Directorate General of Drug Administration

Ministry of Health & Family Welfare,Government of the People's Republic ofBangladesh

Drug Regulatory Authority of the country.

Supervises and implements - DrugRegulations in the country, Regulates allactivities relatedimport, procurement of raw and packingmaterials

Production and import of finisheddrugs, export, sale, pricing, etc. of allkinds of medicine including those ofAyurvedic, Unani, Herbal andHomoeopathic systems

At present – drug manufacturingcompanies in the country

265 Allopathic > 201 Ayurvedic > 268Unani > 25 Herbal >

79 HomeopathicDGDA - Monitors and regulates all

the activities of these 838 companies

The chief of the Directorate >designated > Director General >empowered by the Govt. > asLicensing Authority (LA) of drugs

33 district offices"Drug Inspector" pursuant to the DrugLaws and assist the LicensingAuthority for properly discharging hisresponsibilities.

The Directorate General of DrugAdministration mission is to ensure that thecommon people have easy access to useful,effective, safe and good quality essential andother drugs at affordable price.

MISSION STATEMENT

Drug Advisory CommitteeDrug Appellate AuthorityDrug Control Committee (DCC)Drug Technical Sub-CommitteeDrug Pricing CommitteeDrug Pricing Technical Sub-CommitteeManufacturing Project Evaluation

Committee

Committees

Standing Committee For ImportHerbal Drug Advisory CommitteeStanding Committee for procurementand import of raw materials and finisheddrugsPricing Committee and a number ofother relevant Committees, whichcomprise of experts

Advise the Licensing Authority and torecommend to him matters related todrugs and medicines.

MANUFACTURER

1)Allopathic 2)Homeopathic and biochemic3)Unani4)Herbal5)Ayurvedic

ALLOPATHIC

DGDA supervises and implements all prevailingDrug Regulations

Regulates all activities > to import of raw andpacking materials, production and import offinished drugs, export, sales, pricing, etc. of allkinds of medicines including those of Ayurvedic,Unani and Homoeopathic system of medicines.

265 Allopathic drug manufacturingcompanies in Bangladesh.

HOMEOPATHIC AND BIOCHEMIC

DGDA supervises and implements all prevailingDrug Regulations

Regulates all activities related to import of rawand packing materials, production and import offinished drugs, export, sales, pricing, etc. of allkinds of medicines including those of Ayurvedic,Unani and Homoeopathic system of medicines

79 Homeopathic and Biochemic drugmanufacturing companies in Bangladesh.

UNANI

DGDA supervises and implements all prevailingDrug Regulations

Regulates all activities related to import of rawand packing materials, production and import offinished drugs, export, sales, pricing, etc. of allkinds of medicines including those of Ayurvedic,Unani and Homoeopathic system of medicines.

267 Unani drug manufacturing companies inBangladesh.

AYURVEDIC

Directorate supervises and implements allprevailing Drug Regulations

Regulates all activities related to import andprocurement of raw and packing materials,production and import of finished drugs, export,sale, pricing, etc. of all kinds of medicineincluding those of Ayurvedic, Unani andHomoeopathic systems

202 Ayurvedic companies operating inBangladesh.

HERBAL

Directorate supervises and implements allprevailing Drug Regulations

Regulates all activities related to import andprocurement of raw and packing materials,production and import of finished drugs, export,sale, pricing, etc. of all kinds of medicineincluding those of Ayurvedic, Unani,Homoeopathic and Herbal systems

25 Herbal companies operating in Bangladesh

WHOLESALERSCOMMUNITY PHARMACIESHOSPITAL PHARMACIES

PHARMACIES

ADRM

ADR NEWS

ADR REACTION MONITORING

ADR REPORTS

ADR REPORTING FORM

ADR REACTION MONITORING

1962 > thalidomide disaster > WorldHealth Assembly requested WHO toestablish an international system ofmonitoring adverse reactions to drugsusing information derived from nationalcentres.

A common reporting form had to bedeveloped

Agreed guidelines for enteringinformation had to be formulated

Common terminologies andclassifications had to be prepared

Compatible systems for transmitting,storing, retrieving and disseminatingdata had to be created.

Upon the successful completion of thesetasks > international data base wererelocated 1978 to a WHO collaboratingcentre situated in Upsala, Sweden.

ADRM IN BANGLADESH

Safety and efficacy of drugs (ADR's) inBangladesh left unanswered > due tolack of a systematic mechanism ofmonitoring.

Under the guidance of WHO, a cell hasbeen established in Directorate of DrugAdministration in 1996.

Initially the cell circulated posters,bearing awareness slogans of drug usethroughout the country, organizedawareness meeting among the chemistsof different area and also publishedawareness instructions in the dailynewspapers and broadcasted theseawareness slogans in RadioBangladesh.

