CCM's Halal Presentation - hdc

Presentation toWORLD HALAL RESEARCHSUMMIT 201023 rd June 2010

CCM : Championing Halal PharmaceuticalsByLEONARD ARIFF ABDUL SHATARDirector, CCM Pharmaceuticals DivisionCHEMICAL COMPANY OF MALAYSIA BERHAD

PHARMACEUTICAL INDUSTRY

Pharmaceutical Industry• The Pharmaceutical Industry researches,develops, produces, markets and/or distributeslicensed medicines.• Medicine is a substance used to prevent or curedisease or to relieve pain, anxiety or any form ofperceived discomfort, categorised as:– Prescriptive (Ethical) and– Over-The-Counter (OTC).

Pharmaceutical IndustryMEDICINESHEALTH/DIETARYSUPPLEMENTSInnovatorPatented productsGenerics•Off-patent productsThose provided by the PharmaceuticalIndustry will be of the same standard ofSafety, Efficacy and Quality as definedfor medicines and produced in highhygienic conditions.

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

Pharmaceutical Industry• Pharmaceutical Industry is HIGHLY REGULATED.• Companies in this industry are subjected to avariety of laws and regulations relating to theirproducts:– Research & Development (R&D) activities,– testing methods,– manufacturing processes,– marketing, sales and distribution.

Value Chain AnalysisA pharmaceutical industry value chain analysis dictates that the highestvalue activity resides at the upstream end of the chain.Presently, the local generics manufacturers (including CCM), are onlyfocused in Finished Products manufacturing, Sales and Marketing, andDistribution.Current focus of local pharmaceutical industryHigher value activities

HALAL PHARMACEUTICALS:AN OVERVIEW

Primary Objectives of ShariahShariah: Islamic Laws & Ways of Life prescribed by Allah s.w.tPreservationof FaithPreservationof LifePreservationof PropertyObjectivesofShariahPreservationof IntellectPreservationof Progeny

Definition of Halal PharmaceuticalsSOURCE:DRAFT MALAYSIAN STANDARD FOR HALAL PHARMACEUTICALS: GENERAL GUIDELINES

DEFINITION OF NAJS(Pharmaceutical Context)SOURCE:DRAFT MALAYSIAN STANDARD FOR HALAL PHARMACEUTICALS: GENERAL GUIDELINES

Halal ProductsHalal certified products not only benefit Muslims butEVERYONEbecause of the WHOLESOMENESS (“THOYYIBAN”) aspects:•SAFE for consumption and use•HYGIENICALLY processed•QUALITY standard of production & ingredients/materials•Assurance of product EFFICACY

HALAL PHARMACEUTICALS:INDUSTRY PERSPECTIVE

source:Halal Pharmaceuticals

Uniqueness of thePharmaceutical IndustryStrictly governed by International Standards of:Good Manufacturing Practice (GMP)Good Hygiene Practice (GHP)Good Clinical Practice (GCP)Good Laboratory Practice (GLP)Good Storage Practice (GSP)Good Engineering Practice (GEP)Consistency in: products‟ Safety, Efficacy and Quality. facilities‟ Hygiene standard.

Uniqueness of thePharmaceutical IndustryLAWS OF MALAYSIAAct 366POISON ACT 1952Act 368SALE OF DRUGS ACT 1952Act 290MEDICINES (ADVERTISEMENT AND SALE) ACT 1956SALE OF FOOD AND DRUGS ORDINANCE 1952CONTROL OF DRUGS AND COSMETICS REGULATIONS 1984

Halal PharmaceuticalsTestedTestedTestedGMP requirements:SafetyEfficacyQualityTestedTestedTestedTestedTested

Halal PharmaceuticalsWhat is the source for thesegelatin capsules?What is the source for vaccines,insulin, heparin, etc.?(Bovine, ovine, porcine, etc.)

