Digital Leaflets in Indonesia

Indonesia is taking a significant step toward digital innovation in healthcare by introducing eLeaflets or electronic labelling (e-labelling) for medicinal products. This move, spearheaded by the Indonesian Food and Drug Authority (BPOM), aims to modernise the way drug information is disseminated to healthcare professionals and the public. With the issuance of the Decree of the Indonesian FDA Chairperson No. 317 of 2023, the nation has officially embarked on a two-year pilot project to implement e-labelling across various pharmaceutical products.

What is E-Labelling?

E-labelling refers to the electronic version of drug information, accessible via two-dimensional (2D) barcodes printed on product packaging. By scanning these barcodes with the BPOM Mobile application or visiting the website cekbpom.go.id, users can easily access up-to-date product details. This system provides an efficient and sustainable alternative to traditional paper inserts.

The E-Labelling Pilot Project

The pilot project (ref. Tingkatkan Kemudahan Akses Informasi Obat, BPOM Lakukan Pilot Project E-labelling Obat di Indonesia ) is scheduled from December 2023 to November 2025 and is divided into three stages:

1. Stage 1 (December 2023 - February 2024): Focused on 24 vaccine and injection products.
2. Stage 2 (March 2024 - May 2024): Expanded to include 54 prescription drugs.
3. Stage 3 (June 2024 - November 2025): Full implementation across vaccines, injections, prescription drugs, and over-the-counter (OTC) products.

The primary goal of the pilot project is to streamline the distribution of drug information while reducing paper usage and improving accessibility.

Legal and Regulatory Framework

The pilot project is supported by the Decree of the Head of BPOM Number 317 of 2023. This decree outlines the need to protect the public from substandard drugs and food, while promoting the use of information technology for efficient drug labelling. The decree mandates pharmaceutical companies to upload the most recent drug information, which will be accessible via 2D barcodes.

The decree also establishes the regulatory foundation based on various existing rules, including:

• Presidential Regulation No. 80 of 2017: Governing BPOM's responsibilities.
• BPOM Regulation No. 24 of 2017: On drug registration criteria and procedures.
• BPOM Regulation No. 22 of 2022: On 2D barcode implementation for drug supervision.

How to implement e-labelling in Indonesia

In order to implement an eLeaflet solution in Indonesia Pharmaceutical industries must comply with the following requirements:

a. upload the latest approved product information through the BPOM Track and Trace application; b. update the product information within 3x24 hours after any approval for changes; c. submit initial production plans for drugs involved in the pilot project; d. provide a brief report on the number of batches and products manufactured in the last year; e. submit quarterly production reports for drugs in the pilot project; f. provide a distribution plan for drugs included in the pilot project at least one month before implementation; g. educate healthcare professionals and consumers about the use of e-labeling; h. conduct monthly monitoring and evaluation of the pilot project's implementation; i. ensure proper risk management and mitigation; j. report monitoring, evaluation, and mitigation results to the National Agency of Drug and Food Control.

Key Players and Their Roles

• BPOM: Responsible for system infrastructure, content approval, and evaluation.
• Pharmaceutical Industry: Tasked with educating healthcare professionals and patients, monitoring the system's performance, and reporting outcomes.
• Healthcare Professionals and the Public: Expected to engage with the new system, provide feedback through surveys, and help educate others about its use.

Pharmaceutical Companies Involved

The pilot project involves several key pharmaceutical players, including: • PT Combiphar • PT Pfizer Indonesia • PT Kalbe Farma • PT AstraZeneca Indonesia • PT Dexa Medica

These companies are required to provide regular reports, conduct public education, and ensure the accuracy of the electronic information.

Early Results and Insights

The initial results from Stage 1 are promising: • 66.7% of the targeted products successfully implemented e-labelling. • 94% of these products were accessed through the BPOM Mobile application. • 7 out of 24 companies reported a notable reduction in paper usage.

Challenges and Future Directions

Despite these achievements, several challenges remain: • Limited public awareness and adoption. • Technical difficulties with scanning and accessing information. • Inconsistent coverage in remote areas.

