2016.11.24.THU

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インドネシア製薬関連動向【2016年10月号】

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執筆者:サンドロ イワント

インドネシア製薬関連動向【2016年8月号】


 
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CMP  BIMONTHLY  REPORT  NO. 002
October  2016
 
Health and Pharma Issues :
Dengue Hemorrhagic Fever (DHF) is an endemic viral infectious disease in Indonesia. The vectors are mosquitoes (Aedes aegypti and Aedes albopictus). These vectors usually bite for blood between 09.00 a.m. – 16.00 p.m. When it bites an infected person and then a healthy person, it transfers the virus to infect the latter.

The symptoms are high fever (38.5 – 40 degrees C) for a course of 5 – 7 days, headache, nausea, general weakness/fatique, and blood lab test shows drastic lowering count of thrombocytes. These may lead to external and/or internal bleeding that can cause death. The fatal case in Indonesia is +/- 2%, of which most are children <= 12 years.

To date, no antiviral medicine to cure it yet. The management is in general a combination of analgesic, antiinflamation, and isotonic infusion solution to prevent from excessive bleeding.

Sanofi Pasteur, a French multinational company has introduced a vaccine named CYD-TDV (Chimeric Yellow Fever 17D-Tetravalent Dengue Vaccine), which has been approved in Indonesia this year. The vaccine is claimed effective up to 67% to prevent from DHF among children 12 – 16 years.

There is a government-owned company in Indonesia that deals with production of numerous varieties of vaccine. The company, Biofarma located in Bandung, West Java, has produced and marketed its products both for local as well as for export purposes to over 130 countries. Due to the high incidence of DHF, Biofarma in cooperation with several universities and biomolecular – biogenetic engineering entities is deeply involved in search of vaccine to effectively prevent from DHF. It is supposed to introduce within ten years from now.

Although most vaccines have been produced locally, some are imported still. The opportunity to build this hi-tech pharma company in Indonesia is widely open still.
 
Law and Regulations :
There are not any new Law or Regulations concerning with health and/or medicine/pharma within the last two months. However, there is an explanation on the Law of the Republic of Indonesia no.36 year 2009 on HEALTH enacted in October 2009.  In Article 105 it says “The standard is Farmakope Indonesia and/or other standard compendia.” What is meant by ‘other standard compendia’ when it is not mentioned in Farmakope Indonesia (FI) are USP, BP, or International Pharmacopeia. EP and other countries’ Pharmacopeia are not considered as referral standards. This explanation is stressed by BPOM (Indonesia FDA) when they check for new drug application submitted by pharma companies.
 
Jakarta, 2nd November 2016

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サンドロ イワント

サンドロ イワント

PT. Mirota KSM Inc. でセールスマネージャーとして、1985年まで乳児用調整粉乳に携わる。その後PT. Pfrimmer Infusol Indonesiaに入社し、生産部長として大量非経口投与剤及び少量非経口投与剤の製造に従事し、さらにPT. Triyasa Nagomas Farmaにて、生産部長として避妊用無菌ホルモン注射剤及び経口避妊薬の生産に携わる。1993年にRoche Indonesiaに入社し、2004年まで工場長として錠剤、経口液剤、半固形及び無菌抗腫瘍剤の製造に従事する。PT. Bayer Indonesiaで工場長としてOTC医薬品に携わり、退職後、数社の医薬品メーカーとフリーランスのコンサルタントとして従事し現在に至る。