Licensing Departments

Office of the Drugs Controller & Drugs Testing Laboratory Thiruvananthapuram
Address: Red Cross Road, Vanchiyoor, Thiruvananthapuram, Kerala 695035
Hours: Open today · 9AM–5PM
Phone: 0471 247 1896

Drug Controller Office
Address: Civil station,Kakkanadu, Ernakulam, Kerala 682030
Hours: Open today · 10AM–5PM
Phone: 084824 22819

Clinical establishments act and Standard for Ayurvedic Clinics

1. The Clinical Establishments (Registration and Regulation) ACT, 2010 Minimum Standards for AYURVEDA CLNICS Dr. Surendra Chaudhary dr.surendra.chaudhary@gmail.com
2. These Standards are for Ayurveda Clinics,Dispensaries and Therapy centres only. Standards for Hospital & Teaching institutes with In-patients hospitals are different -My views- Recommendations of he draft committee on standards for Ayurveda clinics and hospitals are not explanatory in nature and so many points are not covered.
3. The Clinical Establishments (Registration and Regulation) ACT, 2010
1. The Act is for the Registration and Regulation of the clinical Establishments in the country and for matters connected therewith
2. Act passed by Parliament in August 2010 and notified on 1st March, 2012
3. National Council under the Act notified on 19th March, 2012 and Central Rules notified on 23rd May, 2012L
4. Model State Rules have been circulated to the States/UT’s
5. Ministry has requested the Chief Ministers to adopt and implement the Act
6. Highest priority of Govt. for implementation and monitored by the PMO
4. Definition of Clinical Establishment
1. a hospital, maternity home, nursing home, dispensary, clinic, sanatorium or an institution by whatever name called that offers services, facilities requiring diagnosis, treatment or care for illness, injury, deformity, abnormality or pregnancy in any recognized system of medicine established and administered or maintained by any person or body of persons, whether incorporated or not.
2. a place established as an independent entity or part of an establishment referred to in sub-clause (i), in connection with the diagnosis or treatment of diseases where pathological, bacteriological, genetic, radiological, chemical, biological investigations or other diagnostic or investigative services with the aid of laboratory or other medical equipment, are usually carried on, established and administered or maintained by any person or body of persons, whether incorporated or not.
5. Coverage All clinical establishments - including diagnostic centres and single doctor clinics, Including ALLOPATHY AYUSH Ayurveda YOGA Unani Siddha Sowa-Rigpa Homoeopathy Naturopathy (Exception: establishments of the Armed Forces).
6. Objectives of the Act To establish digital registry of Clinical Establishments at National, State and District level. To prevent quackery by unqualified practitioners by introducing registration system, which is mandatory. To prescribe minimum standards of facilities and services for all categories of health care establishments (except teaching hospitals, health care) and ensure compliance of other conditions for registration like standards treatment protocols, display of range of rates to be charged, maintenance of records.
7. Objectives of the Act The minimum requirements of personnel as may be prescribed; Provisions for maintenance of records and reporting as may be prescribed; The clinical establishment shall undertake to provide within the staff and facilities available such medical examination and treatment as may be required to stabilize the emergency medical condition of any individual who comes or is brought to such clinical establishment.
8. Registration under Clinical establishments act (Data accessed on 4-8-2016) State Total Registration Ayurvedic Registration Andaman&Nicobar 311 22 Bihar 1 1-Homeo Chandigarh UT 310 24 Dadra&Nagar Haveli 42 13 Daman & Diu UT 147 25 Himachal 5186 1839 Jharkhand 3096 111 Rajasthan 88 17 U.P. 5 - Total 9186 2052.
9. Type of Ayurvedic Establishments
1. Clinic
2. Dispensary
3. Therapy Centre
4. Hospitals
1. Minimum 10 Beds
2. 11 to 25 Beds
3. 26 to 50 Beds
4. 51-100 Beds
5. More Than 100 Beds
10. CATEGORIES OF CLINICAL ESTABLISHMENTS- AYURVEDA1
1. Ausadh Chikitsa
2. Shalya Chikitsa
3. Shodha
4. Chikitsa
5. Rasayana
6. Pathya Vyavastha
7. As categorised by Central Government * *section 13(1) under the Clinical Establishments (Registration and Regulation) Act, 2010 reads; “Clinical Establishment of different systems shall be classified into such categories as may be prescribed by the Central Government from time to time”.
11. Mandatory Requirements Clinic
1. Display the name of doctor with the degree
2. Registration number of the doctor
3. Fee
4. Timing of the clinic
5. Experience of the doctor Dispensary- in addition to the clinic
12. Minimum Standards for Ayurvedic Establishments Specifications Clinic Dispensary Therapy Centre Space(Sq.Feet) 100 100 150 Human Resource Doctor One One One Multi-purpose Worker One One One Pharmacist X One Pharmacist cum therapist.
13. Minimum Standards for Ayurvedic Establishments Equipments Clinic Dispensary Therapy Centre Stethoscope 1 1 1 B.P. apparatus 1 1 1 Thermometer 1 1 1 Torch 1 1 1 Tongue depressor 1 1 1 X – Ray view box 1 1 1 Weighing machine 1 1 1 Hammer 1 1 1 Kharal 1 1 1 Other-as required Panchkarma equipments.
14. Minimum Standards for Ayurvedic Establishments Equipments Clinic Dispensary Therapy Centre Doctor’s Table 1 1 1 Doctor’s Chair 1 1 1 Attendant Chair 2 2 2 Patient’s stool 1 1 1 Examination Table 1 1 1 Foot Step 1 1 1 Panchkarma Furniture X X As per requirement.
15. Facilities@Clinic Essentials
1. Name of the physicians with qualification & Registration Number inside the clinics
2. Biomedical waste management authorisation certificate
3. Fire Extinguisher
4. Display of services provided
5. Minimum physical, furniture and equipments
6. Hand washing facility, Drinking Water and some waiting space Optional
1. Noise and Air Pollution authorization certificate
2. Electricity back up
3. Toilet facility
16. Licenses Name of the act Authority Status Registration under shop and Establishment act Local authority- Municipal board etc If applicable Registration under clinical establishment act State government Applicable Clearance for radiation safety Imaging Not applicable Licenses for distribution of medicine Drugs authority Not applicable Biomedical waste collection agreement BWM agencies Applicable* Noise pollution control certificate Pollution control board Applicable if generator is there Generator Exhaust air quality -do- -do- *-Applicable if any process is being offered.There are certain other licenses which are applicable on Ayurveda clinics if being run by societies or charitable trusts.
17. Template for Clinical establishment Rate/Charges Name & Address of establishment with e-mail Registration number-provisional/ permanent Type of establishment Facilities available Charges/ consultationFee OPD General OPD Specialty Investigation/Diagnostic-if any Therapeutic Charges Doctor consultation + any consumable expenditure + Medicine Charges(actual)+ any other Specialty- Doctors fee + Consumable( during punch karma , ksharsutra ) + Therapy charges + any other + Medicine.
18. Clinical Records supposed to be kept OPD registration record Treatment record Medication Record Report of investigations Consent forms (All records are supposed to keep for three years).
19. Template for basic Processes- Registration Registration number, Name Age Gender Socioeconomic status Address with pin code Marital status Contact number/e-mail, Veg/Non-veg Date and time of visit, diagnosis Investigations if advised Name of the doctor (Records can be kept electronically).
20. Assessment/ History taking Template Primary complaint of the patient Family History History of the primary complaint General Examination History of Medication Systemic Examination History of implants Physical Examination Past History Prakriti estimation History of Allergies Agni Pariksha Diet & Lifestyle History Pathya-Apathya Personal History Diagnosis-Provisional/Final Treatment Re-visit instructions Take note of any advise regarding home remedies, yogic advise,Anupan etc.

