CDSCO Drug Registration in India: The Complete Process

Most people who start a pharmaceutical business in India get confused in the first week. Not because the regulations are impossibly complex, but because nobody clearly explains the split between central and state authority. Here's the short version: CDSCO approves what can be manufactured. State FDAs approve who can manufacture it.

Get that distinction right and everything else falls into place. Get it wrong and you'll waste months chasing the wrong approvals from the wrong offices.

This guide walks through the entire process -- from understanding which license you need, to filing applications, to surviving your first inspection. No jargon without explanation, no hand-waving over the hard parts.

CDSCO and State FDA: Who Does What

CDSCO -- the Central Drugs Standard Control Organisation -- operates under the Drugs & Cosmetics Act, 1940. It's India's national regulatory authority. Think of it as India's equivalent of the FDA, though the comparison is loose. CDSCO approves new drugs, regulates clinical trials, controls import permissions, and sets standards.

State FDAs (also called State Drug Controllers or State Licensing Authorities) handle the actual manufacturing licenses. India has 36 states and union territories, each with its own drug control apparatus. When you apply for a license to manufacture a drug, you're applying to your state FDA, not to CDSCO.

Here's where it gets practical. If you want to manufacture Paracetamol 500mg tablets:

• Paracetamol is already an approved drug in India. You don't need CDSCO's permission for the product itself.
• You need a manufacturing license from your State FDA -- typically a Form 25 license.
• You need to comply with Schedule M (GMP requirements) for your facility.
• If you later want to export using a WHO-GMP certificate (COPP), you then go to CDSCO for that certificate.

If you want to manufacture a New Drug (one not yet approved in India), you need CDSCO approval first. Then you go to your state for the manufacturing license.

License Types: Which One Do You Need?

This is where most of the confusion lives. India has several license forms, each covering a different scenario.

Form 25: The Standard Manufacturing License

This is what most pharma companies need. Form 25 covers manufacturing of non-biological drugs at your own facility. It covers tablets, capsules, syrups, ointments, injectables -- basically everything except biological products. The license is product-specific; you'll list every product (by generic name, strength, and dosage form) that you intend to manufacture.

Valid for five years. Renewable.

Form 28: Biological Products

Same as Form 25 but for sera, vaccines, blood products, and other biologicals. The regulatory bar is higher. You'll need CDSCO involvement even for already-approved biologicals because of the additional safety requirements. Biocon, Serum Institute of India, and Bharat Biotech all operate under Form 28 licenses for their biological products.

Form 25A / 28A: The Loan License

This one is enormously popular in India, and for good reason. A loan license lets you manufacture drugs at someone else's facility. You don't own the plant. You don't need to invest in a manufacturing facility. You use a licensed manufacturer's equipment, their staff, their premises -- but the products are manufactured under your name and your license.

The PCD (Propaganda Cum Distribution) pharma franchise model runs on loan licenses. Hundreds of small pharma companies across India operate this way. You get the marketing authorization, you own the brand, and a contract manufacturer does the actual production.

Critical point: the loan licensee (loanee) is legally responsible for product quality. Not the facility owner. If there's a quality failure, the regulatory authority comes after you, the loanee. The manufacturer has its own license and its own responsibilities, but you can't point fingers at them and walk away.

Loan licenses are valid for five years, same as standard licenses.

Form 29: Test License

Need to make trial batches before you commit to commercial manufacturing? Form 29 is your tool. It's a limited license for manufacturing test batches, typically to generate stability data or to conduct bioequivalence studies. The process is faster -- 15 to 20 days turnaround in most states -- because the regulatory bar is lower for non-commercial batches.

The Application Process, Step by Step

Let's walk through getting a Form 25 license, since that's the most common scenario.

Step 1: Facility Setup and Schedule M Compliance

Before you apply for anything, your facility needs to comply with Schedule M of the Drugs & Cosmetics Rules. Schedule M is India's GMP standard. The 2024 revision brought it much closer to WHO-GMP and PIC/S standards.

What Schedule M requires in practice:

• Pharmaceutical Quality System (PQS): Documented quality management covering all operations.
• Quality Risk Management (QRM): Formal risk assessment processes, not just common sense.
• Product Quality Review (PQR): Annual review of all manufactured products.
• HVAC systems: Classified areas with validated air handling, pressure differentials, and temperature/humidity control.
• Water systems: Purified Water and, for injectables, Water for Injection meeting pharmacopoeial standards.
• Equipment qualification: IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) for all critical equipment.
• Validated analytical methods for every product.
• Trained personnel: B.Pharm or M.Pharm qualified staff in key positions (production head, QC head, QA head).

The compliance deadlines were firm: June 28, 2024 for large manufacturers. MSMEs got an extension to January 1, 2026, and the government has signaled there won't be further extensions.

If you're building a new facility, budget 6-12 months for construction and qualification before you even file the application.

Step 2: Prepare Your Documentation

The application requires four categories of documents.

Entity documents: Company registration, partnership deed or certificate of incorporation, PAN card, GST registration, board resolution authorizing the signatory.

