India’s drug pricing regulator has issued a notice seeking explanation from companies found to be selling new versions of essential medicines without government approval on their pricing, a statement released on its website late on Wednesday showed. The move could result in penalties for several drugmakers, and is the latest in a series of recent actions by India’s National Pharmaceutical Pricing Authority (NPPA) towards tightening control of drug prices. More than 300 medicines that India defines as essential are currently under a government price cap, and the law requires companies to seek approval of the NPPA before launching new dosage forms or combinations of such drugs.
Yet, a high number of companies are flouting this rule, the NPPA said in its notice, adding that it has sought details from such companies on the sales and pricing of their drugs by June 15, 2017. “It is also not clear whether these formulations have the approval of the Central Drug Standard Control Organisation (CDSCO) and whether these are rational or irrational combination drugs,” the NPPA said, referring to India’s main drug regulator. Roughly half the medicines sold in India are so-called fixed-dose combination drugs – cocktails of two or more medicines in fixed dosages. The health ministry banned hundreds of such drug cocktails last year saying they lacked therapeutic efficacy, were potentially harmful, and did not have the central drug regulator’s approval.
The industry filed hundreds of lawsuits against the government, obtaining stay orders on the ban, and the cases will collectively be heard by the Supreme Court starting July. The NPPA, which comes under India’s chemicals ministry, can in the meantime fine the offending companies and recover the overcharged amount from them, according to India’s drugs law.