The Beginning
Our journey commenced with the import of Biochemistry, Hematology, and Urine Chemistry products. In 2013-14, Merck Diagnostics India decided to discontinue its IVD operations in India. A group of visionary diagnostics professionals decided to continue the IVD business, taking on Merck's established products. Thus, POCT Services Pvt. Ltd. (now known as Q-Line Biotech Pvt. Ltd.) was born with around 20 employees, importing products from France, the USA, Spain, South Korea, and Sweden.
Manufacturing Biochemistry Reagents
In 2016, we entered product development, setting up our first ISO 13485:16 certified production facility in New Delhi. We received approval from CDSCO (Central Drugs Standard Control Organization) and state FDA for the production and commercialization of over 20 Biochemistry parameters.
Expansion into Electrolytes and Coagulation
We expanded our product range by introducing electrolyte analyzers, coagulation analyzers, and electrophoresis. This year also marked the transfer of technology for the indigenous manufacturing of electrolyte reagents.
Rapid Test and ELISA Kit Manufacturing
We set up our second GMP-certified manufacturing unit for rapid tests and ELISA kits. Through a joint venture with a South Korean company, we expanded our manufacturing capabilities to include glucometers, glucose strips, Hb meters, lipid meters, and associated strips. Our R&D investment focused on instrument and reagent development, resulting in the production of various rapid products and ELISA kits for hCG, HIV, HBsAg, HCV, Syphilis, Malaria, and Dengue.
Responding to the COVID-19 Pandemic
During the COVID-19 pandemic, we began in-house manufacturing of RT-PCR kits, Nucleic Acid Extraction kits, and VTM kits. We signed MOUs with institutions like RGCB, Department of Biotechnology - Govt of India, for technical support in product development and quality evaluation. We received approvals from CDSCO, ICMR, Indian-FDA, and CE for our indigenous RT-PCR kits, Nucleic Acid Extraction kits, ELISA kits, and Rapid Cards.
Diversification and Innovation
In line with our registered product brand name Q-Line, we changed our company name to Q-Line Biotech Private Limited. Our focus shifted to core innovations in diagnostics, molecular biology, bioprocessing, and various IVD analyzers. Partnering with a French company, we established a manufacturing unit in India for high-end instrument production. Our extensive product line now includes raw materials like gold nanoparticles and magnetic beads, hematology reagents, urine strips, over 40 biochemistry parameters, 5+ ELISA parameters, and 10+ lateral flow assays. With over 15,000 customers in India, including corporate chain labs, hospitals, medical colleges, pathology labs, and CROs, our products are also exported to various countries.