Presentation to WORLD HALAL RESEARCH SUMMIT th April 2011

Transcription

1 Presentation to WORLD HALAL RESEARCH SUMMIT th April 2011

2 THE BENEFITS OF HALAL PHARMACEUTICALS STANDARD - MS2424 By MR. LEONARD ARIFF ABDUL SHATAR Director, CCM Pharmaceuticals Division CHEMICAL COMPANY OF MALAYSIA BERHAD

3 HALAL AND THE PHARMACEUTICAL INDUSTRY

4 Primary Objectives of Shariah Shariah: Islamic Laws & Ways of Life prescribed by Allah s.w.t Preservation of Faith Preservation of Life Preservation of Intellect Preservation of Progeny Preservation of Property

5 The Pharmaceutical Industry It researches, develops, produces, markets and/or distributes licensed pharmaceutical products which maintain and restore health by the prevention and treatment of illnesses. Innovator MEDICINES Generics HEALTH/DIETARY SUPPLEMENTS Those provided by the Pharmaceutical Industry will be of the same standard of Safety, Efficacy and Quality as defined for medicines and produced in high hygienic conditions. Patented products Off-patent products

6 Halal Products Halal certified products not only benefit Muslims but EVERYONE because of the WHOLESOMENESS ( THOYYIBAN ) aspects: SAFE for consumption and use Assurance of product EFFICACY QUALITY standard of production & ingredients/ materials HYGIENICALLY processed

7 RATIONALE FOR HALAL PHARMACEUTICAL STANDARD

8 IMPORTANCE OF STANDARDS INDUSTRY S PERSPECTIVE Source of reference for: CONSISTENCY of operations SELF-REGULATION building CONSUMER CONFIDENCE MULTI-MARKET access CONSUMER S PERSPECTIVE Independent 3rd party ASSURANCE on: Consistency product SAFETY, EFFICACY & QUALITY HYGIENIC manufacturing process RESPONSIBLE & ETHICAL operations => INCREASE TRANSPARENCY & RELIABILITY of certification process

9 Halal Pharmaceutical Standard HALAL PHARMACEUTICALS STANDARD APPROVED HALAL MATERIAL LIST SHARIAH ALIGNMENT GMP (PIC/S GUIDELINES)

10 WHY THE NEED FOR HALAL PHARMACEUTICAL STANDARD? Facilitate Lobbying for Halal Logo to be on Primary Packaging

11 WHY THE NEED FOR HALAL PHARMACEUTICAL STANDARD? Consumer Demand source:

12 *Literary means: Hopefully it s Halal, more or less

13 DEVELOPING THE MS 2424: HALAL PHARMACEUTICALS- GENERAL GUIDELINES

14 Halal Pharmaceutical Standard: The Development Process *Source: Guide to the Malaysian Standards System

15 Starting point of MS 2424 Pharmaceutical Inspection Co-operation Scheme (PIC/s) The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (jointly referred to as PIC/S) are two international instruments between countries and pharmaceutical inspection authorities, which provide together an active and constructive co-operation in the field of GMP Member Countries Europe Non-European 28 Countries - Argentina, Australia, Canada Israel, South Africa, the USA - MALAYSIA (OIC member)

16 HALAL STANDARD: COVERGENCE OF MIND SHARIAH, SCIENCE & INDUSTRY As a pre-cursor for the development of the Halal Pharmaceutical Standard, in 2009, CCM had supported HDC in conducting the:

17 HALAL STANDARD: COVERGENCE OF MIND SHARIAH, SCIENCE & INDUSTRY This FIRST Halal Pharmaceutical Audit Workshop, was attended by key organisations: Regulatory Body Shariah Standards Industry National Pharmaceutical Control Bureau, Ministry of Health, Malaysia JAKIM (Department of Islamic Development Malaysia) 1. SIRIM 2. Standards Malaysia Selected CCM Halal Council and CCM Halal Committee members Speakers 1. Science scholars from reputable universities Facilitators 2. Innovax - CCM s R&D Centre Halal Integrity Division, HDC

18 Halal Pharmaceutical Standard: The Development Process Request for New Standard Written Request was submitted jointly by CCM and HDC in October 2008 New Work Item Registered August 2009 Working Draft Comm ittee Draft August 2010 Working Group established in September 2009, with Prof Zhari Ismail of Universiti Sains Malaysia (USM) as Chairman, HDC as Secretariat and SIRIM as Standards Writer Active members: JAKIM, NPCB* and CCM ISC I Accept ance September 2010 Verificatio n by Standard s Malaysia Approva l by Minister *NPCB=National Pharmaceutical Control Bureau, Ministry of Health, Malaysia

19 Halal Pharmaceutical Standard: The Development Process

20 Halal Pharmaceutical Standard: The Official Launch 6 th April 2011

21 Halal Pharmaceutical Standard: Additional Benefits 1. Closer collaboration and cooperation between 2 regulators MOH and JAKIM 2. Strengthen relationship between government agencies JAKIM, MOH, Standards Malaysia, HDC covergence of mind. 3. The MS2424 may be used as a working document. 4. Creation of platform for multiple supporting documentation e.g. The Halal Index

