Dinesh Thakur, the whistleblower in the case against Ranbaxy Laboratories, which recently halted production at its API facility, spoke of the difficulties he experienced whilst blowing the whistle on a company that now appears to have multiple problems to deal with.
“Patients today do not have the information to make an educated choice. In many cases, generic prescriptions do not list the manufacturer or the source country,” Thakur said. “Even in cases where this information is available, the choice is between two manufacturers located overseas; not really a choice at all. This is a problem that affects our safety and security as a nation.”
Amir Attaran from the World Bank also explained the basic infrastructure of India’s regulatory body CDSCO (Central Drugs Standards Control Organization), noting that there are no regular training programs for updating the knowledge and skills of regulatory officials. He also noted the inadequate infrastructure at Indian ports monitoring the flow of pharmaceuticals.
A Cleveland Clinic cardiologist who requested to remain anonymous told in-Pharmatechnologist.com that he’s telling his patients not to take drugs manufactured in India.
Similarly, Dr. Preston Mason of the cardiology division of Brigham & Women’s Hospital in Boston explained a study that he conducted with his own funding. He said that of a sample of dozens of Lipitor generics from more than 30 manufacturers, when compared with their branded counterparts, proved to be consistently substandard.
“The generic Lipitor samples from overseas had elevated and alarming levels of impurities. Such impurities were not observed in actual Lipitor produced by Pfizer or only at trace levels,” Mason said.
However, Mason noted that he did not see impurities in generics produced by Mylan or Watson (now known as Actavis).
“The source of such an impurity in generic Lipitor was attributed to improper manufacturing,” Mason said.
One particular synthesis seems to be the step the manufacturers are missing, Mason told us. Mason’s finding were reviewed and invited for presentation at the National Lipid Association meeting in 2013.
Another major concern for all of the panellists seemed to be the supply chain, which was mentioned by nearly all participants.