Financial Daily from THE HINDU group of publications
Thursday, May 05, 2005
Financial Daily from THE HINDU group of publications Thursday, May 05, 2005 |
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Regulatory Bodies & Rulings Marketing - Standards & Benchmarks FDA may pass order on Johnson's baby oil today Rahul Wadke
Mumbai , May 4 THE Food and Drug Administration (FDA), Maharashtra, is set to pass an order pertaining to the `safety' factor of Johnson & Johnson (J&J) Ltd's baby oil on Thursday. According to sources in the FDA, the company has been given a couple of months' time to get a certification from the Drug Controller of India, that the baby oil is safe for infants to use. This certification were not to come through, the FDA could ask J&J to drop the `baby' from the label of the product. The FDA Commissioner for Maharashtra, Mr A. Ramakrishna, told Business Line today that a final order with respect to safety of the product is likely to be issued on Thursday and get uploaded on the Maharashtra Government Web site for public knowledge. He, however, refused to share details on the content of the order. The domestic baby products market is an estimated at Rs 200 crore, and some of the other players are Dabur, Emami and Wipro. In mid-March 2005, the FDA had issued a notice to J&J to remove the word `baby' from its products. The notice was issued, as the company's product did not make the grade as a childcare product by FDA standards. The action was prompted by consumer complaints that on application of the oil, babies developed rashes. Subsequently, the FDA also placed on the scanner, baby oil products manufactured by Wipro. At that time, J&J had said in a release: "All baby care products in India, including Johnson's baby oil, meet stringent global quality standards. Products made in India are manufactured and sold under licence and approval of the FDA.'' As per the company release, more than 200 safety tests and product trials have been conducted in India and many more across the world on babies and adults to ensure that J&J's baby product formulations are mild, gentle and safe for use on a baby's sensitive skin.
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