FDA Making Life Difficult For Indian Pharma Companies
July 7th, 2024 // 1:52 pm @ jmpickett
Some industry experts believe the US regulatory system is using the FDA inspection process to combat Indian pharmaceutical competition in the US. Eight Indian pharmaceutical companies have recently received 483s for cGMP violations since the start of 2024.
All eight of the Indian companies sell their drugs in the United States. The eight companies from India that have been hit with 483s are Cipla Limited, Torrent Pharmaceuticals, Laurus Synthesis Ltd, Jubilant Generics, and Alkem Laboratories Limited. The other companies that have received 483s this year are from Japan, China, and Iceland. In 2023, FDA served 483s to 20 different Indian pharma firms. These companies are among the biggest manufacturers of pharmaceuticals in India.
Big Pharma is highly influential in all US administrations, which is the reason that pharmaceutical prices are much higher in America than in the US.
The FDA 483 often encourages pharmaceutical companies to improve their cGMP standards in their manufacturing facilities. In a situation where the purpose isn’t to squelch competition, FDA’s efforts benefits markets and consumers in India by encouraging higher quality pharmaceuticals.
Recent data shows that Indian drug exports in the NUS increased to $7.8 billion in the first quarter of 2024, which was a billion more from a year earlier. The total drug exports from India rose by 9% to $25 billion from $22 billion from 2023 to 2024. The US is involved in about 30% of India’s drugs exports.
In the last few years, drugs made in India have become more popular in the US because they are of good quality and more affordable. Drugs made in India are cheaper than ones produced in the US because of lower labor and manufacturing costs. Usually, quality isn’t affected.
Many pharma companies in India run manufacturing plants approved by FDA to ensure their products adhere to American standards. This allows India to offer high quality generic drugs that are a good alternative to expensive name brand drugs. Insiders in the drug business say that healthcare costs are high and getting higher in the US, so demand for affordable products from India is rising quickly.
Pharma insiders on both sides of the Atlantic believe that FDA is putting pressure on Indian drug manufacturers by conducting more rigorous inspections and handing out more 483s. In Cipla’s case, the drug company in India was given its latest 483 last month for issues at its plant in Verna, Goa. The site had test methods that were not correctly verified, and there also were deficiencies in disinfecting and cleaning where drugs are produced.
The Torrent Pharmaceuticals drug plant in Indrad, Gujarat was given a 483 on June 12, 2024. The FDA auditor said there were not any testing programs made to assess drug product stability. The FDA also said that the company kept its manufacturing and releasing drug tablet batches into the American market with an analytical testing technique that was not clearly understood and may have given unreliable test results. The agency also said the plant’s utensils and equipment were not correctly cleaned and maintained at the right intervals.
The recent FDA inspections of these plants in India shows that FDA may be trying harder to reduce competition with Indian drug manufacturers.
