Overview: Health regulators and pharmaceutical companies have been circumventing approval laws for at least 31 drugs in India, including Novartis’ hypertension drug Tekturna/Rasilez (aliskiren), according to a report from a parliamentary panel. An investigation found evidence that the Central Drugs Standard Control Organization (CDSCO) approved the drugs without proper clinical trials. The report isn’t good news for Novartis, who already roused safety concerns over Tekturna in December.
- A parliamentary investigation showed that 31 out of 42 drugs were approved without clinical trials, including Novartis’ Tekturna
- According to the parliamentary report, there is enough evidence to conclude that the CDSCO had collaborated with pharmaceutical companies while putting patients at risk
- Tekturna has been under some skepticism after safety concerns were raised during the ALTITUDE trials in December
- Novartis says they use “one global ethical standard” in conducting drug trials
Product: Tekturna (aliskiren), also sold under the brand name Rasilez outside the US
Side Effects & Complications
- Heart attacks
- Acute renal failure
- Renal complications
- Hyperkalemia (high levels of potassium)
- Hypotension (low blood pressure)
According to Bloomberg News, the parliamentary report was based on a one and a half year investigation of 42 drugs approved by the CDSCO from 2004 to 2010; 31 drugs were approved without any clinical tests. Apparently, the evidence unearthed during that time was strong enough to draw a definitive link between regulators and pharmaceutical companies. The report states, “There is sufficient evidence on record to conclude that there is collusive nexus between drug manufacturers, some functionaries of CDSCO and some medical experts,” and that “Such irregular approvals spare drug producers the cost and efforts but put Indian patients at risk.” reports Bloomberg News.
Among the illegally approved drugs are Novartis’ Tekturna, as sold under the brand name Rasilez, and Sanofi’s Multaq (dronedarone). But the list also included drugs that are banned in the US and Europe due to harmful side effects. The investigation revealed that these drugs were approved following a trial of less than 50 participants, even though the legal minimum is 100 patients.
Tekturna Safety Issues
Novartis told Bloomberg news that it follows “one global ethical standard for conducting clinical trials,” The company has already raised safety concerns in the past few months over Tekturna. In December, the ALTITUDE trials were stopped due to reports of serious side effects such as non-fatal stroke and renal complications among participants. Novartis originally conducted the trials in the hopes of demonstrating Tekturna’s efficacy on cardiovascular and renal health in high-risk diabetic patients. The event triggered investigations leading to recent label changes in Europe, Canada and the US.
Last month, the U.S. Food and Drug Administration (FDA) updated the safety label on Tekturna, contraindicating its use in patients with diabetes or moderate renal impairment (GFR< 60 mL/min) taking ACE inhibitors or ARBs.