ड्रग लाइसेंस

What is a Drug License?

A drug licence is a legal permit under the Drugs and Cosmetics Act, 1940 to manufacture, sell, distribute or import drugs. It is issued for one specific address and cannot be transferred; a new owner must apply afresh.

A sale licence is now perpetual, but you must pay a retention fee every 5 years, equal to the original fee.

Types of Drug Licenses

• Retail: pharmacies and medical stores (Form 20/21)
• Wholesale: bulk supply to retailers and hospitals (Form 20-B/21-B)
• Manufacturing: for making medicines under GMP
• Loan licence: for marketing your brand using another company’s licensed unit
• Import: for importing drugs or raw material (CDSCO)
• Restricted (Form 20-A): general stores selling a limited list of household remedies without a pharmacist
• Multi-drug licence for chains under one name

Medical devices need a separate licence under the Medical Devices Rules, 2017.

Who Is Eligible?

• Applicant aged 21 or above
• Registered business: proprietorship, partnership, LLP or company, with GST registration
• No past conviction under the Drugs and Cosmetics Act (affidavit)
• Retail: a full-time registered pharmacist (D.Pharm or B.Pharm)
• Wholesale: a competent person (graduate with 1 year, or non-graduate with 4 years of drug experience)
• Premises: permanent shop of at least 10 sq. m. (15 sq. m. for retail plus wholesale) with racks, refrigerator and AC

Documents Required

• Application form and fee receipt
• Incorporation papers, partnership deed or LLP agreement; PAN of the entity
• PAN and Aadhaar of proprietor, partners or directors
• Premises ownership proof or rent agreement with owner NOC, and electricity bill
• Site plan and key plan
• Affidavit of non-conviction
• Pharmacist or competent person: qualification, registration certificate, appointment letter and experience proof
• Invoices of refrigerator and AC
• Manufacturing: Site Master File, pollution and fire NOCs, layout plans, machinery list and SOPs

Upload clear, readable PDFs; blurry scans cause delays.

How to Apply – Step by Step

1. Decide the licence type and check your state drug control rules.
2. Register on the state portal (ONDLS); central approvals go through CDSCO SUGAM.
3. Fill the application form (Form 19 series) with business, premises and staff details.
4. Upload documents and pay the fee.
5. Authority scrutinises the application.
6. Drug Inspector visits and checks premises, storage and pharmacist.
7. Receive the Drug License Number (DLN) and download the licence.

Typical time: 30–45 working days for retail or wholesale, 60–90 days for manufacturing.

Government Fees & Retention

Fees can vary by state. Pay the retention fee late (within 6 months) with a 2% per month late fee; after 6 months the licence is cancelled.

Compliance & Penalties

• Keep purchase and sales records, and display the licence
• Store drugs as required (refrigeration where needed)
• A pharmacist or competent person must be present during business hours
• No changes to premises or firm constitution without approval
• Be ready for inspections at least once every three years
• Follow NPPA price ceilings

Selling without a licence can mean 1–3 years’ jail and a fine of at least ₹5,000. Spurious or adulterated drugs attract much stricter punishment, up to life imprisonment, with stock seizure and licence cancellation.

Why eMitrawala?

• Experienced team for quick document checking and filing
• Support from application to certificate
• Renewal and compliance reminders
• Clear pricing with no hidden charges