Five days after Firstpost investigation into faulty test kits, Centre orders recall of COVID-19 kits from Chinese companies
According to government sources, antecedents of several Chinese companies that figure in the CDSCO-approved list will be verified after state governments flagged faulty test kits and quality control issues to ICMR
Editor's Note: This article was originally published on 22 April, 2020. It is being replugged in the view of the central government cancelling orders of several testing kits procured from Chinese companies like, Guangzhou Wondfo Biotech Co Limited and Zhuhai Livzon Diagnostic Inc, among others.
New Delhi: The government is likely to put on hold several procurement orders of COVID-19 test kits from China that has been approved by the Central Drugs Standard Control Organisation (CDSCO).
According to top sources in the government, antecedents of several Chinese companies that figure in the approval list will be verified after state governments flagged faulty kits and quality control issues to Indian Council of Medical Research (ICMR). Most of these kits were procured from China, and in many cases, were procured directly by the states.
On 20 April, the CDSCO cleared the future procurement of test kits from several Chinese companies, including Ghangzhou Wandfo Biotech Co Limited, Hangzhou Clongene Biotech Co Limited and Hangzhou All Test Biotech Co Limited. Except for Ghangzhou Wandfo, none of the other two companies have been authorised by Chinese regulator National Medical Products Administration (NMPA) to manufacture coronavirus detection products.
There's another list of Chinese companies which were approved for procurement of test kits for COVID-19 on 21 April by CDSCO. Among them Ghangzhou Wandfo Biotech, Shanghai Fosum Co Limited, Zhuhai Livzon Reagent Co Ltd, Shanghai Zhijiang Biotechnology Co Ltd and Hangzhon Biotech Limited are approved by Chinese regulator NMPA. However, several other firms like Getein biotech Inc, Shangdong biotechnology, Zybo Inc, and Coyote biosciences doesn’t figure in the official NMPA list of approved manufacturers of CVID-19 test kits.
As a regulator, CDSCO is responsible to ensure safety, efficacy and quality of the medical products manufactured, imported and distributed in the country. These kits are supposed to be procured through private Indian firms.
“Since these procurements will be made by Indian suppliers, a re-verification process will be initiated before the final approval,” government sources said.
Dr Rajni Kant Srivastava, head of research management of ICMR told Firstpost that a thorough investigation will be conducted in the next two-three days and if the kits sent to the states are faulty, all future procurement from the related companies, including from China will be cancelled.
“We cannot afford to have faulty test kits in the time of crisis. The credential of all these Chinese companies will be re-verified. ICMR had recently rejected procurement from some Chinese companies due to lack of documentation. The field experts will verify the source of those kits as well and an elaborate advisory will also be issued after the probe,” Dr Srivastava said.
Top sources in the government said that following the first report of faulty kits in Spain sometime in March, it was decided at the highest level that extreme precautions should be taken in case of Chinese test kits and their credentials must be verified with the Indian suppliers.
Spanish authorities had said that accurate detection rate of Chinese test kit was just 30 percent. The State of Rajasthan has said that rapid test kits for coronavirus gave only 5.4 percent accurate results, much lower than the result in Spain.
Goldsite Diagnostics Inc of China is another Chinese company, which was approved by the CDSCO but doesn’t figure in NMPA's list of authorised test kits manufacturers. The big questions is: why and how did the CDSCO give approval and what kind of documents and certificates were submitted by the Indian suppliers?
Despite repeated attempts, Dr VG Somani, Drugs Controller General of India and head of CDSCO did not respond to calls. A text message sent to Dr Somani remained unanswered till the time of filing this story. Despite repeated attempts, Public Relation Officer of CDSCO, Sunil Kulshreshtha was also not available for comments while numerous calls to CDSCO Public Relation Helpline went unanswered.
CDSCO has also approved Autobio Diag Co Ltd, China for the procurement of antibody test kits. This company too doesn’t figure in the NMPA list of authorised manufacturers.
Dr T Jacob John, the former head of the ICMR for Advanced Research in Virology said that the whole thing smells a rat. Dr John, who is closely working with the Kerala government in the fight against COVID-19 said a thorough investigation is required to ascertain whether proper documents of these companies were submitted and if or not their antecedents were verified.
“It is important to find out the process of approval to the un-approved Chinese companies and if they are operating on the basis of forged certificates, the government must withdraw the procurement orders. Since these manufacturers are not even recognised in China, why should India procure from such companies? Also, there was enough time to rope in Indian manufacturers because our record in pharma-technology is one of the best in the world. Even now, we should encourage the Indian consortium of firms and make the test kits in India as fast as we can,” Dr John added.
