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    099698

    IUDS for India were safe [letter]

    Bronnenkant LJ

    REPRODUCTIVE HEALTH MATTERS. 1994 May; (3):104.

    In reply to a summary of an article by Bhupesh Mangla (Lancet, May 29, 1993), a representative of Finishing Enterprises, Inc, the original licensee of the Population Council for manufacture of the Copper T IUD, maintains that the components supplied to Hindustan Latex Ltd (HLL), the Indian company selected in a program of the Indian government and the UN Population Fund (UNFPA) to manufacture the finished IUDs, were neither defective nor substandard. The National Centre of Technical Evaluation of the Indian Institute of Technology, which had no previous experience in this area, established its own specifications prior to transfer of the technology. Finishing Enterprises was uninformed of the changes and delivered components made according to US Food and Drug Administration and international standards. Since they did not meet the Indian specifications, it was recommended that they be held. This does not mean they were unsafe. Differences in the standards were discussed in March 1992 by experts during a Population Council meeting organized by the Indian government and UNFPA. The components were certified to meet international standards and were found to be safe and suitable. The statement that the Ministry was pressured to accept the consignment without further action is, therefore, inaccurate. The Indian Ministry of Health and HLL have since resolved the issue, and manufacture of the IUDs is proceeding with the components supplied by Finishing Enterprises. This resolution was complicated by political motivation, personal bias, and pressure brought by competing Indian firms. In order to prevent this in the future, manufacturers who are experienced with international standards should be involved in evolving national standards, and care should be taken that these are communicated to the appropriate parties.
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