Govt speeds up approval for COVID-19 testing kits, drugs

The note also said that the data requirement for clinical performance evaluation etc for the test kits may be “abbreviated, deferred or waived on case to case basis depending on type & nature of diagnostic kit, existing data on the product and evidence of available clinical performance evaluation data of such kit”. The CDSCO will also provide guidance on the steps to be taken.

In a separate development, the Union Cabinet is believed to have approved a package for Active Pharmaceutical Ingredients (APIs), essential in manufacture of medicines, and an announcement is expected on Saturday. Coronavirus-hit China is one of the main suppliers of APIs to the world. Under the proposed programme, drug parks will be set up across the country.

Last week, the government had said it would examine commercial testing kits for their “accuracy and validity”. India is currently using diagnostic kits developed by the National Institute of Virology (NIV) in Pune.

While the government data doesn’t indicate any community transmission so far, India has to be ready for that eventuality, when it would require a substantially larger number of test kits.

Some public health experts also feel India must ramp up its COVID-19 testing. Currently, the country has testing capacity of a little over 6,000 a day, but is only doing about 1,000 tests daily. In all, India has conducted about 15,000 tests in 72 government laboratories. Private labs are not allowed to do tests still.

Globally, testing kits for coronavirus are manufactured mainly by American healthcare company Roche and some Chinese firms.

According to sources, the NIV and its associated labs have one lakh testing kits currently and the government has placed an order to import 10 lakh probes, a key component used in the kits, from Germany. About five lakh are expected to reach soon.

In a separate notice on medicines and vaccines, the CDSCO announced similar easing, saying a firm that had approved drugs or vaccines for COVID-19 in any other country could directly approach the PRO for “expedited review/accelerated approval”. It added, “Data requirement for animal toxicity study, clinical study, stability study etc may be abbreviated, deferred, or waived on case to case basis depending upon the type of vaccine, nature of drug, plant from which the drug is extracted.”

The CDSCO will expedite applications for clinical trial permission and import or manufacture.

On Friday, the government also prohibited the export of ventilators, surgical/disposable masks with immediate effect.

Here’s a quick coronavirus guide for you to stay updated: Who all should be tested for Covid-19 and when? | How should you quarantine yourself? | How often (and how) should you clean your home? | What is the Janata Curfew announced by PM Modi? | Who are restricted from coming to India, and from when? | How long can the virus live on surfaces or in air around you? | Still more Coronavirus Q&A Explained news here