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How to Start a Pathology Lab in India

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Introduction: Pathology Lab

In this article, we'll discuss the pathology lab industry, one of India's most lucrative businesses in the twenty-first century. As India's literacy rate rises, it is generally known that people's concerns about their health are growing. Today, this trend is seen in both urban and rural areas. We'll examine the steps and requirements for setting up pathology labs in India as well as the legal standards that must be adhered to. Today, every course of treatment is predicated on testing.

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The majority of modern medical procedures don't proceed until the doctor has confirmed that the sickness actually exists, which requires a lab test. In India, there is a greater demand for pathology due to the growth in epidemics and viral infections. We can observe that diseases are spreading more quickly today as a result of people's changing lifestyles. In response to this, the medical business community is keen to establish pathology labs to meet the needs of the public.

What Are The Kinds Of Pathology Tests Performed In Labs In India?

Let's talk about a selection of the varying kinds of diagnostic tests that are carried out in the laboratory:

Services provided include the basic composite test, which can be completed anywhere using a mobile laboratory, the medium-level test, which can be completed anywhere with the addition of a basic test lab, and the advanced test, which is completed in addition to the medium level testing laboratory at a proper setup lab Center.

  • Biochemistry: The test that is being performed at the basic level like Liver functioning tests, Lipid profile Cerebro-spinal Tests, blood sugar, Lipase and Amylase tests, renal functioning, Cerebro-spinal fluid tests, and other biological tests like Chemical phosphate tests, biochemistry rapid tests, Chemical phosphate tests, Electrolyte tests, Tumor, Plasma and Electrophoresis test, etc. however, at the advanced level the drug monitoring, Coagulation test and toxicology test, genetics tests, is performed.
  • Histopathology: The test that is performed in Histopathology includes hemogram, Clotting time Prothrombin time, Blood grouping, Activated Partial Thromboplastin time, etc.
  • Molecular genetics: the tests relating to Molecular genetics are performed at the advanced level.
  • Cytopathology: the test that is performed in Cytopathology is CSF cytopathology, Sputum, Fine Needle aspiration Cytology, Pap smear, etc. However, at the advanced level of it the Immunocyto chemistry, CT Guided FNAC or ultrasound and other Biological fluid Cytology is performed.
  • Immunohistopathology: the tests that it includes are performed at the advanced level through Immunohiso-chemistry.
  • Medical Microbiology & Immunology: the test that Medical Microbiology includes are basic tests like point infection tests, rapid tests, routine examination of Urinal, Microscopy, Vibrio Cholerae tests, HIV positive tests, Stool ova tests, Vibrio Cholerae tests. The advanced level test included in Medical Microbiology and Immunology are Culture Sensitivity tests, tissue identification tests, infection disease tests, RTPCR tests, Serological tests, and Parasite, Bacterial, and fungi tests.

What is the Requirement for a Pathology License? 

Government institutions find out the legality of the Lab projects and businesses. Pathology labs play a very important role and have a sensitive part in people's lives, and business is one of the most lucrative industries in India. The Pathology labs provide services relating to the diagnosis of the Patients, and gives evidence of the existence of some form of disease or malfunction of the body, it makes critical decisions and saves the lives of the people, however, the team and member involved in the functioning of laboratories have to be extremely careful while performing their functions in the laboratory. The Laboratory performs functions such as a collection of samples and storage with proper care from the environment and reactions, performs experiments on them and provides results and transport the same, the laboratories currently functioning in India are not performing their perfect reality, and they ignore the important processes. As a result and transportation of collected samples affect the mass of society. In India, it is regulated by the Clinical Establishments (Registration and Regulation) Act, 2010, it was enacted to formulate the standards for the services and facilities relating to healthcare, however even today many states are left behind and still are not being regulated through these enactments.

The Licenses Required For Setting Up Of The Laboratories Are:

Who In India Has The Authority To Open Pathology Labs?

  • A pathologist who has received certification and a license from the Indian Medical Council.
  • Since the number of microbiologists and biochemists needed depends on the size and scope of the company, an assistant pathologist is necessary.
  • A degree in medicine is required for the lab technician.

