The Indonesian Food and Drug Monitoring Agency (BPOM) has launched an initiative called the e-Labeling Pilot Project which certainly will make a significant impact in the healthcare industry.
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Current labelling and packaging regulations
Pharmaceutical products must comply with specific labelling and packaging requirements, including information on indications, dosage, contraindications, and precautions. BPOM’s regulations also govern the use of product inserts and patient information leaflets.
Market overview
Indonesia’s pharmaceutical market is the largest in the Southeast Asia region. Sales of medicines in Indonesia were valued at Rp 110.6 trillion (roughly US$7.6 billion) in 2020 and are forecasted to expand to Rp 176.3 trillion by 2025, according to US-based Fitch Ratings.
For the last 10 years, the country’s pharmaceutical market has been one of the fastest growing in the SEA region.
This is driven by both the country’s massive market of over 265 million people – the fourth largest population in the world – as well as the expansion of healthcare access via the government’s universal healthcare program enacted in 2014.
Traceability requirements
The project aims to revolutionize the labelling system for medical products by integrating it with 2D barcodes, specifically QR codes, which will serve both as a means of Track and Trace solution and as an e-Labeling service.
What are the phases?
Now, this pilot project, which is set to span two years, will be carried out in three distinct phases.
- Phase I for Vaccine and Injection
The first phase, scheduled to take place from the first to the third month, will focus on vaccines and injections. - Phase II for Rx drugs including Vaccine & Injection
The second phase, spanning from the fourth to the sixth month, will encompass prescription drugs, including vaccines and injections. - Phase III for OTC and Rx drugs including Vaccine & Injection
the third phase, covering the seventh to the twenty-fourth month, will include over-the-counter (OTC) drugs, as well as prescription drugs, including vaccines and injections.
Conclusion
The e-Labeling pilot project spearheaded by BPOM presents an exciting opportunity for companies to embrace technological advancements and actively engage in the modernization of the healthcare industry.
By integrating 2D barcodes and e-Labeling, this initiative promises to enhance product tracking, improve consumer safety, and streamline regulatory processes. It is an excellent opportunity for companies to demonstrate their commitment to innovation and contribute to the growth and development of the Indonesian pharmaceutical landscape.
It is important for pharmaceutical companies operating in Indonesia to stay updated with the evolving regulations and guidelines set by BPOM. Compliance with these regulations is essential to ensure the safety, quality, and efficacy of pharmaceutical products in the Indonesian market.
Source:
https://business-indonesia.org/pharmaceuticals
