Johnson & Johnson gets show cause notice from DCGI

There are a number of healthcare and beauty product brands which have become iconic and have gained the Indian consumers’ trust—after being in the business for decades. Such brands have to be extra-cautious in ensuring that no ingredient that may cause harm to consumers is used in their products. The responsibility doesn’t end here. The companies not only have to ensure that they don’t make any tall claims in their advertisements but also not cite government reports for any such communication. In the latest development, the Drug Controller General of India (DCGI) has slapped a show cause notice to Johnson & Johnson for alleged violation of legal provisions by the latter’s use of government report in its advertisement

The Drug Controller General of India (DCGI) has slapped a showcase notice to healthcare products giant, Johnson & Johnson, to explain in seven days, why did it violate legal provisions by issuing advertisements mentioning a government laboratory test report on its baby powder to state that the product is asbestos-free. The DGCI issued the notice to Johnson & Johnson, indicating that publication of any advertisement on the basis of any test report of a government analyst is not permitted under Section 29 of the of Drugs and Cosmetics Act, 1940.

DGCI, under the gamut of Central Drugs Standard Control Organization (CDSCO), is responsible for the approval of licences of specified categories of drugs such as blood and blood products, IV fluids, vaccines and sera in India. It comes under the aegis of Ministry of Health & Family Welfare, Government of India. CDSCO is the national regulatory body for Indian pharmaceuticals and medical devices.

The notice issued to the MNC, stated, “It has come to the CDSCO’s notice that advertisements had been published in various national and regional newspapers recently, inter alia with the heading: ‘Your Johnson’s baby powder is pure, safe & gentle; Government lab tests confirm Johnson’s baby powder is asbestos-free,” the notice said. It further stated that “publication of any advertisement on the basis of test reports of government analysts is not permissible under Section 29 of the Drugs and Cosmetics Act, 1940.”

Facing penal action

The notice was issued after Johnson & Johnson carried advertisements in the media with the following statement. “Your Johnson’s baby powder is pure, safe & gentle” the title read, which was followed with a declaration that government lab tests confirmed that the talcum powder was asbestos-free.

The advertisements further stated, “This conclusion reinforces the findings of decades of independent tests by universities, research labs and government regulators around the world that have consistently found our talc is safe.”

Section 29 of the Act also mandates a penalty of up to Rs 5,000 for a defaulting company for carrying out advertisements of its cosmetic and drug products, citing government analysts’ test reports.  The notice further added that the publication of such advertisements have the potential to mislead the general public which is against the public interest. Asking the Johnson & Johnson to explain why penal actions should not be taken against it for breaching the Section 29 provisions, the DGCI notice also restrained the company from issuing henceforth similar advertisement, based on the government test reports of its products.

Earlier in December 2018, on the orders from DCGI, drug inspectors had apprehended samples of the company’s several baby products from distributors, wholesalers, retailers from across India. This action was taken with the objective of investigating Johnson & Johnson’s baby powder after a media report was published that stated the company knew for decades about the presence of cancer-causing asbestos in their product. The Reuters report had stated that there were bits of asbestos, a carcinogen, in the company’s baby powder products.

Of complaints and litigations

The same Reuters report, also stated that from 1971 to the early 2000s, Johnson & Johnson’s raw talc and finished powders had sometimes been found to have traces of asbestos. The company executives supposedly knew this, but they did not reveal it to the Food and Drug Administration (FDA) or to the public.

The company denied all allegations, wherein its litigators told jurors that the records of the asbestos presence found in talc were in the product intended for industrial use. In other cases, the company contended that the tests had picked up the carcinogen in the background like stray fibres that could have come from elsewhere and polluted the samples.

However, in July 2018, in St Louis, Missouri in the US, 22 complainants had won the case against Johnson & Johnson. They had argued that the company’s two products – Baby Powder and Shower to Shower Talc – were stained with asbestos, which resulted in them developing ovarian cancer. The jury had ordered the company to pay the petitioners $4.67 billion as damages. As of December 2018, the company had failed to reverse this jury judgment.

Following this Reuters report, the Indian regulator had restrained the company against using the talc raw material from its Mulund plant in Mumbai and Baddi unit in Himachal Pradesh for production till further directions.

Subsequently, the samples of raw materials that were tested in Central Drugs Laboratory were found to be asbestos-free, a senior CDSCO official was quoted in a report. The test result was also conveyed to the company, which decided to advertise the analyst report to promote its product, leading it to further trouble.  A company spokesperson was quoted in a news report by the News Minute, as saying the idea behind the Advertisement was to reinforce what the government lab tests had found, and what Johnson & Johnson had been claiming for the last 130 years, that its talcum powder is safe and asbestos-free.

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