Benefits of NABL Certification 

The governmental organization, National Accreditation Board for Testing and Calibration Laboratories(NABL) certification have so many benefits in itself, NABL is collaborated with various regulatory organizations like APEDA, FSSAI, EIC, and others to ease the process of worldwide acceptance of the Center and streamline the recognition process from various Certification bodies. They work together through a single combined assessment rather than separate assessments. The patient has confidence in the technicians performing the tests because the laboratory equipment is recognized as genuine owing to the NABL certification.

The NABL is recognized through the International Laboratory Accreditation Cooperation (ILAC) Arrangement or Mutual Recognition Arrangement (MRA) as a full-time member, the NABL accreditation enables one to be recognized as an ILAC MRA in markets around the world, wherever the ILAC MRA is in effect. Through this process, the Traders got the simple process of doing business worldwide with ease and reduced the costs Traders. The NABL certifies that the technological measures being implemented in the laboratory are accurate and the the technology being used is of National Standard and can efficiently meet the criteria. The Asia Pacific Laboratory Accreditation Cooperation and the NABL have a Mutual recognition agreement for the conduction of the business operation of accreditation.

Procedure for NABL certification

  • File Application for accreditation
  • Acknowledgment by authority (NABL)
  • Document review
  • Pre-assessment of CAB
  • Final assessment of CAB accreditation
  • Scrutiny by assessment report
  • Recommendation for accreditation
  • Approval for accreditation
  • Issue of accreditation certificate 

For getting information about the procedural aspects of getting certification; follow the page through the link NABL Approval for Lab

What Is The Legal Procedure That Needs To Be Followed For Establishing A Pathology Lab In India 

The National Accreditation Board for Testing and Calibration Laboratories (NABL) is the organization responsible for accrediting and registering laboratories that fall under the purview of the Department for the Promotion of Industry and Internal Trade (DPIIT), Ministry of Commerce and Industry, Government of India. NABL determines the competence and conducts a quality assessment of laboratories and other science and technology-related establishments. It enables the proficiency testing provider to be acknowledged for conducting business in accordance with international standards and for having technical competencies pertaining to all testing schemes. It exhibits proficiency in all technical areas and guarantees that there is little chance that the laboratory will measure inaccurate data.

What Documents Are Required 

The applicant must have to send five copies of the application and five copies of the quality manual must be submitted by the applicant laboratory to NABL. The NABL will send the Quality Manual to a Lead Assessor to determine whether the Check the Quality Manual to see if it complies meets ISO 15189 specifications. The Lead Assessor will then spend the following day doing a Reassessment of the laboratory. Based the laboratory may indicate on the Pre-Assessment report must take specific corrective measures in order to be completely ready for the evaluation. The documents required by the NABL may differ from project to project as per the requirement of the Laboratory, the purpose of the project, the total procedure being followed in an assessment, and competencies, etc. however the following are the standard Documents that need to be maintained while filling the form:

  • Standard operating procedures (SOP)
  • Objectives 
  • Policies and procedures
  • System manuals 
  • Checklist 
  • Forms 
  • Records 
  • Formats

Consult with us for detailed information for certification of the same.

The Regulatory Body For Drug Manufacturing 

The Indian government is the governing body for the system of drug licensing for manufacturers, laboratories, pharmacies, etc. The 1940 Drugs and Cosmetics Act is the legislation that controls license issuance in India. The following categories are added to the list of licensing authorities:

  • Organization for the Central Control of Drugs (CDSCO)

The Ministry of Health and Family Welfare, Government of India, oversees the Central Drugs Standard Control Control Organization through the Directorate General of Health Services. The 1940 Medications and Cosmetics Act gives the CDSCO authority and responsibility for the licensing and approval process for newly developed drugs and other associated services. The CDSCO is the authority responsible for regulating the process of quality drug importation and coordination with the SDSCO.

  • Drug Standard Control Organization for the State (SDSCO)

Under the authority of CDSCO, the State Medications Standard Control Organization oversees and controls the licensing process for the manufacture, sale, and distribution of drugs.

