Indian pharmaceutical industry received yet another blow to its
reputation from the US FDA when it charged Wockhardt Ltd of
manipulating data related to production trials of drugs at its two
Indian factories, which had earlier been banned from shipping medicines
to the US. The Wockhardt factories located at Waluj and Chikalthana in
Maharashtra had to halt exports to the US sometime ago. The US FDA in a
letter to the company stated that the lack of reliability and accuracy
of data generated by Wockhardt’s laboratory is a serious cGMP deficiency
that raises concerns about the integrity of all data generated by the
company.
Data integrity issues at drug manufacturing plants attract severe penal action from the US FDA and other international regulatory agencies. The US regulator further said that the company had not only violated standards of manufacturing practices but also misguided the regulator. These are serious charges on a company like Wockhardt which earns a substantial part of its revenue from exports to various developed markets and the US is perhaps the most important destination among them.
Data integrity issues at drug manufacturing plants attract severe penal action from the US FDA and other international regulatory agencies. The US regulator further said that the company had not only violated standards of manufacturing practices but also misguided the regulator. These are serious charges on a company like Wockhardt which earns a substantial part of its revenue from exports to various developed markets and the US is perhaps the most important destination among them.
No comments:
Post a Comment