Clinic, Polyclinic & Pharmacy Registration in Nepal

The Rule That Decides Everything

Under Rule 12(1) of the Public Health Service Regulations 2077, no one may operate a private, non-governmental, cooperative or non-profit community health institution — or provide health services through one — without a licence certificate.

The question is not whether you need a licence. It is who issues it. Rule 12(2) sends you to Schedule 9, which allocates every category of health institution to the federal Ministry, the province, or the local level. There is no discretion and no single counter: a dental clinic and a physiotherapy centre are licensed by different tiers of government.

Schedule 9 in Full — Who Licenses What

What Gets Checked, and in What Format

The process is unusually prescriptive, which is helpful once you know it:

• Apply in the Schedule 10 format (Rule 12(4)) — it asks for the institution’s name, service type, address, and details of every promoter holding 5% or more of the shares.
• The agency checks your institution against the criteria in Schedule 8 (Rule 12(5)).
• If the criteria are met, the licence issues in the Schedule 11 format.
• The agency may attach operating conditions to the licence (Rule 12(6)), and complying with them is a duty of the institution, not a suggestion.

Because the criteria live in a schedule rather than in departmental discretion, this is a sector where preparing properly genuinely determines the outcome. Get the infrastructure, staffing and equipment right against Schedule 8 before applying, rather than applying and negotiating.

Renewal Is Five-Yearly — Which Is the Danger

Rule 13(1): the licence is renewed from the issuing agency every five years. Rule 13(2): the renewal application, in the Schedule 12 format, must be submitted at least three months before the deadline. The agency then renews after checking that you have actually been operating to the Schedule 8 criteria.

Upgrading, and the Six-Month Grace That Expires

Two provisions are worth knowing in advance.

Rule 12(8): an institution that wants to move to a higher level of health institution, having met the criteria, must obtain a licence certificate of that level. You do not grow into a category by adding beds — you re-licence, potentially at a different tier of government. A 15-bed hospital expanding to 30 beds moves from local to provincial licensing.

Rule 12(7): institutions operating with some permission when the Regulations commenced could ask for more time to meet the criteria, and the licensing agency could extend by a maximum of six months on justification. But an application that does not produce a licence within that period is automatically cancelled, and the assets and liabilities of the institution are then dealt with under prevailing law. This is not a regime that tolerates indefinite drift.

The Practitioner Is Licensed Separately from the Business

The institution licence says the premises and the organisation meet the standard. It says nothing about the people. Separately, the professionals must hold current registration with their council — the Nepal Medical Council for doctors and dental surgeons, the Nepal Health Professional Council for physiotherapists and allied professionals, the Nepal Pharmacy Council for pharmacists.

Both are required, and neither substitutes for the other. A fully compliant clinic staffed by an unregistered practitioner is not compliant.

Pharmacies Are a Different Regime Entirely

A pharmacy is not licensed through the health institution route. It is licensed by the Department of Drug Administration under the Drug Act 2035, and the requirements are their own:

• A pharmacist or pharmacy assistant registered with the Nepal Pharmacy Council attached to the shop — the binding constraint, and not something to arrange late.
• Suitable premises. Published minimum floor-area figures vary between roughly 100 and 200 square feet depending on the source, so confirm the current requirement with the Department before you sign a lease.
• Ordinary business registration and a PAN underneath it all.

Wholesale and manufacturing sit further up the same ladder. Pharmaceutical manufacturing needs a DDA manufacturing licence, GMP certification, and per-product drug registration — a different order of undertaking from a retail counter.

Who Monitors You Afterwards

The Regulations also allocate monitoring, and it mirrors licensing: the federal level monitors institutions it licensed, and provincial governments monitor those licensed by local levels. In practice this means the tier that licensed you is the tier that will inspect you, so the relationship you build during licensing is the one you keep.

Step by Step

Frequently Asked Questions

Who issues the licence for a polyclinic or dental clinic?

The provincial government — Schedule 9 places dental clinics, specialised clinics, polyclinics and eye care centres with the province. The Ministry takes large and specialised hospitals, IVF, blood transfusion and Group A/B labs; local levels take health clinics, physiotherapy and hospitals up to 15 beds.

How often is the licence renewed?

Every five years (Rule 13(1)), with the application due three months before the deadline (Rule 13(2)) in the Schedule 12 format.

Can I operate while the application is pending?

No — Rule 12(1) prohibits operating without a licence certificate. Existing institutions had a transition window, and agencies could extend by up to six months, but applications not resulting in a licence in that period are automatically cancelled.

What does a pharmacy need?

A Department of Drug Administration licence under the Drug Act 2035, with a Nepal Pharmacy Council-registered pharmacist or pharmacy assistant and suitable premises. Published floor-area minimums vary between about 100 and 200 sq ft — confirm before leasing.

Does a yoga or physiotherapy centre need a health licence?

Schedule 9 lists physiotherapy, rehabilitation, natural treatment, acupuncture and yoga, meditation and physical exercise centres among health institutions licensed by local governments. Enforcement against ordinary studios and gyms varies by municipality — ask your ward.