A senior FDA official told Business Standard: "Following three hearings on the issue, the order issued today has asked J&J to contact the DCI for certification allowing it to continue using the term "baby" on its product label. If it is able to do so, we have no issue. But if it is unable to do so we will not allow it to sell its products in Maharashtra using the word "baby". |
Principal Secretary for Medical Education and Drugs (Maharashtra Secretariat) GS Gill told Business Standard: "I am yet to receive the copy of the order from the FDA. Our issue pertained to the fact that J&J had carved out a niche among the general population for its baby oil product. If the product was meant for the general public, we would not have had any issue. If it was meant for infants we felt the company should have conducted tests on children first." |