lR;eso t;rs Directorate General of Health Services Ministry of Health & Family Welfare Government of India Contents List of Participants i Preface to National List of Essential Medicines 2003 ii Preface to National Essential Drugs List 1996 v List of Additions viii List of Omissions x List of Drug Movements Across Categories xi Therapeutic Categories xii List of Essential Medicines 1. Anaesthetics 1 1.1 General Anaesthetics and Oxygen 1 1.2 Local Anaesthetics 1 1.3 Preoperative Medication and Sedation for 1 Short Term Procedures 1.4 Postoperative Respiratory Stimulant 2 2. Analgesics, Antipyretics, Nonsteroidal Antiinflammatory 2 Medicines, Medicines used to treat Gout and Disease Modifying Agents used in Rheumatoid Disorders 2.1 Non-Opioid Analgesics, Antipyretics and Nonsteroidal 2 Antiinflammatory Medicines 2.2 Opioid Analgesics 2 2.3 Medicines used to treat Gout 2 2.4 Disease Modifying Agents used in Rheumatoid Disorders 3 3. Antiallergics and Medicines used in Anaphylaxis 3 4. Antidotes and Other Substances used in Poisonings 3 4.1 Nonspecific 3 4.2 Specific 4 5. Anticonvulsants/Antiepileptics 4 6. Antiinfective Medicines 5 6.1 Anthelminthics 5 6.1.1 Intestinal Anthelminthics 5 6.1.2 Antifilarials 5 6.1.3 Antischistosomals and Antitrematode Medicines 5 6.2 Antibacterials 5 6.2.1 Beta Lactam Medicines 5 6.2.2 Other Antibacterials 6 6.2.3 Antileprosy Medicines 7 6.2.4 Antituberculosis Medicines 8 6.3 Antifungal Medicines 8 6.4 Antiviral Medicines 9 6.4.1 Antiherpes Medicines 9 6.4.2 Antiretroviral Medicines* 9 6.4.2.1 Nucleoside Reverse Transcriptase Inhibitors 9 6.4.2.2 Non-nucleoside Reverse Transcriptase Inhibitors 9 6.4.2.3 Protease Inhibitors 9 6.5 Antiprotozoal Medicines 10 6.5.1 Antiamoebic and Antigiardiasis Medicines 10 6.5.2 Antileishmaniasis Medicines 10 6.5.3 Antimalarial Medicines 10 6.5.3.1For Curative Treatment 10 6.5.3.2For Prophylaxis 11 6.5.4 Antipneumocystosis and Antitoxoplasmosis Medicines 11 7. Antimigraine Medicines 11 7.1 For Treatment of Acute Attack 11 7.2 For Prophylaxis 11 8. Antineoplastic, Immunosuppressives and Medicines 12 used in Palliative Care 8.1 Immunosuppressive Medicines 12 8.2 Cytotoxic Medicines 12 8.3 Hormones and Antihormones 13 8.4 Medicines used in Palliative Care 14 9. Antiparkinsonism Medicines 14 10. Medicines affecting the Blood 14 10.1 Antianemia Medicines 14 10.2 Medicines Affecting Coagulation 15 11. Blood Products and Plasma Substitutes 15 11.1 Plasma Substitutes 15 11.2 Plasma Fractions for Specific Use 15 12. Cardiovascular Medicines 16 12.1 Antianginal Medicines 16 12.2 Antiarrhythmic Medicines 16 12.3 Antihypertensive Medicines 17 12.4 Medicines used in Heart Failure 18 12.5 Antithrombotic Medicines 18 13. Dermatological Medicines (Topical) 18 13.1 Antifungal Medicines 18 13.2 Antiinfective Medicines 18 13.3 Antiinflammatory and Antipruritic Medicines 19 13.4 Astringent Medicines 19 13.5 Medicines Affecting Skin Differentiation and Proliferation 19 13.6 Scabicides and Pediculicides 19 14. Diagnostic Agents 19 14.1 Ophthalmic Medicines 19 14.2 Radiocontrast Media 20 15. Disinfectants and Antiseptics 20 15.1 Antiseptics 20 15.2 Disinfectants 21 16. Diuretics 21 17. Gastrointestinal Medicines 21 17.1 Antacids and other Antiulcer Medicines 21 17.2 Antiemetics 22 17.3 Antihaemorrhoidal Medicines 22 17.4 Antiinflammatory Medicines 22 17.5 Antispasmodic Medicines 22 17.6 Laxatives 22 17.7 Medicines used in Diarrhoea 23 17.7.1Oral Rhydration Salts 23 17.7.2Antidiarrhoeal Medicines 23 18. Hormones, other Endocrine Medicines and Contraceptives 23 18.1 Adrenal Hormones and Synthetic Substitutes 23 18.2 Androgens 23 18.3 Contraceptives 23 18.3.1 Hormonal Contraceptives 23 18.3.2Intrauterine Devices 24 18.3.3 Barrier Methods 24 18.3.4Non Hormonal Contraceptives 24 18.4 Estrogens 24 18.5 Antidiabetics and Hyperglycaemics 24 18.5.1Insulins and Other Antidiabetic Agents 24 18.5.2Hyperglycaemics 24 18.6 Ovulation Inducers 24 18.7 Progestogens 24 18.8 Thyroid and Antithyroid Medicines 25 19. Immunologicals 25 19.1 Diagnostic Agents 25 19.2 Sera and Immunoglobulins 25 19.3 Vaccines 25 19.3.1 For Universal Immunisation 25 19.3.2 For Specific Group of Individuals 26 20. Muscle Relaxants (peripherally acting) and Cholinesterase Inhibitors 26 21. Ophthalmological Preparations 26 21.1 Antiinfective Agents 26 21.2 Antiinflammatory Agents 27 