In India, manufacturing medicine without a valid license is a serious crime. A license means that your manufacturing plant complies with Good Manufacturing Practices (GMP), uses quality raw materials and adheres to stringent hygiene standards.
It also allows you to market, export and sell pharmaceutical formulations legally across state and international borders. Applying for a license can feel tricky at first. Thanks to a large number of forms to fill and papers to gather. However, things can get easier if you know the steps to meet drug manufacturing license eligibility. This is what we did in this very guide.
If you don’t go through the hassles of licensing, you can hire a contract manufacturer like Pushkar Pharma. Let’s get started.
2026 Drug Manufacturing License Eligibility Requirements
To get a drug manufacturing license in India in 2026, you need a GMP-compliant facility, qualified technical staff (B.Pharm with 18+ months experience), and a quality control expert on-site. Apply via Form 24 through the Sugam portal or your state FDA portal, submit required documents, pass document review and site inspection, then receive Form 25 (or Form 28 for Schedule C/C1 drugs). The process takes 60-90 days.
There are some criteria that applicants must meet before applying, such as space, technical expertise, and equipment.
Some of the key Considerations for drug manufacturing license eligibility
1. Qualified Technical Staff:
Your unit should have qualified staff on a full-time basis to qualify for a drug manufacturing license. You will need a graduate in pharmacy (B.Pharm) with a minimum of 18 months of practical experience in drug manufacturing. It is a basic yet important step to get your medicine manufacturing license.
2. Quality Control Expert:
One of the major requirements for drug manufacturing license eligibility is to involve a qualified testing analyst who has a degree in Pharmacy, Chemistry or Microbiology and relevant laboratory testing experience.
3. Space and layout:
Ensure you have enough space for your drugs. But keep in mind that the space should be created according to the type of drugs.
4. Compliance with GMP (Revised Schedule M):
Your facility layout, ventilation and sanitation systems should be compliant with revised GMP standards.
All the drug manufacturing licenses meet the eligibility criteria, so there is no problem in getting approval during the official site inspection.
Types of Drug Manufacturing Licenses in India
As per your business model, there are various types of licenses you can apply for:
• Formulation Manufacturing License:
This is needed for manufacturing finished goods such as tablets, syrups or ointments.
• Bulk Drug (API) License:
This is needed to manufacture Active Pharmaceutical Ingredients that are used as the base materials in medicines.
• Loan License:
If you want to manufacture medicines using the equipment and premises of another licensed manufacturer, then this license is issued.
• Repackaging License:
It is required to repackage drugs from bulk containers into retail packs. It is a key important drug manufacturing license eligibility.
CDSCO vs. State FDA approval: What’s the Difference?
Knowing the difference helps you file your application with the right regulatory authority.
State Licensing Authority (State FDA/SLA):
State-level manufacturing licenses for standard formulations, bulk drugs and routine site inspections.
CDSCO (Central Drugs Standard Control Organisation):
CDSCO gives approvals for new drugs, clinical trials, imported drugs and large-scale manufacturing facilities.
For most routine pharmaceuticals, your main interface would be with the State FDA. But for new molecules or new formulations, you need clearance from the central CDSCO.
Documents Required for a Drug Manufacturing License
Here is the list of important documents for drug manufacturing license application in 2026:
- Form 24 (Application for licence grant/renewal)
- Proof of constitution of the firm (Partnership deed, MOA/AOA or Registration certificate)
- Site plan and detailed layout of the manufacturing premises
- Ownership documents or lease agreement for the property
- Qualification and experience certificates of technical manufacturing and testing personnel
- Plant machinery, equipment and laboratory testing tools list.
- No Objection Certificate (NOC) from local municipal authorities and Pollution Control Board
- Safety certificates (Fire NOC, etc)
To avoid administrative delays, check every item on this list of documents required for drug manufacturing license applications.
How to Apply for a Drug Manufacturing License: Step-by-Step
The process of getting a pharma manufacturing license in India is an important part of being compliant from start to end.
Step 1: Design a Facility in Compliance
Construct your plant in compliance with Revised Schedule M. Incorporate suitable cleanroom zoning, HVAC air filtration and dedicated storage for both raw materials and finished goods.
Step 2: Apply Online
Submit your application either on the Sugam portal or the online FDA portal of your state. Submit the required papers with the prescribed government fee.
Step 3: Document check
Drug inspectors check your application file. If something is needed, reply fast.
Step 4: Site Inspection
A team of Drug Inspectors (State FDA and CDSCO, as applicable) will visit your premises to test machinery, inspect sanitation and verify technical staff credentials to confirm your eligibility for a drug manufacturing license.
Step 5: License Granted
Once your plant passes, you get Form 25. Some Schedule C and C1 drugs need Form 28 instead.
Don’t Want to Go Through the License Hassle? Pushkar Pharma Can Help
Obtaining a pharmaceutical manufacturing license in India is difficult, time-consuming, costly, and requires regulatory know-how. It is easy to see why many pharmaceutical companies, distributors and entrepreneurs choose a third-party manufacturer. A third-party pharma manufacturer produces and labels medicines on behalf of their client. This way, it saves them costs and hassles associated with a drug manufacturing license.
If you are looking for such a manufacturer, Pushkar Pharma has got you covered. Pushkar Pharma is an Indian pharmaceutical company that specialises in the manufacturing of quality drugs, PCD pharma franchising, and third-party contract manufacturing services.
- They have world-class production units with strict WHO-GMP standards.
- It takes care of the entire end-to-end production cycle right from formulating and sourcing raw materials to regulatory compliance and packaging. I
- If you want to start your own product line under a loan license or want to expand your production, Pushkar Pharma is the right partner for you.
To know more, please contact us at +91-9355622444 and +91 94661 82151.
Frequently Asked Questions
1. How long does it take to get a drug manufacturing license in India?
It can take 60 to 90 days from the date of submission.
2. What is the minimum qualification required to get a drug manufacturing license?
The manufacturing supervisor should be a B.Pharm graduate with a minimum of 18 months of experience in drug manufacturing.
3. Can I manufacture medicines with a third-party company?
Yes, you can. All you need to secure a Loan License to manufacture medicines at any existing WHO-GMP certified unit like Pushkar Pharma.
4. How long is the drug manufacturing license valid in India?
Under current rules, once you get a manufacturing license, it is yours forever as long as you pay the retention fee every 5 years.

