ESSENTIAL MEDICINES

CONCEPT AND DRUG

REGULATION IN SRI LANKA
Prof Rohini
Fernandopulle
December 2010
 Objectives 1
• What is the background which led to the
development of the concept of essential drugs?
• What is the definition of an essential drug?
• What are the criteria for inclusion of a drug in the
Essential Drugs List (EDL)?
• How are drugs classified in the EDL?
• Why are revisions of the EDL necessary?
• What is the use of EDL to the Ministry of Health?
• What was the role played by Professor Bibile in the
development of the EDL?
• What are the recommendations made by
Professor Bibile towards optimizing use of
pharmaceutics in Sri Lanka?
• Know the essential medicine list of 2009 and be
able to name the medicines in the list.
 Objectives 2
• What are the recommendations on
• Drug procurement
• Distribution
• Education of prescribers
• Education of the public
• Explain the meaning of the term - Rational Drug Use
(RDU) overuse, use, inappropriate use, polypharmacy.
• What is the Cosmetics, Devices and Drugs Act?
• What is a registered drug & What criteria are used when
drugs are registered in this country?
• How are drugs scheduled?
• What is a drug dossier and what are its contents?
 Background
• The essential medicines concept was launched in
1977, and became one of the eight pillars of WHO's
"Primary Health Care" strategy.
• Initially country lists were a means to guide the
procurement of medicines.
• Initially was mainly for adults with some paediatric
medicines included
• Since 2007 paediatric list developed separately by a
Subcommittee and included in the final WHO – ML
• It is a global list
 Essential Medicines
• Definition by World Health
Organisation
Essential medicines are MEDICINES
that satisfy the priority health
care needs of the population.
• Selection
– on disease prevalence and
– evidence on efficacy and safety and
– comparative cost-effectiveness
 Purpose of WHO essential
medicines concept
• Essential medicines are intended to be
available at all times in adequate
amounts, in the appropriate dosage
forms, with assured quality and
adequate information, and at a price the
individual and the community can afford
 Other principles
• Only one member from a
pharmacological group can be
chosen
– Example hypertension ONLY
• one beta blocker, one ACE
inhibitor, one calcium channel
blocker is chosen from the
several available
• Medicines are listed only in generic
name, never in the brand names
WHO Model List of Essential
Medicines
• The is a model product and a model process
• Updated every two years by an expert
committee
• In Sri Lanka the WHO list is used as a model
• Exactly which medicines are regarded as
essential remains our national responsibility
 WHO – EML

• Medicines classified into

– Core List

– Complementary List

Sri Lanka has also divided our list

accordingly

9
 Core list 
• List of minimum medicine needs for a basic 
health care system
• Lists the most efficacious, safe and cost
effective medicines for priority conditions
• Priority conditions are selected on the basis of 
current and estimated future public health 
relevance

10
 The complementary list
• Consists of essential medicines for
priority diseases which are
efficacious, safe and cost-effective
But
• not necessarily affordable, or
• for which specialized health care
facilities or services may be needed.

11
 Cost  comparisons
• Cost  of  the  total  treatment not  only  the  unit  cost of
 the  medicine,  is  considered.  
• Comparisons  may  be  made  among  alternative  
treatments  within  the  same  therapeutic  group for
example high blood pressure  but not  be  made
  between therapeutic  categories for  Eg. not between
 treatment of tuberculosis  and  treatment  
of  malaria.  
• The  patent  status  of  medicine  is  not  considered  in
selecting  medicines  for  the  Model  List if all main criteria
are met.

12
 Single medicines/ Fixed
dose combinations (FDCs)
 Most essential medicines should be formulated as single c
ompounds. 
• FDCs selected only when the combination has a proven ad
vantage in therapeutic effect, safety or compliance 
over single compounds administered separately. 
• Examples of FDCs that have met 
these criteria include new formulations for HIV
tuberculosis and malaria. 

