Detailed Project Report on diagnostic reagents

DIAGNOSTIC REAGENTS

[CODE NO.3807]  

Diagnostic kits or in-vitro diagnostic devices (IVDs) are being increasingly used to identify communicable diseases including transfusion transmissible infections. These devices may be sold and used indiscriminately where systems of regulations do not exist or are inadequate. The results are transmission of infection through blood transfusion, inaccurate diagnoses and poor epidemiological information. The international movement of IVDs between countries may remain unchecked and often uncontrolled. Importing countries with functioning national regulatory systems can evaluate these devices to assure they meet international standards. Those countries which do not have adequate infrastructure to evaluate and assure the quality of IVDs require a comprehensive national policy and strong regulatory mechanism. This will support safe blood, accurate diagnoses and reliable epidemiological statistics.

A national policy is an essential component of the strategy to ensure that only quality IVDs are made available to the users. The regulatory mechanism can be implemented through the National Regulatory Authority (NRA) which is the agency in which all the legal powers for assuring quality of IVDs are vested.

The National Reference (or Regulatory) Laboratory (NRL) should provide the advisory technical support for the NRA. It should operate a comprehensive system for assuring the quality of IVDs prior to marketing and in post-market surveillance. Its operation must be independent from the NRA.

In all the countries of the South-East Asia Region (SEAR) of WHO a national regulatory authority for assuring quality of pharmaceutical products is functional. The indigenous production and import of various pharmaceutical products should be regulated by this agency with appropriate legislative support and legal framework. This legal framework could be used for the establishment of policy guidelines for quality assurance of IVDs.

The private-sector provision of health services is quite large and growing in many low- and middle-income countries. Recognition of the importance of private-sector health care providers has led to the formation of several international working groups, forums, and technical assistance projects in recent years. Their discussions, however, have predominantly focused on provision of clinical health care by private-sector providers. Very little knowledge exists regarding the provision of diagnostic services by the private sector in developing countries in terms of market structure, size, and services being offered.

Through decades of work on diagnostics technology development, PATH is cognizant of the difficulty of introducing new diagnostic technologies and then attaining wide-scale use of them in low-income countries. In the past, PATH has primarily focused on delivering new technologies by using public-sector channels and did not fully exploit other types of service delivery models. In recent years, private-sector service delivery models have emerged in lowand middle-income countries and can be used for delivery of new diagnostic technologies.

Expanding the scope of delivery models used for introduction and scale-up of diagnostic products/services would have significant advantages, including:

 Gaining feedback from a larger network of potential users and service providers in order to develop user-centric product designs, which will increase acceptability of new products.

 Facilitating market entry of new diagnostic products by:

 Evaluating how innovative products can be “piggybacked” onto the delivery models of existing products and then evaluating how both new and existing products can be subsequently scaled up.

 Expanding the network of early adopters.

 Demonstrating delivery of innovative diagnostic products on a relatively large scale in a timely manner.

 Creating incentives for manufacturers and distributors of new products by showing them potential new markets for those technologies.

 Creating a larger circle of potential collaborators for future introduction and scale-up of new diagnostic products in order to attract donors and investors interested in public-private partnerships.

 Gaining experience and knowledge and applying it to other projects at PATH.

As the initial step toward expanding our understanding of delivery models and developing a strategy to leverage them, we conducted a landscape analysis to investigate private-sector service delivery models, with a focus on India.

Modern diagnostic centre provides a wide scope for detection of ailments and affords facilities for a detailed medical check-up through diagnostic procedures. To accomplish this objective a modern diagnostic centre is well equipped with most modern instruments. Which help in following the requisites measures for diagnostic purposes.

Quite a number of tests are carried out including pathological tests viz:- Haematological test, sputum test, semen test, Urelogical test, stool test etc. Besides, other tests are also carried out such as:- Radiological Test (X-rays) Ultrasound Test, Electrocardiagraphic and Electro Encephlographic Tests, IVP Test, Gyneacological Test Endoscopic test, BP Test, Kochssyndrome Test (For Tuberculosis), MMR Test, Pregnancy Test, cardiological test etc.

In a diagnostic centre desired facilities are available for attending patients through doctors, nurses, specialised doctors in their respective fields required for a thorough diagnostic check-up of diseases of their fields viz. Cardiologist for heart, Pathologist for pathological test, Radiologist for X-rays, Neurologist for Brain & Nervous system checkups, Endrocronologist for harmone test, ENT specialist for Ear, Nose, Throat ailments, Opthnologist/Eye Specialist for eye checkup pertaining to ocular ailments and refractive anomalies, specialist for Orthopaetics etc.

 COST ESTIMATION

Plant Capacity               :  500 Nos/Day

Land & Building              : (600 sq.mt.) 

