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Status of essential medicines in India

One of the major functions of the Governments and hospitals in India is the provision of essential medicines (EM) to its populations at all times, always. The Government of India has strategies for pricing the EM to increase the affordability in country. However the pharmaceutical industry, which is driven by profit motive, often finds ways out to continue their run for making huge profits from the medicines sold by them.

The Indian Government’s effort to make 50 EM available to the entire population of India, free of charge is appreciable.1 The union Health Minister of India Dr Harsh Vardhan had stated that in order to accomplish the Government’s health for all mission, it has listed providing free generic medicines and insurance among its top priorities.2 The health ministry’s vision is to provide the 50 essential generic medicines, free of cost from “birth to death” to all Indians across the nation, which will address 75% of the healthcare needs of the majority.3

This programme will be rolled

Indians to get free 50 essential medicinesVIJAY THAWANI, ABIN MANI

ABSTRACT

Considerate, progressive and pro-citizenry countries of the world extend the service of supplying free essential medicines to their ailing and needy populations in time of their suffering. Joining this league of concerned national governments is India. The Indian Government’s announcement and subsequent implementation to make 50 essential medicines available to the entire population of India, free of charge is appreciable. Making needed medicines available free of cost during the health needs is a laudable service because during sickness the concerned individual’s capacity to earn is decreased and expenses on health are increased, as very few have the health insurance in our country.Key words: Healthcare, Indian Government, Rational Use, medicine affordability, generic medicine.

out in phases, beginning with select hospitals across India, with the objective of reaching every citizen.3 The list of these medicines contains analgesics, antibiotics, antihypertensives, and antidiabetic medicines to name a few.1

The supply of listed EM will ensure that for the same amount 35% more medicines of superior quality can be procured to meet the health needs of the majority. The statement from Health Minister was encouraging that it will focus on efficient procurement, quality control and rational use – 50% medicines are wasted or overused, leading to complications and drug resistance.3

The $5.4 billion policy to provide free medicines could change the lives of hundreds of millions, but a ban on branded drugs stands to cut Big pharma out of the windfall.4 Now the India’s public doctors will be limited to a generics only drug list and face punishment for prescribing branded medicines. If doctors are found to be prescribing medicines which are not on the list or which are branded, then disciplinary action will be initiated. The policy of the Government is to promote greater and rational use of generic medicines that are of standard quality. If these generics only prescriptions succeed in future, it

will please generics manufacturers who stand to gain substantially in competing for contracts while the interests of global drug makers selling branded medicines are surely going to be hit. Currently India is a fertile market for branded and branded generic sector – which exists exclusively in India and favors the industry and not the common cause.4

The move of providing the essential, generic, common, 50 medicines free of cost to the needy populations from birth to death is laudable. It has been pleaded that if EM are not available to the ailing in times of need, the very purpose of having the essential medicine list (EML) is defeated. The goal of attaining “health for all” is not possible without making the EM available to the populations.

By bringing in this long awaited reform, the Government is not doing any philanthropy. All affording national governments must ensure that their populations get the minimal health facilities which include provision of free EM. By doing so the democratic governments justifiably utilize the tax payers’ money as custodians, for betterment of the health of people of own country. If the health of people is good, health of the Nation will be good. The tenets of the practice of Trusteeship of

Vijay Thawani, Professor of Pharmacology, People’s College of Medical Sciences & Research Centre, Bhanpur, Bhopal – 462 037.Abin Mani, Scientist, Centre for Scientific Research & Development, People’s University, 4th floor, Bhanpur, Bhopal - 462037

Specially Contributed to "The Antiseptic" Vol. 113 No. 12 & P : 12 - 14

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Mahatma Gandhi teach that the elected representatives are the trustees, in whom the electorate of country has reposed their trust by electing them. The trustees should not break this trust which is bestowed upon them. They should endeavor to do all good for their populations. Under no circumstances the Governments in a democracy should develop the aura that they are in seats of power to govern because populations to be governed are available. When the realization of trusteeship sets in, the democracy grows, thrives and prospers.It is hoped that this announced scheme will come through on time and ensure availability and accessibility to EM.

