How To Get a Drug License in India

How To Get a Drug License in India – Want the most recent procedures to apply for a drug license in India? Our guide will tell you the requirements, cost, paperwork, process, updated data, comparisons, and faq for a wholesale drug license, retail drug license, and manufacturing drug license for your pharma or PCD company.

In India, as stipulated in The Drugs & Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945, anyone dealing with drugs, medicine, or cosmetics-whether involved in manufacture, sale, stocking, exhibition, or distribution-is obligated to obtain a license. Looking for steps to register for a drug marketing license in India? Want the steps to get a wholesale drug license in India? In this post, we will be discussing the requirements, documents, and other important points to obtain a drug marketing license in India for pharma PCD business.

Introduction | Drug License

The Act states that the Drugs Control Department is overseen at the federal as well as the state government levels. CDSCO (Central Drugs Standard Control Organisation), guided by DCGI (Drugs Controller General of India), is the main regulatory body that handles drug applications, imports, and manufacturing, whereas retail & wholesale drug licenses are overseen primarily by the state’s drug licensing body.

If you are planning to commence a pharmaceutical or PCD (Propaganda Cum Distribution) company, you can’t sell, exhibit, store, or advertise scheduled drugs without having a proper drug selling license. Doing business without a drug license for pharma companies, or without a license for retail sale of medicines, can lead to imprisonment under the Act.

Drugs & Cosmetics Act, of 1940 made licensing of pharma compulsory. The law consolidates rules and regulations related to drugs, cosmetics, and medicines establishing a Drugs Control Department. The Central Drugs Standard Control Organization (CDSCO) is the head official of the Drugs Controller General India (DCGI). They are the main regulatory body for drug registration in India.

1. Central Drug Standard Control Organization Or
2. State Drug Standard Control Organization

Drug Licensing Framework in India

The licensing of drugs in India is conducted in two different tiers:

CDSCO (Central Drugs Standard Control Organisation)

This authority is responsible for new drug approvals, clinical trials, import and manufacturing licenses for some drug categories and medical devices.

SDCDO (State Drug Standard Control Organisation)

The authority that grants drug licenses for wholesale and retail, and also monitors inspections.

Some features that each pharma business owner must know about a drug license:

1. It is compulsory for every drug and cosmetics business to have it, small or large scale.
2. A license must be displayed on the premises of the business.
3. A new drug license is needed for each state in which you are doing the business.
4. The license will be granted to a commercial property or separate property, not usually on the residential premises and not for a storeroom.
5. For businesses being shifted or for changed business owners, a new license should be applied for in the prescribed form.

Types of Drug Marketing Licence

A drug marketing licence is one of the several categories, each governed by a specific application form under the Drugs and Cosmetics Rules. Have a look at the types of drug marketing licence.

For sales of drugs not falling in Schedule X, either Form 19 or 19A, where the retailer operates in cities or towns having a population less than 5,000, may be applied. For Schedule C, C(1) and X drugs, either 20, 20A or 20B form is applicable based upon whether the applicant desires a licence to carry on wholesale business or retail business.

India Drug Licence Statistics – Quick Snapshot

Known as the “Pharmacy of the World”, India’s pharmaceutical sector is among the fastest-growing sectors globally, and this has increased the volume of licences granted, a trend which is expected to continue in 2026.

Not to mention, India also has the highest number of US FDA-approved manufacturing facilities outside America and accounts for about 20% of the world’s total output of generic drugs – another reason the compliance barrier for manufacturing licenses is high even when wholesale and retail is eased by online portals.

Application Procedure: Step-by-Step

1. Register on the state’s Online National Drug Licensing System (ONDLS/NLD) or State Drug Control Department portal.
2. Enter your business details and choose the right category of licence (e.g., retail, wholesale, restricted, manufacturing).
3. Upload scanned versions of all supporting documents within the portal’s file size limits.
4. Pay the appropriate government fee through the payment gateway or fee challan available on the portal.
5. The Drug Inspector will conduct a physical inspection of your premises on an appointed day to assess storage facilities, staff qualifications and documents.
6. The State Licensing Authority approves and issues a digitally signed drug licence, downloadable from the portal, upon satisfactory inspection.

What All Do You Need for a Drug License?

