In this blog, we have curated a detailed guide for starting an IVD manufacturing plant in India. Additionally, we have discussed the necessary CDSCO license required for setting up an IVD manufacturing facility.
What are IVDs?
IVDs or in vitro diagnostic devices are basically instruments, reagents, kits, and systems used for diagnosing diseases and health conditions. The IVD tests are usually performed in test tubes or other similar equipment outside the body. IVDs are used to collect and examine specimens obtained from the human body. Basically, they are used to understand the current state of health to determine the course of treatment required. IVD tests can be performed using various instruments from small handheld devices to complex laboratory equipment. Moreover, these tests can be performed at the patient’s homes, laboratories, or health care facilities.
Furthermore, IVD devices are used for testing patients in the primary health care facilities where labs are not available. Hence, IVDs have a crucial role in patient diagnosis and determining the subsequent course of treatment. Given their role in patient diagnosis, stringent regulations for IVDs are required for patient safety.
Setting up an IVD manufacturing plant
IVDs have a vital role in healthcare industry. Hence, they are in high demand. Thus, medical device entrepreneurs may venture into the IVD manufacturing business. We have listed some of the common IVD devices that are in demand in the healthcare industry.
Common IVDs required in the healthcare industry
- Blood grouping devices
- Blood coagulation analyser
- Blood gas analyser
- Human genetic tests
- Immunoassays
- Next-generation sequencing tests
- Blood glucose self-monitoring systems
- COVID-19 tests
- Pregnancy tests
- Urinalysis test strips
- Influenza Diagnostic Tests
- HIV test kits
How to set up an IVD manufacturing plant in India?
For establishing an IVD manufacturing plant, you will require careful planning and regulatory compliance. Financial planning is also important for setting up a manufacturing facility. Considerable investment is required for starting an IVD manufacturing facility. Furthermore, the target capacity of the plant will determine the size of the plant to be established and the machinery required. Moreover, after setting up the facility, operational protocol, budget, and resource allocation will have to be planned. Notably, a thorough target market analysis will be required to identify the products in demand and which IVD segment you should venture into. We have highlighted some of the major segments of the IVD industry.
Major segments of IVD industry
IVD industry manufactures a broad spectrum of diagnostics. We have listed some of the major segments of the IVD industry:
- Immunoassay
- Clinical Chemistry
- Haematology
- Flow Cytometry
- Blood Grouping & Typing
- Microbiology
- Coagulation
- Urinalysis
In each of these segments of the IVD industry, different IVD products intended for monitoring and diagnosing different diseases are manufactured. Hence, an IVD manufacturing business has a huge potential in terms of scope.
Machinery required for starting an IVD manufacturing plant
We have provided an overview of the machinery required for setting up an IVD manufacturing facility.
- Set of moulds for various parts
- Sealing machine
- Automatic packaging machine
- Blister Packaging machine
- Sterilization Plant
- Scrap Guiding machine
- Chilling Plant
- Testing Equipment
- Electrical Fittings & Socket
- Weighing scale
- Water Pump
- Air Compressor
Total investment required for setting up an IVD manufacturing facility
The investment required for setting up an IVD manufacturing facility will depend on the IVD product being manufactured and manufacturing capacity. Additionally, technical complexity of the manufacturing process, raw material, and infrastructure required will also have to be considered. The approximate investment required for setting up an IVD manufacturing plant may range between 7–15 crores.
What is the size of an IVD manufacturing plant?
The IVD manufacturing facility size will depend on the product, production capacity, and infrastructure required. Moreover, sufficient space for a smooth flow of personnel and materials is a crucial requirement. Additionally, segregated areas for raw material handling, production, packaging, and quality control will be required. Hence, a well-planned plant layout design will be helpful in establishing a facility for manufacturing IVDs. Approximately, 6500 to 15000 square feet area is required for setting up an IVD manufacturing plant.
Step by step guide to starting an IVD manufacturing company
- Perform in-depth market research and identify target IVD products
- Formulate a detailed business plan
- Select a location with good transport connectivity
- Recruit technical staff and non-technical staff for running the facility
- Set up your manufacturing facility with necessary infrastructure
- Ensure regulatory compliance and secure the necessary CDSCO manufacturing license
We at Pharmadocx Consultants create detailed project reports for IVD manufacturers to help start and run an IVD manufacturing business. Our detailed project report focuses on market research, market analysis, target market size, and feasibility of the device. Additionally, it covers the infrastructure and equipment required to manufacture IVDs. Moreover, it will provide projection of expenses, sales, and turnover. Thus, you can make an informed decision regarding the feasibility of your IVD business. Additionally, we prepare realistic project reports with current and accurate data. By reviewing our detailed project report for IVD manufacturing businesses, you will get an idea of the fund required. Therefore, our report will be all you need to guide you through your IVD manufacturing business journey. Get in touch with us to have your IVD manufacturing plant business road map created by experts.
CDSCO regulations for manufacturing IVDs
The Central Drugs Standard Control Organisation (CDSCO) regulates all IVDs manufactured for sale and distribution in India. CDSCO is aimed at enforcing regulations to monitor the quality, efficacy, and safety of IVDs. It provides guidelines for IVD manufacturers to ensure their devices are safe and effective. Compliance with Indian IVD regulations is mandatory to register your products in India. Additionally, IVD manufacturers will have to comply with the Medical Device Rules and Good Manufacturing Practices.
CDSCO IVD classification
CDSCO has categorised IVDs into 4 classes to simplify the license application process. The CDSCO IVD classification system is based on the risk associated with the device.
- Class A IVD devices: These are low risk devices. Reagents and solutions used for laboratory testing are categorised as Class A IVD devices.
- Class B IVD devices: These are moderate risk devices. Blood glucose test strips, pregnancy test kits, and urine analysis test strips are classified as Class B IVD devices.
- Class C IVD devices: These are high risk devices. Hepatitis testing kits, HIV testing kits, and cancer diagnostic kits are classified as Class C IVD devices.
- Class D IVD devices: These devices have the highest risk. Companion diagnostics and genetic testing kits are classified as Class D IVD devices.
CDSCO IVD manufacturing license
Companies intending to manufacture and sell IVDs in India will have to secure the IVD manufacturing license from the CDSCO. Per CDSCO regulations for invitro diagnostic devices, different application forms and licenses are required for different CDSCO IVD classes.
- Class A and B IVD devices: The applicant will have to use MD 3 to apply for a license to manufacture, sell, and distribute Class A and B IVD devices in India. The license to manufacture Class A and B IVD devices for sale and distribution in India will be granted under MD 5.
- Class C and D IVD devices: The applicant will have to use MD 7 to apply for a license to manufacture, sell, and distribute Class C and D IVD devices in India. The license to manufacture Class C and D IVD devices for sale and distribution in India will be granted under MD 9.
Pharmadocx Consultants: We will help you set up an IVD manufacturing plant in a hassle-free manner
CDSCO has laid down stringent regulations for IVDs in India to ensure patient safety and improve patient outcome. We at Pharmadocx Consultants provide customised and tailored regulatory support for IVD manufacturers. Call/Whatsapp on 9996859227 or drop an email at [email protected] to avail our comprehensive IVD manufacturing plant set up service. With our support, you can secure the CDSCO IVD manufacturing license in a seamless manner.
