The regulatory agency determined that the company had produced several batches of Piracetam 400mg hard capsules with minor changes compared to the approved drug registration dossier, but these changes had not been approved by the competent authority as required by regulations.
In addition, Traphaco also produced several batches of drugs with significant changes compared to the approved registration dossiers, but these changes had not yet been approved. The products in question include Piracetam 400mg hard capsules, Methorphan cough syrup, Nostravin, and Loratadin 10mg.
The third violation involved the use of Luzenac 00 talc powder, which the manufacturer claimed was for both pharmaceutical and food use, in the production of various drugs. According to the Drug Administration, this was done improperly, deviating from the approved drug and raw material testing procedures outlined in the registration dossier.
For the three violations, Traphaco was fined a total of 160 million VND. Specifically, the violation of producing Piracetam 400mg with minor modifications that had not been approved resulted in a 40 million VND fine. The violation of producing drugs with major modifications that had not been approved resulted in a 60 million VND fine. The violation of using talc powder in drug production that did not follow the registered process also incurred a 60 million VND fine.
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| Decision on sanctions by the Drug Administration |
The Drug Administration Department stated that each violation had two aggravating circumstances: repeated administrative violations and large-scale violations involving a large quantity of goods. Because there were two or more aggravating circumstances, the maximum penalty within each range was applied. The decision did not acknowledge any mitigating circumstances for the enterprise.
According to data provided by the inspection team based on the decision dated June 8th by the Inspector General of the Government, from January 1st, 2023, the recorded violations include: 2 batches of Piracetam 400mg with minor changes; 66 batches of Piracetam 400mg with major changes; 473 batches of Methorphan; 11 batches of Nostravin; 50 batches of Loratadin 10mg; and 21 types of drugs using talc powder.
However, based on Traphaco's explanatory report dated September 30th, at the time the administrative violation report was drawn up on September 24th, the number of drug batches still within the statute of limitations for penalties was determined to be as follows: 2 batches of Piracetam 400mg with minor changes; 26 batches of Piracetam 400mg with major changes; 242 batches of Methorphan; 4 batches of Nostravin; 23 batches of Loratadin 10mg; and 20 types of drugs using talc powder.
In addition to the 160 million VND fine, the decision did not impose any further penalties. Traphaco is responsible for paying the fine within 10 days of receiving the decision. The company also has the right to appeal or file an administrative lawsuit against this decision in accordance with the law.