The Government has submitted a draft law on Drug and Food Supervision (“Bill“) to the House of Representatives, just in time following the recent uncovering of the counterfeit vaccine and drugs scandal. The Bill has been included in the 2015-2019 National Legislative Program, even though it is not placed in the priority category for the year 2016.
Serving as an umbrella for regulations on supervision of foods and drugs, the Bill covers a wide range of aspects of the supervision, among others:
c. Export and Import;
d. Promotion and Advertising;
e. Laboratory Testing, Recalls and Disposal;
f. Liabilities; and
g. Criminal Sanction.
The following is noteworthy:
- Pursuant to its definition, “Drugs and Foods” includes: (i) Drugs, (ii) Drug Raw Materials, (iii) Herbal Drugs, (iv) Herbal Extracts, (v) Cosmetics, (vi) Health Supplements, and (vi) Processed Foods (including packaged foods and ready-to-serve foods).
- The Bill shows the government’s intention to expand and strengthen the role and authority of the National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan or “BPOM”). Under the Bill, BPOM replaces the role of the Ministry of Health in granting Pharmaceutical Manufacturing Licenses (Izin Industri Farmasi), Pharmaceutical Wholesaler Licenses (Izin Pedagang Besar Farmasi), and Cosmetic Manufacturing Licenses (Izin Industri Kosmetik). Processed foods manufacturing licenses are still granted by referring to the Industrial Business License issued by the Ministry of Industry.
- The BPOM will maintain its current role as issuer of Drugs and Foods marketing authorization (izin edar).
- The Bill emphasizes the previous BPOM requirement that the information stated on drug and food product labels be objective, comprehensive, correct and not misleading.
- The Bill stipulates the following drug distribution channeling:
Pharmaceutical industries a. Pharmaceutical wholesalers; and
b. Governmental pharmaceutical stock storage facilities.
Pharmaceutical wholesalers a. Other pharmaceutical wholesalers;
c. Governmental pharmaceutical stock storage facilities;
d. Hospital pharmaceutical facilities;
e. Clinic pharmaceutical facilities;
f. Drugstore, except for prescribed drugs; and
g. Scientific institutes
Governmental pharmaceutical stock storage facilities a. Other governmental pharmaceutical stock storage facilities;
b. Government-hospital pharmaceutical facilities;
c. Public Health Centers (Puskesmas); and
d. Clinic pharmaceutical facilities.
- The Bill allows online distribution of Drugs and Foods, provided that the licensing, manufacturing and labeling standards and requirements are complied with. However, it is still unclear as to whether there are restrictions on the online distribution, given the restrictive nature of prescribed drugs.
- In addition to the usual import licenses (API), Drugs and Foods exporters and importers are required to obtain an export/import certificate (Surat Keterangan Impor) from the BPOM.
- The promotion and advertising of Drugs and Foods products require the approval of BPOM. The scope of BPOM’s authority in this is still unclear.
- Marketing authorization holders are obliged to recall Drugs and Foods products (i) which do not meet the standards and/or (ii) which marketing authorization is revoked. The Head of BPOM has the authority to announce Drugs and Foods products which are being recalled from circulation.
- Drugs and Foods manufacturers must ensure the safety, quality and efficacy of their products. Failing to do so may cause the manufacturer to face a tort claim.
- The sanctions imposed on corporations for violations of certain responsibilities, obligations or requirements under this draft law are 3 (three) times heavier than the sanctions for the same violations imposed on individuals.
The Bill is currently being deliberated between the Government and the House of Representatives. When it has become a law, its implementing regulations will still need to be issued by the BPOM.