<p><strong>New Delhi: </strong>The Drugs Controller General of India on Thursday announced that the foreign-made vaccines for Covid-19 can now be launched in the country without the requirement of post-approval clinical trials and testing every batch of the vaccine.</p> <p>In a notice, the DGCI stated that the requirement of conducting post-approval clinical trials and the requirement of testing every batch of the vaccine by Central Drugs Laboratory (CDL), Kasauli can be exempted if the vaccine batch has been certified and released by the National Control Laboratory of the country of origin.</p> <p><strong>ALSO READ |<span style="color: #e03e2d;"><a style="color: #e03e2d;" href="https://ift.tt/3g3EA23"> Global Vaccines Pfizer, Moderna Step Closer For India Rollout As Govt Grants Indemnity - All You Need To Know</a></span><br /><br /></strong>Besides the Covid vaccine, the concerns and fears regarding the impending third wave which people believe will affect children in particular, also need to be clarified.</p> <p>Senior ABP News journalist Dibang spoke to Dr. Sanjay Rai for <em><strong>Uncut</strong></em>. Dr. Sanjay is a professor of community medicine in AIIMS, he is also the principal investigator for vaccine trials in the premier institute. The AIIMS official made several important clarifications pertaining to Covid third wave and vaccines.</p> <p><strong>Q: Are you able to find volunteers easily for Covid vaccine trials being conducted among children? </strong></p> <p><strong>Dr. Sanjay:</strong> We have received a lot more applications than we required. Previously, while conducting trials for adults, we received a lot of applications wherein people were filled with a sense of duty for the nation. However, while then people were showing enthusiasm, now when I talk to mothers, they are ridden with fear and worry which shouldn&rsquo;t be the case. Nevertheless, we have a lot more volunteers than needed, almost 10 times more than the required number.</p> <p><strong>Q: It was being said that the Covid third wave will severely impact children which is why vaccines are urgently needed for them, do you agree with this notion?</strong></p> <p><strong>Dr. Sanjay:</strong> There should be a scientific basis to such a statement as to how such a third wave can take place. A future wave can arrive at any point in time and waves keep appearing and ending when it comes to such diseases. We try to predict when the next wave will strike on a scientific basis.</p> <p>When it comes to children, serosurvey can be the best indicator. Several Serosurveys reveal that more children have already been infected as compared to adults but they are experiencing mild disease symptoms. So there is no scientific basis to believe that Covid third wave will severely impact children because they have not been infected so far.</p> <p>No person in epidemiology is able to understand why this is being spread. Parents and children should not live in this fear. There is no scientific basis to it.</p> <p><strong>Q: Are pharma companies selling this notion so that people are compelled to pay attention and these firms are able to earn profits through vaccines?</strong></p> <p><strong>Dr. Sanjay:</strong> It can&rsquo;t be entirely stated that pharma companies are spreading this claim. However, if this environ has been created without a scientific basis, then it can be said that some people with a vested interest may be involved. We should think about this with an open mind. If there is no scientific basis to this claim then we should be open to thinking if vested interests are trying to push it. Why is this notion being talked about and spread so widely? Even experts sometimes can become emotional about such matters instead of thinking scientifically.</p> <p><strong>Q: The government has announced that the vaccines coming from abroad will not undergo local trials or testing. How do you view this decision? </strong></p> <p><strong>Dr Sanjay:</strong> Earlier, we were required to have clinical trials for foreign vaccines as we need to see how a disease spreads within a particular region and how the vaccine works within the local population. For example, the Covid mortality rate in Asia was lower than seen in Europe. The same disease or drug does not work similarly everywhere. The government approved this (foreign vaccines) acting on the urgency.</p> <p>In April, the decision was taken to not have a clinical trial and instead have a bridge clinical trial seeing the emergency of the pandemic situation.</p> <p>But in terms of the decision announced a few days ago, we should have opted for having a random trial instead of total exemption, so that the companies are wary of it and a quality standard is maintained. We should not compromise on quality or else who will be held responsible for it?</p> <p>The basic principle of medicine: &lsquo;Do no harm, if there is no benefit there should be no harm either - needs to be maintained.</p>

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