CDSCO Drug Manufacturing License in Delhi NCR – Complete Guide (2025)

If you want to start a drug manufacturing unit in Delhi NCR—whether in Noida, Greater Noida, Delhi, Gurugram, Faridabad, or Ghaziabad—you must obtain a CDSCO Drug Manufacturing License. The Central Drugs Standard Control Organization (CDSCO) is India’s national regulatory authority for pharmaceuticals, responsible for ensuring the safety, quality, and efficacy of drugs manufactured in the country.

In 2025, CDSCO has strengthened its licensing, online portals, inspections, and documentation rules—making compliance essential for every pharma manufacturer. This guide explains the process, documents, eligibility, fees, validity, and how PSR Compliance can help you get your drug manufacturing license smoothly.

What Is a CDSCO Drug Manufacturing License?

A CDSCO Drug Manufacturing License is an approval issued to companies involved in manufacturing, testing, packaging, labeling, and distribution of pharmaceutical drugs. It is mandatory under the Drugs & Cosmetics Act, 1940.

This license ensures that your drug manufacturing unit adheres to GMP standards, meets infrastructure requirements, and produces drugs that are safe and quality-compliant.

CDSCO Full Form

CDSCO full form: Central Drugs Standard Control Organization

Types of Drug Manufacturing Licenses Issued by CDSCO

Depending on your operations, you may need one of the following:

1. Loan License

Manufacturing in another company’s approved facility.

2. Contract Manufacturing License

For third-party manufacturing.

3. Manufacturing License

For your own pharma production unit.

4. Test License

For testing purposes.

5. Import License

For importing bulk drugs, APIs, or formulations.

Who Needs a CDSCO Drug Manufacturing License in Delhi NCR?

You need the license if you are planning to manufacture

➔ Allopathic medicines

➔ Ayurvedic/herbal drugs

➔ Cosmetics

➔ Nutraceuticals

➔ Homeopathic drugs

➔ Medical products requiring testing

➔ Bulk drugs APIs

➔ Pharmaceutical formulations

NOTE : Manufacturers in Delhi, Noida, Greater Noida, Gurugram, Faridabad, Ghaziabad, and nearby NCR regions must register under CDSCO before initiating operations.

Eligibility for CDSCO Drug Manufacturing License

To apply for a license, your unit must have:

● Qualified & Competent Staff

‣ At least 1 Technical Staff with a

‣ Bachelor in Pharmacy (B.Pharm), or

‣ Degree in Chemistry/Pharmaceutical Chemistry

● GMP-Compliant Facility

‣ The premises must strictly comply with GMP norms.

● Minimum Area Requirements

‣ Tablet/capsule unit: 1,000 sq. ft (approx.)

‣ Injectable unit: Separate sterile area

‣ General medicines: Segregated manufacturing zones

● Equipment & Machinery

‣ Granulation

‣ Drying

‣ Mixing

‣ Packaging

‣ Quality control/testing lab

● Quality Control Laboratory

‣ Stability testing

‣ Raw material testing

‣ Finished product testing

Documents Required for CDSCO Drug Manufacturing License

➤ Applicant Documents

✔️ PAN of company

✔️ Aadhar/PAN of directors/partners

✔️ Board Resolution/Authorization letter

➤ Unit Documents

✔️ Proof of premises (Rent agreement, ownership papers)

✔️ Blueprint/layout plan of the premises

✔️ Electricity bill

✔️ Site plan & floor plan

➤ Technical Staff Documents

✔️ Degree certificates

✔️ Appointment letter

✔️ Experience certificate

✔️ Bio-data

➤ Manufacturing Unit Documents

✔️ List of machinery/equipment

✔️ List of products to be manufactured

✔️ Water system & HVAC details

✔️ GMP compliance declaration

✔️ Stability study protocols

✔️ SOPs (Standard Operating Procedures)

➤ Quality Control Lab Documents

✔️ Lab equipment details

✔️ Calibration certificates

✔️ Testing methods

CDSCO Drug Manufacturing License Online Process (Step-by-Step)

• Register on SUGAM Portal – Create your company login using PAN, GST, email, and mobile.

• Upload Documents – Complete the application and attach all required scanned documents.

• Pay Fees – Government fees vary by product and license type.

• Site Visit – State Drug Inspector verifies machinery, hygiene, storage, GMP, and records.

• Authority Review – CDSCO reviews all documents.

• License Granted – Approved license is issued digitally.

Government Fees for CDSCO Drug Manufacturing License (Approx.)

These fees vary per state & product; PSR Compliance provides accurate fee calculation.

Processing Time (Delhi NCR)

⏳ 45 to 90 days (average)

Time depends on:

‣ Completeness of documents

‣ Site inspection

‣ Product type

‣ State drug authority workload

Validity & Renewal

CDSCO Drug Manufacturing License is valid for 5 years and must be renewed before expiry.

How PSR Compliance Can Help

PSR Compliance is a trusted regulatory consultancy in Delhi NCR providing complete assistance for CDSCO licensing.

Our End-to-End Services

✔️ Checking eligibility

✔️ Verifying documents

✔️ Preparing layout & GMP compliance

✔️ Filling CDSCO SUGAM online forms

✔️ Coordinating with Drug Inspectors

✔️ Follow-up until license approval

✔️ Assistance in product endorsements

✔️ Packaging & labeling guidelines

Why Choose Us?

⭐ 100% Compliance Handling

⭐ Fastest Approval Time

⭐ Affordable Pricing

⭐ Team of Regulatory Experts

⭐ Support for Delhi, Noida, Greater Noida, Gurugram, Faridabad & all NCR areas

If you want a smooth, error-free registration — PSR Compliance handles everything for you.

FAQs on CDSCO Drug Manufacturing License

1. What is CDSCO?

CDSCO is India’s national authority that regulates the approval and manufacturing of drugs.

2. How to apply for a CDSCO manufacturing license?

You must apply online through the CDSCO SUGAM portal with the required documents.

3. What is the validity of a CDSCO manufacturing license?

The license is valid for 5 years.

4. Is CDSCO registration mandatory for drug manufacturers in Delhi NCR?

Yes, every manufacturing unit in Delhi NCR must obtain a CDSCO license before operations.

5. How long does it take to get a CDSCO manufacturing license?

The approval process usually takes 45–90 days.