Questions have been raised about how Australia ensures the quality of its imported medicines is up to standard after a major pharmaceutical company was warned over lapses in contamination control and manufacturing practices.
The US Food and Drug Administration (FDA) has written a letter to multinational company Sun Pharmaceuticals accusing it of "significant" manufacturing violations at its plant in Halol, India.
The FDA inspected the facility in April and May last year and uncovered several violations that could have affected the strength, quality or purity of the company's medicines.
The violations included operator errors, water leaks in a cleanroom and inappropriate equipment that in one instance left "blackish fine metallic particles" in a vial.
The letter also mentions complaints received as early as January 2020 about stains, specks and spots found in tablets.
The relevance for Australian consumers is that Sun Pharmaceuticals' local subsidiary, Sun Pharma, has several hundred medications registered with our regulator, the Therapeutic Goods Administration (TGA). Many of these are generic medicines.
Generic drugs can be made by any approved manufacturer after the brand-name drug loses its patent protection. They are generally cheaper than the brand-name version.
While the FDA letter specifically names two injectable drugs which Sun Pharma does not have on the Australian market, other medications are referred to but not named due to commercial in confidence.
Sun Pharma has been contacted for comment, as has the TGA, which says that commercial in confidence provisions prevent them from naming which, if any, Sun Pharma medications registered in Australia are made at the Indian facility.
The US FDA introduced an alert on imports from the company's Halol firm on December 7. However, the regulator will continue to allow 14 products into the US, subject to certain conditions.
While Sun Pharmaceuticals has not specified which products are exempt, the FDA website lists 14 that "may be released" because of supply concerns.
These include medicines used to treat cancer, Parkinson's disease, heart failure, seizure disorders and migraines.
The President of the Pharmaceutical Society of Australia, Fei Sim, says Sun Pharmaceuticals plays a major role in the global supply chain.
"We know that accessibility of medicine is quite important to try and avoid a sudden medicine shortage," Dr Sim says.
Australia is no stranger to supply shortages. Close to 400 products are on the TGA's list of medicine shortages, including 46 considered critical. More than 80 other products are on the verge of being added to the list.
Among the current shortages is a list of antibiotics, including one of the most commonly used penicillin-based drugs amoxicillin.
The shortfall has been blamed on manufacturing issues and an "unexpected increase in demand".
Two products identified in FDA letter
Dr Sim says the FDA's warning letter to Sun Pharmaceuticals didn't detail the severity or implications of the company's manufacturing violations.
But considering the FDA has given Sun Pharmaceuticals time to address its concerns, Dr Sim believes there's no immediate cause for alarm.
Only two Sun Pharma products are identified in the US FDA's letter: medroxyprogesterone acetate and testosterone cypionate.
Inspectors flagged other medicines of concern but the names have been kept confidential.
Medroxyprogesterone acetate, commonly known as Depo Provera, is a hormone injection used for contraception, while testosterone cypionate is an injection used to treat low testosterone levels.
The TGA has assured the ABC that neither Sun Pharma product is available in Australia, but the regulator has not mentioned the status of the confidential medicines of concern.
The TGA is contacting all companies using the Halol site for products supplied to Australia and says if any risks are identified, an inspection of the manufacturing site will be undertaken.
Dr Sim is confident the TGA will be working closely with the US FDA to ensure medicines coming into Australia are safe and effective.
Supply issues complicate matters
The issue has raised broader questions about how regulators weigh up quality concerns with ongoing supply issues.
Dr Sim says while the integrity and safety of medicines should never be compromised, shortages of potentially life-saving drugs must be avoided.
"It's also equally important that people who rely on these medicines — to manage their health conditions, to keep them safe and healthy — continue to have access to those medicines."
The dilemma, according to Dr Sim, is weighing up the potential risks of poor manufacturing practice with people being denied important drugs because their supply has been cut off.
"There's a balance here," Dr Sim says.
"Following a risk-based approach is the best way forward."
The letter on December 15 made it clear that the FDA was unhappy with Sun Pharmaceuticals' initial response following last year's inspection.
The regulator has called the company's actions inadequate and accused it of putting patients at risk.
Sun Pharmaceuticals has been ordered to "comprehensively" assess its operations.
For the US import alert to be lifted, Sun Pharma must conduct an independent, retrospective assessment of its cleaning effectiveness and cross-contamination hazards.
The company was given 15 working days to respond to the FDA's letter. At the time of writing, the ABC understands that no response has yet been received.
