Welcome Doctor!
Are you considering opening an Unani clinic in India? This can be an exciting and rewarding venture, especially if you are passionate about holistic healing and natural therapies. The Unani system, with its roots in ancient Greek and Islamic medicine, focuses on balancing the body’s humours and using natural remedies to promote overall health and well-being.
However, setting up a clinic is no small task. It requires careful planning, understanding of legal requirements, and effective clinic management to ensure smooth operations and a safe environment for your patients.
In this guide, we’ll take you through the essential steps you need to follow to open and run your own Unani clinic. From legal compliance and infrastructure setup to patient care and safety protocols, this guide covers everything necessary to help you establish a well-organized, patient-friendly, and legally compliant Unani clinic.
Let’s dive in and explore the necessary steps for successfully setting up your clinic.
Legal and Statutory Compliance for Unani Clinic In India
Before setting up your Unani clinic, it’s crucial to ensure compliance with legal and statutory requirements. This will help your clinic function smoothly and avoid any legal complications. Below is a simplified and structured breakdown of key requirements:
Registration under the Shops and Establishment Act
Your Unani clinic must be registered under the Shops and Establishment Act, which governs the operation of commercial establishments.
The registration is typically done through the local authorities such as Panchayat, Nagarpalika, Mahanagarpalika, Municipality, or Municipal Corporation, depending on the jurisdiction in which your clinic is located. This registration will give you legal recognition to run your clinic.
Registration under the Clinical Establishment Act
All healthcare establishments, including Unani clinics in India, are required to register under the Clinical Establishment Act. This law applies to all clinics, hospitals, and healthcare facilities, ensuring they meet the minimum standards for medical services.
The registration process is carried out through the local authorities, such as Panchayat, Nagarpalika, or Municipal Corporation, based on the location of your clinic.
AERB Clearances for CT/MRI/Imaging
If your Unani clinic plans to offer imaging services such as CT scans, MRIs, or X-rays, you must obtain clearances from the Atomic Energy Regulatory Board (AERB).
Common Biomedical Waste Collection, Transportation, Treatment, and Disposal Facility
According to the Biomedical Waste Management Rules, 2016, every healthcare facility must have an agreement for common biomedical waste management.
This includes the collection, transportation, treatment, storage, and disposal of biomedical waste. You will need to collaborate with a licensed biomedical waste management service provider, and the local Pollution Control Board will oversee compliance.
Registration under the Air (Prevention and Control of Pollution) Act, 1981
To ensure that your Unani clinic adheres to environmental regulations, you must obtain registration under the Air (Prevention and Control of Pollution) Act, 1981. The local Pollution Control Board is the relevant authority that will assist you in obtaining this registration.
Approval of Radiation Safety Officer (RSO)
In case your Unani clinic uses any form of radiation, such as in diagnostic imaging or therapeutic procedures, you must get approval from the Radiation Safety Officer (RSO).
Boiler License under the Indian Boiler Act, 1923
If your clinic uses boilers, either for heating or sterilization purposes, you need to obtain a Boiler License under the Indian Boiler Act, 1923. This license ensures that all safety standards regarding boiler use are met, and it is issued by the concerned regulatory body.
Building Permit (From the Municipality)
Before starting construction or renovation for your Unani clinic, you must obtain a building permit from the local authorities, such as Panchayat, Nagarpalika, Mahanagarpalika, or Municipality. This permit ensures that the building complies with local zoning laws and construction codes.
Certificate for Narcotics & Psychotropic Substances
If you prescribe medicine, you will need a certificate from the Drug Controller. This certification is essential to ensure that these substances are handled responsibly and in compliance with the Narcotic Drugs and Psychotropic Substances Act, 1985.
Certificate of Registration under the Society Act, 1860
If your Unani clinic operates as a trust or non-profit organization, you will need to obtain a Certificate of Registration under the Society Act, 1860. This registration is mandatory for any organization operating as a society or charitable institution.
Certificate under Section 80-G of the IT Act
In case your clinic qualifies as a charitable institution and you are applying for tax exemptions, you can obtain a certificate under Section 80-G of the Income Tax Act. This allows your donors to receive tax deductions for their contributions to your clinic.
Class Clearance Certificate for Mobile X-ray Equipment
If your clinic uses mobile X-ray equipment, a Class Clearance Certificate from the AERB is mandatory. This clearance certifies that the equipment is safe to use and meets the regulatory standards.
Commissioning Approval of Linear Accelerator
If your Unani clinic uses a linear accelerator (for radiation therapy), you must seek commissioning approval from the AERB. This approval ensures that the equipment is safe to operate and is functioning correctly.
ESIS Registration (for >20 Employees)
If your clinic employs more than 20 staff members, you must register under the Employee State Insurance Scheme (ESIS). This provides medical insurance and benefits to employees in case of illness or injury.
Excise Permit to Store Spirit
If your clinic uses spirit for medical purposes (such as in preparing medicines or disinfectants), you need an excise permit from the local Excise Department.
Generator Exhaust Air Quality Report
If your clinic uses generators for power supply, you must ensure that the exhaust air quality is in compliance with environmental standards. An authorized air testing laboratory can issue this report.
License for Sale or Distribution of Drugs (Form 20, 21, 21C)
Your Unani clinic will require a license from the Food and Drug Administration (FDA) to sell or distribute medicines. Form 20, 21, or 21C is necessary depending on the type of drugs being sold.