Halal Pharmaceuticals: Traceability

Pharmaceutical Research &Development Process

Pharmaceutical Research &Development ProcessChemical ProcessCatalystChemicals: The whole range of organic andinorganic chemical products for chemicalprocess and reaction

Pharmaceutical Research &Development ProcessFormulation of Final Products• Pharmaceutical Excipients:– Solvents/co-solvents– Gel forming agents– Lubricant, Binder & Disintegrant– Preservatives– Dye & pigment– Minerals, etc

Rate-limiting Step in Vitamin ProductionTo prepare Liquid Vitamin into Free-flowingpowders for compressed Tablet or CapsuleStep 1: To mix with combination of:- Active material (emulsion containing active vitamin material)- Gelatin + water + gum acacia + sugar and/or starchConverting emulsion to droplet formStep 2: Collection of individual droplet in a mass of starchy formStep 3: Separating the vitamin-active particles from starchy collectingpowder

Halal Pharmaceuticals:Industry Impact• Recognition by ingredient suppliers of theMuslim market• Recognition that alternatives can be sought‣ There was a move from bovine into porcine research asbase materials for majority of pharmaceutical products dueto the BSE/mad-cow disease and the porcine basedmaterials are easily available because of its organisedsupply chain for their animal parts in developed countries.

HALAL PHARMACEUTICALS:CONSUMER PERSPECTIVE

A Question of Choice:Compliance in Medicine Taking“Research shows that some 50% ofmedicines prescribed for long termconditions are not taken asprescribed ”From Compliance to ConcordanceRoyal Pharmaceutical Society of Great Britain, 1997

A Question of Choice:Compliance in Medicine Taking• Patients not taking medicine is still a major cause ofunnecessary ill health and death.• Such non-compliance is mostly intentional andresults from a considered decision made by patientsabout the benefits and disadvantages of medicines,rather than just „forgetfulness”• Patients are much more likely to follow treatment ifthey have been active partners in prescribingdecisions and their views and preferences have beenrecognised and taken into account.Task Force on Medicines Partnership 2003

INFORMED CHOICE IN MEDICINE TAKINGThe Medicines Partnership Programme was established by the Department of Health, UnitedKingdom in 2002 and has promoted the concept of concordance – or shared decision-making- as an approach to help patients to get the most from their medicines.Content:http://www.npc.co.uk/med_partnership/resource/our-publications/drugs-of-porcine-origin.html

INFORMED CHOICEIN MEDICINE TAKING- THE NPC UK APPROACHEXCERPTSNPC UK = National Prescribing Centre (United Kingdom)

INFORMED CHOICEIN MEDICINE TAKINGEXCERPTS- THE NPC UK APPROACHNPC UK = National Prescribing Centre (United Kingdom)

INFORMED CHOICEIN MEDICINE TAKING- THE NPCB MALAYSIA APPROACHTo declare by Sept ‟09Source/Origin for :1.API and Excipients2.Hard (Empty) Gelatin Capsules3.Soft gelatin capsulesFindings:1. Capsules declared as non-animal sourced contained bovine/porcine elements2. Capsules declared as bovine-sourced contained porcine orcombination of bovine and porcine elementsNPCB = National Pharmaceutical Control Bureau

Halal Pharmaceuticals:Consumers’ Informed Choice• Consumers are now more knowledgeable/discerning• Information on Halal and health matters areeasily accessible on the internet• Halal agenda is gaining greater prominence

HALAL PHARMACEUTICALS:CCM‟S ROLE

About CCM: History2000s1990s Became a subsidiaryof PNB in 20051930s1960s Became a full-fledged Malaysian companyin 1994 via a Management-Buy-Out (MBO)exercise Incorporated on 7th August 1963 as a subsidiary of ICI PLC Listed on the Main Board of Bursa Malaysia since 1966Trading arm

CCM’s Current Equity Structure1.97%10.02%Others69.54%CCM is one ofMalaysia‟s Top GLCs(Government Linked Companies)As at 31 st May 2010

