Jojy Cheriyan MD,MPH.Feb 17,2014

Indian Drug Companies have been under widespread criticism by the U.S. and the WHO (World Health Organization)  for lack of quality and standards. Falsified drug tests and fake medicines from India is the top news in many leading news papers across the world. The New York Times report last week made a scathing attack on the corrupted practices in Indian pharmaceutical industry.

India is the second largest exporter of over-the-counter (OTC) and prescription drugs to the United States, exporting medicines worth $15 billion annually. Pharmaceutical export is an important economic engine of India, and the American scrutiny can cause profound impacts on Indian pharmaceutical production and export.

Since last few years, U.S Food and Drug Administration (FDA) has detected and confirmed falsified drug test results, and many quality lapses at a handful of pharmaceutical firms in India, which also include some leading drug companies like Ranbaxy and Sun Pharma.

The commissioner of U.S FDA, Dr.Margaret Hamburg has been sent to India by the Federal government to warn the companies with final words. She reached India last week to express her growing concerns and enforce more inspections on Indian drug plants.

Ranbaxy , one of India's largest drug manufacturers, was penalized with $500 million last year, charged with felony for fake medicines sold to American consumers. Ranbaxy immediately paid the penalty pleading guilty, to prevent further losses to its production. But U.S refused to buy anymore products from the drug plants of Ranbaxy that violated the standards. This is the largest penalty ever paid by a generic drug company. Several other small companies were also penalized by the FDA, and some of their products were withdrawn from the US markets.

According to Drug Controller General of India  Mr. G.N Singh, “If I have to follow U.S. standards in inspecting facilities supplying to the Indian market, we will have to shut almost all of those.”

 Please click this link to read his interview--

Many Indian medicines proved to be fake by  American inspectors are still being sold in India. In a recent incidence, counterfeit medicines at a pediatric hospital in Kashmir killed 3800 infants, since 2008. Another widely used antibiotic which contained no active ingredient was tested in government lab, but the test was kept secret for over a year until some pregnant women got killed.  

Repeated warnings by U.S inspectors were neglected by the Indian authorities. If  America decides to stop import from Indian Pharmaceutical companies it will be a disaster for Indian economy. 40% of generic supplies in the U.S are from India when other Asian drug companies are competing to improve their exports to the U.S.