Drug Licence in India — Retail, Wholesale and Manufacturing Licence under the Drugs and Cosmetics Act, 1940
Video Explanation & Insights
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What a drug licence is, and which one you need
Selling, stocking, distributing or manufacturing drugs and cosmetics in India requires a licence under the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945. Sale and manufacturing licences are granted by the State Licensing Authority (the state Drug Controller) through its drug inspectors; import licences and new-drug approvals sit with CDSCO at the centre. Most states now accept applications on the Online National Drug Licensing System (ONDLS) or their own drug-control portal.
| Business | Licence forms | Key condition |
|---|---|---|
| Medical store / pharmacy (retail sale) | Form 20 (drugs other than Schedule C and C1) and Form 21 (Schedule C and C1 drugs, e.g., injectables, vaccines, insulin) | Registered pharmacist present during sale; premises at least 10 sq m |
| Restricted retail (no pharmacist, listed drugs only) | Form 20A / 21A | Only household remedies in Schedule K; general stores in villages |
| Wholesale / distribution / stockist | Form 20B and 21B | Competent person: registered pharmacist, or graduate with 1 year's experience in drugs, or matriculate with 4 years' experience; 10 sq m minimum |
| Schedule X (narcotic / psychotropic) | Form 20F / 20G | Separate licence, secure storage, prescription records |
| Manufacturing of drugs | Form 25 (drugs other than C/C1), Form 28 (Schedule C/C1); loan licence 25A / 28A | Schedule M GMP premises, technical staff, testing |
| Cosmetics manufacturing | Form 32 | Schedule M-II conditions |
| Blood bank / centre | Form 28C | Central and state approval |
Requirements for a sale licence (retail and wholesale)
| Requirement | Rule | Source |
|---|---|---|
| Premises | Minimum 10 square metres for retail or wholesale; 15 square metres where both are carried on at the same premises; adequate storage, lighting, ventilation | Rule 64(2), Drugs Rules 1945 |
| Cold storage | Refrigerator and air-conditioning where drugs requiring storage below 30°C or under refrigeration are stocked (vaccines, insulin, sera) | Rule 64(2) |
| Person in charge — retail | Sales under the personal supervision of a registered pharmacist (registered with the State Pharmacy Council) | Rule 65(2) |
| Person in charge — wholesale | Registered pharmacist, or a graduate with one year's experience in dealing in drugs, or a person who has passed matriculation with four years' experience, approved by the licensing authority | Rule 64(2) |
| Records | Purchase and sale records, bills with batch number and expiry, prescription register for Schedule H/H1/X, Schedule H1 register kept three years | Rules 65, 65A |
| Applicant | Proprietor, partnership, LLP or company; no conviction under the Act; separate licence for each premises | Rule 59 |
Documents required for a drug licence
Business and premises
- •Constitution: proprietorship proof / partnership deed / incorporation certificate and MoA
- •PAN and GST
- •Ownership proof or rent agreement with NOC
- •Site plan and key plan of the premises with dimensions
- •Photographs of premises, refrigerator and storage racks
- •Purchase invoice of refrigerator / AC
Pharmacist / competent person
- •Pharmacy degree or diploma and State Pharmacy Council registration
- •Or degree/matriculation certificate with experience certificate for wholesale
- •Aadhaar, PAN, photographs
- •Appointment letter and affidavit of full-time engagement
- •Bio-data and declaration of not being engaged elsewhere
Declarations
- •Application in the prescribed form (Form 19 for sale licences) on the portal
- •Affidavit of proprietor / partners / directors (no conviction, premises ownership)
- •Declaration on the storage of Schedule H, H1, X drugs
- •Fee challan / online payment receipt
Drug licence process in the state
- 1Week 1 — Premises and person: premises measured against Rule 64, storage and cold chain arranged, pharmacist or competent person engaged and documents verified.
- 2Week 1–2 — Filing: application with documents and fee filed on the state drug-control portal or ONDLS; separate applications for Form 20 and 21 (retail) or 20B and 21B (wholesale).
- 3Week 2–5 — Inspection: the drug inspector visits, verifies the premises, refrigerator, pharmacist's presence and records, and files a report.
- 4Week 4–8 — Grant: the licensing authority issues the licence in the relevant forms; the licence is displayed at the premises.
- 5Every 5 years — Retention fee paid before expiry of each five-year period to keep the licence in force; changes of pharmacist, constitution or premises intimated and endorsed.
Fees, validity and renewal
| Item | Amount / period | Notes |
|---|---|---|
| Government fee | Prescribed under Rule 59 for each licence form (retail Forms 20 and 21, wholesale 20B and 21B); manufacturing fees are higher and include inspection fee | Paid online on the state portal; states may add processing charges; charged at actuals |
| Validity | Licence valid for five years from grant | Rule 63 |
| Retention fee | Paid before expiry of every five-year period; licence continues in force on payment | Rule 59 as amended; late payment attracts additional fee and, beyond the grace period, a fresh application |
| BookMyCA professional fee | Fixed fee quoted before filing | Retail, wholesale or manufacturing scope |
| Time to grant | 30–60 days | Inspection scheduling drives it |
Worked example: a medical store in Jaipur
A proprietor takes a 14 sq m shop in Malviya Nagar and wants to sell general medicines and insulin. Because insulin is a Schedule C drug, both Form 20 and Form 21 are needed, a refrigerator with a temperature log is installed, and a D.Pharm holder registered with the Rajasthan Pharmacy Council is appointed as the full-time pharmacist. The application is filed on the state portal with the site plan, rent agreement, pharmacist's registration and affidavits; the drug inspector visits in the third week, and both licences are granted in the sixth week. The retention fee falls due in five years, and any change of pharmacist must be intimated within the prescribed time.
Mistakes that delay or cancel a drug licence
- •Taking a premises under 10 sq m, or 15 sq m when retail and wholesale share it
- •A pharmacist on paper who is not present at the counter; inspectors check attendance
- •Stocking Schedule C/C1 items on a Form 20 licence without Form 21
- •Missing the five-year retention fee and continuing to trade
- •Not intimating a change of pharmacist, partner or premises, which invalidates the licence
Frequently asked questions on drug licences
Ten square metres for a retail or wholesale licence, and fifteen square metres if both are run from the same premises, with storage, lighting, ventilation and a refrigerator where required.
No. Wholesale needs a competent person: a registered pharmacist, a graduate with one year's experience in dealing in drugs, or a matriculate with four years' experience, approved by the licensing authority. Retail sale requires a registered pharmacist.
Five years. Since the 2017 amendment the licence stays in force if the retention fee is paid before the end of each five-year period, so there is no fresh application unless the fee is missed.
Online sale still requires a physical licensed premises with a registered pharmacist; the sale is deemed to take place from that premises. Separate e-pharmacy rules are under consideration by the Government.
Typically 30 to 60 days, most of it waiting for the drug inspector's visit.
Yes. A licence is granted per premises. A chain applies for each outlet.
Ayurvedic, Siddha and Unani products are licensed by the state AYUSH licensing authority; medical devices follow the Medical Devices Rules, 2017 with their own forms. We handle both.
Official sources this page is based on
- Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945 — CDSCO
- Online National Drugs Licensing System (ONDLS) — state licence applications
- Drugs and Cosmetics Act — India Code
Fees, thresholds and timelines above are taken from these Acts, Rules, notifications and official portals; where the authority's current notification differs, the notification prevails.