NEW DELHI – With pharmaceutical sector regulations in urgent need of reforms, India has taken the first step, tightening rules for fixed-dose combination (FDC) drugs. Two key drug regulatory agencies, the Drugs Controller General of India and the Central Drugs Standards Control Organisation, have issued notices to several companies, guiding phase IV postmarketing surveillance trials and for manufacturing and selling FDCs in the country without approval from the Drugs Controller General of India. The letters to 283 companies are part of the country’s efforts to examine the safety and efficacy of FDCs licensed for manufacture or sale in the country.