Pune Lab Gets Approval to Make Hundred Thousand Diagnostic Kits for Covid-19 | 25 March, 2020

Pune, India: Pune based molecular diagnostics company Mylab Discovery Solutions and Germany’s Altona Diagnostics have been approved by the Indian Council of Medical Research (ICMR) to make diagnostics kits to test people for Covid-19.

The two companies received approval to mass manufacture the kits after they received commercial approval from Indian FDA/ Central Drugs Standard Control Organisation (CDSCO).

“ICMR NIV Pune has completed evaluation of nine non-US FDA EUA/CE IVD kits. Only test kits with 100% concordance among true positive and true negative samples have been recommended for commercial use in India,” the council said in a statement.

Currently, the probes required for testing a patient for Covid-19 are procured from the USA and these kits will continued to be used after due approval from Drug and Controller General of India (DCGI) and intimation to ICMR.

“Even early stage infection can be detected with highest accuracy as has been seen during tests at ICMR,” Shailendra Kawade, executive director of Mylab, said in a statement. For the government labs, it would cost nearly Rs 1,200 per test kit, about one-fourth of what ICMR pays, and the terms are still being worked out for private labs, he added.

“The support and immediate action from regulatory bodies (CDSCO/FDA), evaluation centre of ICMR, NIV, Biotechnology Industry Research Assistance Council (BIRAC) and the central and state governments is commendable,” Hasmukh Rawal, managing director, Mylab Discovery Solutions, said.

(Source: TNN)