Your license form will need to attach a set of documents for attestation and proof. The documents intended to be filled or attached may vary from state to state. Here is the indicative list of generic documents that need to be submitted along with the form for obtaining a drug license in India:

• Application form as per your need.
• Blueprint of key plan and site plan of the premises. You will also need a written proof of rent agreement of ownership of the premises.
• This is the basis of possession of the premises.
• Declaration form
• Covering Letter from the applicant stating the purpose of the application with sign, name, and designation.
• Fee challan submission.
• A copy of the invoice receipt for the purchased refrigerator and air conditioner.
• Copy of original Incorporation Certificate/ AOA / MOA / Partnership Deed
• A copy of the appointment letter with signature and affidavit of (Full-time working) registered pharmacist or competent person.
• Affidavit of non-conviction of partners/ proprietor/directors under Drugs and Cosmetics Act, 1940.
• In the case of a Private Limited Company, You need to submit a board resolution and a list of directors with a sign.
• Property tax receipt.
• Four Rs 2 stamps

Fees and Validity

The government fees for a drug licence differ from state to state. Government fees can vary depending on specific license type, whether retail, wholesale, or manufacturing, but the normal fees range from ₹1,000 to ₹10,000.

Following the amendment in Rule 63 that was issued by the Ministry of Health and Family Welfare on 27 October 2017, there’s no need for renewal of the drug licence every 5 years, as it now remains valid in perpetuity, but with a licence retention fee payable every 5 years. The mandatory physical inspections by the licensing authority will be done at least every 3 years.

Frequently Asked Questions: How to Get a Drug License:

1. Retail vs. Wholesale drug license – What’s the difference?

A retail drug license (Form 20/21) allows the holder of the pharmacy to sell drugs directly to consumers. A wholesale drug license (Form 20B/21B), however, allows a distributor to sell drugs in bulk quantities to other wholesalers, hospitals and retailers.

2. How long does it take to obtain a drug license in India?

Usually, after applying, it takes anywhere from 20 days to 45 days to obtain the drug license, which is dependent on the state you’re applying in, the documentation provided and how quickly the Drug Inspector conducts the physical check of the premises.

3. Is it required to have a registered pharmacist in all types of drug licenses?

For retail pharmacy operations, having a registered pharmacist is a mandatory requirement. In the case of wholesale business operations, a registered pharmacist or a competent person who has worked for adequate years of experience in sales and distribution can also serve the purpose.

4. Do I have to renew my drug license every year?

No. Based on the amendments made to Rule 63 in the year 2017, a drug license once issued does not expire; it’s a perpetual license. However, license holders need to pay a retention fee once in five years to keep their drug license valid.

5. Can a single drug license cover my business across various states?

No, you will have to obtain a separate drug license in each state you operate in. All states have their own Drug Control Department, which issues licenses independently.

6. What is CDSCO’s role in drug licensing?

CDSCO, under the DCGI, is responsible for approving new drugs, conducting clinical trials and issuing licenses at the national level for import and manufacture of drugs.

However, state licenses for retail and wholesale distribution of drugs are done at the state level by the state drug control authorities.

7. What happens if I sell medicines without a valid drug licence?

Selling or stocking of drugs without a valid drug license is an offence punishable under the provisions of the Drugs and Cosmetics Act, 1940, and the penalties may include confiscation of the stock or prosecution of the offender/ business.

8. What premises requirements apply to a wholesale drug licence?

Generally requires a minimum area of 10 to 15 square metres of floor space, and good and safe storage accommodation for drugs (preferably with facilities like air conditioning and a refrigerator, including proper cold storage arrangement with the required storage capacity) to prevent contamination, deterioration and damage to the drugs. A good safe accommodation for Schedule H, H1 & X drugs should also be ensured.

9. Can a general store sell medicines without a full drug licence? 

A restricted general store license is required for a retail pharmacy if one plans to dispense and sell OTC (Over the Counter) medicines, by a qualified person in such store with restricted drug license (Form 20A) where one can operate like a retailer.

10. Is the drug licence application process fully online now?

Most states currently have adopted an online application system (via ONDLS/NLD portal) to facilitate a smooth application process for all drug licenses, including grant and renewal of drug licenses at the state level.

Conclusion 

A Drug License serves as the bedrock for any legal pharma, PCD, or pharmacy business in India and ensures you save significant time and money right away. Understand the criteria for eligibility, gather all necessary documents in advance, and don’t forget to consider current fee structures and perpetual licensing guidelines that have been incorporated under the revised Rule 63. Every state might have specific requirements, so it’s a good practice to double-check with your State Drug Control Department or with any regulatory consultant before filing your application.