Drug License in India: Types, Process, Requirements, and Compliance Guide

Section 27 of the Drugs and Cosmetics Act 1940 makes selling or stocking drugs without a valid drug license punishable by up to three years' imprisonment and fines starting at ₹5,000. This isn't theoretical enforcement. State drug control departments across India run active market surveillance, and unannounced inspections are standard operating procedure.

Getting the license before that happens starts with understanding which authority actually issues it for your type of business. 

Central vs State Authority

The Drugs and Cosmetics Act, 1940 creates a dual licensing structure that confuses a lot of first-time applicants. The Central Drugs Standard Control Organisation (CDSCO) handles manufacturing licenses for specialised product categories vaccines, blood products, large-volume parenterals and all import licenses. Their portal is SUGAM at cdscoonline.gov.in. A separate initiative, the Online National Drugs Licensing System (ONDLS) at statedrugs.gov.in, coordinates with state regulators toward a "One Nation One Drug Licensing" model.

Which License Type Applies to Your Business

Retail Drug License

The minimum requirement for a retail pharmacy is 10 square metres of dedicated floor area. That area must have proper shelving, adequate ventilation and refrigeration for drugs that need cold storage. The Drug Inspector will verify all three during the visit. More critically, a pharmacist registered with the State Pharmacy Council must be employed at the premises and physically present during operating hours. The pharmacist's name is on the license. If that person leaves and you don't update the license, you're in violation regardless of whether you hire someone else.

Read MoreHow to get a Drug License in Delhi?

Wholesale Drug License

The person-in-charge qualification for wholesale is where most applicants get tripped up. A registered pharmacist mandatory for retail is not required. Instead, the Drug Wholesale License Requirements specify a graduate in science (pharmacy, chemistry, or biology preferred) with at least one year of experience working with drugs, or a non-graduate with four years of such experience. This person takes legal responsibility for ensuring purchases come only from licensed manufacturers and sales go only to other licensed entities. Their name goes on the Form 20B, and their credentials are what the Drug Inspector examines first.

Documents required for wholesale drug license go beyond what retail needs:

• Completed drug license application form covering Form 20B and Form 21B

• Premises proof — ownership documents or a registered lease that names the applicant

• Site plan and area measurement certificate (state-specific minimums apply; Maharashtra's requirements for wholesale premises sometimes exceed the national baseline)

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• Qualified person's degree certificate and experience documentation — both, not just one

• Storage facility details specifying temperature control capability for cold-chain drugs and separate locked areas for Schedule H/H1 products

• NOC from the property owner

• Business registration certificate, GST registration, PAN

• Board resolution or partnership deed authorisation for non-individual applicants

Manufacturing License

For manufacturing, the entry point is different from either retail or wholesale. General allopathic drug manufacturing Form 25, covering tablets, capsules, ointments, liquid formulations goes to the State SDLA first, though CDSCO gets involved at various points depending on the product category. Biological drug manufacturing under Form 28  vaccines, sera, recombinant products goes directly to CDSCO at the central level regardless of where the facility is located.

Applying Online

The online drug license process varies by state, but the general sequence is consistent. 

• Go to your state drug control authority's official portal. 

• Register an account using Aadhaar, PAN and a working mobile number

• Select the license type and fill the corresponding form. 

• Upload scanned PDFs of all required documents within the portal's file size limits. 

• Pay the government fee approximately ₹1,500 for retail, ₹6,000 or more for wholesale and manufacturing, varying by state.

• After payment the system generates a reference number you'll use to track the application and respond to any queries

Validity and What "Perpetual" Actually Means

The 2018 amendment to Rule 63 of the D&C Rules 1945 made drug license validity perpetual ending the old five-year expiry-and-renewal cycle. But "perpetual" doesn't mean maintenance-free. Licensees pay a retention fee every five years non-payment triggers cancellation. Drug license Renewal in the old sense no longer applies but the retention obligation functions similarly in practice

Read MoreWhat is the Process of Drug License Renewal?

State Variations and the Food-Drug Confusion

Drug License Maharashtra applicants face among the highest inspection-scheduling delays in India due to Drug Inspector caseloads in the Mumbai, Pune and Thane districts. Wholesale premises area requirements in Maharashtra sometimes run above the national baseline so verify the current district-specific minimums with Maharashtra FDA before signing a lease

Conclusion

The drug license process in India is dual-authority, state-variable, inspection-dependent, and permanent once granted if retention obligations are met. What delays applications most consistently isn't the portal or the authority; it's premises that don't clear inspection, documentation that doesn't hold up under scrutiny, or a qualified person whose credentials don't match what was declared.

For those navigating the online drug license application, drug and cosmetic license requirements, or Schedule M compliance for manufacturing, Agile Regulatory provides advisory support across the full licensing cycle  including applicants searching for a Drug License Consultant in Delhi or managing multi-state wholesale compliance. Get in touch with us today!