When Indians were Treated as Lab Rats for Covid-19 Booster doses by Modi Government...

  • Central Drug Standards Control Organisation (CDSCO) – India's nodal drug-regulation agency and an independent scientific body under the Government of India – never approved the Covid-19 Booster doses for human use that Prime Minister Narendra Modi flagged for rollout from January 10, 2022.
  • At press conferences in November and December 2021, the top brass of India’s COVID-19 response programme – Union health secretary Rajesh Bhushan, Indian Council of Medical Research (ICMR) director-general Balram Bhargava and COVID-19 task force chief Vinod K. Paul – were opposed to rolling out booster doses. Their answers were confusing, but in all, their position was clear.
  • India's top scientific and regulatory body, CDSCO, also rejected the application for booster roll out in 10th December 2021 on concerns regarding public safety. But, boosters were announced by Prime minister Narendra Modi on 25th December, 2021. 

What changed in 15 days?

India has two legal instruments to govern drug regulation: the Drugs and Cosmetics Act, 1940 and the New Drugs and Clinical Trial Rules, 2019. Under these laws of Constitution, any new vaccine or drug has to have the CDSCO’s approval before it becomes eligible for market authorisation.

The safety bar for vaccines are higher because they’re given to healthy people. Hence any adverse effects is treated as a serious offence according to Scientific community. Whereas, for regular drugs & medicines that are given to sick people are approved with less stringent safety benchmarks than vaccines.

For any drug or vaccine to be approved in India, the company that makes the vaccine/drug has to file an application for approval with the CDSCO. The important aspect of approval of any vaccine is clinical trials. Clinical trails is a global standard for testing any vaccine before its roll out to public. Here, they will test the vaccine to a small group of people(in hundreds) and study them carefully to find if there are any side effects due to the vaccine. This gives scientist a clear picture about the efficacy of a vaccine.

The SEC (Subject expert Committee) is an scientific advisory committee that studies approval application of vaccines and makes recommendations to the CDSCO about what it should do. The CDSCO may or may not accept the recommendation.

On December 10, 2021, SEC examined an application filed by Serum Institute of India's for approval of third vaccine dosage of Covishield(Booster doses). SEC rejected the application stating that there was no clinical trials done i.e no safety studies for Indian population. SEC has asked Serum Institute to conduct clinical trials on Indian population and then come back for approval. This clearly indicated that Covid Booster shots were rejected by India's scientific body as they are unsafe and could cause serious side effects to public.

AstraZeneca, a UK based company has licensed its COVID-19 vaccine to be manufactured in India by Serum Institute. The vaccine is known in India as Covishield. Interestingly, UK regulatory agency has also not approved Booster doses of Covidshield.

Despite this, Prime Minister Narendra Modi annouced roll out of Covid 19 booster doses for all people above 18 years, on January 10,2022.

Legal experts claim this move as illegal, immoral, unethical and is against the constitution of India.

An RTI application was filed by The Wire Science, a respected news agency, to CDSCO, the nodal drug regulation agency of India, to know who approved Covid-19 booster doses.

CDSCO replied, "CDSCO has not recieved any application for grant of permission/approval for precautionary doses(booster doses) of Covaxin and Covishield."

This cleary shows that CDSCO hasn't approved the Covid-19 booster doses.

This has raised eyebrows of scientist from various communities.

Murali Neelakantan, a former global general counsel at Cipla and at Glenmark told, "If you have changed the dosage of a drug or vaccine [from two to three], it is a new drug for the purposes of the Drugs Act. And therefore, it has to be approved by CDSCO [even if it is an existing vaccine], after a clinical trial.”

The CDSCO has to examine the clinical trial data and tell the country’s people why it is recommending a dose change, he added. “If the CDSCO has not approved it, then who has? Who takes the responsibility in that case – the government, the hospitals or the doctors administering the booster vaccines ?”



Then, Who approved Covid-19 Booster doses?

Another RTI was filed in Union Health Ministry asking Who approved Booster shots. Though the Union Government has not answered the question directly, it said, "Issue of Covid boosters were discussed NTAGI meeting in December 2021".

The NTAGI, National Technical Advisory Group on Immunisation, is composed of independent experts as well as officials of the government who provide recommendations on Vaccines.

When the issue of Vaccine safety came up to Supreme court on May, 2022, Union Government has said in Supreme Court that all vaccines that have been approved by NTAGI and that the detailed minutes of the "all" NTAGI’s meetings has been published on the website of the Union health ministry.

But, when checked in the health ministry's website, the minutes of particular meeting when NTAGI approved Covid-19 Booster was missing. This showed the Union Government lied in Supreme Court about important Public health matter.

Two members of NTAGI categorically told The Wire Science that none of the NTAGI working group or the main body of NTAGI had approved Covid-19 booster doses. (They wished to remain anonymous because their membership of NTAGI requires them to remain confidential.)

The members also said, none of the NTAGI’s independent experts have received any data either from the government or the companies that are manufacturing the vaccines about Covid-19 booster's safety studies before its approval.

Other RTI applications by Wire Science, to know who approved Covid-19 boosters where declined to be answered by Government bodies.This makes us to come to a conclusion that some mysterious forces approved Covid-19 booster doses. 

Since any science is based on logical reasoning and explanation, scientist have questioned the reason for hiding the scientific evidence behind Covid-19 booster approval. Any evidence based Medicine or Science should be and will be transparent. If they are hiding something against laws, scientific guidelines and ethics, then there is something seriously wrong about it. The issue of Vaccine is so important public health matter since all people of India are involved. Bypassing regulations will lead to unknown public health crisis.

This issue also raises many questions like, Is Covid-19 booster safe? Why is constitutional machinery violated for boosters approval? What is the role of Prime minister in it? Why is public health programmes made a mockery? Who holds responsibility for boosters doses safety? Why did ministry misled Supreme court? Are vaccines safe? Why mainstream media is silent on this? Why doctors haven't not spoken on this? Who was mysterious force behind the approval? Is booster doses really scientific? Is all vaccines approved like this? Why is the booster dose approval not transparent? Is corruption involved in it? What is the future of our country’s health care system and questions goes on for any logical mind.

Till now, around 23 crore people in India has been administered Covid-19 booster doses. Nobody knows what holds in their future.

Anbu, a daily wage labourer asked, "If Government health agencies regulating pharma companies function like this, how can we trust them in future?"

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Credits & Reference,

https://science.thewire.in/health/cdsco-approval-precautionary-doses-investigation/


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