Indonesia has a strong generic drugs sector that accounts for 80% of the entire Rx market, of which Rx and OTC products make up 70% and 30%, respectively. In recent years, the OTC segment has exhibited a steady growth, attributed to the increasing amount of self-medication and accessibility to more affordable drugs. Add in the sheer size of its population, and you know:
Indonesia simply cannot be dismissed.
Of the 200-300 drug companies that operate in the Indonesian market, approximately 40 are foreign-owned, and there are numerous food supplement, cosmetic and medical remedy players. Of the overall pharmaceutical market in Indonesia, foreign drug-makers constitute around 30%. Despite concerns about counterfeiting and the low efficacy of generic products, the IP protection and GMP manufacturing standards in Indonesia are improving with effective national regulations, foreign investments and joint ventures with multi-national companies. A limited number of foreign chain pharmacies can be found in most major cities in Indonesia; these include Guardian, Watsons and Century Healthcare. There are also many privately owned local pharmacies (apotik). One of the better privately owned chains is Apotik Melawai, which is based in Jakarta.
The National Agency of Drug and Food Control (NA-DFC) is responsible for the regulation of pharmaceutical products and drugs in Indonesia. The primary duties of the NA-DFC include pre-market evaluations, legislation, regulation, standardisation and GMP certification of medical products.
A drug registration application can only be undertaken by pharmaceutical companies located in Indonesia, and this must go through a pre-registration process, which can take up to 40 working days. This process involves a consultation on the completion of a registration dossier, as well as paying document and registration fees. Companies based outside Indonesia need to find a good local partner they can trust to conduct the registration process on their behalf.