Drug Licence for a Pharmacy in India: Types, Fees & Process

This covers exactly which licence applies to which situation, the ONDLS process end to end, real fees and documents, and the specific reasons applications get rejected on a first attempt.

What is ONDLS, and why does it matter more than a state portal?

ONDLS, the Online National Drugs Licensing System at statedrugs.gov.in, is a "One Nation One Drug Licensing System" initiative connecting the central government and State and Union Territory drug regulatory authorities into a single application system, rather than each state running an entirely separate, disconnected portal.

This matters practically because it's the authoritative entry point for the application regardless of which state you're filing in, even though the underlying review and approval still happens with your specific state's Drug Control authority. Older guidance sometimes points directly to a state's own drug control website, like Delhi's, and those remain valid for state-specific procedural detail.

But ONDLS is the actual current filing system, and starting there rather than a state-specific portal is the more reliable path for a first-time applicant unsure which state process applies. It's also where you confirm which of your state's drug control offices has jurisdiction over your specific premises, since that detail isn't always obvious from a general web search.

Which licence form does your pharmacy actually need?

Retail pharmacies selling directly to consumers need Form 20 for general allopathic drugs and Form 21 for drugs specified under Schedule C and C(1). Wholesale operations, supplying other pharmacies or institutions rather than individual patients, need the equivalent Form 20-B and 21-B. A pharmacy doing both retail and wholesale from the same premises needs both sets, and that combination also raises the minimum floor area required.

Getting the form wrong is a common, entirely avoidable delay. Filing Form 20 alone when your actual business model includes supplying other pharmacies means reapplying later for the wholesale equivalent, rather than filing both together the first time. Our retail versus wholesale drug licence guide walks through this decision in more depth if you're unsure which side of that line your business sits on.

Who is eligible to hold a drug licence?

Any individual, partnership, or company can be the licence holder, but the applicant must generally be at least 21 years old, and a registered pharmacist with a current State Pharmacy Council registration must operate the retail counter.

For wholesale operations specifically, the requirement shifts to a "competent person" with at least one year of drug-handling experience. That's a lower bar than the full pharmacist qualification retail requires, but still a real, checkable requirement rather than a formality state inspectors treat loosely.

This distinction matters for planning. A retail pharmacy owner without a pharmacy degree must employ a registered pharmacist regardless of their own qualifications, while a wholesale operation has slightly more flexibility in who can meet the competent-person requirement. Neither requirement can be worked around by hiring someone on paper who doesn't actually work at the premises; that arrangement is illegal and voids the licence entirely if discovered during an inspection.

What premises does a drug licence require?

The statutory minimum is 10 square metres for a licence in Form 20 or 21 alone, rising to 15 square metres the moment you're also applying for the wholesale equivalent at the same address.

Beyond floor area, premises need a refrigerator and cooling equipment for temperature-sensitive medicines, and this isn't a suggestion. The refrigerator's purchase invoice is itself a required document in the application, not just something an inspector happens to check later during a site visit.

Clear height and ventilation matter too, following the National Building Code of India as amended, and a site plan that doesn't match what an inspector actually finds on the premises is one of the more common, entirely avoidable reasons an otherwise complete file still gets held up.

What documents does the ONDLS application need?

Getting the paperwork right the first time matters more than it might seem, since a rejected file forfeits the fee already paid. The application itself is Form 19, system-generated through the portal rather than a document you draft separately.

Supporting it: proof of premises ownership or a registered rental lease agreement together with electricity bills, a blueprint or site and key plan of the pharmacy, the pharmacist's registration certificates and qualification proof alongside a formal appointment letter, an affidavit of non-conviction under the Drugs and Cosmetics Act, and the refrigerator purchase invoice mentioned above.

The fee payment receipt closes out the list, and it needs to be the actual receipt from payment, not merely proof that payment was initiated. Every document should be scanned and ready before you start the ONDLS session, since the portal in most states expects a single continuous filing rather than a save-and-resume workflow across several days.

Our full documents checklist covers each of these in more detail, including the state-specific variations in exactly how they're formatted, and our setup guide covers where this licence fits into the broader process of opening a pharmacy.

