While some commentators in India tend to blame foreign multinationals for producing lower-quality goods for Indian consumption, even when this claim turns out to be true, the real fault lies with Indian authorities. With a patchwork quilt composed of a central regulator and an array of state government regulators, many of which are woefully understaffed, it's a miracle that this system finds any product quality lapses at all. In such an environment, it's hard to see how Prime Minister Narendra Modi's grand "Make in India" initiative to turn the country into a global manufacturing powerhouse can possibly come to fruition. India is not yet a major exporter of manufactured food products, but it does export its generic pharmaceutical products to over 200 countries. Could a Maggi-style disaster be awaiting the Indian drug industry?
If you believe the results of a 2014 academic study by a team of researchers from the University of Maryland, the University of Ottawa, and the American Enterprise Institute, a conservative Washington, D.C., think tank, the answer could well be yes. The researchers tested samples of antibiotic and tuberculosis drugs labeled "made in India" and sold in India, Africa, and other non-African middle-income countries. They found that 10.9 percent of the products were of poor quality — that is, they either contained none or less than the required dosage of active pharmaceutical ingredients. Of this 10.9 percent, 7 percent contained less than the required dosage of active ingredients, while 3.9 percent were duds without any of the necessary active ingredients. Drugs without or with less than the required pharmaceutical ingredients will be ineffective, and therefore potentially harmful since they won't treat the condition they're meant to address.
What's more, poor-quality drugs were more likely to show up in Africa than in India or other middle-income markets. While some of this difference could be due to counterfeit drugs and poor storage conditions, the authors of the study claim that a more plausible explanation is that Indian companies are directing lower-quality drugs to the African market. Roger Bate, one of the researchers on the drug study, believes that Indian drugmakers or their distributors are deliberately doing this since regulation in African markets is even looser and laxer than it is in India. For those who claim that Western multinationals are producing lower-quality products for India, the shoe might be on the other foot. Meanwhile, U.S. regulators are poised to keep Indian drugmakers on a tight leash. In May 2013, Ranbaxy Laboratories Ltd., a major Indian drug company,pleaded guilty to seven felony charges and paid a $500 million fine for fabricating data, committing fraud, and selling adulterated drugs in the U.S. market. Regulation may be at the heart of the issue. India's national drugs regulator, the Central Drugs Standard Control Organization, has a staff of a little more than 300 employees, or about 2 percent the size of the U.S. Food and Drug Administration (FDA). What's more, it only has authority over newer drugs; pharmaceuticals that have been on the market for over four years are under the regulatory jurisdiction of state-level regulators, who are understaffed and, in some cases, corrupt.
Low-cost Indian generics also continue to draw the ire of advanced economies like Canada, whose socialized medical system is trying to cut costs by importing cheaper drugs from India. Currently, some 5 percent of generic prescriptions in Canada are filled by drugs made in India. Meanwhile, in the United States, a whopping 40 percent of over-the-counter and generic drugs consumed are made by India's pharmaceutical companies."
V.H.POTTY
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