How Indian pharmaceutical and diagnostics firms are preparing for monkeypox outbreak and treatment? | The Financial Express

How Indian pharmaceutical and diagnostics firms are preparing for monkeypox outbreak and treatment?

It is noteworthy that as India has eradicated smallpox since 1979, there are no domestic manufacturers of the smallpox vaccine.

How Indian pharmaceutical and diagnostics firms are preparing for monkeypox outbreak and treatment?
Test tubes labelled "Monkeypox virus positive" are seen in this illustration taken May 23, 2022. (Image Credit: Reuters)

The ongoing monkeypox outbreak has become a cause of worry among healthcare experts and scientists across the world. With over 45,000 monkeypox, health authorities are gearing up to control the outbreak. India has reported 10 cases and one death so far. Meanwhile, eight Indian pharmaceutical companies are seeking to develop a vaccine against Monkeypox. As the cases continue to rise, the Union Health Ministry had issued guidelines recently to increase awareness about the zoonotic disease among the people.

According to reports, the central government designated 15 virus research and diagnostic laboratories (VRDLs) spread across 13 states to monitor the incidence of monkeypox in the country.

On July 14, India reported its first human monkeypox case from Kerala. Since then, 10 confirmed cases of monkeypox have been identified from Kerala and New Delhi (five each) till August 12.

Pune-based Serum Institute of India (SII), Reliance Life Sciences, Dr. Reddy’s Laboratories, Biological E, and two state-owned units – Mumbai-based Haffkine Institute and Indian Immunologicals Ltd – are among those that have come forward to join hands with the Indian Council of Medical Research (ICMR) to develop vaccines.

Last month, the Indian Council of Medical Research (ICMR) called for experienced pharmaceutical companies and research organisations to “collaborate on a royalty basis” for developing monkeypox vaccine and diagnostic kits. August 10 was the last date for submitting the EOIs. Reportedly, 31 companies applied out of which 28 companies applied for diagnostic kits and eight for vaccines.

ALSO READ | WHO: Monkeypox cases drop 21%, reversing month-long increase

This comes after the National Institute of Virology (NIV) announced that it has successfully isolated the monkeypox virus from the patients’ samples. Consequently, this can be used by researchers to grow it in labs.

Moreover, the ‘Expression of Interest’ issued by the ICMR states that NIV has achieved “bulk propagation of the virus stock”. The document states that ICMR will reserve the intellectual property rights and commercialisation rights for monkeypox virus isolates, and the protocols for purification, propagation, and characterisation.

“In the event of default in payment of royalty as above, interest @12% per annum on the royalty due shall be charged for the first six months. If default persists for more than six months, interest at a similar rate will be charged on the accrued interest also from the due dates of payments till realisation/recovery of such amounts by the ICMR,” the document stated.

It is noteworthy that a similar contract was signed between the medical research institute and Bharat Biotech for sharing the isolates of the SARS-CoV-2 virus and for developing the vaccines.

Meanwhile, the drug makers of the country have already started planning to manufacture anti-virals and other medicines which may be effective for monkeypox. According to reports, at the moment, there is a lack of data on treatment, and companies across the globe are waiting for guidelines from international health agencies including the World Health Organization (WHO) to get ahead. However, reportedly, companies that already have the capabilities of manufacturing anti-virals and antiretrovirals may start working on it soon.

In the case of COVID-19, many domestic generic companies have either launched drugs, anti-virals, and potential therapies either individually or entered into partnerships for the same. In 2020, companies like Cipla, Hetero, Mylan, Dr. Reddy’s, Biocon, Jubilant Lifescience signed agreements with US-based Gilead to launch remdesivir in India while for tocilizumab, Roche partnered with Cipla for marketing and distribution.

ALSO READ | Monkeypox in India: Centre forms task force to monitor virus situation in country

Several industry experts told Financial Express.com that many companies are considering developing new drugs and vaccines and diagnostic kits against the viral disease. Meanwhile, some companies have already introduced monkeypox diagnostic tools.

“As of now BDR Pharmaceutical is looking at antivirals including tecovirimat, brincidofovir, and cidofovir, which could be useful in treating monkeypox infection,” Dharmesh Shah- Chairman and MD at BDR pharmaceuticals told Financial Express.com.

Earlier this month, Adar Poonawalla, CEO of Serum Institute of India (SII) said that all preparations are underway for manufacturing a vaccine against the disease after his meeting with Union Health Minister Mansukh Mandaviya.