Premises documents: Factory layout drawings (drawn to scale), site master file, No Objection Certificate (NOC) from the Pollution Control Board, factory license, lease agreement or ownership proof, photographs of the facility.

Technical documents: Master formula records for each product, SOPs for all operations (manufacturing, testing, cleaning, calibration, deviation handling, change control), validation protocols (process validation, cleaning validation, method validation), stability study protocols.

Personnel documents: Appointment letters and qualification certificates for the Competent Technical Staff. The head of production and head of quality control must hold a degree in Pharmacy (B.Pharm minimum) or Pharmaceutical Chemistry with relevant experience. This is non-negotiable.

You'll also need complete details of your Quality Control laboratory -- equipment list, instrument calibration records, reference standards, and lab SOPs.

Step 3: File on the ONDLS Portal

As of 2025, all state-level drug licensing applications in India must go through the ONDLS portal -- Online National Drug Licensing System, available at statedrugs.gov.in. Paper applications are dead. If someone tells you to submit physical copies, they're working from outdated information.

ONDLS is the state-level portal. Don't confuse it with SUGAM, which is CDSCO's portal for central-level applications (new drug approvals, import registrations, clinical trial permissions). Different portals for different purposes.

The filing process on ONDLS:

1. Create an account and register your entity.
2. Select the license type (Form 25, 25A, etc.).
3. Fill in facility details, product list, and personnel information.
4. Upload all required documents as PDFs.
5. Pay the government fee online.
6. Submit and receive an acknowledgment number.

Government fees are modest. Rs 7,500 covers applications for up to 10 products. The real cost isn't the filing fee -- it's everything you spent getting the facility to Schedule M compliance, which can run from Rs 50 lakh for a small oral solid dosage facility to Rs 50 crore or more for a sterile injectable plant.

Step 4: Inspection

After your application is accepted, the State Drug Controller's office schedules a joint inspection. "Joint" means both state and central inspectors participate, though the state inspector typically leads for Form 25 applications.

Inspectors will check:

• Facility: Does it match the layout drawings you submitted? Are production areas properly segregated? Are classified areas maintaining their rated conditions?
• HVAC: Pressure differentials, air changes per hour, temperature and humidity logs. They'll look at trends, not just the reading at the moment of inspection.
• Water systems: Purified water testing data, alert and action limits, system qualification records.
• Equipment: IQ/OQ/PQ documents for critical equipment. Calibration status. Maintenance logs.
• Documentation: SOPs for all critical activities. Are they current? Are they actually being followed? (Inspectors compare what the SOP says to what they observe on the floor.)
• QC lab: Is the lab adequately equipped for the products you've listed? Are analysts trained and competency-assessed? Are reference standards properly stored and within validity?
• Personnel: Are qualified persons actually present and employed? Inspectors will ask to see appointment letters and may interview key staff.
• Storage: Raw material warehouse, finished goods warehouse, cold storage (if applicable). Temperature mapping data.

The inspection typically takes one to two days for a standard oral solid dosage facility. Injectable or sterile facilities take longer.

Step 5: License Issuance

If the inspection is satisfactory, the license is issued. If there are deficiencies, you'll get an inspection report listing observations. You address them, submit evidence of corrective action, and a re-inspection may be scheduled.

Typical timelines: from application submission to license issuance runs 60-90 days if your documentation is clean and your facility passes inspection the first time. End-to-end, including facility setup and qualification, budget 6-18 months depending on the complexity of your dosage forms.

Common Reasons for Rejection

Based on patterns from multiple state drug authorities, here's what actually gets applications rejected or delayed.

• Incomplete documentation: This is the number-one reason. Missing SOPs, unsigned documents, expired qualification certificates. The ONDLS system catches some of this at upload, but not all.
• Non-compliant premises: The layout doesn't match Schedule M requirements. Cross-contamination risks between production areas. Inadequate material and personnel flow.
• Unqualified staff: The Competent Technical Staff don't meet the educational requirements, or they're listed on another company's license simultaneously (which is not permitted).
• Inadequate SOPs: SOPs that are clearly generic templates downloaded from the internet, not customized to your actual facility and equipment. Inspectors can tell immediately.
• QC lab deficiencies: Missing critical instruments for the products you've listed. No validated methods. Analysts without documented training.

If you're applying for the first time and want to avoid delays, consider hiring a regulatory affairs consultant who has worked with your specific State Drug Authority. Procedures and expectations vary state to state.

WHO-GMP Certificate (COPP): The Export Enabler

Once you have your manufacturing license (Form 25 or 28), you can apply for a WHO-GMP certificate, formally known as a Certificate of Pharmaceutical Product (COPP). This is essential if you plan to export to most developing countries. Many African, Southeast Asian, and Latin American regulatory authorities require a COPP as part of their import registration process.

The process:

1. Prerequisite: Valid Form 25 or Form 28 license. You cannot apply for COPP without an active manufacturing license.
2. Application: File through the ONDLS portal. Since July 15, 2025, COPP applications are online-only via ONDLS. No physical submissions accepted.
3. Joint inspection: CDSCO and state inspectors conduct a GMP inspection specifically against WHO-GMP guidelines. This is a separate inspection from your manufacturing license inspection, and typically more rigorous.
4. Certificate issuance: If the facility passes, the COPP is issued. Valid for two years. Cost is Rs 1,000 per copy of the certificate.

