A lot of energy and effort is going into ensuring the supply chain of drugs from China. The FDA has a proposal to begin stationing inspectors in China as soon as next year.
But I’ve been noticing a growing trend of problems with the Indian pharmaceutical industry. A huge proportion of the world’s active pharmaceutical ingredients (API) come from India. Over the years, Indian firms haven’t been content merely to provide API, they are now manufacturing finished products.
The growing number of Indian firms comes with a dark side. These Indian firms seem to have a culture of compliance problems, fraud and endangering patient’s lives. It’s become so problematic that the Indian Pharmaceutical Association uses the motto “A crusade for professionalism.” In India, there have been ethical problems with many different companies, but now the flagship of the Indian pharmaceutical industry – Ranbaxy – has stumbled…badly.
Ranbaxy is one of the major powerhouses in the manufacture of generic drugs for the U.S. market. Ranbaxy has global sales of over $1.4 billion dollars and was the 19th largest manufacturer (by prescriptions) according to IMS Health in 2007. Yet, according to papers filed by the U.S. Government, Ranbaxy has committed a “pattern of systemic fraudulent conduct.” The Government asserts that the generic drugs manufactured by Ranbaxy were not identical to the original branded products because they were either too weak, too strong or lacking the required stability to considered identical to the original branded product. I’ve been saying it for a long time and Ranbaxy just proved it – generic drugs are not identical to the original products (contrary to rhetoric of the Generic Pharmaceutical Association). Generics are usually “close enough” or “similar enough” to the originals, but in the case of Ranbaxy, they weren’t. It is unclear exactly how many patients were possibly harmed or even killed through exposure to Ranbaxy products.
The problems are not limited to India alone. A number of companies operating in the U.S., but founded by individuals from India have been plagued by these same problems. These companies include Scientific Laboratories (see Another Contract Firm Impodes) and the infamous case of Able Laboratories.
It would be unfair (and irresponsible) of me to say that all problems in the industry are from firms with Indian origin, or that all Indian firms are committing criminal acts. However, even a casual observer of the pharmaceutical industry couldn’t help but notice this trend. As quickly as the FDA has moved to crack down on problems in China, they should be moving even faster in India – the lives of millions of people depend on it.
Source: DNA
