DCGI needs communication strategy on COVID-19 approvals: WHO's Swaminathan

India is well prepared for the vaccine rollout. However, the Indian drug regulator - Drugs Controller General of India - should have a communication package that goes along with the emergency use approvals (EUA) given for COVID-19 vaccines, says World Health Organization's (WHO) chief scientist, Dr. Soumya Swaminathan.

Her comments come in the backdrop of several Indian vaccine makers and medical experts complaining about the confusing manner in which DCGI has granted emergency use approvals for COVID-19 vaccines in India.  

"As far as the (regulatory) approvals are concerned, what we need is a good communication package that goes along with the approvals by the Drugs Controller General of India explaining clearly how and on what basis a particular vaccine has been approved," Dr. Swaminathan says.

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In an exclusive interaction with Business Today, she says a communication strategy is important because India is going to have a mix of vaccines - some manufactured in India, some outside or developed outside but manufactured in India because of tie-ups - based on different platforms, including innovative ones. "During a pandemic, one can have extraordinary situations and rules that can be adapted, so you have emergency use listings which many countries are doing, and there is an opportunity to start using products before they are tried and tested in the usual way which would take years to do," she said. At the same time, it is going to be extremely important to have a uniform and clear criterion for approval of vaccines, she adds.

"It is a question of both communicating prior to approval what the benchmarks are going to be and what the rules are going to be and making sure those rules are the same for all. After the approval, in a particular case, explaining what exactly is going to be done," Dr. Swaminathan notes.

WHO had in October 2020 prepared the criteria for emergency listing of vaccines, the minimum criteria for safety, efficacy, and quality of production. Manufacturers will have to follow this criteria when they apply to WHO for approval under emergency use or for pre-qualification. "Countries are free to use that. It is very much aligned with what (US) FDA, for instance, is using in their assessments. In terms of communication, we have developed a lot of materials to be shared with governments around the world. We have a whole package for that national vaccine deployment plan, one of which is communication, including risk communication," she adds.

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On India's preparations for the COVID-19 vaccine rollout, Dr. Swaminathan said the country has done a good job. "From what I have seen in the trial runs that have been conducted, the amount of training given at the district level, at the local level, the guidelines that have been provided, the list of frequently asked questions, all of that has been very good. India does have a history of having the world's largest immunisation programme, very good electronic tracking systems for vaccines, supply chain, etc. The country has also been able to rise to the occasion and produce vaccines and syringes. So, the preparations that have been made will come in good stead now," she states.