Hyderabad: Will it be a Vaccine, a drug or a combination of drugs, that will tame the COVID-19 scourge that has virtually brought the entire world to a grinding slow down?
The race is definitely on a global level to produce a vaccine that could prevent the virus from spreading in future. Scores of potential drugs are being tested, with regulators loosening guidelines for repurposed drugs. Some hopes have already emerged.
Pfizer, AstraZeneca, Sanofi, Gilead Life Sciences, Moderna, etc. You name them and both big and small as well as startup’s have thrown in their hat to come up with the magic bullet. India too is not far behind.
India’s Efforts:
Indian Pharma and Vaccine makers too have been very proactive in their efforts to develop, forge collaborations to come up with solutions to ensure treatment options to COVID-19, whose numbers have been rising alarmingly in recent weeks.
Biggies in pharma like CIPLA, Glenmark, Hetero, Biocon, Biophore India have got the Indian Drug Regulator nod to launch versions of antiviral drugs that have demonstrated some promise in providing relief to COVID-19 patients in limited trials.
Today, medical practitioners have Cipla’s brand Cipremi and Hetero’s Covifor as generic versions of Gilead’s Remdesivir. Glenmark’s (Favipiravir under brand name Fabiflu), Biocon’s Itolizumab etc. are also in the list.
Gilead has also given licence to Jubilant Life sciences and Mylan to manufacture in India. Zydus Cadila, Dr Reddy’s and Syngene too have permission from the US Pharma major to produce Remdesivir versions in the country.
In addition, treatment using hydroxychloroquine, the anti-malarial drug; which is made/manufactured by over a dozen companies in India, Dexamethasone, the low cost steroid and anti-inflammatory drug used in severely ill patients is being carried out.
Interestingly, Dexamethasone became popular as ‘Doxamma’ in Telangana thanks to doctors who simplified it to patients, mostly women who could not pronounce it a few years ago.
On the vaccine front, Serum Institute of India (SII), Pune in collaboration with Astra Zeneca and Oxford University; Bharat Biotech in consortia with National Institute of Virology (NIV), Pune & ICMR; Indian Immunologicals Ltd with an Australian University are in active pursuit.
The big advantage is that the SII is the world’s largest manufacturer of vaccines. India has several WHO qualified makers of vaccines. Therefore, it has the capability to both mass production and also to bring down the costs of the vaccine.
Zydus Cadila, which recieved regulatory nod to initiate human trials for it's Vaccine ZyCoV-D hopes to complete all trials in 7 months.
Therefore, be it a vaccine or drugs, India promises to be at the centre of the action and a global player against the pandemic.
India’s Strengths:
The prospects of India emerging as a major player in the development, producing and marketing of the prospective drug or vaccine is considered high by experts.
The reasons are it’s strengths in having USFDA approved manufacturing facilities, a solid track record in producing generic versions and finally coming up with cost-effective or affordable pricing for drugs when required.
A fit case is the story of the AIDS drugs regime.
There are interesting parallels between the development of treatment for HIV/AIDS drugs in the late 1980’s & 1990’s and COVID-19, though the scale, pace and investments vary to a very large extent. Scientists succeeded in managing the deadly disease by a combination of Anti Retrovirals (ARVs) and bringing down the death rate to a minimum.
It’s interesting to note that Indian Pharma has played a critical role in this entire process of taming the HIV/AIDS epidemic from the point of management with low cost drugs.
The huge effort was led by CIPLA and supported by the Hyderabad-based, Indian Institute of Chemical Technology (IICT), led by Dr A V Rama Rao and National Chemical Laboratory (NCL), Pune.
“In 1989, we made AZT ( azido deoxythymidine), the only drug from Wellcome Burroughs ( brand name Retrovir) cleared by FDA as an Orphan Drug for the treatment of HIV patients at the IICT on a small scale. It is like Remdesivir now, a repurposed drug”, recalled Dr Rao.
AZT (azido deoxythymidine) based drug under the brand name Zidovir that will substantially reduce the cost of AIDS treatment.
“I approached Dr Yusuf Hamied, Chairman & Managing Director of CIPLA. But, he expressed reservations on grounds of few cases, small market and issue of IPR. In 1991, Hamied took up the challenge and we got over the hurdles and CIPLA brought the drug to the market as Zidovir”, he said.
The big breakthrough came around 2000, when the WHO organised a meet on HIV/AIDS. Three potential drugs were presented to have effect in bringing relief to patients. They were made by different companies. At the event, Hamied said his company can make them all. WHO asked “Can you produce them for $ 1 dollar? If all waivers and patent issues are sorted out, we can” he asserted.
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Nelson Mandela, the South African President gave the go ahead.. CIPLA made and supplied the drugs to Africa, where the cases were maximum and affordability lowest.
Companies filed patent infringement. US President, Bill Clinton requested companies to withdraw cases and helped the WHO to go ahead with supplying drugs at low cost to African nations, recalled Dr Rao.
Thereafter, Hetero, Ranbaxy and Milan too started producing the anti-retro viral combination drugs at low cost. Thus Indian companies played a huge role in supplying a large percentage of global demand for the HIV/AIDS drugs.
Can something like this be repeated now in the case of COVID 19?
The 85 year old Dr Rao, who now manages, AVRA Labs, a discovery cum contract manufacturing company says, there are good chances of finding a cost effective drug or combination to treat the present virus too.
Coincidentally, Dr Hamied, with whom Dr Rao’s association goes back to 1970-71 ( Dr Rao was at the NCL then), has again team up with AVRA Labs to take a shot at developing a candidate drug. “We are positive about coming up with something soon”, Dr Rao says.
Meanwhile, the IICT too has joined hands with CIPLA to develop a drug against viral diseases, including coronavirus. “We will make the active pharmaceutical ingredients (APIs) for the potential drug and hand it over to the company, who will manufacture the drug”, said S Chandrasekhar, the present Director.
The CIPLA Chairman, Hamied has requested us to manufacture 3 compounds — Favipiravir, Remdesivir and Bolaxivir. Cipla would look after trials, approvals, and mass production of the drugs. Clinical trials have been done on Favipiravir and Remdesivir and the third one will begin soon, Chandrasekhar explained.
(Written by M Somasekhar. Author is a Hyderabad-based senior journalist.)
