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INDIAN FIRMS REFORMULATE DRUGS TO ESCAPE REGULATION

June 27, 2005

According to local reports in India, many leading pharmaceutical firms are increasingly altering the composition of their branded products without notice, in order to avoid intrusive regulation on "irrational combinations" of ingredients.

Aside from the obvious risks to consumers posed by this trend, such practices are somewhat unsurprising in view of recent arbitrary regulatory decisions on certain pharmaceutical combinations. The tendency towards such regulation has reportedly affected about 100 leading products and led to considerable price increases.

The changes in regulation have mostly impacted the OTC sector, with at least two US firms and one German company linked to the reports. Despite the fact that such products are approved as safe for over-the-counter dispensing, well-intentioned efforts to limit consumer exposure to overly powerful substances appear to be having precisely the opposite results.