– Core List
– Complementary List
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
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
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