Home » DCGI issues a show cause notice to Serum Institute of India

DCGI issues a show cause notice to Serum Institute of India

by Raju Vernekar
0 comment 4 minutes read

By Raju Vernekar
New Delhi, Pune Sept. 10:
 
The Drug Controller General of India (DGCI) has issued a show cause notice to the Pune based Serum Institute of India (SII) for progressing with the COVID-19 vaccine trials and not  sending a report about the patient, who took ill after the vaccine was recently administered to him in the UK.
In the notice dated 09 September DCGI Dr V G Somani has stated that the permission was given to the SII, on 02 August 2020 to conduct Phase II and III clinical trials of “ChAdOx1 nCov-19” corona virus vaccine (recombinant), at various sites in the country to determine its safety and immunogenicity.
However it has been widely reported in national and international media that “Astrazeneca PLC”, the British-Swedish pharma giant, has paused the ongoing trial of nCov-19 corona virus vaccine, since a volunteer developed an unexplained illness. Besides clinical trials have been put on hold across the countries where it is conducted – USA, Brazil and South Africa.
As per condition No 2 of the permission granted to the SII, the clinical data generated in this trial shall be considered along with the data from the Astrazeneca/Oxford clinical trial. However, the SII has not informed the Central licensing authority (DCGI) about the pausing the clinical trial carried out by M/s Astrazeneca in other countries and has also not submitted casualty analysis of the reported serious adverse event with the investigational vaccine for continuation of the phase II and III trial of the subject vaccine in the country in light of the safety concerns.
In view of the above, a show cause notice is issued under Rule 30 of the New Drugs and Clinical Trial Rules 2019, why the permission granted in Form CT-06 (No CT-18/2020 dated 02 August 2020) should not be revoked till patient safety is established. “You reply shall reach undersigned immediately, else it shall be construed that you have no explanation to offer and the action deemed fit will be taken against you”, the notice added.     
The SII which began with conducted clinical trials at Bharati Vidyapeeth Deemed University Medical College in Pune on 26 August and at KEM Hospital in Mumbai on 27 August, was in the process of enrolling volunteers for the phase III trial of the “Covishield”, being developed jointly by the Oxford University and “AstraZeneca”. As per the plan the SII is  expected to conduct the clinical trials under phase III on 1,600 participants are across 17 sites in India, from next week..
Reacting to the DGCI notice SII sources said on Wednesday evening, that the SII will follow, the DCGI’s direction and so far the institute has not been told to pause the trials. “If DCGI has any safety concerns, we will follow their instructions and abide by the standard protocols”, they added. In earlier statement, SII had said that the Indian trials are continuing and they have faced no issues at all. The company had also said it can’t comment much on the UK trials.
“AstraZeneca”, the British-Swedish pharma giant that’s developing the vaccine jointly with “Oxford University”, had said a volunteer had suffered “an unexplained illness” and such pauses in drug trials are “routine” and it is too early to determine the sick participant’s specific diagnosis. The trials by “AstraZeneca”, were halted once earlier, in July, after a participant had  developed neurological problems. The patient was later diagnosed with multiple sclerosis, something that was assessed to be unrelated to the vaccine.
 The trials in India, which begun in August, are different stages. So far nearly 100 participants have been injected with the vaccine. The data generated from these participants has to be submitted to an independent expert body, that will assess it for safety and then decide whether further enrolment of more volunteers could be permitted.
Besides “Covashield” being manufactured by Astrazeneca/Oxford, another vaccine “Covaxin” is being manufactured by Indian pharmaceutical company “Bharat Bioetch”. It is an “inactivated” vaccine” which works by injecting doses of the virus that have been killed aiming to prompt the body to build antibodies against it without the virus posing a threat.

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