Breathalysers are in high demand in India. Hence, manufacturing or importing breathalyser is a lucrative business opportunity for medical device companies. To ensure poor quality and ineffective products do not reach the Indian market, CDSCO has formulated stringent regulations for breathalysers. Hence, securing the CDSCO license for breathalyser is a mandatory requirement.
What is a breathalyser?
A breathalyser is a non-invasive diagnostic device used to measure the amount of alcohol in the air a person breathes out. Basically, it is used to estimate how much alcohol is in the blood or the blood alcohol content (BAC). BAC is the concentration of alcohol in a person’s system. A breathalyser functions by measuring BAC.
The breathalyser measures BAC to gauge a person’s intoxication level. Upon consuming alcohol, the body absorbs it through the stomach lining into the bloodstream. As blood passes through the lungs, some alcohol evaporates and moves into the lungs. The concentration of alcohol in the lungs reflects its concentration present in the blood. Hence, the breathalyser can be used to determine the BAC almost instantly using the air a person exhales. Thus, breathalyser can help do away with the need for blood samples to measure the concentration of alcohol in a person’s system.
Types of breathalysers:
- Preliminary alcohol screening (PAS) tests: PAS are small handheld devices used to determine a person’s BAC. Notably, PAS may not always be accurate.
- Evidential breath tests (EBTs): EBTs are large stationary machines used to measure a person’s blood alcohol concentration. These devices are accurate and reliable.
Hence, breathalysers are efficient easy to use devices used to measure a person’s blood alcohol concentration.
Indian breathalyser market: Demand for breathalysers
The Indian breathalyser market size attained approximately USD 264.3 million in the year 2024. Furthermore, experts predict the market to achieve USD 2,039.9 million by 2033. Moreover, it is expected to grow at a rate of 24.22% during the period 2025 to 2033.
India is witnessing a rise in alcohol consumption owing to changing lifestyle and increase in disposable income. Hence, this is driving the demand for breathalysers due to the rise in road accidents caused by alcohol abuse. Government authorities and healthcare sectors are increasingly using these analysers to monitor blood alcohol concentration. Additionally, breathalysers are also being used in workplaces to ensure employees are not under the influence of alcohol. Being handheld, easy to use, and almost accurate, breathalysers are the most efficient devices for measuring blood alcohol concentration. Therefore, legal framework for road safety, ease of use, and technological advancement are all driving the demand for breathalysers in India. Thus, the Indian breathalyser market has a bright future.
CDSCO regulations for breathalyser in India
Central Drugs Standards Control Organization (CDSCO) regulates the safety, quality, and performance of IVDs and medical devices in India. It ensures the devices are manufactured or imported as per regulations and will function as intended. The CDSCO functions under the purview of Medical Device Rules (MDR), 2017. As per the MDR, breathalysers have been placed under the clinical chemistry category of in-vitro diagnostic devices (IVDs). Similar to other IVDs, breathalysers are also strictly regulated. A CDSCO license for breathalyser is required to legally launch the product in the Indian market. To secure the CDSCO license for breathalyser, you need to comply with the applicable CDSCO regulations for breathalyser. CDSCO is aimed at enforcing these regulations to monitor the quality, efficacy, and safety of these devices. Additionally, it takes required corrective measures in case of any non-compliance.
CDSCO class for breathalyser
For ease of the license application process, CDSCO has categorised IVDs into 4 classes, A, B, C, and D. This CDSCO IVD classification system depends on the risk level and intended use of the IVD. As per CDSCO risk-based classification system, breathalysers belong to CDSCO class A. CDSCO class A IVDs are low-risk devices. The application process and necessary CDSCO license for breathalyser will be those required for CDSCO class A IVDs.
CDSCO license for breathalyser
We have enlisted the different types of CDSCO license for breathalyser in India.
- CDSCO license for manufacturing breathalysers in India: An application has to be filed under MD 3. The license to manufacture breathalysers for sale and distribution in India will be granted under MD 5.
- CDSCO loan license for manufacturing breathalysers in India: A loan license permits a company without a manufacturing facility to manufacture IVDs. With the loan license, the company can use the manufacturing facility of another company that is manufacturing the particular product. An application has to be filed under MD 4. The loan license to manufacture breathalysers without a manufacturing facility will be granted under MD 6.
- CDSCO license to conduct clinical performance evaluation of breathalysers: The importer will have to apply for the permit to conduct clinical performance evaluation under MD 24. The clinical performance evaluation license for breathalysers will be granted under MD 25.
- CDSCO clinical investigation permit for breathalyser: The manufacturer will have to apply for the permit to conduct clinical investigation under MD-22. The clinical investigation permit for breathalysers will be granted under MD 23.
- CDSCO license for importing breathalysers into India: An application has to be filed under MD 14. The license to import breathalysers into India for sale and distribution is granted under MD-15.
Necessary documents required for CDSCO license for breathalyser
- Cover Letter
- Application
- Fees challan
- Documents presenting company details
- Site ownership/Rent agreement deed
- Plant master file
- Device master file
- Performance evaluation report (if applicable)
- Test license copy (if applicable).
- In case of loan license application, consent letter from principal manufacturing unit, principal manufacturer’s manufacturing licenses and product permit, and wholesale licenses of the applicant.
- Quality assurance certificate
- ISO 13485 certificate
- CE design certificate
- Free sale certificate
Feel free to contact us for a detailed list of necessary documents required for applying for CDSCO license for breathalyser. Furthermore, we at Pharmadocx Consultants provide document preparation service. We will help you prepare and compile the necessary supporting documents per the CDSCO guidelines.
How to apply for CDSCO license for breathalyser?
We have provided an overview of the CDSCO breathalyser license application process.
- Login or signup on the official CDSCO online registration portal, SUGAM.
- Prepare the essential supporting documents per CDSCO regulations for breathalyser.
- Fill out the applicable application form for the necessary CDSCO license for breathalyser.
- Submit the application form and upload the supporting documents on the online portal.
- The regulatory officials will review the application and verify the documents submitted.
- If all the criteria are satisfied, the regulatory body will approve the CDSCO license application. It will grant the necessary license to manufacture or import breathalysers as required.
How can Pharmadocx Consultants assist in securing the CDSCO license for breathalyser?
We offer a suite of services:
- Expert guidance and support: We have extensive knowledge of the CDSCO regulations. Our team will help you select the appropriate CDSCO license for your product. Additionally, we will help you navigate through the CDSCO regulations for breathalyser. Furthermore, we will help you fill out the CDSCO license application form.
- Document preparation service: We offer comprehensive document preparation service. Our team will not only help you prepare the necessary supporting documents but also compile them per CDSCO guidelines.
- Query resolution: In case CDSCO raises any query regarding the license application, we will help you promptly respond to it.
- End-to end solution: Our support does not end with license application. We will provide support till you successfully secure the CDSCO breathalyser license.
Need expert guidance for easily securing the CDSCO license for breathalyser? Call/Whatsapp on 9996859227 or email at [email protected].
