Mumbai: 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.
"These companies have launched formulations by altering (an essential drug) ... without even applying for price approval from NPPA as required," it said in its notice.
The action targets a group of more than 300 medicines that India defines as essential, whose prices it controls to ensure they are affordable. By law, drugmakers must seek NPPA approval for new dosages or combinations of such drugs.
Many companies are flouting the rule, however, the regulator said, adding that it had asked them for details of drug sales and pricing by a deadline of June 15, after which it would take action.
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.
India's largest drugmaker by sales, Sun Pharma, will check every product listed in the regulator's notice to ascertain its status and respond in time, a spokesman told Reuters.
Glenmark Pharmaceuticals, another drugmaker named in the notice, aims to respond to the pricing authority at the earliest, a company spokesman said in an email.
Other companies contacted individually did not immediately respond to requests for comment.
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.
About half the medicines sold in India are cocktails of two or more drugs in fixed doses, known as fixed-dose combinations.
The health ministry banned hundreds of such drug cocktails last year, as being lacking in therapeutic efficacy and regulatory approval, besides having potential to cause harm.
The industry filed hundreds of lawsuits against the government, obtaining stay orders on the ban, and the Supreme Court will hear the cases collectively from July.
Until then, the law allows the NPPA, a part of India's chemicals ministry, to fine offending companies and recover the overcharged amounts.