New Delhi: The United States Food and Drug Administration (USFDA) has issued a warning to top Indian drugmaker Torrent Pharmaceuticals for selling ‘bacteria-contaminated drugs’ in the American market.
The US drug regulator has accused Torrent Pharma of manufacturing nasal solutions, oral solutions and rectal suppositories through a contaminated water system.
In the letter published on its website Tuesday, the USFDA said the water system of company’s plant based in Levittown, Pennsylvania tested positive for ‘Burkholderia cepacia’ — a group of bacteria which is often resistant to common antibiotics and generally a cause of respiratory illness. The bacteria were discovered in the samples of water used to rinse manufacturing equipment at the plant.
This is USFDA’s 23rd warning letter to an Indian drugmaker in the last eleven months, and third for the Gujarat-based Torrent Pharma. Previously, the company received warnings in July and October this year for its manufacturing facilities in Dahej and Indrad.
ThePrint reached Torrent Pharma over email for a comment but there was no response until the time of publishing this report.
What the letter says
In the latest letter dated 28 October, the USFDA told Torrent Pharma, “An investigation identified your water system as the source of the contamination. Subsequent sampling of your water system revealed an adverse pattern of B. cepacia contamination in your pretreatment and downstream distribution system.”
It further noted that the company “produced drug products such as rectal suppositories and oral solutions with this inadequate water system. Until recently, you also produced nasal solutions with this system”.
The regulator added that water from the system was used in the manufacture of “numerous batches of distributed drug products”.
“Pharmaceutical water must be suitable for its intended use and routinely tested to ensure ongoing conformance with appropriate microbiological attributes. Systems that produce water for manufacturing and cleaning are critical determinants of the quality and safety of your drug products,” it added.
Why are warning letters crucial?
The USFDA warning letters are critical for drugmakers that export medicines to the US as failure to correct the listed violations lead to a complete import ban, causing a drastic fall in revenues.
Moreover, the reputation of the company is dented as a seller, in the US and even globally.
According to the Ministry of Health and Family Welfare data, India supplies 40 per cent of generic medicines demand in the US and about 25 per cent of all medicines in the UK.
USFDA warnings to Torrent Pharma
The USFDA had blasted Torrent Pharma just last month for allegedly disregarding standard drug manufacturing protocols and consciously releasing substandard medicines in the market.
In its strongly-worded letter, the regulator had accused the company of “repeating the failures and lacking control over the manufacture of drugs” at its Indrad-based facility in Gujarat.
Earlier in July, the drug regulator had classified Torrent Pharma’s Dahej facility as Official Action Initiated (OAI). Under this classification, the FDA doesn’t grant new approvals to the company for selling the products from the particular site until its reservations are addressed.