21.3 Local Anaesthetics 27 21.4 Miotics and Antiglaucoma Medicines 27 21.5 Mydriatics 27 21.6 Ophthalmic Surgical Aids 27 22. Oxytocics and Antioxytocics 27 22.1 Oxytocics 27 22.2 Antioxytocics 27 23. Peritoneal Dialysis Solution 28 24. Psychotherapeutic Medicines 28 24.1 Medicines used in Psychotic Disorders 28 24.2 Medicines used in Mood Disorders 28 24.2.1Medicines used in Depressive Disorders 28 24.2.2 Medicines used in Bipolar Disorders 28 24.3 Medicines used for Generalized Anxiety and Sleep Disorders 28 24.4 Medicines used for Obsessive Compulsive Disorders and 29 Panic Attacks 25. Medicines Acting on the Respiratory Tract 29 25.1 Antiasthmatic Medicines 29 25.2 Antitussives 29 26. Solutions correcting Water, Electrolyte, and Acid-Base Disturbances 29 26.1 Oral 29 26.2 Parenteral 30 26.3 Miscellaneous 30 27. Vitamins and Minerals 30 Index 31 NATIONAL LIST OF ESSENTIAL MEDICINES 2003 List of Participants in the preparation of National List of Essential Medicines (i) Dr. S. D. Seth, Chairman (ii) Mr. Ashwini Kumar, Member Secretary (iii) Dr. Y. K. Gupta, Prof. of Pharmacology, AIIMS Member (iv) Dr. C. P. Singh, M. S., RML Hospital Member (v) Dr. Y. N. Rao, DDG(M) Member (vi) Dr. Sandeep Guleria, AIIMS Member (vii) Dr. P. L. Joshi, Addl. Project Director, NACO Member (viii) Dr. G. P. Sinha, Prof. of Medicine, Patna Medical College Member (ix) Dr. J. N. Pandey, HOD (Medicine), AIIMS Member (x) Dr. G. K. Biswas, Addl. DG (Stores) Member (xi) Dr. Nikita Gupta Kamal Member (xii) Dr. Rita Sood (co-opted) Member (xiii) Dr. R.N. Salhan (co-opted in April 2003) Member (xiv) Dr. Usha Gupta (co-opted in December 2002) Member (xv) Mr. Brijesh Regal, WHO Consultant in DCG(I) office Coordinator i Preface to National List of Essential Medicines 2003 The review of National Essential Drugs List 1996, was due in the context of contemporary knowledge of the therapeutic products. An expert core committee was constituted by the Director General of Health Services in June 2002 for this purpose. The committee comprised of the following members: 1. Dr. Y. K. Gupta, Prof. of Pharmacology, AIIMS, New Delhi 2. Dr. C. P. Singh, Medical Suprintendant, RML Hospital, New Delhi 3. Dr. Y. N. Rao, DDG(M), DteGHS, MOHFW, New Delhi 4. Dr. Sandeep Guleria, AIIMS, New Delhi 5. Representative from ICMR, New Delhi 6. Representative from NACO, New Delhi 7. Dr. G. P. Sinha, Prof. of Medicines, Patna Medical College, Patna 8. Dr. J. N. Pandey, HOD (Medicines), AIIMS, New Delhi 9. Dr. G. K. Biswas, Addl. DG (Stores), DteGHS, MOHFW, New Delhi 10. Dr. Nikita Gupta Kamal, Ophthalmologist 11. Mr. Brijesh Regal, WHO Consultant in DCG(I) office 12. Mr. Ashwini Kumar, DCG(I), DteGHS, MOHFW, New Delhi Dr. S. D. Seth, Chair in Clinical Pharmacology, ICMR represented ICMR on the committee and was nominated by members to be the Chairman of the core committee. Dr. J. N. Pandey nominated Dr. Rita Sood, Addl. Prof. of Medicine, AIIMS to participate in the committee's delibrations. Dr. R. N. Salhan, Medical Suprintendant, RML Hospital contributed as member of the core committee, consequent to the retirement of Dr. C. P. Singh. Dr. P. L. Joshi was nominated by NACO as member of the committee. Dr. Usha Gupta, HOD Pharmacology, MAMC was coopted as member of the committee. After detailed delibrations in its first meeting, the committee agreed on the following criteria for identifying medicines for inclusion in the revised list: • Consideration of relevant disease burden in the country • Information on the efficacy, safety and comparative cost effectiveness of the products • Preference for single active compounds • Cost effectiveness in the context of cost of treatment • Available health delivery infrastructure (e.g. treatment facilities, training and experience of the available personnel; availability, financial resources; and environmental factors etc.) Addition of drugs required in emergency care/life threatening situations were also considered. The committee also decided to follow the principles and concepts of “Essential” drugs as enunciated by WHO, as was done for the 1996 list. Accordingly, the description of the list as 'Essential Medicines' List was adopted and includes three components: a definition, a description of the selection criteria and a description of the ii purpose for which such a list is developed, as follows: