April 7, 2014
I love the nonsense that companies put in their replies to accusations of willful negligence. Consider this from Wockhardt after a US FDA inspection found piss, mold and samples tested “into compliance” [emphasis mine] at its Chikalthana manufacturing plant in Aurangabad, India.
We are also leveraging technology and deploying enterprise-wide software that will streamline the entire quality and compliance system. This is backed by a comprehensive compliance training program for all personnel responsible for manufacturing and quality control.
Over the last few days, speculation has been rife that Wockhardt will be able to reach a quick resolution with the FDA. Earlier today, Sun Pharma announced that it will be fully acquiring Ranbaxy Labs – two other companies that have come under fire from the FDA for maintaining unsanitary working conditions.
What Wockhardt has rambled on about in its reply should’ve happened before the plant received a license to manufacture drugs (goes to show how terrible India’s regulatory measures are). One of the drugs is a variant of metoprolol, a beta-blocker used to treat some cardiovascular diseases, hypertension and angina pectoris. It finds mention in a WHO factsheet of essential medicines.
In the US alone, 27 million prescriptions for metoprolol are filled yearly according to a US National Library of Medicine assessment. After the FDA find, exports to the US are likely to be stopped from Wockhardt. For India, I couldn’t find the exact amount of consumption, but according to many manufacturers, it’s a ‘high growth trajectory’ drug and its consumption through multiple variants could easily be in the tens of millions.
Of course, Wockhardt is not alone in this – its Waluj plant has also come under scrutiny. Last month, Sun Pharma’s Gujarat plant was barred from exporting to the USA as was, in 2013, Ranbaxy’s Toansa plant. Incidentally, a Bangalore-based facility of Canadian manufacturer Apotex, Inc., has also been banned. This goes to show that, even though the insignificant exports may not hit us financially, our regulations are sparse enough to allow both foreign and domestic players to operate in shoddy conditions and release their products into the domestic market.
That three companies manufacturing such an important drug were awarded a license to manufacture without what appears to be a lack of even customary inspections is startling, especially with the contrast painted by Wockhardt’s swanky Mumbai corporate office and the conditions in its manufacturing units strewn around suburban and rural India. A Reuters report mentions that,
There are just 1,500 drug inspectors responsible for more than 10,000 factories in India, where one in every 22 locally made samples was of sub-standard quality according to a study carried out two years ago.
Here’s FDA’s letter to Wockhardt CEO Habil Khorakiwala from November 2013 warning about the Chikalthana plant’s working conditions, and another letter about the Waluj plant’s from July 2013.