Wockhardt in muddy waters

Active Pharmaceutical Ingredient sites under UK regulator's scanner, too

Drug maker Wockhardt’s Active Pharmaceutical Ingre-dient or active substance manufacturing sites are also under review of the UK drug regulator, as part of the latter’s risk-based surveillance programme. This is apart from its three facilities – in Waluj, Chikalthana (both in Aurangabad, Maharashtra) and Kadaiya (in Daman & Diu) – which are already under the scanner.

“The Wockhardt active substance manufacturing sites remain under review as part of the programme of risk-based surveillance,” a spokesperson of the Medicines and Healthcare Products Regulatory Agency (MHRA), the UK drug regulator, told Business Standard.

According to MHRA, the company has six dosage form (facility that produces the finished medicine) and two active substance (main medicinal ingredient) manufacturing sites registered on UK product licences, which are operated by Wockhardt in India. In addition, Wockhardt also operates manufacturing and importation sites in Ireland and the UK which are registered to supply the UK market.

On Tuesday, Wockhardt informed the Indian bourses that MHRA had withdrawn the Good Manufacturing Practice (GMP) certification for its manufacturing facility at Kadaiya, where the company manufactures tablets for European markets. While withdrawing the previously issued GMP certificate to the company’s manufacturing facility at Kadaiya, MHRA has decided to issue a restricted GMP certificate. Under the restricted GMP, products can be manufactured at a plant to avoid shortage of medically essential products.

Earlier this month, the company received similar enforcement on its Chikalthana-based unit, while its Waluj formulation facility was barred by both the US and UK regulators earlier this year from supplying medicines to these markets.

With reference to Wockhardt’s Kadaiya site, MHRA clarified that currently there is “no evidence of a safety risk, and patients should continue to take their medicines as prescribed.” However, it said the Agency was working with the European Union and international regulatory partners to assess the impact of the inspection findings.

“We are currently assessing the implication that our inspection findings have on the quality and supply of medicines supplied to patients in the UK and Europe. People should continue to take their medicines as prescribed as our inspection findings have not identified a safety risk to patients,” the MHRA spokesperson said. The regulator inspected Wockhardt’s manufacturing site at Kadaiya in September. “During the inspection, a number of issues were identified that breach good manufacturing practice regulations and we have written to Wockhardt to inform them that we are planning to issue a statement of non-compliance against this site,” the regulator said.

After crashing almost five per cent on Tuesday following the announcement of enforcement at the Kadaiya unit, shares of the company recouped on Wednesday to close at Rs 466.60, up 1.8 per cent from their previous close.