License for Lift
If your clinic has an elevator, you must obtain a lift license from the relevant authorities. This ensures that the lift operates according to safety standards.
License to Play Music for Public Use
If you plan to play music or other audio in your clinic for public use, you will need a license from the appropriate authority. This is generally managed by organizations such as the Indian Performing Rights Society (IPRS).
No Objection Certificate from the Chief Fire Officer
For the safety of your patients and staff, a No Objection Certificate (NOC) from the Fire Department is necessary. This certification ensures that your clinic is equipped with proper fire safety measures.
Weighing Equipment Clearances under the Weights and Measures Act, 1976
If your clinic uses weighing equipment (for example, in a pharmacy or laboratory), you need to obtain a clearance from the Department of Weights and Measures.
Occupation Certificate
Once your clinic is fully constructed, you will need to obtain an Occupation Certificate from the local revenue authorities like Panchayat, Nagarpalika, or Municipality. This certifies that the building is fit for occupancy.
PNDT Act, 1996 Compliance (for Sonography)
If your clinic provides sonography services, compliance with the Pre-Natal Diagnostic Techniques (PNDT) Act, 1996, is required. This law regulates the use of diagnostic techniques to prevent sex selection.
Registration of Births and Deaths
Under the Registration of Births and Deaths Act, 1969, your clinic must register all births and deaths that occur within the facility. This ensures that official records are maintained.
SMPV License for Storage of Liquid Oxygen
If your clinic uses or stores liquid oxygen in pressurized vessels, you need a license under the SMPV (Static and Mobile Pressure Vessels) Rules, which ensures the safe handling of medical gases.
TAN and PAN Numbers
For tax purposes, your clinic will need a TAN (Tax Deduction and Collection Account Number) and PAN (Permanent Account Number) issued by the Income Tax Department.
Vehicle Registration Certificates for Ambulance
If your clinic operates an ambulance, you will need to register the vehicle with the Road Traffic Authority.
Water Prevention and Control of Pollution Act
If your clinic generates wastewater, compliance with the Water (Prevention and Control of Pollution) Act is necessary. You will need approval from the local Pollution Control Board.
Basic Processes for Clinic Operations
Running a successful Unani clinic in India involves a structured approach to ensure smooth operations and quality patient care. Below are the essential processes for effective clinic management:
Registration Process
The registration process is the first step in opening your Unani clinic. Collect the following essential details to create a comprehensive patient database:
- Personal Information: This includes name, age, gender, socioeconomic status, address with PIN code, marital status, contact number, and type of diet, such as vegetarian or non-vegetarian.
- Visit Information: This includes CR/OP/IP number, date and time of visit/admission, diagnosis and name of treating doctor.
Patient Assessment
After registration, the next step is patient assessment. A thorough assessment helps in formulating an effective treatment plan. Collect the following information:
- Medical History: This includes primary complaint and history of the complaint, history of medication, implants, surgeries, allergies, family history, and personal history, general and systemic examination.
- Diagnosis and Care Plan: It includes provisional or final diagnosis, plan of care, nutritional assessment and Mizaj assessment.
Infection Control
Infection control is essential to protect both patients and staff:
- Cleaning and Disinfection: Follow manufacturer guidelines for daily cleaning.
- Infection Control Team: Appoint an Infection Control Officer if your clinic has more than 50 beds.
- Monitoring: Regularly check for adherence to infection control practices.
Safety Considerations
Ensure a safe environment by:
- Radiation Safety: Follow AERB guidelines for radiation safety.
- Physical Safety: Use clear safety signs and maintain equipment regularly.
- Emergency Exits: Ensure they are always clear and accessible.
Surgical Safety
If offering surgery, follow the WHO surgical safety checklist, covering:
- Pre-Anesthesia: Identify patients and mark surgical sites.
- Intraoperative: Ensure all team members are ready before starting surgery.
- Post-Operative: Complete tasks like wound closure before discharging the patient.
Biomedical Waste Management
Ensure safe and compliant management of biomedical waste by:
- Segregation and Disposal: Follow regulatory guidelines for waste disposal.
- Monitoring: Regularly check compliance.
First Aid & Basic Life Support (BLS)
Train all staff in Basic Life Support (BLS) to handle medical emergencies effectively. Keep emergency equipment like resuscitation sets available at all times.
Disaster Preparedness
Prepare for potential disasters like fires or power outages:
- Staff Training: Conduct regular drills.
- Stocking Supplies: Ensure you have emergency supplies on hand.
- Emergency Training: Ensure that your staff is trained for emergency situations.
Clinical Records (Including Consents)
Maintain proper clinical documentation, including:
- OPD/IPD records
- Treatment orders and medication records
- Procedure and nursing monitoring records
- Consents (general consent at admission, specific consent for procedures)
Discharge Summary
When discharging a patient, provide a detailed summary including:
- Patient details (name, contact, medical history)
- Diagnosis and treatment given
- Emergency contact information
Wrapping it Up
Starting an Unani clinic in India requires careful planning, legal compliance, and operational efficiency. To ensure smooth operations and high-quality care for your patients, it is essential to adhere to the necessary safety protocols, secure the required licenses, and maintain detailed clinical records.
By following these processes and guidelines, you can build a clinic that not only meets regulatory standards but also offers effective, safe, and comprehensive Unani healthcare services.
Proper registration, patient assessment, infection control, and documentation are key elements in establishing trust and delivering quality healthcare.
Good luck on your journey to establishing a successful Unani clinic in India!
