Regulatory inadequacies are holding back India’s drugs industry, argues DG Shah of the Indian Pharmaceutical Alliance
In May, Ranbaxy, an Indian pharmaceutical company that is part of the Daiichi Sankyo Group, was fined US$500 million by the United States Food and Drug Administration (FDA) for offences relating to the manufacture and distribution of adulterated drugs that were made in India.
India has the largest number of FDA-approved plants outside the US, and there are fears that the penalty has damaged the image of the country’s pharmaceutical industry. It has also focused attention on the shortcomings of India’s regulatory infrastructure for the sector.
The FDA has zero tolerance for manufacturing deficiencies. Statistics on import alerts, which are issued by the FDA when a product is deemed to present a safety risk, show that complying with the regulator’s exacting standards is a challenge for every company, whether Indian or American, generic or innovator. Indeed, 63 import alerts are currently in force for Canadian products, 42 for UK products, 40 for Japanese products, 35 for German products and 47 for Indian products.
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DG Shah is the secretary general of the Indian Pharmaceutical Alliance, which comprises 19 leading research-based Indian pharmaceutical companies.