Last month, Poonawalla said that he is planning to develop an mRNA vaccine against monkeypox in association with its global partner Novavax. Poonawalla also said that he is also considering importing the smallpox vaccine manufactured by Bavarian Nordic, a Danish pharmaceutical company.

At present, the only licensed vaccine for monkeypox is the one manufactured for smallpox by Bavarian Nordic, and the live virus on which it is based, is stored at two locations only – the Centers for Disease Control lab in Atlanta, Georgia and the State Research Center of Virology and Biotechnology (VECTOR Institute) in Koltsovo, Russia.

Jynneos vaccine, developed by the Danish pharma firm, was approved in 2019 for the prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.

While announcing its Q1 results last month, drugmaker Cipla had told reporters that they are looking at the possibility of partnering with others to repurpose some existing antiviral drugs to treat Monkeypox patients.

“We are speaking to a few people, and partners, and we will see what comes out of that,” Umang Vohra, managing director of Cipla, said at the company’s post-earnings media call.

According to the World Health Organization (WHO), smallpox vaccines can also be useful against monkeypox. However, only people who are at risk should be considered for vaccination such as close contact with confirmed monkeypox cases.

“While the smallpox vaccine was shown to be protective against monkeypox in the past, current data on the effectiveness of newer smallpox/monkeypox vaccines in the prevention of monkeypox in clinical practice and in field settings are limited,” the WHO said adding that mass vaccination is not recommended at this time.

ALSO READ | Monkeypox spread unusual, says WHO’s Dr Soumya Swaminathan

It is noteworthy that as India has eradicated smallpox since 1979, there are no domestic manufacturers of the smallpox vaccine.

In India, two companies–Genes2Me and Trivitron Healthcare–have launched monkeypox testing kits which have reduced result time as compared to the conventional RT-PCR for the zoonotic disease recently. Meanwhile, Kit manufacturers such as NeoDx and Mylab have expressed interest in developing tests.

Genes2Me Pvt. Ltd, an In vitro diagnostics (IVD) player in India last month announced that they have developed the Real-Time PCR-based kit for quick detection of Monkeypox virus with a fast turnaround result time of fewer than 50 minutes. Now it has expressed interest for developing a detection kit in partnership with the government.

“Genes2Me POX-Q Multiplex real-time PCR kit contains a specific ready-to-use multiplexed assay for the qualitative detection of Monkeypox DNA virus and differentiation from varicella-zoster viruses DNA through a real-time PCR system. The protocol time of the kit is less than 50 minutes wherein it is compatible on all standard Real-Time PCR instruments and is also available on Genes2Me Rapi-Q HT Rapid PCR Point of Care system. The Point-of-Care solution can be used for screening at multiple sites including Hospitals, Diagnostic Labs, Health Centres, Health Camps, etc,” Neeraj Gupta, Founder and CEO of Genes2Me told Financial Express.com.

Gupta also informed that they have been getting a lot of customer inquiries from India, Europe, Africa, the Middle East & USA. “We have the current capacity to manufacture 5 million test kits in a week, however, it can be scaled up to 2 million tests in a day,” he added.

Similarly, a monkeypox viral detection kit based on RT-PCR has been created by Trivitron Healthcare. With a one-tube single reaction format and a one-hour turnaround time, Trivitron’s Monkeypox Real-Time PCR Kit can distinguish between Smallpox and Monkeypox using four different colours of fluorescence, the company claims.

As the number of cases is rising across the world, Danish pharma firm Bavarian Nordic, which is the only company with an approved vaccine for monkeypox, recently said that it is “uncertain” if it can meet the global demand. According to reports, the Danish company is looking for exploring the possibility of outsourcing some of the production, including technology transfer to a US contract manufacturer, to meet accelerating demand. Earlier this week, the UK health authorities said that it is facing a temporary shortage of the vaccine as it awaits further production of doses by the manufacturer.

Jynneos vaccine, developed by Bavarian Nordik, was approved in 2019 for the prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection. According to USFDA, there are no data available to indicate that one dose of Jynneos will provide long-lasting protection, which will be needed to control the current monkeypox outbreak.

ALSO READ | Antiviral tecovirimat found safe, effective for monkeypox treatment: Study

Last week, the World Health Organization (WHO) said that The number of monkeypox cases reported globally dropped by 21% in the last week, reversing a month-long trend of rising infections and a possible signal the outbreak in Europe may be starting to decline. According to the global health agency, over 45,000 monkeypox cases have been reported in 98 countries since April.

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