Wockhardt, a leading Indian pharmaceutical company, has decided to recall 12 to 15 of its products from the US market on grounds of quality. These products are manufactured at the company's factories at Waluj and Chikalthana in Maharashtra. No brand names or their therapeutic groups of the products were disclosed by the company.
Habil Khorakiwala, chairman, Wockhardt said, "Withdrawal of the products is a proactive action taken by the company to allay the concerns of the global regulators which according to them should go away in a timely manner. This he said would help the company to get back to normalcy much faster.
This is in line with keeping up with the commitment towards quality and compliance based on the global regulatory concerns on how to deal with products which are already in the market.
Wockhardt Ltd has also informed BSE that during the last US FDA cGMP inspection of the facilities at L1- Chikalthana and Waluj in Aurangabad, Maharashtra, some observations were reported pertaining to batches of some products manufactured prior to the US FDA import alerts. Whereas the company continues to supply some of the products in the US market manufactured in the same facilities, several batches of other products, manufactured prior to the import alerts may still be in the US market.
As a measure of preparedness and as an abundant precaution, the Company has now decided to recall, as a part of remedial measure all the remaining batches in the US market that were manufactured prior to the US FDA import alerts even though there is no evidence of risk to patient safety from the products currently available in the US market. Additionally, the UK MHRA has restored the EU GMP certification of the company's potent product facility at Kadaiya, Daman.
Shares in Wockhardt fell as much as 5.3 per cent before recovering a little after the drug maker said the US FDA had raised fresh concerns about its Waluj plant over quality issues.
The FDA concerns were raised after a week-long inspection of Wockhardt's Waluj manufacturing plant in central India. Waluj is one of seven plants in India owned by Wockhardt, which also has production facilities in the United States, Britain and Ireland. Like other Indian generic drug makers, the United States is the largest market for Wockhardt.
"Withdrawal of products have been taken with a global approach towards quality and not a plant specific approach," Dr Khorakiwala concluded.
Wockhardt has put in place a new leadership team to supervise its quality operations, informed Dr Khorakiwala further saying that this was a follow-up of the inspection of Wockhardt’s remedial measures late last year.
He said that the company had created a global quality system with offices in India, the US and UK, besides training quality operations staff whose numbers have been increased and installing IT infrastructure. The company’s Kadaiya plant in Nani Daman continues in full compliance of the UK regulator’s requirements, he said, referring to earlier troubles. Incidentally, the Chikalthana facility, which also faced some rough weather in the UK, has since been cleared.