a drug license in India:

The applicant can apply for the drug license online on the respective drug controlling authority or regulating authority website based on the type of license required.

The applicant can also download the license forms from the drug controlling authority website and submit the filled application to the officer of the drug controlling authority.

The required documents must be submitted or uploaded to the drug controlling authority along with the licensing application.

Once the application form is submitted, all the documents are marked for inspection.

An inspector will visit the pharmaceutical shop or company premises for the final verification.

After the verification, the drugs controller issues the drug license.

How do I get my CDSCO license?

The registration on the CDSCO portal is entirely online. The steps for obtaining registration under the CDSCO portal are as follows:

Visit the CDSCO registration portal and click on the ‘Login/Sign Up’ button.

Click on the ‘Sign Up Here’ option to apply for registration. Select the ‘Registration Purpose’ from the options in the drop-down box and click on ‘Submit’.

The ‘Applicant Registration’ page opens. Fill the details on the application form and click on the ‘Submit’ button.

A confirmation link will be sent to the registered email id to verify the registration. Click on the link sent to the email to activate the account on the CDSCO portal.

Once the confirmation link is clicked, the application for registration will be sent to the concerned authority (CDSCO Officials) for approval.

After the application is approved, an email of the approval will be sent to the registered email id. The registration is complete upon receipt of the approval email.

Click here for more information on CDSCO Online Registration.

How can I get a wholesale drug license in India?

The application process for applying for a wholesale license is as follows:

Go to the respective state’s drug controlling authority website.

Download or fill the application form for a drug license online on the drug controlling authority website.

Upload or submit the required documents along with the application form and pay the required fees. 

An inspector will visit the premises or shop and verify all the documents and the correctness of the filled data.

After the verification, the drugs controller issues the drug license.

How can I verify my drug license number in India?

Drug license verification can be done online through the respective state’s drug authority website. You need to enter the unique drug license number to verify the details of the drug license on the website.

Who can get a drug license in India?

The following persons can apply for a drug license in India:

Any registered pharmacist under the State Pharmacy Council.

A graduate with a minimum of one year experience in drugs sales and marketing in a reputed pharmacy.

An individual with four years of experience in pharma marketing and has passed S.S.L.C.

A person approved by the department of drug control to conduct drug business in India.

What is the cost of a drug license in India?

The application fees for obtaining a license vary from Rs.1,500 to 500 depending on the type of application. However, there may be additional charges that the applicant needs to pay for obtaining lab tests, tests or analysis by the Central Drugs Laboratories or State Drugs Laboratories or test or analysis by the Pharmacopoeial Laboratory for Indian Medicine (PLIM) or the government analyst for obtaining the license. The Drugs and Cosmetics Rules, 1945 prescribes the fees for every license application and different tests for different products.