Companies are based in Himachal Pradesh, Hyderabad.
By Deepak Chitnis
WASHINGTON, DC: The US Food and Drug Administration (FDA) has slapped two Indian companies with warning letters, ordering them to cease and desist the manufacturing of certain ingredients used in pharmaceutical products.
Sentiss Pharma (formerly known as Promed Exports) and Posh Chemicals, based in Himachal Pradesh and Hyderabad, respectively, were notified by the FDA earlier this week that their facilities had raised concerns over their lack of a monitoring program to track and ensure the quality of what the factory manufactures.
“The environmental monitoring program is not adequate to ensure the environment is suitable for aseptic processing of sterile products,” said the warning letter.
The letter sent to Sentiss was also in regards to a failed investigation by the company to explain the fault behind a bad batch of pills that were produced there some months ago. The FDA had ordered a thorough investigation but one was never conducted.
These two are just the latest in a long line of warning letters sent from the FDA to various Indian drug manufacturers over the past three months, as part of an effort to crack down on sale of foreign-produced supplements in the US, particularly dietary and nutritional ones. This past year, letters to foreign manufacturers spiked 10%, with 62 countries getting 46 warning letters and 813 inspections being carried out.
In the last few weeks even a website that sells “beedis” was issued a warning by the FDA. German company Wockhardt has come under scrutiny from the FDA recently for allegedly falsifying some of the data from a facility they have in India. The warnings are bound to have an impact on the Indian economy, since the country makes up about 10% of the pharmaceutical imports in the US.
A copy of the letter sent to Posh Chemicals can be found on the FDA website.
To contact the author, email to deepakchitnis@americanbazaaronline.com