22 ...Supporting Publications While much have been written on the subject of Halal and Haram substances found in food, there is no single work which deals exclusively on Halal and Haram compounds used in the pharmaceutical sector. This publication represents a first dealing with pharmaceutical compounds from porcine (pig based) origins. It is addressed to the Muslim Ummah and all those who serve this market which is currently estimated at USD 100 billion per annum. The content of the book comprises monographs of the compounds may be manufactured. In addition, the therapeutic categories of the compounds and brief narratives are included. Additonal information includes ATC codes, compound synonyms and trade names. The reader is also guided with an extensive bibliography and references together with an accompanying website for updated information. This index is indispensible for the Halal regulatory bodies, research and development, manufacturers and a must have item for public use Prof. Dr. Zhari Ismail Professor in Pharmaceutical Chemistry Chairman for drafting the Malaysian Standards for Halal Pharmaceuticals Guidelines Publication : The Halal Index Volume 1 Pig Based Pharmaceuticals Hardcover : 164 pages Publisher : Phytorex Press Sdn. Bhd. ( K) No. 21A, Lorong Rahim Kajai 13, Taman Tun Dr. Ismail Kuala Lumpur, Malaysia. Language : English ISBN : (vol. 1) Dimensions : 176 X 250 X 12 mm Weight : 750g Genre : Reference Ultimately, we hope users of this book will be able to appreciate the significance and depth of the information to make learned decision in choosing among the variety of products available Y. Bhg. Dato Seri Jamil Bidin Chief Executive Officer Halal Industry Development Corporation

23 MS 2424: WHAT S NEXT?

24 The Global Halal Pharmaceutical Market Potential GLOBAL MARKET VALUE for PHARMA INDUSTRY: 2006 = US$607b* 2013(e) = US$818b* 2020 (f) = US$1,300b** >20% of world s population are Muslims Source: *Frost & Sullivan Market Insight 2 April 2008 **PricewaterhouseCoopers Report 13 June 2007 Map from Wikipedia/CIA-The World Factbook

25 Halal Pharmaceuticals: Traceability

26 Value Chain Analysis A pharmaceutical industry value chain analysis dictates that the highest value activity resides at the upstream end of the chain. Presently, the local generics manufacturers (including CCM), are only focused in Finished Products manufacturing, Sales and Marketing, and Distribution. Current focus of local pharmaceutical industry Higher value activities

27 Halal Pharmaceuticals: Industry Impact Recognition by ingredient suppliers of the Muslim market Recognition that alternatives can be sought There was a move from bovine into porcine research as base materials for majority of pharmaceutical products due to the BSE/mad-cow disease and the porcine based materials are easily available because of its organised supply chain for their animal parts in developed countries. Sensitizing international agencies on concept of informed choice, e.g. NPC (National Prescribing Centre, United Kingdom)

28 INFORMED CHOICE IN MEDICINE TAKING - THE NPCB MALAYSIA APPROACH To declare by Sept 09 Source/Origin for : 1.API and Excipients 2.Hard (Empty) Gelatin Capsules 3.Soft gelatin capsules Findings: 1. Capsules declared as non-animal sourced contained bovine/ porcine elements 2. Capsules declared as bovine-sourced contained porcine or combination of bovine and porcine elements NPCB = National Pharmaceutical Control Bureau

29 CCM s Key Focus: Halal Integrity KNOWLEDGE = COMMITMENT & SINCERITY TRAINING/KNOWLEDGE SHARING CCM s Halal Awareness Programme: 1. Halal Awareness Roadshows & Workshops for Employees 2. Halal Awareness Seminar for Suppliers 3. Halal Talks for Customers 4. Dialogue Sessions with regulatory authorities/ related bodies

30 CCM s Halal Journey 2009

31 INCREASING HALAL CERTIFIED PRODUCTS 1999 = 44 products NOW = 177 products

32 CCM s Halal Initiatives: Key Focus FARDH KIFAYAH SHARED RESPONSIBILITY INFORMED CHOICE MARKETING CAPACITY BUILDING HALAL INTEGRITY

33 CCM Pharmaceuticals Division: Manufacturing Facilities - Capacity Oral Solid Dosage (OSD) Tablets Capsules Softgel Other Dosage Form Liquid 1 st IBC 1 st Capacity 3 billion 300 million 144 million capsules Capacity 2 million litres Ampoules Dental cartridges Vials liquids Eye drops Haemodialysis Irrigation solution Sterile Production Capacity The only in ASEAN 36 million ampoules 7.4 million vials 3.6 million vials 168,000 litres 5 million litres 3 million litres 1 st Cream 72,000 kg Cephalosporin Capacity Penicillin Tablets Capacity 55 million Tablets Capsules 144 million 36 million Capsules 115 million Powder 72,000 kg Powder 72,000 kg SVI vials 2.5 million vials

34 INCREASING HALAL CERTIFIED PRODUCTS OTHER SIGNIFICANT 1 ST IN MALAYSIA 1 st SVI (Small Volume Injectibles) 1 st Dental Cartridge 1 st Soft Gel 1 st Patent Controlled Release mini-tabs in capsules 1 st state-of-art IBC plant COMING SOON 1st Halal Vaccines F& F 1st Halal Bio-similar

35 Halal Pharmaceuticals Healing is achieved by medicine when the soul readily accepts it and believes in its usefulness and in the blessing of healing which Allah s.w.t. has put into it. What is beneficial is that which is blessed and the most beneficial is that with the greatest blessing. And blessed among the people is he from whom benefit comes wherever he may be. Ibn Qayyim Al-Jawziyya: Medicine of the Prophet

36 Conclusion 1. Halal Pharmaceutical is the emerging growth sector in the Halal industry. 2. There are still a lot of matters to address in terms of Halal compliance in this industry, and also the acceptance of the necessity of its Halal certification, but with good collaboration: Together Everyone Achieves More

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