Remdesivir Comes to India
American pharmaceuticals giant Gilead Sciences is the developer of Remdesivir, an anti-viral drug. Recent evidence has claimed its “clear cut” impact on Coronavirus. The company recently agreed with 5 companies to allow them to manufacture the drug to supply to 127 countries. The companies are:
- Hetero Labs
- Jubilant Life Sciences
- Ferozsons Lab
The first 4 are based in India, while the last one is based in Pakistan. They would be supplying to “low-income and lower-medium-income countries and upper-middle and high-income countries”, including developing nations like Afghanistan, Brazil, India, Pakistan, Thailand etc.
The licenses are royalty-free until WHO declares the end of the Public Health Emergency of International Concern regarding COVID-19, or until a pharmaceutical product other than remdesivir or a vaccine is approved to treat or prevent Covid-19, whichever is earlier.Gilead Sciences
India’s Cancer Patients Aid Association has criticized the “granting of monopoly” to one group in times of pandemic. Some health groups are seeking assurance over the drug’s cost, particularly in the “low-income” nations.
The licenses divide the global market into two and profitable markets are retained with Gilead and less profitable markets are given to the five generic companies.K. Gopakumar, Senior Legal Researcher at Third World Network
ICMR’s National Institute of Virology (NIV) has developed ELISA test for Coronavirus. With a sensitivity of 98.7% and specificity of 100%, the test would make checking for the virus swift and accurate. 90 samples can be tested in 1 run which would last up to 2.5 hours. The testing is also safer due to containing inactivated virus, and would make testing available at the district level too. NIV has signed a non-exclusive deal with Zydus-Cadila over ELISA’s mass production. However, NIV can also sign deals with other companies owing to the situation.
Vaccine On Trial
Serum Institute of India (SII) has recently tied-up with Oxford University and US company Codagenix to develop Coronavirus vaccine. Being the world’s largest vaccine producer, making over 1.5 billion doses, SII has started the mass production of vaccine which would be available after its successful testing.
Deal Over HCQ
Hydroxychloroquine (HCQ) is an anti-malarial drug previously considered effective against Coronavirus. On 7 April, India removed restrictions from the export of HCQ after Modi-Trump call. On 11 April, a consignment of more than 3.5 million tablets arrived in US from India.
Approval Spree for Indian Pharmaceuticals
Increasing number of Indian Pharmaceuticals have received approvals from the US Food and Drug Administration (FDA).
- 26 March: Strides Pharma receives Establishment Inspection Report (EIR) for its Bengaluru plant
- 1 April: Biocon insulin plant in Malaysia cleared by (FDA) barring minor “voluntary improvements”
- 2 April: Zydus-Cadila receives FDA approval for Lamotrigine tablets, used to treat seizures
- 9 April: Dr Reddy’s Lab receives EIR for its Telangana plant
- 15 April: Lupin pharma receives EIR for its Madhya Pradesh plant from FDA
- 14 May: Lupin pharma gets EIR for its Vizag plant