CCM Group StructureDevelops, manufacturesand markets genericmedicines and over-thecounter(OTC) health/dietery supplements &healthcare productsManufactures andmarkets general andspecialty chemicals,as well as providesservices to the publicand manufacturingsectorsManufactures andmarkets a completerange of fertilizersfor all crop needsand conducts soiltesting and progressdevelopments thatbenefit farmersSupports focusedmarkets:•Singapore•Indonesia•Thailand•Philippines•Vietnam

CCM’S HALALINITIATIVES“FARDH KIFAYAH”[COLLECTIVE OBLIGATION/DUTY]

CCM’s Halal Journey2009

CCM:CHAMPIONING THE HALALPHARMACEUTICALS

THE GUIDING PRINCIPLE

CCM’s Halal InitiativesA formalised framework to spearhead the Halal StrategyTASK DESCRIPTION RESPONSIBILITY OF:Stewardship Custodian of the Halal agenda CCM‟s Chairman &Board of DirectorsOwnership &LeadershipPerformanceDriverStrategic decision makers that:validate and own the strategy to boost theHalal agendaprovide strategic guidance for theimplementation processCore Team that:plans and executes development plansguides and facilitates development ofaction plansmonitors implementation progressCCM Halal Councilchaired byGroup ManagingDirectorCCM HalalCommitteeschaired byDivision Directors

CCM Halal Policy‣ Commitment to manufacture,import and distributeconsumable products thatcomply with Halalrequirements.‣ Assurance that the nonconsumableproducts which wemanufacture, import anddistribute meet the same highstandards.‣ Assurance that our productionand supply chain processesadhere to the high standards.

CCM’s Halal Initiatives: Key Focus“FARDH KIFAYAH”SHARED RESPONSIBILITYINFORMEDCHOICEMARKETINGCAPACITYBUILDINGHALAL INTEGRITY

HALAL INTEGRITY Operating in a socially responsible and ethical manner Convergence of Minds – Shariah and Science

CCM’s Key Focus: Halal IntegrityRITUAL CLEANSING(SAMAK/SERTU)• This exercise is to ensure that all our equipment used inproduction operations are clean and certified pure as perthe Shariah/Halal requirement whilst still meeting GMP*-Pharmaceutical premise requirements.*GMP = Good Manufacturing Practices

CCM’s Key Focus: Halal IntegrityStrategic collaboration with key Halal Industry Organisations:• Relevant Ministries– Prime Minister‟s Office- Departmentof Islamic Development (JAKIM), Health Ministry, TradeMinistries (Domestic and International)• Government Bodies/Agencies – Standards Malaysia, HalalIndustry Development Corporation (HDC), SIRIM• Malaysian Universities – UPM, USM, IIUM, UM• World Halal Forum• IHI Alliance

CCM’s Key Focus: Halal IntegrityAs a pre-cursor for the development of the Halal PharmaceuticalStandard, CCM had recently supported HDC in conducting the:

CCM’s Key Focus: Halal IntegrityThis FIRST Halal Pharmaceutical Audit Workshop, was attended by keyorganisations:Regulatory BodyShariahStandardsIndustryNational Pharmaceutical Control Bureau, Ministry of Health,MalaysiaJAKIM (Department of Islamic Development Malaysia)1. SIRIM2. Standards MalaysiaSelected CCM Halal Council and CCM Halal Committee membersSpeakers 1. Science scholars from reputable universitiesFacilitators2. Innovax - CCM’s R&D CentreHalal Integrity Division, HDC

CCM’s Key Focus: Halal Integrity1. The 1 st Technical Committee meeting, chaired by the Director-Generalof JAKIM was held on 29 th September 2009. CCM is a member.2. Sub-committee was formed to draft the standard, comprising membersfrom Ministry of Health, Pharmacy Scholars, Pharmaceutical Industryplayers. CCM is also a member.‣ 3 meetings had been held to date : 16 th October 2009 – initiator, science scholars & regulatoryauthorities 4 th November 2009 – regulatory authorities & science scholars 5 th November 2009 – industry players, regulatory authorities &science scholars 14 th June 2010 - industry players, regulatory authorities &science scholars3. The Halal Pharmaceutical Standard is drafted with reference to thePIC/S* GMP** Guidelines.*PIC/S = Pharmaceutical Inspection Co-operation Scheme** GMP = Good Manufacturing Practices

