NEW REFORMS TO IMPACT MEXICAN DRUGMAKERS

A number of reforms in Mexico's drug industry have been implemented requiring manufacturers to demonstrate the bioequivalency of their products. It is estimated that up to 3,500 products will have to be re-registered, with each being subjected to a US$60,000 renewal fee. Multinationals as well as Mexico's leading domestic players, are expected to suffer no serious affects from the new regulations although local producers of "similares," patent-infringing copied products, are bitterly disputing the reforms.

The new laws should help the battle against counterfeit drugs in the country. It the government's stated desire to force all similares off the market. Further reforms have included strengthening criminal proceeding against producers of so called 'miracle products' that have no known therapeutic value. Several firms have already shut down production ahead of government inspection, and advertising of these products has been prohibited.