Sandoz, the generic drug division of Novartis ($NVS), has pulled two batches of tuberculosis drugs from the market in India after some packages were found to have improper doses in strips of medications. Authorities say they were alerted by a Mumbai doctor who said a patient had a reaction to the improper dose.
In a statement emailed to FiercePharmaManufacturing, Sandoz confirmed it was pulling one batch of its 4D TB product and one batch of its higher-strength 4D Plus that had been manufactured in India for Sandoz by a contractor.
"Sandoz is aware of two reported faults in India in the packaging of our combination drug 4D and 4D Plus, used in the treatment of tuberculosis. We are working to determine the facts in this case and the potential cause of any fault. … We are fully cooperating with the local health authorities, who are reviewing this matter."
According to the Mumbai Mirror, the drugs are packaged in strips that contain one tablet that is a combo of rifampicin and isoniazid, two tablets of pyrazinamide and one tablet of ethambutol. A Mumbai doctor notified India's FDA that some of his patients had bought packages at a pharmacy in which the strips contained two of the combo tablets. He told authorities one patient began vomiting after getting 5 strips into his regimen with the improper dosage.
FDA Joint Commissioner Sanjay Kale told the publication that the FDA contacted the drug control authority in Uttarakhand, where the treatments are manufactured. "It is an obvious lack of quality control. We have asked the drug control body to take necessary action against the manufacturing unit," Kale said. According to The Hindu Business Line, authorities identified the manufacturer as Themis Medicare of Haridwar, which Sandoz confirmed.
Authorities globally take dosing precision seriously. In September, the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) had Bristol-Myers Squibb ($BMY) and AstraZeneca ($AZN) recall about 92,000 vials of their Type 2 diabetes drug Bydureon from 8 European countries after some were found to be underfilled. Earlier in the year, Johnson & Johnson's ($JNJ) Janssen unit in Korea ran into serious problems with authorities who were investigating whether it continued to sell Children's Tylenol after discovering it might contain more than the labeled amounts of acetaminophen, a problem that can lead to liver damage.
Novartis has certainly had a number of manufacturing problems. In June the FDA took a Sandoz plant in Austria to task for failing to make corrections the FDA had ordered and, as a result, allowing 10 batches of drugs with visible particulates to be released to the U.S. market.
- read the Hindu Business Line story
- here's the Mumbai Mirror story