14 th International Conference of Drug Regulatory Authorities 30 th November December 2010 Singapore
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1 14 th International Conference of Drug Regulatory Authorities 30 th November December 2010 Singapore CURRENT REGULATORY CHALLENGES RELATING TO HERBAL MEDICINES: ADULTERATION OF HERBAL MEDICINES Muhammad Lukmani Ibrahim Pharmacy Enforcement Division Ministry of Health Malaysia Lot 36, Jalan Universiti Petaling Jaya, Selangor, MALAYSIA Tel : Fax : lukmani@moh.gov.my Website : Pharmaceutical Services Ministry of Health Malaysia WHO Collaborating Centre For Regulatory Control of Pharmaceuticals Member of Pharmaceutical Inspection Cooperation Scheme MS ISO 9001:2000 Certified
2 Outline of Presentation Current Regulatory Status In Malaysia Implementation of Hologram Meditag New Emerging Problem & Challenges Reactive & Proactive Approaches Impact & Outcome Adulteration in Traditional Herbal Medicines, Food and Food Supplement Conclusion
3 3
4 Legislation Situation in Malaysia A good set of laws & regulation in place including registration of medicinal products Regulatory WHO Collaborating Centre since 1996 / PICS member since 2002 as 26 th member Enforcement Enforcement Officers (350 Officers) in 15 states Supply Chain Poison / Control Items Govt. supply drugs to all its Health Institutions via controlled concession & contract co.- eg Pharmaniaga Sdn Bhd Private Sectors are licensed / inspected routinely for eg. Pharmacy premises & Pharmaceutical industries. Supply Chain OTC / Traditional Medicine Wholesaler are licensed to sell Public Sectors and Private Sectors for retail are not licensed Facing challenges of adulterated herbal medicines and unregistered medicines/counterfeits
5 Structure Regulatory Function Licensing of manufacturing Licensing of importation Malaysia Responsible DCA/NPCB DCA/NPCB Control of Drugs & Cosmetics Regulations 1984 Pharmaceutical Services Division Pharmacy Board Licensing of wholesale trade NPCB Drug Control Authority (DCA) Poisons Board GMP inspection Inspection of distribution channels Product assessment & registration DCA/NPCB PSD DCA/NPCB Carried out by NPCB: Product Evaluation Product Analysis GMP Inspection & Licensing Post-Marketing Surveillance & ADR Medicine Advertisement Board Quality control DCA/NPCB Control of promotion & information PSD ADR monitoring Price regulation DCA/NPCB Free pricing National Pharmaceutical Control Bureau Licensing and Enforcement Pharmacy Care Chief Pharmacist KL Hospital 15 state Deputy Director Of Health 5
6 Legislation The enabling powers that allow Ministry of Health Malaysia to control and regulate the wellness industry sector are embodied in the following legislations : Registration of Pharmacist Act 1951, revised 1989 Poisons Act 1952 (revised 1989) Sale of Drugs Act 1952 (revised 1989) Control of Drugs and Cosmetics Regulations 1984 Dangerous Drug Act 1952 (revised 1980) Medicines (Advertisement and Sale) Act (revised 1983)
7 Registration Status 1991 October % 3% 7% 0% Product category Control Medicines (Prescriptions) Total 12,980 85% Non-prescriptions (OTC) Natural Products (Traditional medicines) 9,876 20,668 Prescription Natural Products Cosmetics Non-prescription Veterinary Products Veterinary Products 45 Cosmetics (Notification) 236,735 Total 280,304 Effective 1st January 2008 Registration of Cosmetics replaced by Procedure of Notification
8 Implementation of Hologram Technology One Hologram for all Medicinal Products to be marketed in Malaysia - MeditagTM Hologram (1st in the world) The First Edition (2005) The latest edition (Sept 2006)
9 HOLOGRAM DECORDER PLACE IN ALL PHARMACY PREMISES IN MALAYSIA Make available in the pharmacy premises Encourages the publics to check the products that they have bought for authenticity. Promotion and encourage publics to buy medicine in licensed premises (Pharmacy) Encourages the Pharmacist to check the product sold in their premises.
