The Drug Controller General of India has asked Johnson & Johnson to explain why did it violated statutory provisions and issued advertisements citing a government laboratory test report on its baby powder to say that the product is free of asbestos.
The DGCI issued the show cause notice to the multinational company pointing out that publication of any advertisement on the basis of any test report of a government analyst is not permissible under Section 29 of the of Drugs and Cosmetics Act, 1940.
The drug inspectors earlier on DCGI orders had seized samples of the firm’s various baby products from wholesalers, retailers and distributors across the country in December.
The regulator had ordered Johnson and Johnson not to use talc raw material from its Mulund plant in Mumbai and Baddi unit in Himachal Pradesh for production till further directions.
According to a senior Central Drugs Standard Control Organisation (CDSCO) official, the samples of raw materials were tested in Central Drugs Laboratory and were found to be free of asbestos.
The test result was also conveyed to J&J, which used the result to promote its product, he added.
“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.
The notice further pointed out that “publication of any advertisement on the basis of test reports of government analyst is not permissible under Section 29 of the Drugs and Cosmetics Act, 1940.”
The section 29 of the Act also provides for a penalty up to Rs 5,000 to an errant firm for government analysts’ test reports to advertise its cosmetic and drug products.
The DGCI notice further said that the publication of such advertisement has the potential to mislead the general public which is against the public interest.
Asking the firm to explain why the penal actions be not not taken against it for breaching the section 29 provisions, the DGCI notice also restrained the J&J from issuing similar advertisement, based on the government test reports of its products, in future.
The DCGI has sought the company’s reply to its notice within seven days.