The cell is trying to introduce a systematicmechanism for ADR monitoring program inBangladesh for collection, analysis &compilation of ADRs which will bespontaneously reported by the medical &pharmaceutical professional from all healthservices outlets of the country.

The Ministry of Health & Family Welfareformed 10 (Ten) Members ADR AdvisoryCommittee (ADRAC) on 6 July 1997 toevaluate, analyze & make recommendationsfor solving problems of medicinal hazards dueto ADRs.

Side effectA side effect is 'any unintended effect of apharmaceutical product occurring at doses normallyused in man, which is related to the pharmaclologicalproperties of the drug'. Essential elements in thisdefinition are the pharmacological nature of the effect,that the phenomenon is unitended and that there is noovert overdose.

Adverse reactionAn adverse reaction is 'a response to a medicine which isnoxious and unintended and which occurs at dosesnormally used in man,. In this description it is ofimportance that it concerns the response of a patient, inwhich individual factors may play an important role, andthat the phenomenon is noxious (an unexpectedtherapeutic response, for example, may be a side effectbut not an adverse reaction.

Serious adverse events can be defined as those that:

Are life-theratening or fatalCause or prolong hospital admissionCause persistent incapacity or disability;

orConcern misuse or dependence.

TYPES OF ADVERSE EFFECTS

Type A effects (Drug actions) Type B effects (Patient reactions) Type C effects (Spontaneous disease)

Type A effects > drug actions > due toexaggerated pharmacological effects.Tend to be –

fairly commondose related

(i.e. more frequent or severe with higher doses)and may often be avoided by using

doses > appropriate to the individual patient.

Type B effects > patient reactionsOccur in only a minority of patients and display little or no dose relationship.Rare and unpredictable and may be serous and are notoriously difficult to study.Either immunological Or non-immunological Immunological reactions may range from –

RashesAnaphylaxixVasculitisInflammatory organ injury

to highly specific autoimmune syndromes.

Non-immunological Type B effects

Occur in a minority of predisposedintolerant patients, e.g. because of aninborn error of metabolism or acquireddeficiency in a certain enzyme, resulting inan abnormal metabolic pathway oraccumulation of a toxic metabolite.

Examples are chloramphenicol aplasticanaemia and isoniazid hepatitis

Type C effects refer to situation where the useof a drug, often for unknown reasons, increasesthe frequency of a spontaneous disease.

Type C effects may be –

Both serious and common (and includemalignant tumours) and may have pronouncedeffects on public health.

Coincidental and often concern long term effectsthere is often no suggestive time relationshipand the connection may be very difficult toprove.

Law is a system of rules and guidelines whichare enforced through social institutions togovern behavior.

Laws are made by governments, specifically bytheir legislatures. The formation of lawsthemselves may be influenced by a constitution(written or unwritten) and the rights encodedtherein.

The law shapes politics, economics and societyin countless ways and serves as a socialmediator of relations between people.

A Legislature is a kind of deliberativeassembly with the power to pass, amend, andrepeal laws.

The law created by a legislature is calledlegislation or statutory law.

Legislatures are known by many names, themost common being parliament and congress,although these terms also have more specificmeanings.

Ethics, also known as moral philosophy, isa branch of philosophy that involvessystematizing, defending, and recommendingconcepts of right and wrong behavior.

A law, statute, or regulation enacted by a localauthority.An ordinance is a law passed by a localauthority.A local authority, such as a city, town, village,or borough, is a political subdivision of a statewithin which a municipal corporation has beenestablished to provide local government to apopulation in a defined area.

A policy is typically described as a principleor rule to guide decisions and achieve rationaloutcomes.

This is normally referred to as eitherprocedure

Procedures or protocols are developed andadopted.

Policies can assist in both subjective andobjective decision making.

LAWS AND POLICIES

National Drug policy 2005 Drug Act 1940 Drug Control Ordinance 2006 Drug Control Ordinance 1982 Drug rules List of Essential Drug Drug Rules, 1945 Price Fixation Policy Price Fixation Procedure Primary Healthcare List

Essential medicines- 'Essential medicines are thosethat satisfy the priority health care needs of thepopulation. They are selected with due regard topublic health relevance, evidence on efficacy andsafety, and comparative cost-effectiveness. Essentialmedicines are intended to be available within thecontext of functioning health systems at all times inadequate amounts, in the appropriate dosage forms,with assured quality and adequate information, andat a price the individual and the community canafford. The implementation of the concept of essentialmedicines is intended to be flexible and adaptable tomany different situations; exactly which medicinesare regarded as essential remains a nationalresponsibility.