10 Challenges Unregistered products Adulteration in unregistered herbal products Adulteration in registered herbal products. Adulteration in food & Food Supplement Counterfeits products Smuggling, Illegal entry Parallel importation Diversion Tampering Repackaging & re-labeling Fake Hologram meditagtm
11 Adulterants in Traditional products, Cosmetics, Food & Food Supplement Steroids Dexamethasone, Betamethasone Drugs for erectile dysfunction ED s and their analogs Antihistamines Chlorpheniramine NSAID s Ibuprofen, Mefenamic acid, Indomethacine Slimming Agents Sibutramine and their analogs Antidiabetics Metformin, Glybenclamide Source: NPCB, Malaysia
12 What is an analog? The word analog or analogue is used to describe a substance that has a major chemical structures in common with another chemical O O O HN N N N O HN N N N O S N O O S N O N N Sildenafil Homosildenafil
13
14 Common combination of adulterants FOUND IN TRADITIONAL MEDICINE SAMPLES Chlorpheniramine + Dexamethasone Hydroquinone + Tretinoin Dexamethasone + Ibuprofen + Chloramphenicol + Chlorpheniramine Chlorpheniramine + Dexamethasone + Betamethasone + Prednisolone Source : NPCB, Malaysia
15 Registered products adulterated with scheduled poisons Year No. of cases (Oct) 7 Source: NPCB, Malaysia 15
16 WHAT CAN WE DO? 16
17 Intelligence sampling Malaysian Life Style demanding :- Slimming Products women Sex Stimulant Products men Bleaching Agent in cosmetics Signal to look for Prices, labels, claims 17
18 Proactive Approach Demand Reduction Eg Public Awareness Campaign, Exhibition, Pamplets, Press Release, Media Coverage during operation etc National Task Force Headed by Enforcement Division Ministry of Internal Trade include Royal M sian Police, Royal M sian Custom, Immigration Dept., Pharmacy Enforcement MOH etc New Pharmacy Bill Consolidate the 5 Act including Poison Act 1952, Sale of Drug Act 1952 Training for officers Workshop, Courses, Briefing during Meetings, Seminars etc Co-Operation with Industry / Product Owners Discussion for Action When unregistered/counterfeit Products Detected Regional/Global Networking Through Meetings/Seminar, Constant Contact eg (eg.pmas)
19 Restoring the trust in Marketplace Know Your Medicine campaign posters/post-cards/calendars with message Newspapers TV, radio and public talks School exhibitions Customers Day Road-shows on holograms Media announcements & Adv. Increase consumers awareness about the risk of adulterated products and unregistered products. 19
20 20
21 WAY FORWARD- Strengthening Enforcement More branches Increase manpower - currently 352 posts Continuous education Human capital development priority Post-graduate studies Incentive & critical allowances Forensic Laboratory Vigilant at entry points R&D New Pharmacy Bill addressing counterfeit medicine & Stiffer Penalty
22 WAY FORWARD- Strengthening Enforcement Strengthening Enforcement New Pharmacy Bill addresses: Counterfeit medicines Adulterated products and Herbal Products Unregistered products Expired products Penalties: Minimum mandatory Jail sentence Deterrent fines 10x the existing fine
23 WAY FORWARD- Collaboration - National Collaboration - National Ministry of Domestic Trade & Consumer Affairs Customs Department Police Pharmaceutical Industry Consumer Association Health Professional Group
24 WHO IMPACT WAY FORWARD- International Networking PIC/S Rapid Alerts ACCSQ PPWG Post Marketing Alert System ASEAN WGTCP Bilateral & Multi-lateral Cooperation
25 25
26 Consumer Education & Dialogues 2005 Oct Talks Exhibitions Dialogues
27 Research & Development : Study on Public Awareness and Behavior Towards The Control of Medication Sales and Usage in Malaysia. (The Multicenter Study was done in 2005 and 2007) From the study the result of public knowledge on registered medicine in Malaysia has increase from 59% (in 2005) to 70% (in 2007). 27
28 Since the introduction of meditag hologram in 2005, there has been a significant increase in the identification and confiscation of illegal items from the market and prevented their entry into distribution channels. As a result, consumer confidence in the integrity of pharmaceuticals has increased and public health has been safeguarded. 28
29 29
30 Adulteration of Sildenafil in food- coffee mixture
31 Conclusion Adulterated Herbal Medicines & Counterfeits a global issue Address the issue: the whole supply chain Established size and scope of problem objectively Serious treat to public health and safety Combat through multi-pronged and holistic approach. Strong political will Sound legal framework - New & revised laws Reputable regulatory system Registration, Licensing, Surveillance, Testing, ADR Monitoring, Information Established enforcement system Inspection, Investigation, Prosecution, Confiscation, Consumer Education Strengthening collaboration National & International, Inter and Intra Agencies, Consumer groups, Professional bodies, right owners Advanced Security technology ICT, Security labels or embedded (hologram), bank note style security threads Public Awareness and education to reduce the demand for adulterated, unregistered and counterfeit products. 31
32 TERIMA KASIH THANK YOU 32
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