INDIA’S SEARCH FOR VACCINE AGAINST COVID 19

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As the COVID Pandemic rages across the globe and continues to pulverise normal human activities, the race to produce a vaccine has become critical and is certainly accelerating. The pandemic has created such paranoia for mankind that the pursuit of a COVID vaccine has become the singular most scientific activity among world’s scientific community. Governments across the globe are scrambling to ramp up their research activities in their search for the elusive vaccine

COVID Pandemic in India

After India relaxed lock-down condition, it has witnessed increasing daily spikes of infection. As on date, India has reported more than 900,000 positive cases and 24,000 deaths. But these figures show many silver linings: India’s national recovery has been constantly rising. Today its recovery rate stands at 63.02%.  India has one of the lowest COVID19 cases per million population @657 while global average is @ 1638. Against 3,11,565 active cases, recoveries are 1.8 times the number of active cases i.e 5,71,459 patients have been recovered so far. Declining daily growth rate of fresh COVID19 cases have reduced from 31% daily in March to 3.24 % in July this year. Perhaps the important statistic as far as India is concerned is that it has the lowest deaths per million ratio17.2 against global average of 73.  Despite these encouraging numbers, India’s huge numbers are a cause of concern to its policy makers.

India is the world largest vaccine manufacturer

As we speak, 23 clinical trials in search a COVID vaccine are underway across the globe. Encouraging preliminary results from clinical trials from UK, USA, Israel and Russia have raised hopes for an effective coronavirus vaccine.

India has already built up a reputation as the pharmacy of the world and is in fact the world’s largest manufacturer of vaccines. India is also a leading manufacturer of generic drugs globally. Several research institutes in India are also working on separate programmes to find a vaccine for the virus. The Serum Institute of India is the most important and largest vaccine producing entity in the entire world.

Status of India’s efforts for a vaccine

But here we are talking about a scientific breakthrough and a new discovery. So what have been India’s efforts? The Indian Council for Medical Research (ICMR) has been leading India’s efforts in scientific medical research for several years.  In its pursuit for a COVID Vaccine too, it has been at the forefront.

In June, the National Institute of Virology under ICMR in collaboration with Bharat Biotech Pt Ltd developed “COVAXIN”, which has been now cleared by the Drug Controller of India to conduct Phase I & II clinical trials of the drug on human candidates. The clinical human trials are expected to be done in July itself.

Another private Indian pharma company, Zydus Cadila, which has come out with its own vaccine called “ZyCOV-D” which has been partly funded by the Department of Technology under the National Biopharma Mission of India. The company has also been cleared by India’s regulatory authority to conduct human clinical trials. Zydus Cadila has initiated Phase 1 and 2 clinical trials of its COVID-19 vaccine ‘ZyCoV-D this month.

Prior to getting the nod for human clinical trials, both these companies have in the pre-clinical phase demonstrated that the vaccine was found to be safe, immunogenic and well-tolerated. It was also able to produce neutralising antibodies in animal studies, a key requirement for a vaccine. In the phase-I and II trials, the company will assess the safety, tolerability and immunogenicity of the vaccine.  

These two pre-clinical trials have raised India’s hopes significantly for a successful outcome. But what does the approval for human clinical trials signify for India? These approvals given by the Drug Controller General of India for phase I & II of clinical human trials bring India a step closer to an indigenously developed Covid-19 vaccine at a time when the country’s cases have continued to surge.

As part of their phase I & II clinical trials, hundreds of volunteers in India will be immunised with the newly made untested vaccine.

India’s COVID response as Pharmacy of the world

Since the coronavirus crisis broke out, India has been pitching for a coordinated global approach in containing the pandemic. India has already supplied 446 million Hydroxychloroquine tablets and 1.54 billion Paracetamol tablets to 133 countries, including Indonesia, drawing praise from a number of global leaders.

The COVID-19 crisis has demonstrated the importance of international cooperation on humanitarian issues and India has been working closely with G20 countries and WHO on finding ways to check the spread of the coronavirus.

While there is no specific proven treatment for the novel coronavirus yet, patients in India are being administered different drugs that were approved for treating other diseases. There are few proven treatments for Covid-19 at the moment and most of these drugs are helping only the sicker patients.

Most patients in India are asymptomatic and are getting better on their own without specific treatment, physicians in India. However, in the absence of  proven drugs to treat positive COVID patients, India has by and large been relying on generic fever medicines, Dexamethasone, Remdesivir and blood thinners, which have proved beneficial, under very specific circumstances.

With some Indian pharmaceutical companies launching generic versions of Remdesivir and Favipiravir for Covid-19 treatment, it has been found that they help reduce viral load but are not “game changers”.  According to the National Institute of Virology, India has also authorised off-label use of Tocilizumab and Convalescent plasma therapy on specific groups of patients. Moreover, India is already using hydroxychloroquine, an antimalarial drug that has been a subject of debate over its efficacy against Covid-19, as a prophylactic drug.  On June 21, the Central Drugs Standard Control Organisation gave approval to Hetero Drugs Ltd and Cipla Ltd to manufacture and market Remdesivir. Both the firms have already entered into non-exclusive licensing agreements with Gilead Sciences, which is the patent holder of Remdesivir.

Cipla Ltd is now selling its generic version of Remdesivir under the brand name Cipremi. Glenmark Pharmaceuticals has launched the drug under the brand name FabiFlu, making it the first oral Favipiravir-approved medication in India for the treatment of Covid-19. The firm has fixed its price at Rs 100 (IDR 20,000) per tablet.

Bengaluru-based biopharmaceutical company, Biocon Limited, reported that the Drugs Controller General of India has approved Itolizumab produced by Bengaluru based bio-pharm Indian company Biocon Ltd. Similarly, Biophore India Pharmaceuticals has received a license from the Drug Controller General of India (DCGI) to manufacture Favipiravir. The active pharmaceutical salt is an important part of the finished formulation to treat mild to moderate Covid-19 cases.

From a net importer to world’s 2nd largest manufacturer of PPE Kits

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When COVID exploded in India sometime in March, India imported most of its PPE testing kits from other countries. But it soon realised that the humungous scale of testing that would be required to detect infections among its huge population, imports will not be a long term option. India ramped up its production of PPE testing kits and within a space of two months, India has become the world’s second largest manufacturer of personal protective equipment (PPE) body coveralls. On 15 July, India launched the world’s most affordable (US$7) RT-PCR based highly sensitive & specific COVID19 diagnostic kit known as ‘Corosure” developed by Indian Institute of Technology, Delhi.

Can India deliver a vaccine?

The global coronavirus pandemic has exposed many countries’ dependence on foreign-made medicines. As the largest producers of vaccines and generic medicines, India will have an important role to play in the mass production of medicines and vaccines for coronavirus infection once the treatment for the deadly disease is found.

The human trials are currently underway and indications are that the results are encouraging. Though Indian scientists and researchers are optimistic of a break through, their euphoria is tempered with a lot of caution. ICMR believes that if all things go well, it is optimistic that a tried and tested effective vaccine could be produced by mid 2021, one year from now.

Given India’s prowess in medical research and its capability for mass production of vaccines and generic drugs, there is a huge expectation from India on this score. So much so that Bill Gates is putting all his bets on India to produce a vaccine soon for the entire mankind.

By: Raghu Gururaj

The author can be reached at rgururaj@yahoo.com

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