- More on data manipulation - Allegations against Hyderabad-based GVK Bio regarding manipulated data in clinical trials of generic drugs conducted on behalf of European drugmakers might result in over 100 medicines being pulled from the market. Updated to add: Here's a link to another discussion on the subject.
- Patent issues - The Indian patent office has refused to grant US company Gilead a patent for its blockbuster hepatitis C drug Sovaldi on the grounds that the "molecules and compounds of the drug are known elements". Although Gilead had previously granted voluntary licences to Indian companies to manufacture the drug at a lower cost, it still remains out of reach for the poor with a pricetag of 55,000 rupees for a 12-week course. Those backing the production of low-cost, generic versions of drugs to benefit the poor have hailed this decision while experts in intellectual property issues have questioned the validity of the court's judgement.
- FDA issues - Generic drug company Ipca Laboratories has run into trouble with the FDA banning imports from its Madhya-Pradesh-based facility after finding half a dozen violations, including data quality issues.
- And more on the FDA - The Indian government has petitioned the FDA to allow Indian officials to be present during FDA inspections of domestic drug manufacturing units. This is in response to the increasing stringency of FDA inspections which apparently now take place without due notice to the facilities involved, as well as concerns about "cultural differences and body language" which may lead to miscommunications during the inspection process.
Sunday, January 25, 2015
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