No Remedy

India lacks an effective drug recall system

01 June 2016
There have been very few recalls of domestic drugs in India, particularly when compared to the number of recalls of Indian drugs in Western markets.
danish siddiqui / reuters
There have been very few recalls of domestic drugs in India, particularly when compared to the number of recalls of Indian drugs in Western markets.
danish siddiqui / reuters

Last May, the Indian pharmaceutical firm Cipla recalled about 140,000 vials of levalbuterol solution, used to relieve shortness of breath and coughing, from the US market. In mid July, also in the United States, another major Indian drug firm, Wockhardt, recalled over 162,000 cartons of various drugs used in the treatment of hypertension and ulcers. In September, the Canadian company Apotex recalled almost 118,000 bottles of cevimeline hydrochloride pills—used to treat dry mouth, especially in patients with an autoimmune disorder called Sjögren’s syndrome—manufactured by its Indian subsidiary. This, again, was in the United States. So, too, was a recall initiated this February by Sandoz, the generic-drugs division of the pharmaceutical giant Novartis, of 270,000 bottles of a hypertension drug manufactured for it by a firm in Hyderabad.

This is only a recent sampling, from just one country, of instances that form an unsettling pattern. For several years now, drugs of Indian manufacture have come under sharp scrutiny from regulators, particularly in the West, for failing to meet established standards. In 2015, the US Food and Drug Administration blacklisted the manufacturing sites of six Indian drug makers, and issued letters of warning to at least 15 companies manufacturing in India regarding unsatisfactory quality control and record-keeping. Reports of drugs made in India being recalled surface with glaring regularity. This threatens the credibility of the country’s pharmaceutical industry—which is valued at $18 billion, and currently supplies about a third of the generic drugs consumed in the United States, as well as about a quarter of those consumed in the United Kingdom.

But the rejection of these substandard medicines (also known as NSQ, or “not of standard quality,” drugs) in other countries points to an equally pressing concern: their fate in Indian markets. While spurious drugs, which contain little or no active ingredients, are widely recognised to be a problem in India, NSQ drugs, which contain some quantity of active pharmaceutical ingredients but do not meet dosage and quality standards, are less clearly defined or understood. But spurious drugs represent a far lower proportion of the faulty medicines in the Indian market than NSQ ones. According to one government report, spurious drugs comprised 0.17 percent of the pharmaceutical market between 2007 and 2008, while substandard drugs made up 6.3 percent of the market that year. A 2012 audit by the comptroller and auditor general, conducted in armed-forces medical stores, found that the share of domestically procured medicines that did not meet prescribed norms shot up from 15 percent between 2006 and 2007 to 31 percent between 2010 and 2011.

Kaushal Shroff is a staff writer at The Caravan.

Keywords: regulation Drugs manufacturing Pharmaceuticals Health drug recall medicines
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