16-18 November 2021
Indian pharmaceutical manufacturers increasingly attract attention by breaching GMP rules. We recently reported on the unannounced FDA inspections in India as one of the consequences of this practice. In a further case the analysis results not complying with the requirements were deleted and the batch was released for the US market. An employee of Sun Pharmaceutical Industries Ltd. in Vadodara, India simply deleted analytical data of an HPLC testing on impurities of an antibiotic that did not comply. The next day another sample was tested, considered to be fine and the batch was released. This incident took place three years ago.
This fundamental GMP violation of data integrity has become known only now. The FDA's computer forensics experts found traces of a total of 5031 deleted data records in the chromatography system. A senior QC Manager commented that they often made pre-tests and rejected the results before starting the final analysis. This practice is completely inacceptable not only according to FDA understanding. The FDA talks about the regular deletion of undesirable analysis results and about retesting the products without initiating an investigation as required and without documenting the problem. And this is no isolated case.
Similar irregularities concerning the data integrity were found at the site of the Indian producer Ranbaxy who had to pay a penalty in the amount of 500 Mio US Dollars. A responsible at the Indian government announced that India has had good manufacturing practices for the manufacture of drugs for years but that the laboratory guidelines to manufacturers entered in force only in 2012. He continued that usually it would take some years for new regulations to be complied with nationwide. In the case described a ban on exports had been imposed against the company Sun already two months earlier. The underlying report by Bloomberg states that at least 12 Indian pharmaceutical companies were affected by such a ban on exports in the last year. One of these cases concerns the Indian company Smruthi Organics Ltd., for instance which also manufactures an antibiotic. During an FDA inspection the inspectors noticed already in 2013 that batches of active ingredients that did not comply with the specifications were blended with passing batches in order to meet the requirements (= missblending). The relating batch documents had been destroyed.