The State Medicinal Plants Board, Kerala (SMPB) was constituted under the administrative jurisdiction of Health and Family Welfare Department, Govt. of Kerala in 2002, as per the direction of the Dept. of AYUSH, Govt. of India. The aim of the SMPB is to co-ordinate matters relating to the Cultivation, Conservation, Research & Development and Promotion of medicinal plants sector in the State.

SMPB has been functioning in Kerala for the past 10 years. Hon’ble Minister for Health and Family Welfare is the Chairman of the Board. The Board consists of official and non-official representatives from various departments and institutions. The headquarters of the SMPB is located at Thrissur, the cultural capital of Kerala. Till the inception of Board, more than 210 projects are undertaken by SMPB with an estimated cost of Rs. 23 crores allocated by the National Medicinal Plants Board as grant -in -aid for the promotion of medicinal plants sector in the state for the period 2002-11.

Important activities of the SMPB include the following:

1. Promotion of Medicinal Plants cultivation
2. Production of Quality Planting Material
3. Survey, inventorisation and Quantification of Medicinal Plants
4. ex-situ & in-situ conservation of medicinal plants
5. Support to semi processing, value addition and marketing of medicinal plants
6. Conservation & Resource augmentation of RET medicinal species in high demand
7. Research and Development, Quality Certification etc
8. Training , awareness and capacity building of Stakeholders
9. Promotional Activities viz. home /school herbal garden.

