The production of locally manufactured Covid-19 testing kits is likely to start next month
Minister for Science and Technology Fawad Chaudhry recently claimed that locally manufactured coronavirus diagnostic kits would have 90 percent testing result accuracy, about 20 per cent more than imported testing equipment. The production of locally manufactured Covid-19 testing kits is likely to start in July. These kits have been designed and tested by the National University of Sciences and Technology (NUST).
In a recent interview, Chaudhry said that Pakistan had developed indigenous Covid-19 diagnostic kits that have been approved by the Drug Regulatory Authority of Pakistan (DRAP) for commercial use. On June 12, the DRAP approved the first indigenously made testing kit for novel coronavirus, developed by the scientists at National University of Science and Technology’s (NUST) Attaur Rahman School of Applied Biosciences (ASAB).
The testing kits are being developed in collaboration with the Wuhan Institute of Virology, China, DZIF Germany, Columbia University, USA and the Armed Forces Institute of Pathology (AFIP), Rawalpindi. A NUST spokesman while confirming the development says that in order to start commercial production, expressions of interest were invited from the private sector. He says 10 companies have shown interest in the manufacturing of Covid-19 test kits. Out of these, four companies have been shortlisted.
Researchers at the NUST who are involved in the designing and manufacturing of this kit claim that the quality and accuracy of their kits is far superior to that of imported kits available in the market. They claim that 23 percent of total testing kits imported so far are sub-standard. As a result, a lot of patients not only paid twice for the tests but in many cases had to be admitted in the hospitals in critical condition because of false results. They say these testing kits will cost one-fourth and, in some cases, half of the current price of the imported kits used for Covid-19 diagnosis.
Dr Asim Rauf, chairman of the Drug Regulatory Authority of Pakistan (DRAP) confirms this development and says that as a regulator they have already given the go-ahead to NUST for the transfer of this manufacturing technology to the private sector. However, he says, the NUST has to seek validation from the National Institute of Health before transferring this technology to the companies shortlisted for manufacturing.
On the subject of pricing of the locally manufactured kits, he says price determination does not come under the DRAP. “Definitely, the prices of locally produced Covid-19 test kits will be less than what we are paying for imported ones,” he says adding “but their price will be decided by market forces and not by us”. As a regulator, he says, their duty is to make sure that the quality of locally manufactured kits is up to mark and meets international standards. “We also have to ensure that plants or factories where these kits will be produced meet international standards.”
Officials in the National Institute of Health are optimistic. According to them, the technical validation of these kits has been completed and soon the clinical validation will start. Given the surge in Covid cases, they want to complete the procedure as soon as possible.
“We’re expecting the NUST research team to start a clinical trial this week and hopefully. Next week they should be in a position to issue licencses to the manufacturers they’ve shortlisted,” says a senior NIH official on the condition of anonymity since he is not authorised to speak to the media. According to him, 125 laboratories in the country have testing facility for Covid-19. In these laboratories, 100,000 tests can be conducted in three shifts on a daily basis, he says. “When you have such a large number of suspected cases then it means there is a huge appetite for local manufacturers.”
Lt Gen Muhammad Afzal, chairman of the National Disaster Management Authority (NDMA), recently informed the media that 1.2 million testing kits are available to cater to the needs of rising Covid-19 patients. However, despite the availability of sufficient quantity of testing kits, the public in general is paying somewhere between Rs 7,000 and Rs 9,000 for a test. Whereas hospitals and laboratories to which the NDMA provided testing kits free of cost, are charging people Rs 1,000 to Rs 1,500 as service charges. “We hope once the manufacturing of Covid-19 kits starts the testing cost will come down to Rs 2,000 to Rs 3,000, including service charges,” says the NIH official.
Prior to this, the NDMA with the help of private sector started the manufacturing of personal protection equipment (PPEs). The locally manufactured PPE kits cost around Rs 1,600 to Rs 1,700, whereas the imported ones cost around Rs 15,000. The imported N 95 mask is priced at Rs 2,000 whereas the locally manufactured N 95 mask is now available for Rs 250.