There is a debate on the cause for delay in identifying unsafe products in the Johnson and Johnson (J&J) hip implant case.
This gave rise to a bigger question on how we should ensure the safety of consumer.
What is the current situation?
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.
What is the global disparity?
2008 Sanlu milk scandal (China) - Infant formula adulterated with melamine led to infant deaths, resulted 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.
It began when the Drug Controller General of India set up a committee to probe the issue.
Indian patients were eligible for revision surgeries but most were ignorant of this information.
What does their research reveal?
As per the research, in India, there were around 29 recall events across the automobile, drugs and food sectors.
But, the US Food and Drug Administration’s (FDA) import refusal list for India across food, drug and cosmetic products, in 2019 alone reveals an average of 162 refusals/month.
The reasons mentioned were ranging from mislabelling, adulteration and being unsafe for consumption to poor manufacturing practices.
Research suggests that firm-initiated preventive recalls are indicative of mature internal quality control systems which may be the case in automobiles.
What are the regulations?
The consumer protection laws have existed in India but an integrated regulatory framework for product recalls has been largely absent.
However, the factors like increasing consumer awareness, high profile recalls and the attention of policy-makers are helping the product safety movement gain momentum.
This is done 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 a need for stronger enforcement of safety standards and recall data.
What could be done?
Standards systems and recall data can mitigate the impact of a recall and enable faster tracking of unsafe products.
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.
