Technical Guidelines for Drug Distribution UpdatedThe new guidelines now incorporate guidelines for pharmaceutical precursors under a single framework, whereas said guidelines were previously separated from guidelines for pharmaceutical and/or medicinal ingredients.
As an effort to ensure improved safety, efficacy and quality of all drugs and pharmaceutical products which are distributed within the marketplace, the National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan – “BPOM”) recently issued Regulation No. 9 of 2019 on Technical Guidelines for Good Drug Distribution Practices (“Regulation 9/2019”), which updates the previous set of technical guidelines for the implementation of good drug distribution practices (Cara Distribusi Obat yang Baik – “CDOB”).
Previously, the abovementioned guidelines were specifically addressed under the following regulations:
1. Regulation of the Head of the BPOM No. HK.03.1.34.11.12.7542 of 2012 on Technical Guidelines for Good Drug Distribution Practices (“Regulation 2012”); and
2. Regulation of the Head of the BPOM No. 40 of 2013 on Guidelines for the Management of Pharmaceutical Precursors and Drugs Containing Pharmaceutical Precursors (“Regulation 40/2013”).
Scope of CDOB
In principle, all parties which engage in the distribution of drugs and/or pharmaceutical ingredients are responsible for the following:
1. The quality of distributed drugs and/or medicinal ingredients; and
2. The integrity of the distribution chain.
In line with these principles, Regulation 9/2019 requires pharmaceutical wholesalers (including their branches) and government pharmaceutical supply installations (Instalasi Sediaan Farmasi) to implement technical CDOB guidelines when procuring, storing and distributing drugs and/or medicinal ingredients, including any biological products which are intended for use in humans. In addition to the abovementioned parties, these guidelines also apply to pharmaceutical manufacturing business which is engaged in drug distribution activities.
In general, the technical CDOB guidelines encompass a broad scope of activities, including the following:
1. Quality management;
2. Organization, management, and human resources;
3. Buildings and equipment;
6. Complaints and management of drugs and/or medicinal ingredients which are returned, alleged to be fake or recalled;
8. Distribution facilities based on contracts;
10. Special provisions which relate to the following:
a. Medicinal ingredients;
b. Gold chain products: and
c. Narcotics, psychotropics and pharmaceutical precursors.
As background information, pharmaceutical precursors are substances, starting materials or chemicals which may be used as raw/supporting materials for:
1. The manufacturing processes of pharmaceutical Businesses; or
2. The manufacturing of intermediate products (Produk Antara), semi-finished products (Produk Ruahan) and finished products (Produk Jadi) which contain ephedrine, pseudoephedrine, norephedrine/phenylpropanolamine, ergotamine, ergometrine or potassium permanganate.
Prior to the introduction of Regulation 9/2019, guidelines for the distribution of pharmaceutical precursors and drugs containing pharmaceutical precursors by pharmaceutical wholesalers were not incorporated into the official guidelines for the distribution of drugs and/or medicinal ingredients. However, the two sets guidelines have now been merged under Regulation 9/2019 and thus the distribution of pharmaceuticals precursors are now to be treated in the same manner as the distribution of narcotics and psychotropics.
In addition to this merging of guidelines, Regulation 9/2019 now incorporates pharmaceutical manufacturing business as part of the official list of parties which are subject to the mandatory implementation of technical CDOB guidelines. This was not previously the case under Regulation 2012.
Administrative Sanctions for Non-Compliance
Regulation 9/2019 states that pharmaceutical wholesalers and their branches must obtain CDOB certification from the Head of the BPOM. This certification is to be issued in accordance with the provisions which are set out under Regulation of the Head of BPOM No. 25 of 2017 on Procedures for the Certification of Good Drug Distribution Practices. Possession of such certificates proves that the parties in question have properly implemented the technical CDOB guidelines.
Meanwhile, Regulation 9/2019 does not specifically address the abovementioned requirement for government pharmaceutical supply installations and pharmaceutical manufacturing business. However, Regulation 9/2019 clarifies that pharmaceutical wholesalers, branches of pharmaceutical wholesalers, government pharmaceutical supply installations and pharmaceutical manufacturing business will be subject to administrative sanctions for failing to:
1. Implement the technical CDOB guidelines; and
2. Prove the implementation of the technical CDOB guidelines.
Administrative sanctions are to be imposed by the Head of the BPOM and may take the following forms:
1. Written reprimands;
2. Suspension of activities; and/or
3. Revocation of CDOB certificates, specifically for any of the following violations;
a. Misconduct in implementing the CDOB technical guidelines which result in the misuse of drugs and/or medicinal ingredients distribution activities; or
b. Intentional actions were undertaken by pharmaceutical wholesalers or their branches which result in the technical guidelines not being implemented.
With the exception of a new provision which states that pharmaceutical manufacturing business is to be included as a part of the list of parties which are subject to the administrative sanctions, Regulation 9/2019 and Regulation 2012 essentially set out the same provisions as regards this matter.
Regulation 9/2019 came into force on 22 May 2019 and simultaneously repealed and replaced Regulation 2012 (in its entirety) and Regulation 40/2013 (for provisions which are related to the management of pharmaceutical precursors and/or drugs containing pharmaceutical precursor by pharmaceutical wholesalers only).”