As lawmakers and policy experts debate the cause for delay in identifying unsafe products and the paltry compensation in the Johnson and Johnson hip implant case, the bigger question is: how do we ensure consumer safety?
Today, governments and businesses are dealing with the reality that given global supply chains and increased product complexity, recalls are inevitable. Whether it is recalls by automobile majors or food and drug manufacturers, safety issues are widespread. As these occurrences escalate in India, there is an urgent need to build systems, regulation and map data which can mitigate such events instead of turning it into a blame game.
A turning point in global recalls was the 2008 Sanlu milk scandal in China where infant formula adulterated with melamine led to colossal losses and infant deaths, resulting in a blanket ban on Chinese milk products and the final execution of the accused. However, the difference in safety regulations worldwide is stark. The J&J recalls took place in Australia and the US in 2010 but the Indian response began only in 2017 when the Drug Controller General of India set up a committee to probe the issue. Though Indian patients were eligible for revision surgeries, most were ignorant of this information.
Our search (2010-2017) across the automobile, drugs and food sectors reveals 29 recall events in India.
In contrast, the US Food and Drug Administration import refusal list for India across food, drug and cosmetic products, in 2019 alone reveals an average of 162 refusals monthly from firms such as Dabur, Parle, Haldirams, Vicco, Cipla and Sun Pharma for reasons ranging from mislabelling, adulteration and being unsafe for consumption to poor manufacturing practices.
Also striking is the fact that in India almost all automobile recalls were initiated by companies whereas in the food and drugs case they were imposed by regulatory authorities. A case in point is the Maggi recall initiated by the Food Safety and Standards Authority of India (FSSAI).
Research suggests that firm-initiated preventive recalls are indicative of mature internal quality control systems which may be the case in automobiles.
Though consumer protection laws have existed in India, an integrated regulatory framework for product recalls has been largely absent, unlike in other countries. However, increasing consumer awareness, high profile recalls and the attention of policy-makers are helping the product safety movement gain momentum through regulators such as the FSSAI, Central Drugs Standard Control Organisation (CDSCO) and the Society of Indian Automobile Manufacturers (SIAM).
The FSSAI and SIAM introduced the recall process draft and code in 2011 and 2012, respectively, but there is need for stronger enforcement of safety standards and recall data.
A major hurdle in the J&J case was tracing patients who received implants. Standards systems and recall data can mitigate the impact of a recall and enable faster tracking of unsafe products. Evidence from recall data has been utilised to drive policy decisions such as the FDA opening offices in China and India to stem quality problems at the root.
In India, efficient response to safety events is critical. Standardised information mapping of recalls across sectors, stringent regulation and systemic accountability are essential for quick information dissemination to affected consumers.
Chebolu-Subramanian is Associate Professor, IFMR-GSB, Krea University, and Kayal is Assistant Professor, Madras School of Economics