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USFDA inspections taking longer time than usual due to COVID-19 safety protocols

Sun Pharma, Auro Life, Lupin in the queue. Though generally, most inspections are done in a fortnight, now it’s taking almost a month. USFDA is taking precautions to ensure the safety of the investigators and the employees of the facility who assist its staff, say sources.

October 12, 2020 / 04:21 PM IST

US drug regulator, Food and Drugs Administration (USFDA), took almost a month to complete the inspection of the facility of Sun Pharma's New Jersey subsidiary Ohm Laboratories early this year. The Ohm Laboratories plant makes prescription and OTC drugs in solid dosage forms.

The USFDA also took almost a month to complete an inspection of oral solid manufacturing facility at Dayton, New Jersey of AuroLife, a wholly owned subsidiary of Aurobindo Pharma.

Both inspections were conducted during January - February this year.The inspection of Lupin’s Somerset facility in New Jersey, which began on September 17, is still under way.

Lupin's Somerset plant is classified as Official Action Indicated (OAI), which means new approvals from the facility will be put on hold, until the company resolves the regulatory concerns raised by USFDA. The inspection is crucial for Lupin.

COVID-19 Vaccine

Frequently Asked Questions

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How does a vaccine work?

A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

How many types of vaccines are there?

There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

What does it take to develop a vaccine of this kind?

Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

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Slow pace of inspections

Analysts tracking USFDA inspections say that while there isn’t any time-limit for the duration of an inspection, most inspections are completed in a fortnight. The USFDA, generally, takes little more time while evaluating large facilities that produce complex drugs or having compliance issues.

“The USFDA inspections may possibly get stretched because the agency is taking precautions to ensure the safety of the investigators and the employees of the facility who assist the USFDA staff," said a quality compliance executive of a company, who didn’t want to be named.

The USFDA has temporarily paused all inspections, both domestic and foreign, in March, following the outbreak of COVID-19. The New Jersey region -- the hub of pharmaceutical manufacturing activity in the US -- was one of the worst-hit states due to COVID-19. After a hiatus of four months, the agency resumed onsite inspections of US-based sites on July 20.

The USFDA will only prioritise mission critical inspections of plants manufacturing products that have a breakthrough therapy designation or regenerative medicine advanced therapy (RMAT) designation, or is used to diagnose, treat or prevent a serious disease without an appropriate therapeutic alternative.

The agency said that for the foreseeable future, there may not be any surprise inspections, as all prioritised domestic inspections will be pre-announced to FDA-regulated businesses.

The USFDA has also developed a rating system called the COVID-19 Advisory Rating system that uses real-time data on the number of COVID-19 cases in a local area to assist its staff and inspectors in determining when and where it is the safest to conduct prioritised domestic inspections.

Non-US facilities

For facilities outside the US, USFDA is conducting physical examinations of products arriving at US borders or product sampling and testing before being released into the market, reviewing the compliance histories of facilities, using information shared by trusted foreign regulatory partners through mutual recognition and confidentiality agreements, and requesting records directly from facilities in advance about certain drug inspections.

If a product appears to have not met the standards for safety, effectiveness, or quality based, the USFDA will refuse admission of the product into the US.

Viswanath Pilla
Viswanath Pilla is a business journalist with 14 years of reporting experience. Based in Mumbai, Pilla covers pharma, healthcare and infrastructure sectors for Moneycontrol.
first published: Oct 12, 2020 04:21 pm