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Published 10:23 IST, April 28th 2020

China issues stung first response as ICMR cancels 15 lakh inaccurate Covid test kits order

Responding over faulty anti-body testing kits, China has rejected the claims by the Indian Council of Medical Research (ICMR) over the 15 lakh-kit order

Reported by: Navashree Nandini
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Issuing a detailed response over faulty anti-body testing kits, China has rejected the claims by the Indian Council of Medical Research (ICMR). Chinese embassy spokesperson Ji Rong said in a statement issued early on Tuesday that the quality of medical products exported from China is 'prioritized', calling action taken as 'unfair and irresponsible'. China also claimed that the statement made by ICMR is an example of 'prejudice'.

READ | Ready for plasma therapy on COVID-19 patients, sought ICMR nod: Rajasthan health minister

“The quality of medical products exported from China is prioritized. It is unfair and irresponsible for certain individuals to label Chinese products as ‘faulty’ and look at issues with pre-emptive prejudice,” Rong said. The spokesperson also said both Wondfo and Livzon had clarified that their testing kits had been certified by China’s National Medical Products Administration (NMPA), meet the quality standards China and importing countries, and had also been validated and approved by ICMR through the National Institute of Virology (NIV) in Pune.

Earlier on April 24, Rong had taken to Twitter and said that Chinese companies Guangzhou Wondfo Biotech Co. Ltd. & Zhuhai Livzon Diagnostics Inc. made clarifications on the quality of their exported testing kits to India.

READ | No coronavirus test kits procured at Rs 4,500 a piece: ICMR

ICMR takes action 

Acting on faulty anti-body testing kits, the Indian Council of Medical Research (ICMR), on Monday cancelled the order of 15 lakh rapid anti-body test kits from China. The two firms - Guangzhou Wondfo Biotech and Zhuhai Livzon Diagnostics which were given the order - have supplied kits which have produced inaccurate results, the body cited. Earlier in the day, ICMR had issued an advisory to states across the country halting the use of rapid antibody tests procured from two Chinese manufacturers.

READ | ICMR advises states to stop usage of COVID rapid testing kits from 2 Chinese manufacturers

ICMR cancels 15 lakh test kits order

ICMR has also advised states to return the kits to the supplier as the kits have failed inspite of showing 'early promise of good performance for surveillance purposes'  According to an ICMR official, Guanzhou Wondfo Biotech provided about 5 lakh rapid antibody test kits while Zhuhai Livzon provided 2 lakh kits to four suppliers across the country. Several states including Rajasthan, Tamil Nadu and West Bengal had complained of 'faulty' testing kits causing a delay inaccurate results. 

READ | ICMR cancels all 15 lakh anti-body test kits ordered from China after inaccurate results

Here is China's full statement:

Question: On April 27th, Indian Council of Medical Research (ICMR) announced that since some States have raised issues regarding the performance of rapid antibody test kits procured from Guangzhou Wondfo Biotech and Zhuhai Livzon Diagnostics, ICMR has evaluated the kits in field conditions, and the results have shown wide variation in their sensitivity despite early promise of good performance. In view of this, States are advised to stop using these kits procured from above mentioned companies and return them to be sent back to the suppliers. What’s your comment on this?

Answer: We are deeply concerned with the evaluation results and the decision made by Indian Council of Medical Research. China attaches great importance to the quality of exported medical products. Recently, Chinese Embassy in India has maintained close contact with ICMR and the two Chinese companies to find out the real situation.

We have noticed that Guangzhou Wondfo Biotech and Zhuhai Livzon Diagnostics already issued statements on this issue. They both stressed that their COVID-19 antibody rapid test kits had obtained the certification from the National Medical Products Administration of China (NMPA), meet the quality standards of China and exported countries, and have also been validated and approved by ICMR through National Institute of Virology (NIV), Pune and considered as satisfactory products. The COVID-19 antibody rapid test kits produced by these two Chinese companies have been exported to and well recognized in many countries in Europe, Asia and Latin America.

We have also learned that there are strict requirements for the storage, transportation and use of COVID-19 antibody rapid test kits. Any operation which is not carried out by professionals in accordance with the product specifications will lead to the testing accuracy variations. ICMR also made it clear that rapid antibody test kits should only be used for surveillance purposes instead of replacing RT-PCR test to diagnose and confirm the cases, and States are advised to strictly abide by the methods and purpose of the usage according to ICMR’s clear instructions.

Currently, many countries have been purchasing medical products through commercial channels from Chinese market. While satisfying domestic demands, we support export by companies with qualifications and credibility, and provide convenience in production, transport and customs clearance to facilitate foreign procurement and orderly exporting to countries including India. Chinese relevant manufacturers have been working around the clock to try their best to provide medical supplies to help other countries fight the epidemic and protect people's lives and health.

China not only sincerely supports India in its fight against Covid-19, but also takes concrete actions to help. The quality of medical products exported from China is prioritized. It is unfair and irresponsible for certain individuals to label Chinese products as "faulty" and look at issues with preemptive prejudice. Regarding the current issue occurred, we hope the Indian side could respect China’s goodwill and sincerity, strengthen communication timely with relevant Chinese companies based on facts, and resolve it reasonably and properly.

Viruses are common enemy of mankind. Only by working together, can we win this battle against the epidemic. Since the outbreak of the epidemic, China and India have maintained close communication and cooperation on epidemic prevention and control. Following India’s epidemic situation, China has been feeling the same, shared its experiences in epidemic prevention, control and treatment, and donated medical materials to India. We will continue to support India’s efforts in fighting Covid-19, strengthen medical and health cooperation, and jointly work with India to overcome the difficulties at an early date, so as to safeguard the safety and health of our peoples as well as global and regional public health security.

10:20 IST, April 28th 2020