The EML should contain a recognizable set of medicines which will help the country to counter the health needs so, this list should be based on the socio ecological condition of the country and the medicine is to be selected, through an evidence-based process, for its safety, effectiveness and value for money. The Asian population represents similar health problems with similar socio ecological conditions. The WHO had added a 20mg zinc tablet to its 2011 model EML since use of zinc sulfate will reduce the children mortality from diarrhea. Hence zinc is in 350 medicines on the current EML of WHO. As effective EML will serve the development of the country so it should be assisted by national decision makers to reduce the cost of the priority medicine of basic health need.5

The WHO created the first Essential Drugs List in 1977, containing 220 drugs. Since then the EML Expert Committee has met every two years to update the Model List, using a transparent process. Any entity may propose an addition – individuals, governments,

pharmaceutical companies, or medical associations. But they must provide evidence of the proposed drug’s safety, efficacy and cost-effectiveness. They also need to show that the medicine is both essential to meeting priority health care needs and is available in adequate amounts. Situation

It has been observed that there is often a scarcity in the availability of EM in public health facilities. According to WHO the availability of generic medicines in public sector for low and middle income countries were 37.7% and 46.0% respectively but in private sector it was 70.0% and 71.7% respectively.6

Current needs

There are changes and challenges in public health with new health issues that influence mortality rate over the past decade. The present WHO EML supports the treatment of cancer, diabetes, reproductive health, tuberculosis, malaria and HIV/AIDS. The new edition of Model EML includes therapeutics for hepatitis C, cancers (mostly emphasized on including breast cancer and leukaemia) and multi-drug resistant tuberculosis (TB), among others. Presently the innovative medicines came in the list of EML which has clinical benefits and can improve public health globally. When the new effective medicine ensures the safe treatment of the wide spread disease it is essential that the availability is met according to its need. The essential medicines should have efficacy, safety and quality and be cost-effective to the alternatives in the same class of medicines.

Some of newly introduced essential medicine includes the medicine to treat hepatitis C. Five new oral antiviral medicines including sofosbuvir and daclatasvir are listed in essential

medicine by WHO, which can transform chronic hepatitis C from a barely manageable to a curable condition with few side effects and high tolerance in patients. The WHO has included 16 new anti cancer medicines in their EML since some of these medicines produce relevant survival benefits for cancers with high incidence, such as trastuzumab for breast cancer. 5 new TB medicines were included in the EML, four of these, including bedaquiline and delamanid, target multi-drug-resistant TB. Efforts have been made to make these medicines considerably affordable globally as a potential for public health.7,8

The Indian national list of essential medicine (NLEM) 2015 contains a total of 376 medicines with 56 duplication of medicines within and across therapeutic categories. The list is the revised list of 2011 with a total addition of 106 medicines with new area of medicines used in dementia (01), neonatal care (03) and ear, nose, throat (04) got included in the list more over 81 medicine were deleted from the list. There were 348 medicines listed in NLEM 2011. A total of 106 medicines have been added, and 70 medicines have been deleted to prepare NLEM 2015. The NLEM consists anesthetics, analgesics, antipyretics, non- steroidal anti-inflammatory, antiallergics, antidotes, anti- convulsants / antiepileptics, anthelminthics, anti-bacterial, antileprosy, antituberculosis, a n t i - f u n g a l , a n t i v i r a l , antiprotozoal, antimigraine, an t ineop las t i c , immuno- suppressives, antiparkinsonism, affecting blood, cardiovascular, dermatological, ear, nose, throat, gastrointestinal, hormones, endocrine, contraceptives, ophthalmological, oxytocics, antioxytocics, psychotherapeutics, vitamins, minerals, diuretics,

December 201614 THE ANTISEPTIC

immunologicals, muscle relaxants and cholinesterase Inhibitors; medicine used for gout, anaphylaxis, poisonings, palliative care, dementia, neonatal care, respiratory tract and rheumatoid disorders; blood products and plasma substitutes, dialysis solution, solutions correcting water, electrolyte and acid-base disturbances, diagnostic agents, disinfectants and antiseptics.9

Conclusion

It is expected that national availability of these 50 generic EM will address at least 75% current health care needs of Indian population in pediatric to geriatric health care. The year round availability and accessibility of these medicines in all Government facilities is essential to establish the trust of citizenry in healthcare reform. The medicines that are to be made available should be of superior quality.

