IP, EML, RATIONAL USE OF DRUGS

1. Indian Pharmacopoeia
Essential Medicine,
Rational Use of Drugs
Purnendu Mandal
MD PGT
Pharmacology
BSMC, Bankura

2. Indian Pharmacopoeia
• Pharmacopoeia: the word derives from the ancient Greek
word Pharmakon means Drug & Poeia means to make.
• It is a legally binding collection, prepared by a national or
regional authority & contains list of medicinal substances,
crude drug & formulas for making preparation from them.

3. The Pharmacopoeia Contain
List of drug and other related substances.
Sources.
Description.
Tests.
Formulas for preparation ,actions.
Uses.
Doses.
Storage conditions.

4. INDIAN PHARMACOPOEIA
• Indian Pharmacopoeia Commission (IPC) is an autonomous institution of
the Ministry of Health and Family Welfare.
• Sets standards for all drugs that are manufactured, sold and consumed in
India
• The set of standards are published under the title Indian Pharmacopoeia
(IP)
• Vision: The IPC is committed to the promotion of the highest standards for
drugs for use in the prevention and treatment of diseases in human beings
and animals keeping in view the special features of the pharmaceutical
industry in India.

5. HISTORY of INDIAN PHARMACOPOEIA
• 1944- The process of publishing the first
Pharmacopoeia started in the year under
the chairmanship of R. N. Chopra .
• 1948- government of India appointed
an Indian Pharmacopeia committee to
prepare ‘Pharmacopeia of India’ .
• 1955- 1st edition I. P. 1955 was published
• 2018 - 8th Edition I. P.

6. OVERALL PHILOSOPHY
• Official book of standards and medicines produced in india must
comply with the specified standards .
• Pharmacopoeial standards and acceptance criteria are set with the
intention that they be used only as compliance requirements and not
as requirements to guarantee total quality assurance .
• Compliance to pharmacological standards
• Maintain quality during storage and distribution.
• Good Manufacturing Practices .

7. Essential Medicine
• WHO - Essential Medicines
“those that satisfy the priority healthcare needs of the
population.”
• They are selected with due regard to public health relevance,
evidence on efficacy and safety, and comparative cost
effectiveness.
Essential medicines are intended
• To be available within the context of functioning adequate
amounts.
• In appropriate dosage forms.
• Assured quality and adequate information.
• At a price the individual and the community can afford.

8. WHY ?
• only a handful of medicines out of the multitude available
can meet the health care needs of majority of the people.
• in any country, and that many well tested and
cheaper medicines are equally (or more) efficacious and safe
as their newer more expensive congeners.
For optimum utilization of resources, governments (especially
in developing countries) should concentrate on these
medicines by identifying them as Essential medicines.

9. WHO criteria to guide selectionof an essential medicine
(a)Adequate data on its efficacy and safety.
(b) Quality, Including Bioavailability, and Stability .
(c) Pattern of prevalent diseases; availability of facilities and trained personnel;
financial resources; genetic, demographic and environmental factors.
(d) In case of two or more similar medicines, relative efficacy, safety, quality, price
and availability. Cost-benefit ratio should be a major consideration.
(e) Choice may also be influenced by comparative pharmacokinetic properties and
local facilities for manufacture and storage.
(f) Most essential medicines should be single compounds. Fixed ratio combination
products should be included only when dosage of each ingradient meets the
requirements of a defined population group, and when the combination has a
proven advantage in therapeutic effect, safety, adherence or in decreasing the
emergence of drug resistance.
(g) changing priorities for public health action, epidemiological conditions as well
as availability of better medicines/formulations and progress in pharmacological
knowledge.
(h) based on rationally developed treatment guidelines.

10. HISTORY
• 1977- WHO- Model List of Essential Drugs
This has been revised from time to time and the current is the 17th
list
(2011- 433 medicines with 25FDCs)
• 1996- India produced its National Essential Drugs List in and has
revised it in 2011 with the title “National List of Essential
Medicines”. (348 medicines )
2015- 376 medicines with 20FDCs.
• Adoption of the essential medicines list for
procurement and supply of medicines, especially
in the public sector healthcare system, has resulted in improved
availability of medicines, cost saving and more rational use of
drugs.

11. Rational Use of Drugs
• "patients receive medications appropriate to
their clinical needs, in doses that meet their
own individual requirements, for an adequate
period of time, and at the lowest cost to them
and their community".

12. 12 key interventions
1. Establishment of a multidisciplinary national body to coordinate policies on
medicine use.
2. Use of clinical guidelines.
3. Development and use of national essential medicines list.
4. Establishment of drug and therapeutics committees in districts and hospitals
5. Inclusion of problem-based pharmacotherapy training in undergraduate curricula.
6. Continuing in-service medical education as a licensure requirement
7. Supervision, audit and feedback.
8. Use of independent information on medicines.
9. Public education about medicines.
10. Avoidance of perverse financial incentives.
11. Use of appropriate and enforced regulation.
12. Sufficient government expenditure to ensure availability of medicines and staff.

13. Reasons for Irrational use of Drugs
1. Lack of information .
2.Role models – Teachers or seniors .
3. Lack of diagnostic facilities/Uncertainty of diagnosis –
medicine for all possible causes.
4.Demand from the patient.
5. Patient load.
6. Promotional activities of pharmaceutical industries.
7.Drug promotion and exaggerated claim by companies .
8.Defective drug supply system & ineffective drug regulation.

14. Thank you