Health Desk-- May 19, 2017: India's drug pricing regulator has demanded explanations from 65 domestic and global drugmakers for selling new forms of essential diabetes and antibiotic drugs without its approval.
The move could bring penalties for the drugmakers, among them Abbott Laboratories, Sanofi, Novartis and Indian firms such as Sun Pharmaceutical Industries and Lupin, the National Pharmaceutical Pricing Authority (NPPA) said on its website.
Wednesday's action is the pricing authority's latest move to tighten control of drug prices, piling pressure on drugmakers grappling with slowing growth in international markets. It follows a February order capping prices of cardiac stents.
The Indian Pharmaceutical Alliance, the largest drug industry grouping, will wait for the companies named to confirm the data the regulator used, the industry body's secretary-general, D.G. Shah, told Reuters in a statement.
It was not clear if many of the drugs had approval from the central drug regulator, the pricing authority added.
"It is also not clear whether these formulations have the approval of the Central Drug Standard Control Organisation and whether these are rational or irrational combination drugs," it said, referring to India's main drug regulator.