USFDA on Clearance Spree
In the wake of the Coronavirus pandemic, there has arisen a need for essential medicines in the US. Recently, Prez Trump threatened India with retaliatory measures if it did not deliver Hydroxychloroquine (HCQ) medicine. India delivered. US thanked. Meanwhile, the USFDA has given clearances to 5 leading Indian pharmaceuticals.
- Zydus – Received clearance for sale of Lamotrigine used to treat seizures
- Lupin – Its Nagpur manufacturing unit received an establishment inspection report (EIR) from the USFDA. Nagpur facility is its largest and most advanced oral solid dosage manufacturing plant
- Dr. Reddy’s – Its Miryalaguda plant in Telangana received EIR from USFDA
- Strides Pharma – Its Bengaluru plant received EIR from USFDA
- Biocon – Its insulin plant in Malaysia received USFDA nod
It must be noted that this year Indian firms received fewer warnings from the USFDA than American companies. However, the number was up from the previous year. 54 American pharmaceuticals received USFDA warnings in the last fiscal year (US fiscal).
Many political analysts are linking the approvals of the pharmaceuticals to the bargain of HCQ that India delivered to the US.
H1B Visa Extended
The US continued to shower goodness on India by allowing extension of H1B visas of Indian nationals stranded there due to the Coronavirus. Indians who are the largest beneficiaries of the H1B visa can now apply for extension of stay (EOS) or change of status (COS) permits. Delay in filing for extension will be allowed only in extraordinary cases.