The thriving pharmaceutical industry in India is now being closely watched by the world for all the wrong reasons: Lapses in safety measures, fabricated drug test results and the selling of counterfeit medicines has brought pharmaceutical drugs from India under the scanner of the U.S. Food and Drug Administration (FDA). With India being the second largest supplier of over-the-counter and prescription drugs to the U.S, the increased scrutiny signals profound consequences for consumers here.
FDA Commissioner Dr. Margaret Hamburg recently met with generic-drug manufacturers in India to convey her concerns over the safety of Indian medicines. Blaming a “handful” of pharmaceutical firms for the dip in quality, Dr. Hamburg felt it was unfortunate that the other Indian companies, which understood good manufacturing and quality processes, have been overshadowed by these findings. Ranbaxy, one of India’s largest pharmaceutical companies, is a case in point. Last year, the company made history by pleading guilty to felony charges and paying $500 million fine, the largest ever to be imposed on a generic drugs company.
Many fear there is worse to come for defaulting pharmaceutical companies, with the FDA aiming to impose stricter norms and punishments. An Office of Pharmaceutical Quality is in the process of being set up by the FDA to improve the agency’s inspection of brand name, over-the-counter and generic drugs, according to Janet Woodcock, director of the FDA’s Centre for Drug Evaluation and Research. The announcement was made at the Bloomberg Healthcare summit held recently.
Referring to her visit to India in a blog post on the FDA’s official blog, Dr. Hamburg wrote that all pharmaceutical drugs manufacturers must understand that “quality is the basis for the public’s trust and confidence in their products and maintaining high quality standards is part of the cost of doing business.”
The latest blitz of inspections of Indian drug plants by FDA investigators has been funded by the approximate $300 million levied from generic drug manufacturers as annual fees. This follows a 2012 law that makes it imperative to increase scrutiny of manufacturing plants outside the United States. The 160 inspections in India, which were conducted in 2013, have brought under the scanner thrice as many pharmaceutical drug companies as in 2009. This has opened the floodgates on new penalties, more than half of which were warning letters issued to drug manufacturers by the agency last year.
The scrutiny, however, has not been received well in India, which supplies pharmaceutical drugs to over 200 countries around the world. Many of the Indian officials and executives who met with Dr. Hamburg felt that the U.S. FDA was safeguarding a domestic industry from cheaper imports. There is a very sinister perception of these inspections, said Keshav Desiraju, India’s health secretary until this week in an interview. The Indian pharmaceutical industry is among the nation’s premiere economic drivers, generating billions of dollars in revenue every year.
The increased FDA scrutiny is already costing the industry, which has flourished under the lack of an exacting quality control mechanism. While there definitely are world-class factories in India that are practically indistinguishable from those in the West, there are some that function despite serious lapses in quality control. A 2002 estimation by the World Health Organization states that one in five pharmaceutical drugs manufactured in India are counterfeit.
Also, a 2010 survey, conducted by International Policy Network, a non-governmental organization working along with Liberty Institute, Delhi revealed some startling realities in the Indian pharmaceutical market. The survey, which was supported by Legatum Institute, sampled drugs from New Delhi and Chennai and found that 12 percent of them were spurious. Instances of medicines being adulterated with chalk and talcum powder, mixed with pain killers; of antibiotics revealing no active ingredient whatsoever when tested; and of deaths being caused by fake medicines abound in India. In fact Ranbaxy, whose drugs manufactured in India are totally banned in the United States, still continues to populate the Indian market.
Investigations of the deaths are continuing, but convictions of drug counterfeiters in India are extremely rare. The Drug Controller General of India (DCGI), the top regulator of drugs in India, is vastly understaffed when compared to the U.S. FDA. In an interview to Business Standard, Drug Controller General G.N. Singh opined that the Indian pharmaceutical industry may collapse if the stringent norms followed in places like the United States are applied to it. The Indian market, he felt, was in all probability unready to follow global standards.
Representatives of the industry like the Indian Pharmaceutical Alliance (IPA) have however reacted defensively to India being brought under the scanner by the FDA. Satish Reddy, President, IPA has said that Indian drug companies were better than the image being created by the FDA. Though he agrees that quality control measures must be implemented rigorously, he felt that the idea that the Indian pharmaceutical industry was dominated by spurious drugs wasn’t justified.
By Aruna Iyer