An Indian CRO that counts Johnson & Johnson ($JNJ), Novartis ($NVS) and Sanofi ($SNY) among its clients is under fire from the FDA for repeated quality control issues, the latest ding to the country's reputation as a go-to destination for outsourced drug development.
Across multiple FDA inspections dating back to 2009, Hyderabad's Sipra Labs repeatedly failed to maintain and present the necessary documents to back up its drug-testing processes, the agency said in a warning letter, and the CRO failed to follow its own standard operating procedure on numerous occasions.
Sipra's attempts to rectify the issue have thus far been inadequate, the FDA said, and the agency is giving the CRO 15 days to detail how it finally plans to comply with U.S. regulations. If it fails to do so, the FDA has the authority to impose restrictions on its stateside activity and impose fines.
The issue comes amid a spike of scrutiny tied to Indian CROs in light of an ongoing issue with GVK BioSciences, a contract researcher discovered last year to have repeatedly swapped patients' ECG readings with those from healthy volunteers. After French authorities spotlighted 9 trials affected by the improprieties, the European Medicines Agency identified more than 1,000 approved drugs with ties to GVK and recommended 700 of them be suspended from the market.
Last month, the World Health Organization (WHO) chided Quest Life Sciences, among India's largest CROs, for mishandling data in a large HIV study. More than 67% of prestudy ECG readings were duplicates of one another, WHO said, and Quest altered the dates to make it seem as though they came from individual patients. In one case, Quest reused the same ECG 9 times, according to the organization.
- read the letter