The major drawbacks that we

foresee with the free availability of 50 EM in the country in the current scenario is the problem with rational use of these medicines since free availability often leads to overuse, wastage, more adverse drug reactions and drug resistance. However the fears alone should not retard the progressive step towards attaining health for all in the country. Teething problems do occur in all new programmes and have to be faced boldly. “The sustained will” to do good ensures attainment of the goals. REFERENCES

1. Bagchi S. India will make 50 essential drugs available free of charge. BMJ 2014 349: g 4321.

2. Tribune News Service. Focus on free generic drugs, insurance: Harsh Vardhan. The Sunday Tribune, Chandigarh, 134, No 213, 3 Aug 2014, P3, Col 2-5.

3. Sanchita Sharma. Health ministry to give 50 essential medicines free. Hindustan Times, New delhi, 21 June 2014, Vol XC, No 147, P6, Col 3-4.

4. Deccan Herald. India to give free

medicine to hundreds of millions. Deccan Herald. Available from: h t t p : / w w w . d e c c a n h e r a l d . c o m /con ten t / 262000 / i nd ia -g i ve - f r ee -medicine-hundreds.html [Last accessed on 08 October 2016]

5. WHO Technical Report Series 985. The Selection and Useof Essential Medicines.http:/ /apps.who.int/ i r is/b i ts t ream/10665/112729/1/WHO_TRS_985_eng.pdf[Last accessed on 08 October 2016]

6. WHO. Median availability of selected generic medicines. http://www.who.int/gho/mdg/medicines/availability_text/en/ [Last accessed on 08 October 2016]

7. WHO moves to improve access to lifesaving medicines for hepatitis C, drug-resistant TB and cancers. h t tp : / /www.who. in t /med iacen t re /news/releases/2015/ new-essential-medicines-list/en/[Last accessed on 08 October 2016]

8. Holloway K (Ed), Green T. WHO and MSH. Drug and therapeutics committees a practical guide. http://apps.who.int/medicinedocs/pdf/ s4882e/s4882e.pdf. [Last accessed on 08 October 2016]

9. National List of Essential Medicines. http://cdsco.nic.in/WriteReadData/NLEM-2015/NLEM,%202015.pdf. [Last accessed on 08 October 2016]

Cardiac remodeling is defined by complex structural and functional modifications of the myocardium that occur after an acute myocardial injury, such as a myocardial infarction or during the development of heart failure, and cardiac remodeling is associated with poor outcomes. Increased heart rate is associated with progressive cardiac dilation and reduced ejection fraction in experimental models and in the clinic. Pharmacological heart rate reduction is generally associated with reverse cardiac remodelling; however, improvement in outcomes is variable: there is no evidence that digitalis or amiodarone improves outcomes, although they are associated with short-term reverse remodelling. In contrast, -adrenergic blockers and the sinoatrial funny current inhibitor ivabradine induce mid-term reverse remodelling and are associated with a long-term improvement in morbidity and mortality in chronic heart failure.

- Dialogues in cardiovascular medicine

Although arbitrary in the number of medications required, resistant hypertension has been largely defined as hypertension that is uncontrolled despite use of 3 antihypertensive medications, including, if tolerated, a diuretic. The American Heart Association Scientific Statement extended the definition to include patients whose blood pressure was uncontrolled with 3 medications, but was subsequently controlled with use of 4 medications, that is, controlled resistant hypertension.

- Hypertension