Question

The U.S. Food and Drug Administration today announced the following actions taken in
its ongoing response effort to the COVID-19 pandemic:
In response to the demand for alcohol-based hand sanitizers and their active ingredient,
alcohol, certain entities that are not currently regulated by the FDA as drug
manufacturers have requested guidance on the preparation and distribution of alcohol
for incorporation into hand sanitizer products for the public’s use. The FDA issued
another guidance for industry about hand sanitizers, Temporary Policy for Manufacture
of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the
Public Health Emergency (COVID-19) Guidance for Industry. The guidance is for firms
that manufacture alcohol (i.e., ethanol or ethyl alcohol) for use as the active
pharmaceutical ingredient (API) in alcohol-based hand sanitizers for consumer use and
for use as health care personnel hand rubs for the duration of the public health
emergency.

The FDA added hydroxychloroquine sulfate to category 1 under the Interim Policy on
Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food,
Drug, and Cosmetic Act. The FDA does not intend to object to registered outsourcing
facilities using hydroxychloroquine (or chloroquine phosphate, which was already on
category 1), to compound human drugs provided the drugs meet other conditions and
requirements in the FD&C Act. Compounding is generally a practice in which a licensed
pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person
under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients
of a drug to create a medication tailored to the needs of an individual patient. The FDA
is placing hydroxychloroquine sulfate on category 1 after it reviewed the nomination and
determined there was sufficient information for the agency to evaluate the substance for
outsourcing facilities to use in compounding. When FDA categorized
hydroxychloroquine sulfate it did not change its approach, but we prioritized this
substance due to the COVID-19 pandemic. There are currently no FDA approved
therapeutics or drugs to treat, cure or prevent COVID-19; however, there are FDA-
approved treatments that may help ease the symptoms of COVID-19. Additionally,
state-licensed pharmacies and federal facilities that compound drugs under section
503A of the FD&C Act may compound drugs using hydroxychloroquine sulfate or
chloroquine phosphate bulk drug substances because they are components of an FDA-
approved drug, provide other requirements in the Act are met.
The FDA issued an emergency use authorization for ventilators, anesthesia gas
machines modified for use as ventilators, and positive pressure breathing devices
modified for use as ventilators (collectively referred to as "ventilators"), ventilator tubing
connectors, and ventilator accessories. Manufacturers and other stakeholders may
submit a request to FDA under the process outlined in the EUA to have their device(s)
added to the EUA. If you have questions, please email CDRH-NonDiagnosticEUA-
[email protected].
Diagnostics update to date: During the COVID-19 pandemic, the FDA has worked with
more than 190 test developers who have said they will be submitting applications to
make tests that detect the virus. To date, 16 emergency use authorizations have been
issued for nation-wide use. Additionally, under our COVID-19 laboratory developed test
policy, the FDA has been notified by more than 100 laboratories. The FDA also added
additional updates to its COVID-19 Diagnostics FAQ.
The FDA, an agency within the U.S. Department of Health and Human Services,
protects the public health by assuring the safety, effectiveness, and security of human
and veterinary drugs, vaccines and other biological products for human use, and
medical devices. The agency also is responsible for the safety and security of our
nation’s food supply, cosmetics, dietary supplements, products that give off electronic
radiation, and for regulating tobacco products.

Q1) Examine and explain the importance of international business during these critical times?
Support your answer with examples
Q2) Suggest some ways to ease international trade procedures in the current scenario?

Answer 1

International business helps organisations in diversification into different geographical regions and mitigate risks related to political and economic issues. It helps expand customer base and revenue base and achieve global brand image and helps in profitability growth. International business is important for trade relation and forex reserves and interconnectivity of goods and services to be interdependent on goods with competitive advantage.

International trade procedures can be relaxed through ordinances passed by WTO and IMF. Moreover enhanced trade can be formed through consortium of nations and plurilateral agreements as well as free trade zones to facilitate cross broder flow of capital and goods and labor.