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PT Kalbe Farma Tbk, PT Merck Tbk, and PT Kimia Farma (Persero) Tbk.


Behn Meyer Kimia, PT 2. PT. Anugerah Pharmindo Lestari 3. PT. Ciubros Farma 4. Kimia Farma, PT 5. Kalbe Farma Tbk, PT 4 6. Pyridam Farma Tbk, PT 7. Saka Farma Laboratories, PT 8. Rias Sukses Dinamika, PT 9. PT. Songgolangit Herbal Indonesia, 10. PT. Sido Muncul 11. PT. Nyonya Meneer 12. Abbott Indonesia, PT 13. PT. Afiat Industri Farmasi 14. PT. Combiphar 15. PT. Errita Pharma 16. PT. Gracia Pharmindo 17. PT. Medion Indonesia 18. PT. Otto Pharmaceutical Industries 19. PT. Rohto Laboratories Indonesia 20. PT Bayer Indonesia Tbk 21. PT Dipa Pharmalab Intersains 22. Darya-Varia Group 23. PT Boehringer Ingelheim Indonesia 24. PT Phapros 25. PT Erela 26. PT Bernofarma 27. PT. Bio Farma (Persero) 28. Dexa Medica, PT 29. Eisai Indonesia, PT 30. Ethica, PT (Industri Farmasi) 31. Graha Farma, PT 32. Gratia Husada Farma, PT 33. Guardian Pharmatama, PT 34. Hexpharm Jaya, PT 35. Ikapharmindo Putramas, PT 36. P.T. Distriversa Buanamas 37. PT Soho Industri Pharmasi 38. Indofarma PT 39. Interbat, PT 40. Konimex Pharm. Laboratories, PT 41. Landson, Pertiwiagung, PT 42. PT. Lapi Laboratories 43. PT. Mahakam Beta Farma 44. Mecosin Indonesia, PT 45. PT Meprofarm Pharmaceutical Industries 46. Merck Indonesia, PT 47. Molex Ayus, PT 48. Novartis Biochemie, PT 49. PT. Otsuka Indonesia 50. PT Pfizer Indonesia 51. Pharos Indonesia, PT 52. PT. Phytokemo Agung Farma 53. Pyridam, PT 54. PT. Roche Indonesia 55. Saka Farma Laboratories, PT 56. PT. Takeda Indonesia 57. Tempo Group 58. PT. Supra Ferbindo Farma 59. PT Triyasa Nagamas Farma 60. Tunggal Idaman Abdi Pharmaceutical

Enterprises, PT 61. Universal Pharm Industries, PT 62. PT. Bima Mitra Farma

Kalbe Pharma Indonesias largest domestic drug manufacturer holds 15 percent of market share. Together, Bayer, Pfizer and GlaxoSmithKline hold 8 percent of market share.

Indonesias industry association for foreign drug manufacturers the International Pharmaceutical Manufacturers Group (IPMG)

Entering the market According to Indonesias 2008 Ministry of Health Decree on the Registration of Drugs, the following regulations became offi cial at the end of 2010: Almost all pharmaceutical products registered in In donesia must be manufactured in country. The only exceptions are patented products and drugs that cannot be manufactured in Indonesia. Foreign applicants for product registration must have an Indonesian manufacturing facility or appoint an intermediary. Product registration In order to register a drug in Indonesia, applicants must submit their materials to the National Agency of Drug and Food Control (NADFC). The NADFC is responsible for pre-market evaluation of pharmaceutical products, regulations, standardization and GMP certification. Drugs are evaluated based on their risk, quality, safety and efficacy, as well as the needs of the Indonesian public. All drugs are divided into four classes: Narcotics (Category O) Prescription medicines (Category G) OTC medicines with warning labels (Category W) General OTC products (Category F) If the applicant is not the product license holder (for example, if the applicant is an Indonesian drug manufacturer filing on behalf of a foreign pharmaceutical company), they must provide written authorization from the foreign manufacturer. In addition, applicants must provide: A manufacturing license A valid GMP certificate Data from the last GMP inspection A drug master file (in the case of new chemical entiti es, first generic drugs and generics for serious illnesses such as cancer or cardiovascular disease) A manufacturing site master file Other documentation, as required Applicants are required to follow the ASEAN Common Technical Documents (CTD) format in order to be certified. They must also adhere to ASEAN standards in the case of non-clinical and clinical studies, product specification, stability studies, bioequivalent studies and GMP standards.

