Overview of Drug License Registration in India
The Indian pharmaceutical industry is the 13th largest by value and third most extensive by volume in the world. It is one of the most essential industries in India and has a massive impact on people's health and the nation's economy. Before 1940, there was no regulation pertaining to drug licensing in India. With time, by the 20th century, India became home to a variety of quack, low-quality, spurious medicines. On the recommendations of the Chopra Committee Report, the Drugs Act of 1940 came into effect with the objective of regulating the import, manufacture, sale and distribution of drugs. Manufacturing and Selling drugs and medicines is a matter of security that has to be regulated cautiously to avoid a fractional error. In order to manufacture, sell, or distribute any pharmaceutical products in India, you need to obtain a Drug License. This formal document is the foundation for operating legally within the drug industry, ensuring compliance with the Drugs and Cosmetics Act of 1940. The license ensures that the businesses follow safety, quality, hygiene, and the standards established by the government of India. The Central Drugs Standard Control Organization (CDSCO) and State Drug Authorities enforce these laws to maintain quality and prevent the circulation of substandard or counterfeit drugs. The licensing process ensures businesses in drug production and sales follow safety.
Definition of Drugs
As per Section 3(b) of the Drugs and Cosmetics Act of 1940, drugs include:
- Medicines for internal/external use for humans/animals
- Substances for diagnosis, treatment, mitigation, or prevention of diseases/disorders
- Substances affecting human body structure/function
- Substances for destroying disease-causing vermin/insects which cause disease in humans/animals
- Components of drugs, including empty gelatin capsules
- Devices for diagnosis, treatment, mitigation, or prevention of diseases/disorders for human/animals
What is a Drug License?
A Drug License is an official authorization issued by the regulatory authorities in India that permits individuals or companies to sell, manufacture, or distribute pharmaceutical products. It ensures that the drugs you deal with comply with safety, quality, and efficacy standards set by the Drugs and Cosmetics Act of 1940. The main goal of the Drug License is to regulate drug manufacturing and distribution to prevent the release of harmful substances in the market.
Different Types of Drug License in India
There are five types of drug licenses in India:
1. Sale Drug License
This type of license is divided into three kinds of licenses:
- Retail Sale Drug License: This license is issued for the sale of drugs to the end consumer. Chemist Shops must obtain the licence mandatorily, and the Drug Controller Authority of the State issues it.
- Whole-Sale Drug License: This license is issued to the company/distributor/independent agent who works as an authorized agent for a local or foreign manufacturer. The manufacturer and Authorized Indian Representative must obtain the licence, and CDSCO issues it.
- Restricted Licence for Drugs: This license is issued to applicants who want to sell drugs without any supervision of competitive authority.
2. Manufacturing Licence for Drug
It is issued to the manufacturer of Allopathic and Ayurvedic drugs and cosmetic products.
- Test Licence for manufacturing: This license is issued by the State Licensing Authority for examining, testing, and analysing drugs in small quantities.
- Post-successful clinical trial manufacturing licence: This license is issued to the manufacturer of medical devices that are new to the market and have not undergone a clinical trial.
- Notified medical devices manufacture licence: This license is issued to the manufacturer of disposable hypodermic syringes and needles, cardiac stents, catheters, IVD Devices for HIV, HBsAg, HCV, etc.
3. Loan Drug Licence
This license is issued to the applicant who does not have its area and arrangement of manufacturing at the moment of obtaining a license, but the applicant wishes to do so in future under their brand name.
4. Import Drug Licence
It is required to import drugs and cosmetics into India.
Why is Drug License Registration Necessary?
Obtaining a Drug License is essential for several reasons, and some of the reasons are mentioned below:
- Compliance with Law: The Drugs and Cosmetic Act of 1940 mandates that all drug manufacturers, sellers, and distributors obtain a licence from the authority. Operating without a license can lead to severe legal penalties, including fines, closure, or imprisonment in the worst cases.
- Public Health Protection: A Drug License guarantees that only safe, effective, and quality-controlled drugs reach consumers. It helps protect against the sale of counterfeit, substandard, or expired products.
- Quality Assurance: A Drug License ensures compliance with Good Manufacturing Practices (GMP) or Good Distribution Practices (GDP), which ensures that drugs are produced, stored, and distributed safely.
- Business Legitimacy and Growth: Holding a valid Drug License fosters consumer trust, builds credibility, and can lead to growth opportunities such as partnerships and market expansion.
- Consumer Trust: Consumers are more likely to trust businesses that follow regulatory guidelines and provide quality products. A Drug License shows the commitment as well as its compliance with equality and safety laws.
- Traceability and Accountability: The Drug License ensures that products can be traced back to their source. In cases of product recalls or health issues, it helps authorities track the products to the source and hold businesses accountable.
Requirements for Obtaining a Drug License
1. Retail Sale Drug License:
- The premises area of the applicant should not be less than 10 sqr. Mtrs.
- The premises must have a refrigerator and air conditioner.
- The registered pharmacist should be present in the store throughout the working hours.
2. Whole-Sale Drug License:
- The premises area of the applicant should not be less than 10 sqr. Mtrs.
- The premises must have a refrigerator and air conditioner.
- The applicant must hold a degree or diploma in Pharmacy from a recognized university.
- The applicant/pharmacist must have at least 1 year of experience in drug dealing.
3. Manufacturing Licence:
- The premises of the factory have to be as per schedule M.
- The factory should be spacious enough to house all the machinery and equipment.
- The premises should have adequate drug storage arrangements.
