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July 12: Pharmaceutical companies across the country will be operated under good manufacturing practice (GMP) model. “Preparations are underway so that all pharmaceutical companies will be operated under the GMP model within mid-October,” said Balkrishna Khakurel, Director General of Department of Drug Administration (DDA). The industries will be shut down by the government if they do not comply with GMP model by the given period.
Though the DDA had announced deadlines to implement the GMP model in the past, not all industries were able to follow the drug market regulator’s decision. “The entire industry will come under GMP model this time,” he said. The exercise to implement the GMP model in Nepal started in 2008.
According to DDA, currently 36 pharmaceuticals and one ayurvedic medicine manufacturer are following the model. “Around 44 industries have received the GMP certificate,” claimed Khakurel.
There are 50 allopathic pharmaceutical industries operating in Nepal at present. Khakurel informs that the remaining companies have also submitted application for GMP certificates. “Due to the lack of infrastructure, it was not being possible for the government to bring all the pharmaceutical industry under GMP in past,” he said. However, the department claims that now the industries are capable to follow the practice.
According to DDA, pharmaceuticals companies are required to follow GMP practices as a new directive based on the pharmaceutical production has already been issued.
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