Legal Alert : Updates to Good Distribution Practices of Pharmaceutical Products

/ / 2019, Legal News 2019

Recently, the National Agency of Food and Drug Control (“BPOM”) issued BPOM Regulation No. 9 of 2019 on Technical Guideline for Good Distribution Practices for Drug (“BPOMR 9/2019”) which was applied on 22 May 2019. BPOMR 9/2019 provides updates to technical guideline surrounding good distribution practices of commercial drugs (GDP), which is commonly known in Indonesia as CDOB (stands for Cara Distribusi Obat yang Baik).

CDOB Guideline set forth that parties engaging in the pharmaceutical industry must meet certain standards in order to ensure the quality of pharmaceutical products is well maintained throughout the whole process of the supply chain. In general, compliance with CDOB ensures, among others: medicines are stored in proper conditions and are of good quality all the time (including during transportation), quality control is implemented, contamination is avoided, products are being distributed properly to the customers within a satisfactory time period and an effective recall procedure is implemented.

In Indonesia, CDOB has been formally regulated since 2012 through Head of BPOM Regulation No.HK.03.1.34.11.12.7542 of 2012 on Technical Guideline of Good Distribution Practice for Drug and Head of BPOM Regulation No. 40 of 2013 on Management Guideline for Pharmaceutical Precursor and Drug Containing Pharmaceutical Precursor, which were later revoked by BPOMR 9/2019. Through this new regulation, provisions related to CDOB in the previous two regulations have essentially been merged.

BPOMR 9/2019 combines CDOB for drug and pharmaceutical precursor in one guideline and simplifies it. Through BPOMR 9/2019, pharmaceutical manufacturers, government supply installations, wholesalers and its branch offices are obliged to implement CDOB in accordance with the CDOB Guideline during procurement, storage and distribution of drug and/or its ingredients. Under this new regulation, pharmaceutical businesses that are required to implement CDOB shall obtain a CDOB Certificate.

One of the highlights under BPOMR 9/2019 is related to the distribution method of narcotics and psychotropic drugs. This change was made by considering that provisions of the distribution of narcotics and psychotropic drugs in the previous CDOB were no longer suitable with existing practices and industry standards.

Distribution Method of Pharmaceutical Precursor

The term “pharmaceutical precursor” refers to initial substances, materials or chemicals that can be used as raw/auxiliary materials for production processes within the pharmaceutical industry or intermediate products, bulk products and finished products containing ephedrine, pseudoephedrine, norephedrine/phenylpropanolamine, ergotamine, ergometrine, or potassium permanganate. To clarify, pharmaceutical precursors or its substances have a high-risk of being misused, as the ingredients are utilized to manufacture illegal narcotics and psychotropic drugs.

Prior to the issuance of BPOMR 9/2019, BPOM regulated pharmaceutical precursors separately under BPOM Reg 40/2013. Therefore, currently BPOMR 9/2019 treats the distribution of pharmaceutical precursors equally as distribution of narcotics and psychotropic drugs. Correspondingly, the obligation to obtain a CDOB certificate for the distribution of narcotics and psychotropic drugs also applies to pharmaceutical precursors.

Administrative Sanctions

Under previous regulations, the administrative sanction only applied to violations committed by a pharmaceutical wholesaler or its branches against the CDOB Guideline. BPOMR 9/2019 provides stronger sanctions for pharmaceutical businesses that are required to implement CDOB. If pharmaceutical businesses fail to obtain a CDOB Certificate, it can be subject to receiving a written warning or temporary suspension of activities.

Further, a CDOB Certificate can be revoked in the event of the following:

  1. incompliance with CDOB Guideline which leads to the misuse or improper distribution of drug and/or medicinal ingredients; or
  2. pharmaceutical wholesaler or its branches intentionally carries out actions that result in the non-performance of CDOB Guideline.

Conclusion

BPOMR 9/2019 provides simplified CDOB Guideline, yet stricter rules and sanctions, for pharmaceutical companies required to implement CDOB in their respective business processes. From a compliance perspective, we hope such changes ensure local pharmaceutical businesses fully adhere with the regulation to ensure the quality and safety of commercial drugs.

Please contact us, should you wish to know more about this new CDOB Guideline.

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