Licensing and approvals, Karnataka
Every licence your clinic, lab or hospital needs besides KPME, explained in one place, with help to get them.
- Drug, fire, KSPCB, biomedical waste
- PC&PNDT, MTP, AERB
- Trade, shop, FSSAI, NABH
Opening or expanding a healthcare facility in Karnataka needs several approvals from different departments. KPME registration is the core licence; this page covers all the others, what each one is, who needs it, the documents, the process and the official fees where they are published. Medasus Healthcare, Bengaluru, handles them together so nothing holds up your opening.
Jump to a licence
- Drug licence
- CDSCO medical device licences
- Fire NOC
- KSPCB consent (pollution)
- Biomedical waste authorisation
- PC&PNDT registration
- MTP approval
- AERB licence (X-ray)
- Trade licence
- Shop and establishment
- FSSAI food licence
- NABH accreditation
- Other approvals
Looking for KPME? See our complete KPME registration guide.
Which licences does my facility need?
| Licence | Clinic | Dental | Lab | Imaging | Hospital |
|---|---|---|---|---|---|
| KPME registration | Yes | Yes | Yes | Yes | Yes |
| Biomedical waste authorisation | Yes | Yes | Yes | Yes | Yes |
| Trade licence (local body) | Yes | Yes | Yes | Yes | Yes |
| Shop and establishment | Usually | Usually | Usually | Usually | Usually |
| Drug licence | If pharmacy | If pharmacy | No | No | Yes (pharmacy) |
| KSPCB consent (CFE / CFO) | No* | No* | No* | No* | Yes (bedded) |
| Fire NOC | By building | By building | By building | By building | Usually |
| AERB | If X-ray | If RVG / OPG | No | Yes | If X-ray / CT |
| PC&PNDT | If ultrasound | No | No | If ultrasound | If ultrasound |
| MTP approval | If MTP done | No | No | No | If MTP done |
| FSSAI | No | No | No | No | If kitchen / canteen |
| CDSCO / medical device licence | Only if you import, manufacture, sell or distribute medical devices | ||||
* Non-bedded facilities: KSPCB's August 2026 circular says they continue with one-time biomedical waste authorisation. Your exact list depends on your building, services and equipment; ask us for a free check.
Drug licence (pharmacy)
A drug licence from the Karnataka Drugs Control Department is needed to stock and sell medicines, including a hospital or clinic pharmacy. Retail licences are issued in Form 20 and Form 21; wholesale in Form 20B and 21B; Schedule X drugs need Form 20F (retail) or 21G (wholesale). Applications are made online.
Requirements
- Minimum floor area: 10 sq. metres for retail or wholesale; 15 sq. metres for both
- A registered pharmacist (Karnataka State Pharmacy Council) for retail sale
- Refrigerator for drugs that need cold storage
Documents (official checklist for a retail licence)
- Covering letter and Form 19 or 19C
- Additional information sheet
- Fee challan or payment acknowledgement
- Sketch of the premises (in duplicate)
- Rent agreement or lease deed
- Qualified person's proforma and KSPC registration certificate
- Affidavits on Rs 20 stamp paper: pharmacist, constitution and tenancy, biomedical waste disposal
- Refrigerator invoice or declaration
- Proprietorship declaration, partnership deed or MoA
- Address proof and photographs of the applicants and pharmacist
Fees
| Licence | Application form | Licence form | Fee (grant / renewal) |
|---|---|---|---|
| Retail, drugs other than Schedule C & C(1) and X | 19 | 20 | Rs 1,500 |
| Retail, Schedule C & C(1) drugs (excluding X) | 19 | 21 | Rs 1,500 |
| Wholesale, drugs other than Schedule C & C(1) and X | 19 | 20-B | Rs 1,500 |
| Wholesale, Schedule C & C(1) drugs | 19 | 21-B | Rs 1,500 |
| Restricted licence (general store) | 19-A | 20-A / 21-A | Rs 500 |
| Schedule X drugs, retail | 19-C | 20-F | Rs 500 |
Renewal (retention) is shown in Form 21-C, with an additional fee of Rs 30 per month (Rs 10 for some licences) if paid after expiry but within six months. Duplicate licence: Rs 150.
Timeline: the department lists a maximum of 30 working days. A change of premises or constitution needs a fresh licence, so apply in advance.