13
 Criteria for selection of Sri
Lanka EML
• Disease burden in Sri Lanka - from
annual health bulletin

• Reliable and adequate efficacy AND

safety data

• Pharmacoeconomic data to determine

comparative cost-effectiveness 
of available treatments
14
 What is the use of EML to the
Ministry of Health?
• Used for procurement and supply of the
priority medicines for the public sector
• To accept donations in times of emergency
• For local manufacture
• Procurement for the state sector – state
pharmaceutical corporation (SPC)
• Who distributes and quantifies the needs –
medical supplies division (MSD)
 Essential medicine list Sri
Lanka
• First EML published in 1988
• Revised irregularly since then 1999, 2004
• Now will be done every three years
• 2009 latest – you will be given a copy
• You should know the essential medicine list of
2009 and be able to name the medicines in
the list and all the relevant information
 Role of Professor Senaka
Bibile
• First Professor of pharmacology in Colombo
• In 1958 conceived the idea and produced a limited list
(HFL) for poor countries to spend wisely
• Recognized as the person who revolutionized
management of pharmaceuticals in Sri Lanka In 1971
introduced and in the third world
• In 1975 – 1976 WHO accepted the concept and essential
medicines concept was born
• Prof NDW Lionel was on the first expert committee of the
WHO
 Reforms introduced in Sri
Lanka in 1971 by SB
• Set up a central procurement organization
– SPC
• Medicines requirement was quantified
objectively and purchased through world
wide / regional tender system
• Ensured quality of medicines met specified
standards
• Introduced an efficient system for
distribution of medicines through MSD
• Restricted innovator branded products
and introduced generic prescribing
 Trends in percentage expenditure on essential
medicines: 2002-2006
90
80 81 82 80
Percentage of money spent

74
70 71

60
Essential
50 medicines
40 Non essential
medicines
30 29
26
20 19 18 20
10
0
2002 2003 2004 2005 2006
Year
DRUG REGULATION
What is Drug Regulation 
The control of pharmaceuticals that is sold
in a country.
Includes
– What drugs are available in the country
– How they are used
– How they are advertised
– What their prices are
Drug Regulation is an intrinsic sovereign
right of a country as a part of the states
duty in health
 Drug Regulation

• Is done in every country

• Only extent differs between the
countries
• In Sri Lanka drug regulation is
carried out at the Medical
Technology and Supplies division
of the Ministry of Health
Office of
MT&S Directo
r Deputy
Director
Unit
Administration

