India's role in vaccinating the world is crucial

The Drugs Controller General of India's approval for the restricted emergency use to two vaccines is a historic milestone in the country's inspired fight against the Covid-19 vaccine. This is one of the proudest moments for all of us and the scientists, who worked overtime to come up with effective vaccine candidate, deserve all the praise.

They have made India proud by coming out with Covid-19 vaccines with Made in India tag. This is a major step from the pharmaceutical sector towards the Atma Nirbhar vision and goal set by our Hon'ble Prime Minister Shri Narendra Modi ji.

However, as a medical professional and as the Governor, it pains to find some sections of people, possibly with vested interests, unfortunately raising doubts about the approvals and the process of approvals.

The people who create such controversies are doing disservice to the efforts of our proud Indian scientific community. The critics must realise that through their cynicism they are potentially undoing the greatest efforts of our scientific community and are affecting their morale.

It is very important that the unwarranted controversy about the approval also has the potential to create unfound panic among the common people about the vaccine and its use.

The critics must realise that more than 12 million doses of different vaccine candidates for Covid-19 prevention have already been administered all over the world till the January 3rd this year since the inoculation began on December 14th last year.

It is time that India with a population of more than 130 crore people should not lag behind in the vaccination process. Especially in the backdrop of the fact that, India has witnessed the second largest number of Covid-19 cases (10.03 million cases till January 3) in the world next only the USA. India has also recorded a massive 1.5 lakh deaths due to the Covid-19 infection.

There are many factors that huge population also creates potential for more vulnerability and other co morbidity conditions like diabetes, hypertension, cancer, and asthma, and kidney diseases.

For instance, India has the second largest number of diabetics (77 million) in the world and is next only to China (116 Million). It is stated that one in six people with diabetes is from India. This is in other words, God forbid, presents more severe co-morbidity condition in case if the Covid-19 infection spreads.

Regarding the baseless allegations against the Bharat Biotech's vaccine candidate Covaxin, developed in association with the Indian Council of Medical Research (ICMR), the doubts raised are unfortunate.

The Bharat Biotech has made a mark of its own in the field of vaccination not only in India but across the world. It has got the credit for producing 16 different vaccines for different disease prevention and has been conducting clinical trials in a total of 12 countries including the USA and the UK.

I have got the opportunity to visit the Bharat Biotech's research and development centre at the famous Genome Valley in Hyderabad and it was astounding to see the Bio Safety Level-3 (BSL-3) laboratory.

Bharat Biotech's founder and globally acclaimed scientist Dr Krishna Ella claims that even the UK and the US governments do not have the BSL-3 labs. Despite the fact that DCGI has given the approval for Covaxin on the basis of the valid recommendations submitted by the Covid-19 Subject Expert Committee (SEC) of the apex Central Drugs Standard Control Organisation (CDSCO), it is unfortunate that controversy is being created.

Any rumour regarding the efficacy of the vaccine is likely to impact and intensify the vaccine-hesitancy among the people, especially the common people, who have some doubts over any kind of vaccination.

There were instances that some sections of people refrained to take or avoided getting vaccinated to prevent Polio. The Oral Polio Vaccine drops were misconstrued to affect the fertility among a section of the people. During my medical practice days, I still remember the Oral Polio Vaccine drops got the acceptance of the common people when they were promoted by film stars like Rajinikanth. People used to come to the hospital and ask for 'Rajinikanth drops' to prevent polio. This shows how important it is to promote right kind of awareness among the people about the need to get vaccinated to prevent some deadly disease in future. Before the massive immunisation programme to eradicate the polio, the disease used to cripple more than 50,000 kids in the country.

India took up the challenge and embarked on the world's biggest immunisation programme in 1995 to eradicate polio and succeeded in achieving the 90 per cent coverage by 2014, when it was declared as the polio-free nation by the World Health Organisation and the UNICEF. And no wonder, India still remains the polio-free nation with no reported cases during the last five years.

As a gynaecologist, I do know pregnant women throwing the iron supplement pills in the dustbin thinking that they would affect the fairness of the child in the womb. Any immunisation programme is aimed at maintaining the public health at large and it is very vital to prepare them, motivate them and make them part of the immunisation programme by creating enabling eco-system for the immunisation. But the unnecessary controversies and doubts raised by some generalists, who are not subject experts, do not augur well for the proposed massive vaccination programme in our country.

In order to dispel the doubts among the people, Union Health Minister Shri Harsha Vardhan too made a fervent appeal to not to believe the disinformation and misinformation campaign about the efficacy and safety of the Corona vaccines. It is time that we put the things in right perspective as the World Health Organisation (WHO) too certified that India's vaccine regulatory authority is very much compliant with the international standards.

It is relevant to mention here that a team of international experts convened by the WHO found that the country's National Regulatory Authority (NRA) to meet the World Health Organisation's standards for vaccine regulation.

This vital authentication by the WHO unequivocally makes it clear that our country is well equipped to produce and monitor safe, effective and quality vaccines. The approval by the WHO allows the Indian manufactures to supply their vaccines globally through international procurement system.

The approval by the WHO once again highlights our country's image as one of the world's largest manufacturer, supplier and exporter of vaccines. Our National Regulatory Authority's assessment by the WHO international expert team was carried out on the umbrella parameters like safety, efficacy, and quality and the country scored well on all these counts.

The WHO representative to India Dr Henk Bekedam has also welcomed the assessment of the NRA by the international experts. Dr Bekedam explained that that the authentication of country's NRA re-affirms the India's role in global health and the country's strength in pharmaceutical sector and its vaccine regulatory capacity.

Our country has made a steady and strong presence in the pharmaceutical sector. The Invest India statistics point out that India is the largest provider of generic medicines globally. The country occupies 20 per cent share in global supply by volume.

We must all be proud of our scientists and pharmaceutical sector that India supplies 62 per cent of the global demand for different vaccines. India is a prominent and rapidly growing presence in global pharmaceuticals. It is the largest provider of generic medicines globally, occupying a 20 per cent share in global supply by volume, and also supplies 62 per cent of global demand for vaccines.

By volume, Indian pharmaceutical sector ranks 3rd in production and 14th by value. The cost of pharmaceuticals manufacturing in India is 33 per cent lower than in the USA. In the year 2018-19, the Indian pharmaceutical exports were worth 20 billion dollars.

These all show the strong growth of pharmaceutical industry in the country and its huge potential to emerge as the global leader in the pharmaceutical sector. In this backdrop, the country is poised to emerge as the global supplier of Covid-19 vaccine and is firmly on the path.

At the same time ensuring the vaccine accessible to a massive 130 crore people in the country. India's role in the massive production and supply of effective and affordable Covid-19 vaccine is crucial for the public health at the global level, especially in the context of underdeveloped and developing countries.

Keeping aside all the controversies, we must prepare and make the people partner in the world's biggest vaccination programme in our country as stated by our Hon'ble Prime Minister Shri Narendra Modi, the approvals for emergency use are the true game changers in our fight against the Covid-19 pandemic.

It is time that we all join hands and make the world's biggest vaccine programme a success in our country and help protect the public health at the same time ensure the best of the morale of the Indian scientists and our research institutions thus paving way towards the Atma Nirbhar Bharat.

I hail and salute all the Indian scientists who are making India proud through their dedicated research and development and thus helping to realise the goal of Self-Reliant India envisaged by our visionary Prime Minister Shri Narendra Modi ji.

(The author is Governor of Telangana)