Dexa Medica today received another award from the National Agency of Drug and Food Control (BPOM) for its Pharmacovigilance in the category of Domestic Company. The award was presented by the Head of National Agency of Drug and Food Control, Penny Lukito to the Director of Scientific and Business Development Dexa Medica, Raymond Tjandrawinata in a workshop on “The effectiveness of Drug and Food Control through Synergy with Industry Players” at Hotel Arya Duta Bandung, 30 October 2018.
The award ceremony was also attended by the Manager of Risk Management and Clinical Review, Dwi Nofiarny and Head of Corporate Communications Dexa Group, Sonny Himawan. Dexa Medica won the Pharmacovigilance Award for the company’s achievement as a pharmaceutical company with excellent compliance in conducting drug safety supervision or also known as pharmacovigilance.
The pharmacovigilance for Dexa Medica has been in compliance with the Regulation of the Head of National Agency of Drug and Food Control Number HK.03.1.23.12.11.10690 Year 2011. Furthermore, Dexa Medica has carried out pharmacovigilance since 2003 or long before the regulation came into force.
According to legal regulations, the reports on pharmacovigilance consist of spontaneous reporting, post-marketing periodicals, post-marketing safety studies, scientific publications/literature, regulatory follow-up to other country’s regulatory authorities, follow-up to marketing authorization holders in other countries, and/or reporting from risk management planning.
Data from the National Agency of Drug and Food Control has recorded an increase in the number of reports of Adverse Events/Drug Side Effects (ESO) from health workers and the pharmaceutical industry in Indonesia every year since regulations regarding Pharmacovigilance issued. According to the data analysis conducted by the Directorate of Safety, Quality, and Export Import of Drugs, Psychotropic Narcotics, Precursors and Addictive Substances in March 2018, out of a total of 206 pharmaceutical industries in Indonesia, there are 105 industries that have reported pharmacovigilance to the National Agency of Drug and Food Control.
“Health sector is an important and strategic economic development driver for producing food, medicines, traditional medicines and supplements, hence we need to consistently increase its quality and effectiveness. This is in line with the National Agency of Drug and Food Control’s commitment to embrace the 5th and 7th Nawacita (Indonesia government’s key development programs), which is improving the quality of human life and realizing economic independence by supporting strategic industry,” said Penny.
PT Dexa Medica received the award for its excellent compliance and initiative in conducting pharmacovigilance. Raymond Tjandrawinata said that the acknowledgement is a testament to Dexa’s commitment to be in compliance with the regulations of the pharmaceutical industry in Indonesia.
“Pharmacovigilance is very important for pharmaceutical practice in order to ensure quality and safety. Dexa always prioritizes these two essential aspects following the instruction from our founder, Rudy Soetikno. Thus, Dexa Group’s pharmacovigilance team has partnered up with the National Agency of Drugs and Food Control in many areas including speaking and appearances in events related to pharmacovigilance regulations,” said Raymond. Corporate Communications Dexa Medica