Indian Pharmas Get FDA Approval on the Heels of HCQ Deal

As the US battles the COVID19 pandemic, it is on a spree of improving ties with India. In the last 15 days, 5 Indian pharmaceuticals have received clearance from the US Food and Drug Administration (USFDA). Complete Coverage: Coronavirus

Crux of the Matter

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.

1. Zydus – Received clearance for sale of Lamotrigine used to treat seizures

2. 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

3. Dr. Reddy’s – Its Miryalaguda plant in Telangana received EIR from USFDA

4. Strides Pharma – Its Bengaluru plant received EIR from USFDA

5. 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.

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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.

Curiopedia

1. The First Indian pharmaceutical company to produce HCQ was Bengal Chemicals and Pharmaceutical Limited. Although the company stopped producing this anti-malarial drug decades ago, they have again applied for the license to produce the said drug. This company was founded by Prafulla Chandra Ray who is considered to be the father of Indian chemistry.

2. There are over 20,000 prescription drug products approved for marketing by the USFDA. The body is also responsible for the oversight of more than $2.6 trillion of consumption of food, medical products, and tobacco in the US.

3. Over 3,00,000 Indians work in the USA on H1B Visa. If the employer terminates the contract of an H1B holder employee in the US, the latter needs to find new employment within 60 days to retain their H1B status.

Curated Coverage

1. Swarajya – Four Leading Indian Pharma Companies Get United States FDA Clearance For Manufacturing Units

2. Times of India – US pharma companies get more FDA ‘warnings’ than Indian firms

3. Economic Times – Zydus Cadila gets final nod from USFDA to market generic seizures drug

4. Firstpost – Coronavirus Outbreak: US allows H-1B visa extension, relief for stranded Indian professionals

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