CDSCO medical device licences
The Central Drugs Standard Control Organisation (CDSCO) regulates medical devices and in-vitro diagnostics under the Medical Devices Rules, 2017. Devices are classed by risk: Class A (low), B (low-moderate), C (moderate-high) and D (high). Who issues your licence depends on the activity and the class. Applications are filed online on CDSCO's portals.
| Activity | Application form | Licence / certificate | Issued by |
|---|---|---|---|
| Import of medical devices (any class) | MD-14 | MD-15 | Central Licensing Authority (CDSCO) |
| Manufacture for sale, Class A or B | MD-3 | MD-5 | State Licensing Authority |
| Manufacture for sale, Class C or D | MD-7 | MD-9 | Central Licensing Authority (CDSCO) |
| Sell, stock, exhibit or distribute devices (without a drug sale licence) | MD-41 | MD-42 registration | State Licensing Authority |
| Manufacture for testing or trials | MD-12 | MD-13 | Central Licensing Authority |
Key rules
- Sale registration (MD-42): under G.S.R. 754(E) of 30 September 2022, anyone who sells, stocks, exhibits or distributes medical devices and does not hold a drug sale licence must register the premises. The MD-42 certificate remains valid in perpetuity, subject to payment of the retention fee.
- Class A exemption: G.S.R. 777(E) of 14 October 2022 exempted non-sterile, non-measuring Class A devices from the licensing regime; they still have to be registered on the online portal.
- Import licences are applied for by the authorised Indian agent of the foreign manufacturer.
- Manufacturing licences require a quality management system and an audit (by a notified body for Class A and B).
Who needs CDSCO licensing?
- Medical equipment dealers, distributors and online sellers: MD-42 registration (unless covered by a drug sale licence)
- Importers of devices, consumables and IVD kits: import licence through the Indian agent
- Indian manufacturers, including hospital furniture and device makers: Class A/B (State) or C/D (CDSCO) manufacturing licence
- Hospitals and clinics do not need a CDSCO licence just to use medical devices, but should buy only from licensed importers, manufacturers and dealers
Medasus supplies CDSCO-compliant equipment through our medical equipment store and helps dealers and manufacturers with their CDSCO filings.
Full guide: CDSCO medical device licence: MD-42 dealer registration, import licence, manufacturing licence and device classes.
Fire NOC (fire clearance)
Fire clearance is issued by the Karnataka State Fire and Emergency Services. On the state's Seva Sindhu portal, the clearance certificate for high-rise buildings is listed for buildings above 15 metres, with a service time of 45 working days. Hospitals have stricter fire-safety needs than most buildings, so the requirement depends on your building height, area, number of beds and layout.
What fire officers usually check
- Fire extinguishers, detection and alarm systems suited to the building
- Hydrants, sprinklers and fire pumps where required
- Escape routes, exits, staircases and signage, including patient evacuation for wards and ICU
- Electrical safety and safe storage of medical gases
KPME has a field for the fire safety certificate, so plan fire approval early in a new building. Our hospital set-up team designs to fire norms from the start.
KSPCB consent (pollution control)
The Karnataka State Pollution Control Board (KSPCB) issues Consent for Establishment (CFE) before construction or start-up and Consent for Operation (CFO) before operation, under the Water and Air Acts. Applications and online fee payment are through KSPCB's XGN portal, which has separate streams for bedded and non-bedded health care establishments.
- Bedded hospitals and nursing homes: need consent and biomedical waste authorisation.
- Non-bedded clinics, labs and dispensaries: KSPCB's circular of 14 August 2026 says they continue with one-time authorisation under the Bio-Medical Waste Management Rules, 2016. Facilities that took integrated consent between 12 February 2025 and that circular do not need a separate authorisation.
KSPCB rules for clinics changed twice in 2025-2026. Check the latest circular before applying, or ask us.
Biomedical waste authorisation
Every health care facility that generates biomedical waste, from a single-doctor clinic to a hospital, must follow the Bio-Medical Waste Management Rules, 2016 and hold authorisation from KSPCB.
- Authorisation from KSPCB through XGN (one-time for non-bedded facilities)
- Agreement with an authorised common biomedical waste treatment facility in your area
- Colour-coded segregation bins and bags at the point of generation
- Staff training and records of waste handed over
- Annual report to KSPCB where required
The drug licence checklist also asks for a biomedical waste disposal affidavit, so arrange this early.
PC&PNDT registration (ultrasound)
Any facility with an ultrasound machine, or offering genetic counselling or testing, must register under the Pre-Conception and Pre-Natal Diagnostic Techniques (PC&PNDT) Act, 1994 with the District Appropriate Authority before using the machine. Karnataka runs a state PC&PNDT portal.
| Item | Rule |
|---|---|
| Application | Form A, to the District Appropriate Authority |
| Fee | Rs 25,000 (ultrasound clinic, imaging centre, genetic clinic or lab); Rs 35,000 (institute, hospital or nursing home with a combination of services) – Rule 5 |
| Validity | Five years from the date of issue |
| Renewal | Apply 30 days before expiry; renewal fee is half the registration fee – Rule 8 |
Usually needed
- Qualified sonologist or radiologist details and certificates
- Machine details, invoice and installation report
- Premises plan and ownership or rent documents
- Affidavit that sex determination will not be done
PC&PNDT is strictly enforced: buying, installing or moving an ultrasound machine without registration is an offence, and records (including Form F for every pregnant patient) are inspected.