Definition: Essential medicines are those that satisfy the priority health care needs of the population. Selection criteria: Essential medicines are selected with due regard to disease prevalence, evidence on efficacy and safety, and comparative cost-effectiveness. Purpose: Essential medicines are intended to be available within the context of functioning health systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality. Evidently, the word “Essential” does not purport to convey that number of other drugs available in the market are non-essential. Several sub-committees of clinicians were formed to review the various sub-groups of medicines and core committee members coordinated the proceedings of one or more of these respective sub groups. Each of these sub-group members, and indeed all those who provided their professional inputs, were clearly explained about the fundamental doctorine of the “essential” medicine's description as stated above. The medicines that have finally been included in this list have gone through several intensive screenings by the expert group as well as by invited and consulted professionals. Cost of therapy was worked out especially in the context of already available therapies and keeping in view the drugs available for these categories in the WHO list of essential medicines. Essential Drugs List of various states and WHO Model Formulary (2002) were also referred during the review process. Medicines used by various national programmes and emergency care drugs etc. which were earlier identified by health care professionals in the context of drug policy, were also considered. A new section on medicines for HIV-AIDS has been included since it was non-existent in the 1996 list. Several new anti-cancer drugs have been added in the current list. Additional drugs find place in the revised list. The committee is of the opinion that since the word 'drug' is now globally considered to have a different (narcotic) connotation, it may be replaced with the word 'Medicine' a term which is now more widely used to describe therapeutic pharmaceutical substances. WHO has also renamed its list as Model List of Essential “Medicines”. Accordingly, the present list has been titled “National List of Essential Medicines”. The committee gratefully acknowledges the contributions made by the following experts: Dr. M. P. Sharma, Dr. Praveen Aggarwal, Dr. Nikhil Tandon, Dr. P. P. Kotwal, Dr. Arvind Kumar, Dr. Sunesh Kumar, Dr. Rakesh Yadav, Dr. S. K. Maulik, Dr. S. C. Tiwari, Dr. Ravi Saksena, Dr. Renu Saxena, Dr. Kaushal K. Verma. Categories of the medicines as classified in NEDL 1996 have been revised to harmonize with the latest “Sections” used by WHO Essential Medicines List. Although WHO has published two separate lists in its latest revision (core list and complementary iii list) the committee has taken a conscious decision to keep the core and complementary medicines together in the main list itself. The complementary medicines have been marked * and denote those medicines which may be needed when other medicines listed in the category are not readily available or they may be required in specific situations or locations for well founded reasons. The committee observed that critical care or emergency care medicines are many times perceived as “life saving drugs” though this is not a standard terminology in the context of overall use of medicinal products. It would be seen that the essential medicines list consists of medicines meant for the management of a wide variety of conditions ranging from symptomatic relief, public health care, management of infections as well as for “life threatening” - emergency situations & for critical care. An index of therapeutic categories has been included in the final version for ease of reference. The nomenclature of medicines has been made consistent with that used in India [e.g. Epinephrine has been changed to Adrenaline and first letters of names of the medicines have been made capital, as in Indian Pharmacopoeia (I.P.)]. It is felt that this list may be reviewed every two years to keep it relevant in the context of contemporary knowledge and drugs that keep appearing on the horizon. The committee gratefully acknowledges the support provided by WHO-India Country Office for the review process as well as for dissemination of this list. iv