, "More and more foreign drug companies are looking to Indonesia for future profits." , Drug registration can take anywhere from one to three years. According to the NADFC, the evaluation of export-only drugs and me-too drugs takes 40 working days. It takes 100 working days for NADFC to evaluate orphan drugs and drugs that require local clinical trials. It takes 150 working days to evaluate drugs with new indications and drugs that have already been marketed in other ASEAN countries. Finally, it takes NADFC 300 working days to evaluate new drugs, biological and biotherapeutic products not covered in the other categories. Labeling and advertising All pharmaceutical products sold in Indonesia must state their chemical or generic name along with their brand name on the packaging. In addition, they must bear labels declaring whether they contain non-halal (non-porcine) materials or have undergone processes that encounter nonhalal materials. OTC medicines must be labeled in Indonesian. The NADFC regulates all drug advertising and approves all advertising materials. While general OTC medicines can be advertised (as long as they include required warning labels), there is a ban on direct to customer advertising for prescription medicines. Further, the NADFC regulates spending limits on the promotion of pharmaceutical products. Distribution and pricing The distribution of drugs takes place through wholesalers, who sell to both pharmacies and hospitals. Wholesalers distribute their products through Indonesias 11,000 pharmacies and 7,000 registered outlets. In addition, they also distribute OTC medications through Indonesias 1.9 million retail outlets. Currently, wholesale licenses in Indonesia do not expire. After June 28, 2013, they will be valid for only five years. Wholesalers in Indonesia typically mark up factory prices by about 10 percent. Retail outlets then raise drug prices another 2030 percent over wholesale prices. Most generic pricing is controlled by a series of national regulations. Drugs on Indonesias Essential Drug List have a maxim um retail margin of 50 percent. Special, quality assured generics (called OGB generics) have regulated retail prices. Prices are set at the same low levels throughout Indonesia, irrespective of transport and inventory holding costs. To further curb rising healthcare costs, the Indonesian government passed a law in January 2010 that requires doctors at all state run medical facilities to prescribe unbranded generics whenever possible. Foreign companies in Indonesia More and more foreign drug companies are looking to Indonesia for future profits. Despite restrictions on manufacturing and ownership, more than 50 international pharmaceutical companies have business in Indonesia. Wyeth, Sanofi and Merck all have a considerable presence in the country. In October 2012, Merck opened a $21 million packaging plant in Indonesia. It expects annual sales in the country to go up 13 18 percent in 2013. Other Western companies, like Novo Nordisk and Novartis, are heavily engaged in community outreach and education activities. For example, Novo Nordisk recently launched an extensive diabetes education campaign for doctors, healthcare professionals and the public. Novartis is running a similar program for communicable diseases. But if restrictions on foreign ownership are lifted, many foreign pharmaceutical executives have said they would like to expand their Indonesian operations. Novartis president recently revealed that the company would be interested in opening R&,D facilities in Indonesi a, as long as they do not have to worry about Indonesian ownership requirements. Currently, foreign ownership in domestic drug companies is limited to 75 percent. The other 25 percent of a company must be owned by an Indonesian national. Since early 2009, Indonesias MOH has hinted that it wants to drop restric tions on foreign ownership of Indonesian pharmaceutical firms. This has not yet taken place, but it is expected to within the next several years.

Indian pharma industry seeks policy reforms in Indonesia

Monday Mar 25, 2013

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Jakarta, March 25 India hopes the Indonesian government will undertake policy reforms that will enable Indian companies to invest in the South-East Asian nation's pharmaceutical sector. Since Indian pharmaceutical products are affordable and of high standards, India can contribute immensely to the growth of Indonesia's pharmaceutical industry, an Indian embassy release here said. Speaking during a pharmaceutical exhibition, participated by 39 Indian small and medium enterprises (SMEs) between March 20-22, Indian Ambassador Gurjit Singh expressed optimism of "early policy reforms by the Indonesian government". Singh said this would result in "meeting the increasing demand of pharmaceuticals at competitive prices once the Indonesian Government initiates the social insurance cover for its population". Indian exports of pharmaceuticals to Indonesia reached about $75 million in 2011-12 from $44 million in 2008-09. The Indian pharmaceutical industry, valued presently at over $25 billion, has gained recognition as the global pharmacy of the world on account of being able to prove quality generic medicines at affordable price. It has been recognised as a reliable source for bulk drugs (APIs), drug intermediates and formulations (generics), pharmaceutical machinery and packaging. This year major Indian companies in the CPhI-SEA included Morepen Labs, SG Pharma, ACG Group, Sterile India, Thermolab Scientific Equipments, Borosil Glass Works Brothers Pharmamach, and Healthcaps.

Read more: eport+2009.pdf