NEW DELHI: The drug regulator has given the nod to Roche Diagnostics and seven other private companies for conducting performance evaluation studies for Covid-19 tests with Roche saying the regulator has given its approval in record time.The approvals, however, mean that the companies cannot yet commercialise or conduct the tests in open market till the regulator gives a final approval following the validation process. Roche said the Indian regulator gave approval in “record time”, while the US regulator did so a few days earlier.“With this approval, these companies can now test samples that have already been tested by National Institute of Virology (NIV), Pune. If their results match with that of NIV, Pune, they will cross the validation stage,” a senior official in the drug controller’s office told TOI. He added companies will have to seek further approval before they are allowed to sell these tests in the open market.“The test licence accorded to Roche Diagnostics India allows us to initiate steps to import select quantities of the cobas SARS CoV-2 diagnostic test for product performance evaluation. Following successful completion of the evaluation, a decision from the authorities will enable us to commercialise the kits in India,” Roche Diagnostics India managing director Shravan Subramanyam said. Subramanyan said the test received the United States Food and Drug Administration (USFDA) emergency use authorisation a few days earlier and the Indian regulator has provided “the test license in record time”, enabling the company to initiate the process of bringing it to the country.“Though this is the first step towards enabling access to the cobas SARS CoV-2 diagnostic test in India, it reinforces the government’s intent to enable public-private partnership and improve patient access in a potentially serious healthcare situation,” Subramanyan said.The performance evaluation is conducted to ensure efficacy and accuracy are similar to clinical trials. It is however not called so because a typical clinical trial is conducted on real patients, whereas these samples were received from NIV, Pune.Earlier this week, the government decided to rope in private laboratories to ramp up testing network as a preparedness measure to combat any community outbreak. The Indian Council of Medical Research (ICMR) has also issued guidelines for testing and notifying of positive patients by private institutions including hospitals and laboratories.Private labs have been asked to collect samples from doorstep to avoid risk of infection. Besides, appropriate biosafety and biosecurity precautions are to be ensured while collecting samples. Alternatively, a disease specific separate collection site may be created, the guidelines said. Once the validation process is complete, private labs are likely to start testing from next week.