July 8, 2015
By Mark Terry, BioSpace.com Breaking News Staff
The World Health Organization (WHO) issued a “notice of concern” (NoC) to India-based contract research organization (CRO) Quest Life Sciences Pvt Ltd over critical lapses from clinical trial standards.
The report states that the WHO Prequalification Team (PQT) inspected the company’s Chennai, India facility between October 13 and 17, 2014, focusing on Study No. LAZ/032/13, for HA619 Lamivudine, Zidovudine and Nevirapine tablets from Micro Labs Ltd. The three drugs are used to treat HIV.
“The inspection revealed critical and major deviations,” the report stated, “from the WHO Good Clinical Practices (GCP) and Good Laboratory Practices (GLP) standards as published in WHO publications.”
The team described lack of data integrity in records, problems in subject safety, poor quality assurance, and other issues. Approximately 67 percent of pre-study electrocardiograms (ECGs) in the documents were duplicates. WHO stated, “This means that ECGs may not have been performed or were unreliable and therefore ineligible/unfit subjects could have been used in the study and protocol requirements may not have been met.”
Some forms in the files were also blank, suggesting that they would be filled in later.
WHO sent the report to Quest Life Sciences on March 26, 2015. The company responded on April 30. WHO, though, was not satisfied with the company’s response, issued the NoC and recommend rejection of the study.
“Based on the necessary action suggested by WHO, we are in the process of conducting the entire clinical study again at our own costs to ensure that the NoC is lifted at the earliest,” said Joseph Kamalesh, associate vice president and head of operations at Quest Life Sciences to Business Standard.
There have been several high-profile problems with Indian CROs recently. One major case involved GVK Biosciences. An inspection by French regulators brought attention to problems with serveral studies by GVK between 2008 and 2014 for several drug makers. The European Medicines Agency (EMA) recommended suspending the sale of approximately 700 drugs that were involved in the study. This also involved data manipulation of ECGs.
In late 2014 there were quality control issues reported with India-based Sun Pharmaceutical Industries Ltd. A U.S. Food and Drug Administration (FDA) investigation found that some quality test results on drugs shipped to the U.S. were falsified. In addition to Sun, the problems involved 12 other Indian companies.
On Dec. 3, 2014, BioSpace reported that the Maharashtra Food and Drug Administration (FDA) in Mumbai, India initiated hundreds of surprised inspections of WHO certified pharmaceutical units. Those units received WHO certification after joint inspections performed by the Central Drugs Standard Control Organization (CDSCO) and state FDA. Of the more than 450 WHO certified pharmaceutical units, more than 50 had already been inspected.
An unnamed industry source said in a Pharmabiz.com, “It is surprising to note that these inspections seem to be targeted to units that already have WHO certification jointly inspected and issued by CDSCO and State FDA.” It was unclear whether this was an effort to crack down on problems in the industry, or perhaps retaliatory in nature to the WHO inspections.
India is the second-largest exporter of drugs to the U.S. Approximately half of active pharmaceutical ingredients used in the U.S come from India or China. In 2013 India-based Ranbaxy Laboratories paid $500 million to settle fraud allegations that it sold doctored drugs and lying about it to U.S. regulators. This was part of a U.S. FDA $20 million initiative involving a dozen academic centers to test the quality of drugs being imported from abroad. The project will run through 2017.
As New Jersey Biotech Booms, Will It Overtake Other States As Prime Location?
A week after Celgene Corporation announced it is officially the mystery buyer of Merck & Co. ’s former 1 million-square-foot R&D site in Summit, N.J., it quickly became our most popular story last week.
The company announced last Wednesday that it is buying the space, ending months of speculation about what Big Pharma company might move into the neighborhood.
The Summit, N.J. site is zoned research/office. The New Jersey site would put operations closer to some of the major biotech and pharmaceutical hubs on the East Coast.
But, by far, the most tempting part of doing business in the state remains New Jersey’s operating tax credit, which allows companies to sell their net operating losses to the New Jersey Treasury. One of the state’s most recognizable biotechs, Celgene, used the program until it became profitable, which was key to it staying in the state, said local officials.
That has BioSpace is wondering if New Jersey is becoming the new face of biotech. What do you think? Can the Garden State compete with other longtime stalwarts like California or Boston?