Plant & Machinery      :  US$.64285                                                                                                                                                                                                                                                     Rate of Return                :  37%                                                                                                                                                                                                                                                                    Beak Even Point            :  50% 

• INTRODUCTION
• ROLE OF VARIOUS ORGANIZATIONAL GROUPS FOR DIAGNOSTIC REAGENT
• THE GOVERNMENT
• NATIONAL REGULATORY AUTHORITY
• NATIONAL REGULATORY LABORATORY
• REGIONAL AND DISTRICT LABORATORIES
• REQUIREMENTS FROM MANUFACTURERS FOR EVALUATION OF IN-VITRO DIAGNOSTICS
• QUALITY SYSTEM
• THE APPLICATION MUST INCLUDE:
• GENERAL REQUIREMENTS FOR ELISA-BASED KITS FOR DETECTION OF HBS AG,ANTIBODIES TO HIV AND HCV.
• QUALITY REQUIREMENTS FOR RAPID KITS FOR HIV, HBV AND HCV
• GUIDELINES AND IMPLEMENTATION OF DIAGNOSTIC REAGENT & KIT
• LAW AND POLICY
• NATIONAL REGULATORY AUTHORITY
• NATIONAL REFERENCE LABORATORY
• NETWORKING
• GOOD MANUFACTURING PRACTICES
• SETTING UP A DIAGNOSTIC LAB IN INDIA
• SPACE
• FINANCE
• INSTRUMENTS
• STAFF
• LICENSE/ REGISTRATION
• MEDICAL KNOWLEDGE
• OVERVIEW OF DIAGNOSTIC LAB IN INDIA
• OPPORTUNITIES IN THE DIAGNOSTICS LABORATORY
• BENEFITS OF CRM IN THE DIAGNOSTICS SECTOR:
• SURGING AHEAD
• MARKET OVERVIEW OF DIAGNOSTIC REAGENTS
• THE TOP MAJOR COMPANIES IN DIAGNOSTIC REAGENTS MARKET ARE:
• SCENARIO OF HEALTHCARE IN INDIA
• FIGURE: HEALTHCARE PYRAMID
• FIGURE: PRIMARY CARE
• FIGURE: DISTRIBUTION OF DEATHS BY MAJOR CAUSE, INDIA 
• (SOURCE: SPECIAL SURVEY OF DEATHS, REGISTRAR GENERAL OF INDIA)
• FIGURE: CAUSES OF DEATH IN URBAN AREAS (25 – 69 YRS. OF AGE AS %)
• CARDIOVASCULAR DISEASES CONSTITUTE THE LARGEST SEGMENT
• (SOURCE: SPECIAL SURVEY OF DEATHS, REGISTRAR GENERAL OF INDIA)
• FIGURE: CAUSES OF DEATH IN RURAL AREAS (25 – 69 YRS. OF AGE AS %)
• CARDIOVASCULAR DISEASES CONSTITUTE THE LARGEST SEGMENT
• (SOURCE: SPECIAL SURVEY OF DEATHS, REGISTRAR GENERAL OF INDIA)
• MARKET OVERVIEW OF DIEGNOSTIC INDUSTRY
• BUSINESS MODELS
• BUSINESS STRATEGIES
• INTEREST IN NEW AND INNOVATIVE TECHNOLOGIES
• POTENTIAL FOR COLLABORATION WITH PATH
• RECOMMENDATIONS
• GUIDELINES FOR REAGENT MANUFACTURE
• RISK MANAGEMENT
• PERFORMANCE EVALUATION
• STABILITY DATA
• DATE OF MANUFACTURE
• COLOUR CODING OF REAGENTS
• FREEDOM FROM MICROBIAL CONTAMINANTS
• RETAINED SAMPLES
• TESTS REQUIRED
• HUMAN SOURCE MATERIAL
• LABEL REQUIREMENTS
• LABEL COLOUR CODING
• FORMULATION AND MANUFACTURING PROCESS OF DIAGNOSTIC REAGENT
• EXAMPLE 1
• EXAMPLE 2
• EXAMPLE 3
• CLAIMS
• PREPARATION OF COMMON REAGENT SOLUTION
• TABLE PREPARATION OF SOLUTIONS WITH DEFINED HCL CONCENTRATION
• THE USE OF REFERENCE BUFFERS AND THEIR PURPOSE
• PREPARATION OF REFERENCE BUFFERS
• POTASSIUM SODIUM PHOSPHATE BUFFER (39,125 MMOL/L)
• MIX WELL BY SHAKING
• CALIBRATION OF VOLUMETRIC PIPETTES AND FLASKS (GRAVIMETRIC
• PROCEDURE)
• PROFILES OF EXISTING DIAGNOSTIC LABORATORIES
• PLANT LAYOUT
• SUPPLIERS OF PLANT AND MACHINERY

APPENDIX – A:

01. PLANT ECONOMICS

02. LAND & BUILDING

03. PLANT AND MACHINERY

04. OTHER FIXED ASSESTS

05. FIXED CAPITAL

06. RAW MATERIAL

07. SALARY AND WAGES

08. UTILITIES AND OVERHEADS

09. TOTAL WORKING CAPITAL

10. TOTAL CAPITAL INVESTMENT

11. COST OF PRODUCTION

12. TURN OVER/ANNUM

13. BREAK EVEN POINT

14. RESOURCES FOR FINANCE

15. INSTALMENT PAYABLE IN 5 YEARS

16. DEPRECIATION CHART FOR 5 YEARS

17. PROFIT ANALYSIS FOR 5 YEARS

18. PROJECTED BALANCE SHEET FOR (5 YEARS)