Last week 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.
India’s largest pharmaceutical company, Ranbaxy Laboratories Ltd faced probably much more serious charges from the US FDA in the past and had to pay huge penalties to settle the problems. In May this year, the US Department of Justice imposed fines totaling 500 million dollars as criminal and civil fines on the company. Ranbaxy USA Inc, a subsidiary of Ranbaxy Labs, pleaded guilty to charges relating to the manufacture and distribution of adulterated drugs made at its two facilities Paonta Sahib and Dewas in India. In last September, Bangalore based Strides Arcolab came under the US FDA scanner following detection of violations at its injectable facility of its subsidiary, Agila Specialities. And in last week, Jubilant Life Sciences received a warning letter from the US FDA for violation of manufacturing norms at one of its plants located in Washington state. Repeated detection of unacceptable practices at the manufacturing sites of Indian pharmaceutical exporters and subsequent actions by the US FDA are seriously affecting India's image as a reliable supplier of generic drugs to the world. Indian pharma companies regularly export generic drugs to Europe, Africa and south east Asian countries but there has been no such serious complaints or action against the companies by those countries. The repeating actions by the US regulator is despite India having over 160 US FDA approved drug manufacturing facilities in different parts of the country. What does this mean? One has to conclude that Indian pharma exporters do not take enough care to maintain good manufacturing practices once the US FDA approves their facilities initially. Is it that subsequent inspections are not being carried out by the US FDA officials at the approved sites. It is high time the government of India obtained some honest explanations from the Indian exporters on this matter and took appropriate action.