To address these issues, BPOM is committed to enhancing infrastructure, increasing public awareness, and ensuring continuous system improvements.

Conclusions

The introduction of e-leaflets marks a transformative period in Indonesia's pharmaceutical landscape. By embracing digital solutions, BPOM is not only promoting efficiency but also aligning with global trends in healthcare information dissemination. As the project progresses, the success of e-labelling in Indonesia will depend heavily on collaboration between regulators, the pharmaceutical industry, healthcare professionals, and the public.

For more information you can visit the BPOM's official website.

Sources

•   BPOM Regulation No. 24 of 2017
•   BPOM Regulation No. 22 of 2022
•   Decree of the Head of BPOM Number 317 of 2023

Decree of the Head of BPOM Number 317 of 2023

“HEAD OF THE NATIONAL AGENCY OF DRUG AND FOOD CONTROL REPUBLIC OF INDONESIA DECISION OF THE HEAD OF THE NATIONAL AGENCY OF DRUG AND FOOD CONTROL NUMBER 317 OF 2023 REGARDING THE IMPLEMENTATION OF THE PILOT PROJECT FOR E-LABELLING BY THE GRACE OF GOD ALMIGHTY THE HEAD OF THE NATIONAL AGENCY OF DRUG AND FOOD CONTROL,

Considering: a. that the public needs to be protected from drugs and food products that do not meet the standards and/or requirements for safety, efficacy, and quality; b. that to support innovation in drug labelling as regulated in the Regulation of the Head of the National Agency of Drug and Food Control Number 24 of 2017 concerning the Criteria and Procedures for Drug Registration, as amended by the latest Regulation Number 15 of 2023, which aligns with scientific and technological advancements in drug manufacturing, a pilot project for electronic labelling based on systematic information technology is necessary to enhance the effectiveness and efficiency of drug supervision before and during circulation; c. that based on the considerations mentioned in points a and b, it is necessary to establish a Decision of the Head of the National Agency of Drug and Food Control regarding the Implementation of the Pilot Project for E-Labelling; Referring to:

1. Presidential Regulation Number 80 of 2017 concerning the National Agency of Drug and Food Control (State Gazette of the Republic of Indonesia Year 2017 Number 180);
2. Regulation of the Head of the National Agency of Drug and Food Control Number 24 of 2017 concerning the Criteria and Procedures for Drug Registration (State Gazette of the Republic of Indonesia Year 2017 Number 1692) as amended by the latest Regulation Number 15 of 2023 (State Gazette of the Republic of Indonesia Year 2023 Number 559);
3. Regulation Number 21 of 2020 concerning the Organisation and Working Procedures of the National Agency of Drug and Food Control (State Gazette of the Republic of Indonesia Year 2020 Number 1002), as amended by Regulation Number 13 of 2022 (State Gazette of the Republic of Indonesia Year 2022 Number 629);
4. Regulation Number 22 of 2022 concerning the Implementation of 2D Barcodes in the Supervision of Drugs and Food (State Gazette of the Republic of Indonesia Year 2022 Number 1021);
5. Regulation Number 19 of 2023 concerning the Organisation and Working Procedures of Technical Implementation Units within the National Agency of Drug and Food Control (State Gazette of the Republic of Indonesia Year 2023 Number 611). DECIDES: To stipulate: THE DECISION OF THE HEAD OF THE NATIONAL AGENCY OF DRUG AND FOOD CONTROL REGARDING THE IMPLEMENTATION OF THE PILOT PROJECT FOR E- LABELING First: Implement the pilot project for e-labeling for pharmaceutical industries as listed in Annex I, which is an integral part of this Decision. Second: The e-labeling pilot project is a trial activity for implementing electronic drug labels to assess the effectiveness and impact of e-labeling for the government, business operators, healthcare professionals, and consumers. Third: E-labeling, as referred to in the second dictum, is an electronic label containing product information for healthcare professionals and patients, accessible through a 2D barcode scan in accordance with the applicable regulations, using the BPOM Mobile application. Fourth: For drug products that have not implemented 2D Barcode authentication, e-labeling containing product information for healthcare professionals and patients can be accessed via the product's registration number using the BPOM Check application. Fifth: The drugs included in the e-labeling pilot project are over-the-counter drugs, limited over-the- counter drugs, and prescription drugs listed in Annex II, which is an integral part of this Decision. Sixth: The product information for healthcare professionals and patients, as referred to in the third dictum, must reflect the latest information approved by the National Agency of Drug and Food Control. Seventh: Pharmaceutical industries participating in the pilot project must provide both e-labeling and printed product information for over-the-counter and limited over-the-counter drugs. Eighth: For prescription drugs, pharmaceutical industries must implement e-labeling and may provide printed product information. Ninth: To support the pilot project, the National Agency of Drug and Food Control will provide: a. an upload module for product information through the e-labeling feature in the BPOM Track and Trace application; and b. display access for product information to healthcare professionals and patients via the BPOM Mobile and BPOM Check applications. Tenth: Pharmaceutical industries must comply with the following requirements: a. upload the latest approved product information through the BPOM Track and Trace application; b. update the product information within 3x24 hours after any approval for changes; c. submit initial production plans for drugs involved in the pilot project; d. provide a brief report on the number of batches and products manufactured in the last year; e. submit quarterly production reports for drugs in the pilot project; f. provide a distribution plan for drugs included in the pilot project at least one month before implementation; g. educate healthcare professionals and consumers about the use of e-labeling; h. conduct monthly monitoring and evaluation of the pilot project's implementation; i. ensure proper risk management and mitigation; j. report monitoring, evaluation, and mitigation results to the National Agency of Drug and Food Control.Eleventh: The e-labeling pilot project will proceed in the following phases: a. preparation phase (within three months after the Decision's issuance); b. implementation phase (for two years after the preparation phase), consisting of:
6. first phase: months 1 to 3 for prescription drugs such as vaccines and injectables;
7. second phase: months 4 to 6 for other prescription drugs;
8. third phase: months 7 to 24 for prescription drugs, limited over-the-counter drugs, and over- the-counter drugs. c. data collection phase (during and three months after implementation); d. quarterly data analysis and evaluation; e. interim summary after phase completion; f. final reporting within one month after data collection ends. Twelfth: Upon completion of the pilot project, labeling requirements will revert to the existing drug registration regulations. This Decision comes into effect on the date of issuance. Issued in Jakarta, on September 1, 2023 HEAD OF THE NATIONAL AGENCY OF DRUG AND FOOD CONTROL PENNY K. LUKITO Annex I: LIST OF PHARMACEUTICAL INDUSTRIES PARTICIPATING IN THE PILOT PROJECT FOR E-LABELING
9. PT Combiphar
10. PT Soho Industri Pharmasi
11. PT Pfizer Indonesia
12. PT Merck Tbk
13. PT Otsuka Indonesia
14. PT Abbott Indonesia
15. PT Novartis Indonesia
16. PT Hexpharm Jaya
17. PT Finusolprima Farma Internasional 10.PT Global Onkolab Farma 11.PT Aventis Pharma / PT Kalventis Sinergi Farma 12.PT AstraZeneca Indonesia 13.PT Glaxo Wellcome Indonesia 14.PT Organon Pharma Indonesia 15.PT Kalbe Farma 16.PT Pyridam Farma 17.PT Mega LifeSciences Indonesia 18.PT Sejahtera Lestari Farma 19.PT Yarindo Farmatama 20.PT Dipa Pharmalab Intersains 21.PT Taisho Pharmaceutical Indonesia 22.PT Integrated Healthcare Indonesia (J&J) 23.PT Darya-Varia Laboratoria Tbk.24.PT Dexa Medica 25.PT Actavis Indonesia 26.PT Sterling Products Indonesia 27.PT Holi Pharma 28.PT Ifars Pharmaceutical PENNY K. LUKITO”