India's drug pricing regulator has demanded explanations from 65 domestic and global drug manufacturers for the sale of new forms of essential diabetes and antibiotic medications without its approval.
The move could lead to penalties for drug manufacturers, including Abbott Laboratories, Sanofi, Novartis and Indian companies such as Sun Pharmaceutical Industries and Lupine, the National Pharmaceutical Pricing Authority (NPPA) Its website.
Wednesday's action is the latest move of the pricing authority to strengthen drug price controls, resulting in pressure on drug manufacturers struggling against slower growth in markets International. It results from a February prescription limiting the prices of cardiac stents.
"These companies have launched formulations by modifying (an essential drug) … without even asking for NPPA price approvals as needed," he said in his opinion.
The action targets a group of over 300 drugs that India defines as essential, whose prices control to ensure that they are affordable. According to the law, drug manufacturers must apply for NPPA approval for new doses or combinations of these drugs.
Many companies ignore the rule, however, the regulator said, adding that he had asked them details on the sale and pricing of medicines within a deadline of June 15, after which he Would take action.
The Indian Pharmaceutical Alliance, the largest drug industry group, will wait for companies named to confirm the data used by the regulator, the Secretary General of Industry, DG Shah, "Reuters said in a statement.
India's largest pharmacy by sales, Sun Pharma, will check all products listed in the regulator's notice to know its status and respond on time, said a spokesman at Reuters.
Glenmark Pharmaceuticals, another drug manufacturer named in the notice, aims to meet the pricing authority at the earliest, said a company spokesman in an e-mail .
Other companies contacted individually do not respond immediately to requests for comments.
It was not clear if many drugs had gotten approval from the central drug regulator, added the price authority.
"It is also not clear whether these formulations have the approval of the Central Organization for Drug Control and whether they are rational or irrational combinatorial drugs," he said. "He said, referring to the main regulator in India.