It has been a tough year for Johnson and Johnson (J&J) in India. Earlier in the year, the US healthcare company was rocked by the scandal of supplying faulty hip implants to Indian patients.
This time, concerns have resurfaced on their popular consumer product, Johnson’s Baby Powder. The Indian drug regulators have collected samples of the product to test for carcinogenic material asbestos. The Drug Controller General of India or the DCGI has also ordered that J&J cannot use its talc raw material either from its Mulund plant in Mumbai or its Baddi plant in Himachal Pradesh until further notice.
The Indian regulator’s steps come after a
that shed light on concerns over J&J’s talc problem. The report, based on many court documents, said J&J seemed to know their talc contained some amount of cancer-causing asbestos all the way back from the 1970s to early 2000s, but never warned consumers. Reuters report
The company’s stock corrected 10 percent on Friday, reacting to the article. In July 2018, when the company was ordered to pay $4.7 billion to 22 women on claims that the company’s talc contained asbestos that caused ovarian cancer. J&J is currently fighting more than thousands of litigations on its talc products.
This is not the first run-in that J&J’s baby powder has had with Indian regulators. In 2013, the Indian FDA cancelled J&J’s licence of its Mulund facility after it was found to be using ethylene oxide, a chemical that is linked to cancer, nausea and causing irritants. But the licence was eventually restored later.
Industry watchers believe the latest steps taken by Indian regulators are more knee-jerk and late in the day with no concrete steps to protect consumers. The products are freely available with no warning to consumers. While one might say banning the products before testing them would be harsh, awareness about a potential issue was the need of the hour.
However, the regulator DCGI is expected to be stepping up its investigation on J&J. Reports indicate the company will also investigate the company’s soap and shampoo products. Preliminary investigations, according to media reports, indicate that the company has not been complying with testing norms. The company has been testing batches randomly and not each batch as it is supposed to, especially to detect asbestos.
The larger issue here is that drug controllers in India need to step up. Another example cited is the J&J hip implants issue. J&J globally recalled the faulty hip implants in 2010 but it took Indian regulators two years to cancel its licence and ban its import.
In fact, issues with the hip implant surfaced even before, in 2009, when the Australian regulators flagged it off and recalled the product. However, the product’s licence was renewed in 2010 in India, the same year the global recall took place and a year after the Australian regulator recall. And while the issue has gained prominence in India almost a decade later, J&J made a $2.5-billion settlement involving 8,000 patients in 2013 in the US five years earlier.
Experts cite other examples of lax, knee-jerk reactions from Indian regulators in other cases too. These included the overnight ban of over 340 fixed dose combination drugs, while it was principally sound, it was sudden, with no alternatives and a ban on many drugs that existed for years in the market.
A similar thing happened with stents, with a cap on pricing enforced, making foreign available stents unavailable for those who could afford it. A recent example was also the ban of use of the anti-histamine drug Buclizine as an appetite stimulant in children. The drug is developed by MNC UCB and sold by Mankind Pharma.
The government banned the drug two years after it received recommendations from the Drug Technical Advisory Board, saying usage of the drug as an appetite stimulant was not rational. Reports indicate the drug received approval as an appetite stimulant in 2006 and as anti-histamine in 2010 from the DCGI.
Making drug regulators more vigilant is the need of the hour, say experts. A lax image of a regulator hurts the image of Indian regulators globally. It results in global counterparts or companies not taking Indian regulators or recommendations seriously. Many a time it gives companies a free hand to slip up on rules. Companies also find it difficult to operate in India with arbitrary rules and capped pricing. And last but the most important, it hurts consumers and patients.
"Johnson & Johnson is in full compliance with current Indian regulatory requirements for the manufacturing and testing of our talc. We stand behind the safety of our talc, which is routinely tested by both suppliers and independent labs to ensure it is free of asbestos, " the company said in a response to CNBC-TV18's query.
All talc in India is sourced and exclusively sold in India and surrounding markets – including Sri Lanka, Bangladesh, Nepal, Bhutan, Maldives – and fully meets the regulatory standards of the government of India, it said.
Authorities in India such as the CDSCO regularly test samples as part of their ongoing processes and have previously confirmed that our products are free of asbestos, J&J added."K Bangarurajan, a senior official at the CDSCO told Reuters on December 18 that they tested samples in 2016, but no such thing was found in them and the samples were found to be complying with Indian standards," the company said adding that Johnson & Johnson is fully cooperating with recent inquiries to confirm the safety of the talc.