Halal Pharmaceutical StandardHALALPHARMACEUTICALSSTANDARDAPPROVEDHALAL MATERIALLISTSHARIAHALIGNMENTGMP(PIC/S GUIDELINES)

CCM’s Key Focus: Halal IntegrityKNOWLEDGE = COMMITMENT & SINCERITYTRAINING/KNOWLEDGE SHARINGCCM‟s Halal Awareness Programme:1. Halal Awareness Roadshows & Workshops forEmployees2. Halal Awareness Seminar for Suppliers3. Halal Talks for Customers4. Dialogue Sessions with regulatory authorities/related bodies

CAPACITY BUILDINGIncreasing range of Halalcertifiable products

CCM Pharmaceuticals Division:Manufacturing Facilities - SitesKlangBangiShah Alam

CCM Pharmaceuticals Division:Manufacturing Facilities - CapacityOral SolidDosage (OSD)TabletsCapsulesSoftgelOther DosageFormLiquid1 stIBC1stCapacity3 billion300 million144 million capsulesCapacity2 million litresAmpoulesDental cartridgesVials liquidsEye dropsHaemodialysisIrrigation solutionSterile Production CapacityTheonlyinASEAN36 million ampoules7.4 million vials3.6 million vials168,000 litres5 million litres3 million litres1stCream72,000 kgCephalosporinCapacityPenicillinTabletsCapacity55 millionTabletsCapsules144 million36 millionCapsules115 millionPowder72,000 kgPowder72,000 kgSVI vials2.5 million vials

INCREASING HALAL CERTIFIED PRODUCTSOTHER SIGNIFICANT 1 ST IN MALAYSIA1 st SVI (Small Volume Injectibles)1 st Dental Cartridge1 st Soft Gel1 st Patent• Controlled Release mini-tabs in capsules1 st state-of-art IBC plantCOMING SOON‣ 1st Halal Vaccines F& F‣ 1st Halal Bio-similar

CCM Pharmaceuticals Division:R&D CentreHEAD[Medical Doctor with PhD/Doctoratein Pharmacology]Core competency in research &development of special oraldosage forms/ in-drug deliverysystem:Controlled Release (CR)/Sustained Release (SR)CHEMICAL &ANALYTICALDEPTFORMULATION &BIO-PHARMACEUTICALDEPTQUALITYDEPTDRUG INFORMATIONPIPELINEDEPT

INCREASING HALAL CERTIFIED PRODUCTS1999= 38 productsNOW= 178 products

HALAL PHARMACEUTICALS:THE WAY FORWARD

Pharmaceutical IndustryMEDICINESThey are constantly in demand………regardless of economic conditionsHEALTH/DIETARYSUPPLEMENTS• For wellness, immunity andenergy• A preventive healthcare option

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

Halal Pharmaceuticals“Indeed Allah s.w.t. sent down both illness andmedicine, and for every illness He gave remedy. Socarry out medical treatment, but do not use thereinanything unlawful”Saying of the Prophet Muhamad – Hadith of Abu al-Darda“The Messenger of Allah s.w.t. forbade medicationwith impure medicines ”Sunnah of the Prophet Muhamad – from Abu Hurayra“Allah s.w.t. did not place your healing in anythingwhich has been made unlawful for you ”Saying of the Prophet Muhamad – Hadith of Ibn Mas’ud

Conclusion1. Halal Pharmaceutical is the emerging growth sectorin the Halal industry.2. There are still a lot of matters to address in terms ofHalal compliance in this industry, and also theacceptance of the necessity of its Halal certification,but with good collaboration:TogetherEveryoneAchievesMore