The WHO-GMP inspection goes beyond Schedule M in several areas. Inspectors will look more closely at validation practices, change control, CAPA (Corrective and Preventive Action) effectiveness, and annual product quality reviews. If your facility was built to Schedule M minimums, expect to do additional work before your WHO-GMP inspection.

Roughly 2,000+ Indian facilities currently hold WHO-GMP certificates. If you're looking for manufacturers that already have this certification, you can search our directory and filter by certification type.

Import Registration: For Foreign Companies

If you're a foreign pharmaceutical company wanting to register your products for sale in India, the pathway is different from domestic manufacturing licensing.

You need a Registration Certificate -- Form 40 (for drugs manufactured outside India) or Form 41 (for new drugs manufactured outside India). The application goes through CDSCO, not the state authorities.

Key requirements:

• An authorized Indian agent. Foreign companies cannot directly apply. You need an Indian entity to represent you before CDSCO.
• A COPP from your home country's regulatory authority.
• GMP certificate from your home country.
• Detailed product dossier (increasingly in eCTD format).
• Stability data under ICH conditions (including Zone IV conditions relevant to India's climate).
• Samples for testing by Indian government laboratories.

CDSCO may also require a plant inspection, though this is more common for new drugs than for already-approved generics. The timeline from application to approval can stretch to 12-18 months, though recent reforms are aiming to shorten this.

Recent Regulatory Reforms Worth Knowing

India's drug regulatory system has been reforming steadily. A few changes have meaningful practical impact.

NDCT Amendment Rules 2026

The New Drugs and Clinical Trials (NDCT) Amendment Rules halved the approval timeline from 90 to 45 working days for certain categories. This applies to new drug applications where the drug is already approved in specified regulated markets (US, EU, UK, Japan, Australia). If you're a global pharma company seeking Indian approval for a drug already approved by the FDA or EMA, this is significant -- it roughly cuts your Indian timeline in half.

The amendments also introduced a prior intimation pathway for certain activities. Analytical testing and non-clinical (preclinical) studies no longer require prior permission from CDSCO -- you just need to inform them that you're conducting the work. This removes a bottleneck that used to add weeks to early-stage development timelines.

eCTD Rollout

CDSCO is progressively moving to electronic Common Technical Document (eCTD) format for drug applications. This brings India in line with ICH standards used by the FDA, EMA, and other major regulators. The rollout has been gradual, and not all application types are covered yet, but the direction is clear.

ONDLS Mandatory Portal

As mentioned earlier, the Online National Drug Licensing System became mandatory in 2025 for all state-level licensing. This is the single biggest process improvement in Indian drug licensing in decades. Before ONDLS, every state had its own application format, its own processing quirks, and its own timeline. ONDLS standardizes the process nationwide.

It's not perfect. The portal can be slow. Uploading large documents sometimes fails. Some state officials are still learning the system. But it's a fundamental improvement over the paper-based, state-by-state fragmentation that existed before.

Practical Tips From People Who've Done This

A few pieces of advice that don't appear in any official guidance document but will save you time and money.

Hire your Competent Technical Staff early. You need qualified pharmacists for production and QC roles before you can file your application. Hiring takes time, and you can't use placeholder names on the application. Some companies lose months because they start the facility build without having their key technical staff in place.

Don't underestimate the site master file. Inspectors read it before they visit. A well-written site master file that accurately describes your facility, your quality system, and your operations sets a positive tone before the inspector walks through the door. A poorly written one -- or worse, one that doesn't match reality -- creates suspicion that's hard to overcome.

Budget for the second inspection. Very few facilities pass their first inspection without any observations. Plan for at least one round of corrective actions and a re-inspection visit. Factor that time and cost into your project plan.

State-level variation is real. Maharashtra, Gujarat, and Himachal Pradesh process more drug manufacturing licenses than any other states. Their drug control departments are experienced and generally efficient. Smaller states may have less experienced inspectors and longer processing times. This is an uncomfortable truth, but it's worth factoring into your location decision.

COPP is your export ticket, but plan ahead. The WHO-GMP inspection can be scheduled 3-6 months after you apply. If you have export orders waiting, you need to factor this timeline into your business plan. Don't assume you can get a manufacturing license and a COPP back-to-back; they're sequential processes.

If you're looking for contract manufacturers who already hold the licenses and certifications you need, rather than going through this entire process yourself, submit a quote request on GMP Finder. We'll connect you with pre-qualified manufacturers who match your requirements.

Summary: The Timeline at a Glance

Drug licensing in India isn't simple, but it's not the bureaucratic nightmare some make it out to be either. The system has been modernizing. ONDLS has made processes more transparent. The revised Schedule M has raised the quality bar. And for companies willing to invest in proper facilities and proper documentation, the license is there for the taking.

The key is preparation. Do your documentation right, build your facility to spec, hire qualified staff, and the regulatory process becomes the straightforward part. Cut corners on any of those, and you'll find out exactly how difficult Indian drug licensing can be.