MTP approval (place approval)
A private place where medical termination of pregnancy is performed must be approved under the Medical Termination of Pregnancy Act, 1971 and the MTP Rules. Approval is granted by the district-level committee after checking the facility, equipment, drugs and the qualified provider.
- A registered medical practitioner with the experience or training required by the Rules
- Operation table, instruments, resuscitation and sterilisation facilities, drugs and emergency back-up
- Confidential records as prescribed
AERB licence (X-ray, CT, dental X-ray)
All medical diagnostic X-ray equipment, including general X-ray, C-arm, CT, mammography, and dental intraoral, RVG and OPG units, must be registered or licensed with the Atomic Energy Regulatory Board (AERB) through its online eLORA system before patient use.
- Use only type-approved equipment from an authorised supplier
- Room layout that meets AERB shielding requirements
- Quality assurance test of the machine
- Radiological safety officer (RSO) nominated where required
- Personnel radiation monitoring (TLD badges) for staff
Buying X-ray equipment? Our X-ray and radiology store lists machines, and we help with the AERB paperwork.
Trade licence
A trade licence (health trade licence) from the local body is needed to run a clinic, lab, pharmacy or hospital from a premises. In Bengaluru it is issued by the city corporation (formerly BBMP); elsewhere by the city corporation, municipality or panchayat. It is usually renewed every year.
- Property ownership or rent agreement and latest tax receipt
- Premises photographs and sketch
- Owner ID and address proof
- NOCs from neighbours or the building owner where asked
Shop and establishment registration
Clinics, labs and hospitals with employees generally register under the Karnataka Shops and Commercial Establishments Act, 1961 with the Labour Department. It governs working hours, holidays and records for staff. Professional tax registration for salaried staff is usually done at the same time.
FSSAI food licence (kitchen and canteen)
A hospital kitchen, patient diet service or canteen needs FSSAI registration or a licence under the Food Safety and Standards Act, applied through the FoSCoS portal. Small units register; larger ones need a state licence, depending on turnover and capacity.
- Kitchen layout and list of equipment
- Food safety supervisor and staff medical fitness
- Water test report
- Pest control arrangement
NABH accreditation
NABH accreditation is voluntary but valuable: it is required for many insurance and government empanelments, and under the 2026 KPME amendment an NABH, NABL, NQAS or QAI accredited facility is to be granted KPME registration or renewal within 10 days without inspection.
Read more on our NABH accreditation page and NABH process guide.
Other approvals you may need
| Approval | When it applies |
|---|---|
| Lift licence | Buildings with passenger or bed lifts (Electrical Inspectorate) |
| Electrical and DG set approval | HT connections, transformers and generator sets |
| Blood centre licence | Blood banks and storage centres (Drugs Control) |
| Narcotic drugs licence | Hospitals that stock morphine and similar drugs |
| e-DAR registration | Now a pre-requisite for KPME permanent registration and renewal |
| ABDM Health Facility Registry | Listing on the national digital health registry |
| Medical gas and oxygen storage | Hospitals with oxygen manifolds or tanks (as applicable) |
| GST and professional tax | As applicable to your business |
Get a free licence check for your facility
Tell us your facility type and city. We will tell you which KPME category applies, what documents you need and what else your facility must have (fire, pollution, drug licence and so on).
Frequently asked questions
What licences are needed to start a hospital in Karnataka?
What licences does a small clinic need?
What is the drug licence fee in Karnataka?
What is the minimum area for a pharmacy drug licence?
How long does a drug licence take in Karnataka?
When does a hospital need a fire NOC in Karnataka?
Do clinics need KSPCB consent?
What is the PC&PNDT registration fee?
How long is PC&PNDT registration valid?
Does a dental clinic need AERB approval?
Does a hospital canteen need an FSSAI licence?
Do I need a CDSCO licence to sell medical equipment?
What is the CDSCO import licence for medical devices?
Who issues medical device manufacturing licences?
Can Medasus handle all these licences together?
One team for all your licences
Talk to the Medasus licensing team in Bengaluru. We handle the portal filing, documents and inspection preparation.
Last reviewed on 2 November 2026 against: Karnataka Drugs Control Department: help manual and checklist; Karnataka Drugs Control Department: fees and forms; Seva Sindhu: clearance certificate for high-rise buildings; KSPCB XGN online consent; KSPCB notifications and circulars; PC&PNDT Rules (NHSRC copy); AERB eLORA; CDSCO: Medical Devices Rules, 2017 and notifications. Medasus Healthcare Pvt Ltd is a private consultancy that helps establishments prepare and file applications. Licences and approvals are granted only by the respective government departments; Medasus cannot guarantee approval or timelines. Rules and fees change, so always check the official source before applying.
