How to start a pharmacy in India: drug licence and registrations
Pharmacy setup in India: retail drug licence in Forms 20 and 21, registered pharmacist, retention fee every five years, Schedule H1 records and GST.
Short answer
To open a pharmacy in India you need a retail drug licence from the state drug controller, issued in Forms 20 and 21 for allopathic drugs after an application in Form 19. A registered pharmacist must supervise sales. The licence is perpetual if the retention fee is paid every five years. You also need GST registration, shop and establishment registration and a trade licence.
- Licence
- Retail drug licence, Forms 20 and 21
- Application
- Form 19, usually online through ONDLS
- Validity
- Perpetual, with retention fee every 5 years
- Staffing
- Registered pharmacist or competent person
- Wholesale
- Separate licence in Forms 20B and 21B
- Regulator
- State drug control department
Structure and who can own a pharmacy
A pharmacy can be owned by a proprietor, partnership, LLP or company. The owner need not be a pharmacist, but the licence requires sales of prescription drugs to be conducted by or under the supervision of a registered pharmacist employed full-time at the premises.
Chains and online-to-offline models usually use a private limited company because each outlet needs its own licence and the company can hold them centrally. A proprietorship suits a single neighbourhood store run by a pharmacist-owner.
Licences and registrations for a pharmacy
Drug licences are granted under the Drugs and Cosmetics Act 1940 and the Drugs Rules 1945, administered by state drug control departments. Separate licences apply for different categories of drugs and for wholesale.
| Licence | Issuing authority | When required | Typical validity |
|---|---|---|---|
| Retail drug licence (Forms 20 and 21) | State drug controller | Before selling allopathic drugs | Perpetual with five-yearly retention fee |
| Schedule X endorsement or licence | State drug controller | For Schedule X drugs | As per licence |
| Wholesale drug licence (Forms 20B and 21B) | State drug controller | If supplying other pharmacies or hospitals | Perpetual with retention fee |
| GST registration | GST department | Above ₹40 lakh goods turnover (lower in some states) | Until cancelled |
| Shop and establishment registration | State labour department | Most states | Varies by state |
| Trade licence | Municipal corporation | Most cities | Usually annual |
| FSSAI registration | FSSAI | If selling food supplements or nutraceuticals | 1 to 5 years |
What the drug licence application involves
Applications are filed online in most states through the Online National Drugs Licensing System. Typical documents include a premises plan drawn to scale, ownership or rent proof, the pharmacist's registration and appointment letter, an undertaking from the pharmacist, identity documents and proof of fee payment. A refrigerator and temperature monitoring are needed for drugs requiring cold storage.
Fees are set by the rules and collected by the state. Goa's drug department, for example, lists ₹3,000 as the base fee for a retail licence, with the same amount for retention and a late fee of 2% per month for delayed retention. An inspector usually visits before the licence is granted.
GST and record-keeping
Medicines are taxable goods and rates depend on the HSN code; many moved to lower slabs in the September 2025 rationalisation, so update your billing software to the current notified rates. Registered pharmacies can claim input tax credit on purchases from distributors.
The Drugs Rules require prescriptions for Schedule H and H1 drugs, and a separate register for Schedule H1 sales recording the prescriber, patient and quantity, kept for the prescribed period. Schedule X drugs have stricter storage and record rules. Inspectors check these registers during visits.
Online pharmacy and other cautions
India has not finalised a dedicated legal framework for e-pharmacies; draft rules were published in 2018 and the position has been the subject of litigation. Anyone planning online sales should take specialist advice rather than relying on a retail licence alone.
Licences are specific to the premises. Moving the shop, changing the pharmacist or changing ownership requires intimation or a fresh licence, depending on the change and the state.
Pitfalls to avoid
Licence suspension stops all sales, so build the pharmacist's attendance, register maintenance and cold chain checks into daily routines from the first day of operation.
- Operating without the registered pharmacist present during working hours.
- Selling Schedule H1 drugs without prescriptions or register entries.
- Missing the five-year retention fee, which can lead to cancellation.
- Storing vaccines or insulin without a working refrigerator and temperature log.
Step by step
- 1Choose premises
Select a commercial space meeting the area and storage requirements of your state.
- 2Appoint a pharmacist
Hire a registered pharmacist and obtain appointment and acceptance letters.
- 3Register the entity
Set up the business with PAN and bank account.
- 4Apply for the drug licence
File Form 19 online with plans, documents and fee.
- 5Face inspection
Allow the drug inspector to verify premises, storage and staff.
- 6Register for GST and local licences
GST, shop and establishment and trade licence.
- 7Set up registers
Prepare Schedule H1, purchase and sale records before opening.
Related services
Sources
- Goa Directorate of Food and Drugs Administration: Retail drug licence checklist
- EY Tax Alert: GST Council rate rationalisation effective 22 September 2025
- Bajaj Finserv: FSSAI licence types and fees
Written by the Refogo Editorial Team from the official sources above and checked on 2026-10-31. Laws, rates and due dates change, and authorities often extend deadlines, so confirm your own case with a qualified professional. This is general information, not legal or tax advice. Read our editorial policy or report an error to support@refogo.com.
Common questions
Can a non-pharmacist open a medical store in India?
Yes, a non-pharmacist can own the business, but a registered pharmacist must be employed to conduct or supervise sales of prescription drugs at the premises.
How long is a retail drug licence valid?
Under the current rules, the licence remains valid perpetually if the retention fee is paid every five years. Late payment attracts a fee and prolonged default can lead to cancellation.
Is a separate licence needed for wholesale?
Yes. Wholesale sale of drugs requires licences in Forms 20B and 21B, issued by the state drug controller.