Dear Johnson & Johnson, are babies in India of a lesser god?

Johnson and Johnson has no plan to take the product off the market in India. (Representative Image)

Books have been written and movies made on the sordid tales of Big Pharma using the third world as its testing laboratory and flea market for selling drugs banned in the West. While they have paid compensations running into billions of dollars for settling lawsuits in the litigious nations like the United States, where both regulators and customers show zero tolerance for violations of safety standards, in the developing world errant pharma corporations tend to get away with impunity.

Though the drug administration laws in India are at par with international standards, and regulators are equally empowered, implementation tends to be tardy, and inconsistent. As a result, manufacturers tend to get away with non-compliance. Instances of product recall are rare, and often there is a lag in withdrawal of formulations and molecules that are banned in other countries. It is true that local players also take advantage of these loopholes. But the international brands by virtue of the premium they command use this as a lucrative window of opportunity. This does raise serious questions of variable ethical standards of global firms that tend to go by the dictum ‘show me the country and we shall tell you the rules’.

The story of the Johnson & Johnson Baby Talcum Powder that is in the news recently for the wrong reasons is a classic example of principles compromised at the altar of commercial expediency. Johnson and Johnson, the US company, is discontinuing its talc-based baby powder in the face of lawsuits claiming it contains a cancer-causing substance. But it has no plan to take the product off the market in India. The response of its spokesperson, “We will work with retailers to keep the product on the shelves until our supply of talc-based powder runs out,” tantamount to cocking a snook at the Indian authorities, and customers. That this can be the stand of a multinational pharma giant with regard to a product meant for babies reveals a built-in geographical flexibility in its code of business conduct.

What is more astonishing, however, is the nonchalance of the Indian regulator. As per the www.moneycontrol.com report, its queries to the Drug Controller General of India regarding J&J’s decision remained unanswered. It is entirely possible that the product has been classified as a cosmetic rather than a drug under the Act, but as a cosmetic under the Drugs and Cosmetic Act Rules. In that case a different set of standards may apply. There can also be differences in testing methods. Such aberrations are not limited to semi-medicinal products for external application as talc, soaps, creams, and ointments, but also in therapeutic drugs.

Some years back there was a controversy regarding a paediatric formulation of Ranitidine. This particular molecule is either banned or severely restricted in other countries due to its tendency of degenerating into a carcinogenic form. The same phenomenon was seen in other products used for the treatment of other ailments ranging from tuberculosis to diabetes. The solution in every case is not banning the drug, but setting up stringent protocols for testing. But, it is precisely these sorts of anomalies that an authority like the Central Drugs Standard Control Organisation (CDSCO) are expected to plug.

The problem with talcum powder is not limited to J&J alone. There are several other brands of talc recommended for babies in the market. The quality control standards of smaller manufacturers may be even less rigorous than J&J’s. By allowing J&J to continue selling this product, the Government of India may be inadvertently providing an umbrella to the unregulated sector to skirt safety concerns. Besides, the use of talcum powder is wide-spread even among adults in India and tropical countries, whereas in colder climates people have moved onto other forms of deodorants and antiperspirants. Besides, talc is used for other skincare products including cosmetic soaps. There is nothing to indicate that cancer risks for older people have been evaluated.

There is little evidence from their global track record to inspire confidence in MNC and personal care giants voluntarily complying with global product safety standards in every country unless the local regulators insist. We would be naïve to expect they will act any differently in India. The Government of India was realistic on this score while dealing with foreign vaccine manufacturers (including J&J) lobbying hard to sell their COVID-19 vaccines in India.

In hindsight, the government’s decision has been vindicated both medically and commercially. A similar pragmatic approach ought to be adopted in other areas. Especially when it comes to the health of babies, the laws are non-negotiable.