The Steps For Receiving A License From SDSCO For A Homoeopathy Manufacturing Pharmacy

It is necessary to obtain a manufacturing drug license in order to produce any form of medication, including allopathic, Ayurvedic, cosmetic, or other drugs, in accordance with the 1940 Drugs and Cosmetics Act. The state government in question, where the Project would be located, is responsible for licensing. Procedures that must be followed include the following:

  • Visit the relevant State Drugs Standard Control Organization (SDSCO) or Ayush portal website in accordance with the license you need;
  • Sign up for a website account, log in, and complete the application form with the licence you need and the department that is responsible.
  • The applicant must complete out the application form, upload the appropriate papers (be sure all of the documents meet the requirements before submitting the application), and pay the required money.
  • The application is sent to the relevant regional agency, where the drug inspector examines it and visits the location to confirm the information.
  • The licence is finally issued following the conclusion of the inspection.

Requirement of Devices & Tools

The pathology industry depends heavily on medical gadgets, which also need to be approved by Indian and international standards. For the variety of diseases, the lab should have the most modern development available. This depends on the needs of the hospitals with which the lab is affiliated.

For the pathology lab firm to get off the ground, you will also need some equipment. Which extends like.

  • Freeze
  • Desktop/laptop 
  • Injection 
  • Incubator 
  • Test Tube 
  • Flask
  • Thermometer
  • Slide 
  • Microscope 
  • Centrifugation
  • Software 
  • A trashcan
  • Bathroom
  • Pipette

Qualification for Employees 

The position for the post of a receptionist has to be filled Pathologists, helpers, cleaners, and other qualified laboratory personnel Technicians must understand how to treat and diagnose patients, perform checks and balances, conduct practical testing, and operate laboratory equipment. The cleaner must be a specialist in maintaining laboratory hygiene and cleaning machines.

What Are The Tests Performed By Pathology Laboratories

The main tests done in pathology labs are as follows:

  • Gastric brushing
  • Peritoneal fluid cytology
  • Breast core biopsy tissue examination
  • Lymph biopsy tissue examination
  • Fine needle aspiration
  • Skin biopsy
  • CSF Cytology
  • Liver Biopsy Tissue Examination
  • Bone marrow biopsy tissue examination
  • Intraoperative consultation
  • Pericardial Fluid Cytology
  • Organ, bodies
  • Kidney biopsy tissue examination
  • Electron Microscopy Diagnostic
  • Bile duct brushing
  • Gynecological pap smear
  • Bladder washing
  • Anal smear cytology
  • Thoracic Fluid Cytology
  • Urine cytology
  • Assets Fluid Cytology
  • Body cavity washing
  • Cyst fluid cytology
  • Gastrointestinal Biopsy Tissue Examination
  • Bronchial brushing
  • Common bile duct brushing
  • Direct Immunofluorescent Microscopy
  • Pancreatic brushing
  • Duodenal brushing
  • Esophageal brushing

Validity of the Certificate

The certificate remains valid after two years from the date of issuance, however, an annual audit report submission is required.

Conclusion

Looking at the change in lifestyle that has led to the expansion of internal sickness that is difficult to spot in the usual course of business for doctors, the pathology laboratory is one of the most demanding requirements of the current generation. Given the dearth of pathology labs in India, it would be highly sought after from a business standpoint. The government has also taken several initiatives for the development of pathology labs in India, and several discounts are being provided for the same.

This portion of the site is for informational purposes only. The content is not legal advice. The statements and opinions are the expression of author, not corpseed, and have not been evaluated by corpseed for accuracy, completeness, or changes in the law.

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Author
Ravikant Rai
Hi, I am Ravikant Rai, a Technology Lawyer, who graduated with B. A. LL. B. (Hons.) from the school of law and legal affairs at Noida International University I have two years of experience writing about law as a freelancer and aspiring lawyer. In addition, I have experience writing, Content creation and researching legal information. Various articles on business and corporate law, cyber law and cyber security have been authored by me. I currently work in technology deals, corporate, fintech, and cyber law, etc. I have written documents on a variety of subjects, including software licensing, license to use, terms of service, privacy policy, cloud computing service, data security, confidentiality, and data protection, as well as shareholder and founder requirements.

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