Zybo Inc China, which has been approved to procure antibody test kits as well, too doesn't figure in the list of approved entity by the Chinese regulator. Similarly, Changsha Sinocare and WuhanUNScience approved for antibody test kits doesn’t figure in Chinese approval list. Three other Chinese companies all set to supply antibody test kits to India — NewScen Coast, Celtex Biotech and Cellex Inc — are not approved manufacturers of such kits in China.
One of the reason for lapses could be the modified rules by the CDSCO. The organisation had eased the rule for import by allowing self-attested documents to be submitted for import registration citing difficulties in submission of notary, apostilled and embassy attestation of regulatory documents such as power of attorney, manufacturing license with legal signatures, etc. The CDSCO said the applicants may submit required documents with legal signature after normalisation of the situation in the light of COVID-19 outbreak.
ICMR rejects but CDSCO includes unapproved Chinese companies
Interestingly, certain Chinese companies given the go ahead by the CDSCO were rejected by the ICMR. The ICMR had invited Expression of Interest (EOI) for Rapid test Kits on 11 April, however, a majority of manufacturers from China were rejected.
The CDSCO, however, approved and included some of the companies such as Hangzhou All Test Co Ltd, Getein Biotech Ltd and Cellex Inc, which were rejected by the ICMR into the procurement list.
The ICMR had cited at least six reasons, including discrepancy in product catalogue, authorisation from manufacturers, etc, for the rejection.
Many of the Chinese companies rejected by the ICMR doesn’t figure in the official list of China’s regulator NMPA. Some of these unapproved Chinese companies rejected by the ICMR are Szy Bio, Wuhan Life Origin Biotech, Shanghai Outdo Biotech, Shenzhen Watmind Medical Co Ltd, Hangzhou Realy Tech Co Ltd and Guangzhou Darui biotech.
|COVID-19 test kits only"}"> COVID-19 test kits only||Both nucleic acid and anti-body test kits|
|Shanghai Zhijiang Biotechnology Co Ltd||Guangzhou Wondfo Biotech Co Limited|
|Huada Biotechnology (Wuhan) Co Ltd||Innovita Biological Technology Limited|
|Guangdong Hexin Health Technology Co Ltd||Bioscience (Chongqing) Diagnostic Technology Limited|
|Sun Yat-sen University Daan Gene Co Ltd||Xiamen Innodx Biotech Co Limited|
|Shengxiang Biotechnology Co Ltd||Hecin Scientific Inc|
|Shanghai Berger Medical Technology Co Ltd||Vazyme Medical Technology|
|Guangzhou Wanfu Biotechnology Co Ltd||Zhuhai Livzon Diagnostic Inc|
|Innotech (Tangshan) Biotechnology Co Ltd||Shanghai ZJ Bio-Tech Co Limited|
|Chengdu Boao Jingxin Biotechnology Co Ltd||Shanghai Geneodex Biotechnology Limited|
|Beijing Zhuocheng Wison Biotechnology Co Ltd||BGI Biotechnology (Wuhan) Limited|
|Booxes (Chongqing) Biotechnology Co Ltd||Da An Gene Co Ltd of Sun-Yet-Sen University|
|Mike Biology Co Ltd||Sansure Biotech Ltd|
|Xiamen Wantai Kerry Biotechnology Co Ltd||Shanghai BioGerm Medical Biotechnology Limited|
|Guangdong Hexin Health Technology Co Ltd||Beijing Applied Biological Technologies Co Limited|
|Wuhan Mingde Biotechnology Co Ltd||Maccura Biotechnologies Limited|
|Nanjing Nuoweizan Medical Technology Co Ltd||Wuhan Easy Diagnostic Biomedicine Co Ltd|
|Zhuhai Livzon Reagent Co Ltd||Ustar Biotechnology (Hangzhou) Limited|
|Hangzhou Ustar Biotechnology Co Ltd||Anbio (Xiamen) Biotechnology Limited|
|Anbang (Xiamen) Biological Technology Co Ltd||Shanghai Fosun Long March Medical Science Limited|
|Shanghai Fosun Long March Medical Science Co Ltd||Shanghai Rendu Biotechnology|
|Shanghai Rendu Biological Technology Co Ltd||Wuhan Zhongzhi Inc|
|Wuhan Zhongzhi Biotechnology Co Ltd||BGI (Biotechnology Wuhan) Co Ltd|
|Beijing Jinhao Pharmaceutical Co Ltd||Chengdu CapitalBio Co Ltd|
|Dana (Tianjin) Biological Technology Co Ltd|
|Shanghai Xinchao Biological Technology Co Ltd|
|Jiangsu S living shi biological technology Co Ltd|
|Shanghai Jienuo Biological Technology Co Ltd|
|Source: National Medical Products Administration, China|
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