What does a drug licence actually cost?

The core government fee for a drug licence is commonly cited at ₹3,000, covering both retail and wholesale categories, though this is a starting figure rather than the complete cost.

States frequently add separate inspection fees on top of the base licence fee, and Delhi's Drug Control department, for instance, lists inspection charges distinct from the core licensing fee for certain licence categories. Consultants and filing agencies often charge a separate service fee on top of both government figures, which is worth budgeting for separately if you're using one rather than filing directly yourself.

Treat any specific number here, including ₹3,000, as a planning estimate rather than a guaranteed figure for your state. Fees are set and revised by individual state authorities, so confirming the current figure on your specific state's portal before budgeting is the only way to get an exact number rather than a reasonable range.

How long does approval actually take?

A realistic timeline matters for planning, especially if you've already committed to a lease or hired staff ahead of approval. Industry sources commonly cite around one month for the overall licensing process, from a complete application through Drug Inspector review to final approval.

This depends heavily on how complete the initial filing is and how quickly the scheduled premises inspection can be arranged, and the timeline is not evenly distributed. Most of the delay tends to sit in scheduling the inspection itself rather than in the paperwork review that precedes it.

A file missing even one required document restarts much of this timeline rather than merely delaying the missing piece, since incomplete applications typically get returned rather than processed with a placeholder while you gather what's missing.

Why do drug licence applications actually get rejected?

Incomplete documentation is the most common cause, and it's compounded by a rule worth knowing before you file: rejected applications generally forfeit the fee already paid rather than refunding it. A careful first submission is worth far more than a fast one, given that a rejection means paying the government fee a second time and restarting much of the review clock.

Beyond paperwork completeness, premises falling short of the minimum floor area, a pharmacist whose State Pharmacy Council registration has lapsed rather than merely being held, and site plans that don't match what an inspector finds on the actual premises are the recurring, avoidable failure points. None of these require bad luck to happen; they happen because nobody checked them against the state's own checklist before filing, and a second look before submission catches almost all of them.

Does a drug licence pharmacy holder need to renew it?

A drug licence pharmacy holder in India carries is generally valid for a defined period rather than issued permanently, and renewal before expiry is the licence holder's responsibility, not something the state authority proactively reminds you about. Letting a licence lapse, even briefly, technically means operating without a valid licence during the gap, which carries the same legal exposure as never having applied at all.

Building a renewal reminder into your own compliance calendar, well ahead of the actual expiry date, is a small operational habit that avoids a genuinely serious problem. A pharmacy that has run smoothly for years can still find itself technically non-compliant purely because a renewal date was missed during a busy period, and that gap is entirely avoidable with a basic calendar reminder set months in advance.

What happens if a pharmacy operates without a valid drug licence?

Operating without a valid drug licence exposes the operator to penalties under the Drugs and Cosmetics Act, including the possibility of the premises being sealed and stock seized pending resolution.

This applies whether a licence was never obtained or simply lapsed without renewal, and it's a substantially worse outcome than the modest cost and short delay of applying properly in the first place. That's worth remembering when the paperwork feels like an obstacle rather than a genuine legal requirement worth respecting.

A pharmacy that inherited an unclear licensing history, through a change of ownership or an unclear prior arrangement, should verify the current licence status directly with the state Drug Control department before assuming continuity. Assuming a licence transferred automatically with a change of ownership, when it did not, is a specific and recurring way otherwise careful operators end up non-compliant without realising it.

Sources

1. 1ONDLS - Online National Drugs Licensing System — Central Drugs Standard Control Organisation and State Drug Regulatory Authorities
2. 2Procedures for Obtaining Licences — Department of Drugs Control, Government of NCT of Delhi
3. 3Central Drugs Standard Control Organisation — Drugs and Cosmetics Act, 1940 and Rules, 1945
4. 4Pharmacy Council of India — registration requirements under the Pharmacy Act, 1948
5. 5National Building Code of India — Bureau of Indian Standards, premises and ventilation standards

This article is for informational purposes and is not a substitute for professional legal advice. Fees, forms and timelines vary by state and change without notice. Verify current requirements on ONDLS and your state Drug Control department before applying.