India's health agency has vowed that its top drug regulator will clean up its act, saying it will cinch up oversight rules for letting drugs on the market.
Today's announcement comes a couple of days after an parliamentary inquiry found that the agency has essentially been a handmaiden for the industry. A review of 42 drugs approved between 2004 and 2010 found that 31 were allowed on the market without clinical trials in Indian patients. Many of the drugs had already received FDA approval in the U.S. but Indian laws require at least minimal clinical studies there.
"There is sufficient evidence on record to conclude that there is collusive nexus between drug manufacturers," regulators and medical experts, the report states, adding that "irregular approvals" save companies money and time, but put patients at risk, Bloomberg reports.
The scandal is yet another black eye for the Indian drug industry, which has recently seen media reports of how it treats patients in drug trials and some questions about the standards of its generic drug production. Its largest genericsmaker this year signed a 5-year oversight agreement with U.S. regulators to settle charges that it faked data on drugs, and had extensive manufacturing issues, problems the company insists are now behind it.
The Indian health ministry now intends to have a special committee review the allegations and recommend "systemic improvements," The Wall Street Journal reports. It also is to give India's drug regulator, the Central Drugs Standard Control Organization, a going over, proposing changes there.
The inquiry has swept up some of the biggest names in the pharmaceutical industry. Bloomberg reports that GlaxoSmithKline ($GSK), Novartis ($NVS) and Indian genericsmaker Cipla, as well as others allegedly won approvals without the Indian trials required by law. Novartis' blood pressure drug Tekturna allegedly won approval on the basis of studies with fewer than the required 100-patient minimum. It isn't as if the drugs had no basis for approval. All of the drugs approved by Indian regulators for these companies had already been approved by the FDA.
The WSJ points out that the process of relying mostly on drug manufacturers' claims, however, was not even well masked by Indian regulators. The inquiry included several examples of letters of recommendation the agency said were written by different experts but that were "word to word identical." It accused several pharmaceutical companies, including Germany's Bayer AG, of colluding with the regulator. Bayer denies the allegation.
GlaxoSmithKline told the WSJ that it followed Indian rules on clinical trials for the drug ambrisentan, while Novartis said it would investigate the claims but defended its clinical trial standards. Cipla denied any clinical trial violations.
- read the WSJ story
- see the Bloomberg piece