Re: [IAC#RG] IMPORTANT: COVISHIELD vaccine lacked marketing approval from Government

Dear Robin

In reply to your points

1. The vaccines are not sufficiently proven to the satisfaction of the Drugs Controller General of India to issue the mandatory marketing approvals.

2. There is no provision of Emergency Use authorisation in Indian Law. That is an US (American) concept under that country's laws.

3. At best in India we have the New New Drugs and Clinical Trials Rules, 2019 which does not have the term emergency use authorisation anywhere.

4. Merely because some trials were conducted by Astra Zenaca (one of the many vaccine companies owned by Bill Gates and his friends through various small dummy proxies) in UK, Brazil and Africa does not mean that their vaccine COVISHIELD can be administered in India without the permission of the regulatory authorities .. as you falsely imply.

5. If we come to Section 1 (2) (ii) (A) (d) of the second schedule of the New New Drugs and Clinical Trials Rules, 2019 for the purported emergency use  "approval" we will find that it has a very stringent .set of protocols for the Accelerated Approval Process

 .."If the remarkable efficacy is observed with a defined dose in the Phase II clinical trial of investigational new drug for the unmet medical needs of serious and life threatening diseases in the country, it may be considered for grant of marketing approval by the Central Licencing Authority based on Phase II clinical trial data. In such cases, additional post licensure studies may be required to be conducted after approval to generate the data on larger population to further verify and describe the clinical benefits, as per the protocol approved by the Central Licencing Authority. "

Till date no such marketing approval has been granted for COVISHIELD, under the accelerated approval process, or otherwise, by the Central Licencing Authority. This has been confirmed by the o/o Drugs Controller of India under PG and also RTI very recently.

The so called "emergency use authorisation" is a FRAUD on the people of India to enable scamsters and rogues like MODI-SHAH to funnel money to their Swiss Bank accounts via Bill Gates controlled companies and using the loophole of patents and foreign royalties being paid by Serum Institute. It is a GLOBAL SCAM of the highest degree and akin to WORLD WAR 3 and global genocide being committed by US capitalist forces.

NB: COVAXIN is a different case / footing, its administration was for Phase 3 trials conducted in India on Indians.

PS: At this mailing list we have a long tradition of maintaining a very high standard for ensuring that accurate information from all sides is privately presented to IAC members

Regards

R.S. Dalvi

pro-tem Administrator of this IAC#RG mailing list

On Wed, May 5, 2021 at 4:43 PM Robin Deans <robin_deans@hotmail.com> wrote:

I have read your mail but regretably it is misleading. The vaccine is NOT being marketed but is being used under an Emergency Clearance accorded by the authorities after phase 2 trials were successfully completed and phase 3 trials near completion and results under evaluation. 

Hence approval of Drug Controller is NOT required. Phase 3 evaluation has also been now successfully completed. Covaxin was also given emergency use clearance without even phase 3 completing 

Regards

Deans

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From: indiaresists-request@lists.riseup.net <indiaresists-request@lists.riseup.net> on behalf of Rajinder Dalvi <indiaresists@lists.riseup.net>
Sent: Tuesday, May 4, 2021 5:39 PM
To: indiaresists <indiaresists@lists.riseup.net>
Subject: [IAC#RG] IMPORTANT: COVISHIELD vaccine lacked marketing approval from Government

The latest official information from Government of India indicates that o/o Drugs Controller of India did not give any approval to COVISHIELD, ie. Serum Institute of India, to market their vaccine in India. This is stated in RTI reply as well as PG replies. At both levels they could not supply true copies of the permissions which the vaccine manufacturers are claiming originated from their office. It is a great mystery who authorised usage of these vaccines on such a large scale without any records being retained.

It is by now well known that the COVISHIELD vaccine is nothing but plain water suspension of innocuous chemicals like sodium chloride with some deactivated chimpanzee rotted organisms which only generates a fever / reaction in the receipent to fool them. The misguided receipents then go out and mingle spreading the virus even further in communities.There is this a clear and very strong positive correlation between vaccination rates and infection rates.

The company Astra Zeneca is indirectly owned by Bill Gates through a network of small owning dummy companies, Melinda Gates is absolutely furious with Bill Gates and now wants to divorce him..So if you have been injected with COVISHIELD vaccine you may be at considerable risk and should seek proper information from Drugs Controller General of India and demand a copy of CDSCO's marketing approval given to COVISHIELD.