The European Medicines Agency has recommended suspension of scores of medicines tested by Semler Research – an Indian clinical research organization – based on findings by the US FDA and WHO. The two agencies had raised serious concerns related to data integrity and manipulation of study samples conducted by the clinical research firm. The bioequivalence studies, necessary to gain approvals – were done by the Indian CRO for large generic companies including Sandoz, Mylan Teva, Accord Healthcare, Micro Labs and Zydus Cadila.
The move comes three months after the US Food and Drug Administration alerted an untold number of drug makers of problems at the Semler Research Center, which is located in Bangalore. An inspection last fall found “significant instances of misconduct and violations of federal regulations, including the substitution and manipulation of study subject samples.”
Two weeks earlier, the World Health Organization had issued a notice to Semler for the same reasons. The global health agency had examined company computer servers and found a spreadsheet file containing detailed instructions for manipulating drug samples that were used in clinical trials for its clients. The WHO inspections were conducted early and late last year.
These moves are yet another knock on the
Indian pharmaceutical industry, which has been under a microscope in recent years over a raft of quality-control concerns. Numerous drug makers and ingredients suppliers have been issued warnings for various manufacturing gaffes and, in some cases, the FDA has banned shipments into the United States.Last year, for instance, the European Union suspended hundreds of drugs that were authorized for use based on what European regulators called “flawed” studies conducted by GVK Biosciences, a clinical research organization based in Hyderabad. The episode triggered protests from drug makers and caused a brief diplomatic row between the Indian government and the EU. The implications for the generic drug makers affected may be substantial.
The EMA will recommend lifting suspensions if drug makers provide alternative data demonstrating bioequivalence. The FDA is requiring the same thing. And so, these companies must decide whether it will be worth the expense of conducting new studies for pending or approved applications. They will also have to review drugs in their pipelines where studies were run by Semler and find a new CRO, which could result in delayed filings.
However, the agency said that during the evaluation process, alternative studies were provided for a few of the medicines and since those studies showed bioequivalence, the CHMP (Committee for Medicinal Products for Human Use) has recommended that those medicines can remain on the market. Those products mainly belong to Lupin, Mylan and Aristo Pharma. The EMA noted that if the suspension leads to unavailability of alternatives, the member state may temporarily postpone its suspension in the interest of patients.