The Chief Executive Officer
State Medicinal Plants Board (SMPB)
Shornur Road, Thrissur 680 022
Phone: +91 487 2323151; Fax: +91 487 2323151
e-mail: smpbkerala@gmail.com

Before Construction of Building

The following clearances are necessary to be obtained prior to construction of building for the proposed business activity:

1. Permission of Local Body (Panchayat/ Municipality)
2. Development Authority (Trivandrum / Kollam / Kochi / Kottayam / Kozhikode / Idukki / Palakkad / Thrissur)
3. Initial Clearance from the Directorate of Factories & Boilers
4. No Objection Certificate (NOC) from Kerala State Pollution Control Board
5. Power allocation from Kerala State Electricity Board (KSEB)
6. Before Commencement of Production

The following clearances are necessary to be obtained prior to the commencement of production from the proposed business activity:

1. License from the Local Body
2. Factory License issued by the Director of Factories & Boilers
3. Consent from Member Secretary of Kerala State Pollution Control Board

Clearances from Electrical Inspectorate:

1. Approval of Electrical Drawings
2. Final Approval
3. Power connection by KSEB
4. Clearance from Kerala Water Authority

The Beginner’s Guide to Setting up a Wellness Center:

A wellness center is an establishment where healing options are available for both the mind and body. They offer conventional as well as alternative therapies. The most popular alternative therapies are naturopathy, skin care, Ayurvedic massage, spa, gym, fitness center, magneto therapy, colour therapy, acupuncture and other holistic modalities. There is a growing trend for these in India. The National Accreditation Board for Hospitals and healthcare providers (NABH) has set up guidelines to be followed to open and continue operating a wellness center1. This is of vital importance as diseases like Hepatitis B and Hepatitis C can spread in these centers.

Wellness centers have now become an integral part of urban society due to integrated healthcare solutions they provide, and are a vital aspect of medical tourism. Let’s consider the things that go into making of a wellness center.

1. Location

The location is the most important factor when looking to setup a healthcare center. A wellness center should be set up in a place where there is ease of access via transport, area is good and there is no other wellness center in the vicinity. Considering that the wellness center is majorly in demand in metro cities, finding a good location at an affordable price is a task. It should be in a residential area, with less pollution, noise and with 24 hour water and electricity supply.

2. Licences and Insurance

The wellness center should be registered with the state and local governing bodies. Several licences like the fire licence, health licence etc are required to start a wellness center. It should be covered by adequate insurance in case of unforeseen accidents.

3. Staff

Employing staff is a basic requirement. Trained staff, receptionist, medical assistants, nurses, cleaners, etc are the working force for implementation of ideas on a large scale.

4. Facilities

The owner should have a clear idea of the facilities that will be provided, whether it is spa, gym, naturopathy, cosmetic parlour, massage, Ayurvedic massage, Unani , herbal medicines etc. A wellness center which is well equipped with latest technologies and equipment will attract a higher profile clientele.

5. Practitioners

Depending upon the facilities provided, specialists from each of the respective fields need to be employed. It is important for these to train the helping staff under them. Also, there has to be good co-ordination and unity among different specialists for harmonious functioning of the center.

6. Drainage and plumbing

Plumbing and drainage have to be well planned. A neat and clean center is necessary to provide good healthcare and remain in business.

7. Electrical equipment

A large number of electrical equipment is required in case the set up has a spa and gym. Buying the latest machines and keeping them in good condition, day after day is vital. Good air conditioners are required to help in creating a cool atmosphere which is vital to serving clients. Electrical engineers have to be employed or kept on standby in case of problems. Licences are needed to be procured from local governing bodies for electricity meter and various electrical equipment.

8. Water supply

A steady supply of water is required especially in cases of spas or Ayurvedic massage therapy. The necessary permissions and water licences need to be obtained from the local governing body.

9. Fire NOC

A No Objection Certificate needs to be procured from the authorities for accreditation that the center complies to fire safety standards.

10. Interiors

A good wellness center is primarily jugged by its cleanliness and ambience. A quiet, well furnished, visually calming and tastefully designed set up makes a lasting impression on the consumers.

11. Finances

A considerable amount of money is required to setup a wellness center depending upon the location, facilities provided, number of specialists and staff employed. Apart from that electricity, water and maintenance bills need to be incurred and accounted for.

Wellness centers which are gaining popularity in the urban cities, are encouraged and supported by the government and tourism ministry alike. By 2015, the wellness centers have a potential of creating 3 million jobs in our country. These centers provide mental and physical relaxation to the stressed youth of our country which makes up about 34% of the total population. The future of these wellness centers seems to be bright for owners as well as consumers.