Market Place
Last week, 162,000 cartons of different products manufactured by Indian generic major, Wockhardt were recalled from the U.S. market, due to inadequate investigation of customer complaints. This Wockhardt recall, the fifth since March, is an outcome of data falsification observed at two Wockhardt facilities in India in 2013.
At PharmaCompass, we compiled a sequence of events which have occurred over the last two years and concluded that these recalls are positive signs. Wockhardt may well be on its way to turnaround their compliance challenges.
Wockhardt’s Catastrophic Inspections
Over the last two years Wockhardt has generated an enormous amount of negative press. Three facilities in India (Waluj, Chikalthana and Daman) along with their U.S. based Morton Grove Pharmaceuticals facility, ran into problems with international regulators.
Troubles started in March 2013 when U.S FDA regulators visited Waluj to find employees “repeatedly delayed, denied, limited an inspection or refused to permit the FDA inspection”. Among the problems observed, the FDA investigators found unofficial batch records for approximately 75 batches of injectable finished drug products torn in half in a waste area.
FDA banned imports from the Waluj facility in May 2013 and by July, were back inspecting the Waluj and Chikalthana facilities jointly along with the British drug regulator, Medicines and Healthcare Products Regulatory Agency (MHRA).
The inspection outcome was a catastrophe.
The horrific aftermath
The Chikalthana unit had its quality certification withdrawn by the MHRA, products were recalled in the U.K. and the unit was placed on the U.S. FDA import alert list.
Both facilities, Waluj and Chikalthana received U.S. FDA warning letters and during the same period, the facility in Daman, inspected by the MHRA was found to be non-compliant as well.
In the United States, Morton Grove Pharmaceuticals, which is responsible for 50% of Wockhardt’s U.S. sales had FDA inspectors observe the same questionable drug-testing procedures that led the agency to ban two of Wockhardt's Indian plants.
Outcome of re-inspections at Waluj & Chikalthana
Earlier this year, the FDA inspectors were back at the Waluj facility which has one oral solid dose and two injectable units. The inspectors did observe problems however Wockhardt’s management stated that there were no observations on data integrity.
While the
Waluj facility did not receive a clear green light, the inspection observations indicated
significantly better practices than 2013.
The Chikalthana facility was re-inspected by the MHRA in September 2014 and the certificate of compliance was reinstated although it is still limited to “medicinal products critical to public health”. The management demonstrated its intent to get compliance back on track by committing to cease supplies of all active pharmaceutical
ingredients from this facility to Europe.
The FDA visited the Chikalthana facility in March 2015 and “did not find issues”. However, Wockhardt once again seems to want to wipe the slate clean in order to re-start their U.S. business.
Product Recalls – Wiping the slate clean
As the FDA investigators identified the need
for more extensive investigation of past market complaints, Wockhardt issued a 22 page product recall for the batches remaining
on the market. The magnitude of the product recall gives a sense of the amount
of supplies provided by the Wockhardt plants into the U.S. market.
The subsequent four recalls announced, through
the U.S. FDA website on May 13, June 3, June 24 and recently on July 15, cover the same products recalled previously.
Interestingly most products being recalled are scheduled to expire in the coming few months and would have been destroyed regardless!
A slow and steady re-start
At the same time, the facility in Daman had its compliance status restored in March 2015, by the MHRA, while the Morton Grove facility’s response to the FDA was found to be satisfactory.
Wockhardt’s efforts to win the trust of regulators seems to be working. Wockhardt received approval for a generic Oxycodone liquid produced at Morton Grove in June this year.
They also claim to have been regularly filing new products applications in the US and still have 69 ANDAs pending before the FDA, 14 of which were filed last year.
Our View
India’s reputation as a manufacturer of high quality generics has been severely tarnished with all the companies that have run into compliance problems over the past few years.
While there is still a long way to go, efforts by Wockhardt to win back the trust of regulators, by prioritizing compliance over profits, is something which certainly needs to be acknowledged.
After all, as Sun Pharma is learning from their Ranbaxy acquisition, successfully turning around compliance problems is a lot easier said than done!
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