- The premises should conform to India's good manufacturing practice standards.
- The premises should have a laboratory and testing equipment.
Checklist for Drug License Registration
Here is a checklist made for you to help you out in the Registration process:
- Carefully check the type of Drug License needed (Retail, Wholesale, Manufacturing, or Import).
- Take care of the premises and make sure that it meets the safety standards
- Employ qualified professionals, like registered pharmacists.
- Gather all required documents, including identity and address proof.
- Submit your application and fees.
- Be prepared for an inspection by the regulatory authority.
Documents Required to Apply for a Drug License
The following documents are necessary to apply for a Drug License in India:
- Fee deposit receipt
- Identity Proof like an Aadhaar, PAN card, or passport.
- Address Proof like utility bills, rent agreements, or property ownership papers for the business premises, including site plans and key plans of the premises
- An affidavit attested by a notary confirms that the applicant has not been convicted of any drug-related offences in India.
- List of Drugs that shows the list of the drugs or products you plan to manufacture, sell, or distribute.
- A pharmacist qualification certificate is required to show that the pharmacist matches the needed qualifications.
- An appointment letter that shows the pharmacist has been appointed full-time.
- Premises Certificate that shows that premises meet the necessary regulatory standards.
- Company Documents like Company Incorporation Certificates, Partnership Firm Certificates, or societies include incorporation certificates or partnership deeds.
- Memorandum of Association and Article of Association
- Manufacturing Equipment Details to show a list of equipment used in drug production, along with specifications (for manufacturing units).
Forms Required for Drug License Registration
Some of the essential forms required for the Drug License Registration are:
S. No. |
Form No. |
Purpose |
1. |
Form 8 |
It is an application to obtain a licence to import drugs apart from those specified in Schedule X in the Drugs and Cosmetics Rules, 1945 |
2. |
Form 8A |
It is an application for obtaining a licence to import drugs specified in Schedule X of the Rules. |
3. |
Form 14A |
It is an application from a purchaser to do a test or analysis of any drug. |
4. |
Form 19B |
It is an application for a license to sell, stock, exhibit, offer for sale, or distribute homoeopathic medicines. |
5. |
Form 24A |
It is an application for a grant of a loan license or renewal of a loan license to manufacture for sale or distribution of those drugs other than those mentioned in Schedule C, C (1) and X of the Rules. |
6. |
Form 40 |
It is an application for the issuance of a licence certificate for the import of drugs into India. |
What is the government fee for a Loan License for drug manufacturing?
- License Fee = ₹6,000 up to 10 items from Schedule M and Schedule M-III
- Inspection Fee = ₹1,000
- For additional items, ₹300 per item
Process of Drug License Registration in India
Follow the step-by-step guide to the Drug License registration process:
Step 1: Prepare Documents:
The foremost step in obtaining a Drug License Registered in India is to prepare the documents. Make sure you cross-check all the documents.
Step 2: Create User ID and Password:
Create an account on your respective State License Registration portal and log in to your account.
Step 3: File the Application:
Fill out the forms, collect the necessary documents, and apply to your respective State’s Drug Controlling Authority.
Step 4: Inspection of the Premises:
The State Drug Controlling Authority will review the application, and the drug inspector will examine the premises where the drug license is sought. The main object of the inspection is to ascertain whether the premises are suitable for storing drugs.
Step 5: Issuance of License:
If the licensing authority is satisfied with your application and your premises, they will issue a Drug license, which is valid for five years.
Validity of Drug License
A drug license in India is generally valid for 5 years from the date it’s issued. After that, the applicant needs to renew it to keep operating legally.
Before the license expires, the applicant has to apply for renewal. You may need to submit some documents and pay a renewal fee. In some cases, there might be an inspection. If you don't renew your license, you can't legally continue your business. It could lead to fines or even the license being cancelled.
Why Choose Kanakkupillai for Drug License Registration?
Kanakkupillai offers comprehensive assistance to businesses applying for drug licenses in India. You should choose us for:
- Expert Guidance: Our team is well-versed in drug licensing laws and procedure regulations, and we are here to help you at every step of the registration process.
- End-to-End Support: We manage all aspects of the Drug License Registration, from documentation to submission and renewal.
- Timely Processing: We ensure your application is processed quickly to avoid unnecessary delays.
- Customized Solutions: We offer services to meet the specific needs of our clients. Whether you are a pharmacist or a large manufacturing unit, we are here to help.
- Compliance Assurance: We ensure you meet all regulatory requirements and do not miss any compliance.
Frequently Asked Questions
What is a Drug License?
A Drug License is an official document that authorize the manufacturing, sale, or distribution of pharmaceutical products.Do I need a Drug License for over-the-counter medicines?
Yes, a Drug License is required for selling any drug, including over-the-counter medicines.How long does it take to get a Drug License?
The process typically takes 30 to 90 days, depending on the license type and processing time.Is a pharmacist required for a Drug License?
Yes, a registered pharmacist is required for retail and wholesale Drug License applications.What documents are needed for Drug License registration?
You need identity proof, address proof, and a pharmacist’s registration certificate, among other documents.What is the validity of a Drug License?
A Drug License is usually valid for five years and must be renewed before expiration.Can I apply for a Drug License for an online pharmacy?
Yes, online pharmacies must comply with the same regulations as physical ones.What’s the difference between retail and wholesale Drug Licenses?
A retail license allows direct sales to consumers, while a wholesale license allows distribution to other businesses.What makes Us Different

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