Licensing Unit
Registration &

GMP

e Unit
Pharmacovigilanc

Law Enforcement

Substance Unit
Control
Unit
Post-Marketing
Unit

Unit
No of Pharmacist attached to NRA – 11
Pharmacologists , scientists – Permanent Nil
University academics provide advice as a
 Why should there be Drug
Regulation?
History
• 1938 - US, diethylene glycol used as solvent
• 107 children died
• Company could not be prosecuted - within
the law
• Beginning of drug regulation - main issue was
safety, but in US only
• Such poisonings still happens - Bangladesh
1992, Haiti 1995, Bangaladesh 2008
Drug Regulation in Sri Lanka
• Legislative Framework for Pharmaceuticals
• Cosmetics, Drugs and Devices Act 1980 and
the regulations
• Note - Cosmetics and Devices too
• Comprehensive legislation but
implementation patchy - many reasons
• Applies only to Western drugs
• Excludes herbal, ayurvedic & other drugs
 Elements of the CDD Act
• Registration - every drug must be
registered in the Drug Regulatory
Authority before being sold in the country
• Drugs must be stored and sold in the
manner defined in the act
• Registration of pharmacies
• Licence to bring in new drug samples
• Advertisement of drugs must be in
accordance with the regulations
 Registration 1
• Criteria - quality, safety and efficacy
• Quality
 Product must be registered in the country of
manufacture
 Good manufacturing practices – guidelines
given by WHO
 Conform to pharmacopoeia specifications – BP.
USP. IP.
 Analytical reports on starting material and
finished product
 Stability data throughout the proposed shelf life
 Testing by National drug quality assurance
laboratory
 Registration 2
• Efficacy judged on clinical trial data
(RCTs done in phase 3 studies)
• Safety – data provided from clinical
trials but post marketing surveillance
for adverse drug reactions very
important – done in our department
• Doctors are requested to fill a ADR
form if they suspect any ADRs
 Four classes of drugs
• SCHEDULE 1 - Over The Counter
• No licence, sell in original packing
Medical Faculty canteen
• No registered premises, no registered
person e.g. paracetamol, aspirin
Basis - simple drugs with a wide therapeutic
index, can be sold unsupervised, but in a
defined manner - original packing
Advertisement to the public allowed
 Four classes of drugs
(2a)
• SCHEDULE 2A - Pharmacy only Medicines
• Registered premises (pharmacy), registered person
(pharmacist)
• Basis - drugs which do not need prescription
but need supervision
• Cannot be advertised to public
• Can be sold loose
e.g. chlorphenamine, salbutamol / paracetamol
 Four classes of drugs
(2b)
• SCHEDULE 2B - Prescription only
Medicines
• Registered premise (pharmacy), registered
person (pharmacist) on prescription
• Basis - drugs which need prescription
and supervision in dispensing
• Cannot be advertised to public, only to
prescribers
• e.g. amoxicillin, propranolol
 Four classes of drugs (3)
• SCHEDULE 3 - Dangerous Drugs
• Drugs with a potential for dependence
• Imported only by government
• Distributed through Medical Supplies Division
• Pharmacies, doctors need to keep a register. e.g.
morphine, pethidine
Basis - drugs which need prescription,
supervision in dispensing and state control
• Cannot be advertised to public
Four classes of drugs (4)
• SCHEDULE 4 - Banned Drugs
• Considered too dangerous for use
• LSD, thalidomide
• Little relevance to medical practice
• But now problem as thalidomide has re
emerged for treatment of multiple myeloma,
leprosy reactions, cancer
• ? Personal used licence
 Other areas of Drug
Regulation
• Registration of Pharmacies - qualifications,
supervision by Food and Drug Inspectors
• Clinical trials
• Storage of drugs
• Distribution of drugs
• Manufacture of drugs locally
• Advertising – Committee in the drug
regulatory authority goes through all drug
advertisements before it is made public
 Drug Advertisements
• What is the object of advertising drugs?
• To make the public aware of the product, so that it
will be used when need arises - OTC products
• Main object - provide information about product,
NOT stimulate demand (reality?)
• Therefore special rules and regulations for
pharmaceutical advertising.
• CDD Act - drugs must not be advertised in a false
and misleading manner - negative statement
• Consumer directed advertising of precription
medicines prohibited in the act
 Drug Advertisements
(cont.)
• How should drugs be advertised?
• WHO Ethical Criteria for Medicinal Drug Promotion
• “.... to support and encourage the improvement of
health care through the rational use of medicinal
drugs”
• The SLMA has developed these criteria further
(Both SLMA and WHO publications in FILM)
• Specific points - generic name, indications, adverse
effects, contraindications should be in an
advertisement
 Definition of a innovator /
generic product
• Innovator is the first invented medicine
authorized for marketing and is branded
and patented by the company Example
panadol

• Generic product is a multisource

interchangeable ( with the innovator)
pharmaceutical product produced after
the patent expires, may have a brand
name or only the INN. example paracetol,
paracetamol (SPC)
Definition of Rational drug use

WHO - Rational use of Drugs requires

that patient receive medication
appropriate to their clinical needs, in
doses that meet their own individual
requirements for an adequate period
of time, and the lowest cost to them
and their community.
 SUMMARY - EIGHT RIGHTS OF
RATIONAL PRESCRIBING
• THE RIGHT DRUG
• THE RIGHT PATIENT
• THE RIGHT TIME
• THE RIGHT DOSE
• THE RIGHT ROUTE
• THE RIGHT INFORMATION
• THE RIGHT MONITORING
• THE RIGHT COST
 Summary 2
• A major consideration in selection of EML is
prevalence of the diseases
• Efficacy, safety and cost important in selecting
the right medicine
• EML ensures availability, accessibility and
affordabilty
• Drugs are special unlike food and other consumer
goods
• Enormous potential for both harm & good
• Stringent regulation is important
• Thank you