IASbaba’s Daily Current Affairs – 29th April 2017

HEALTH

TOPIC:General Studies 2

Government policies and interventions for development in various sectors and issues arising out of their design and implementation.

Issues relating to development and management of Social Sector/Services relating to Health

Development processes and the development industry the role of NGOs, SHGs, various groups and associations, donors, charities, institutional and other stakeholders

Important International institutions, agencies and fora their structure, mandate.

Dealing with Malaria

Introduction

Malaria is one of the most threatening epidemics of the world with high incidence in the developing world. The efforts to develop a medicine for the same have been all out and repeated trials have been conducted. Eradication of Malaria has been part of Millennium development goals too.

Malaria Elimination:

Malaria elimination is the interruption of local transmission (reduction to zero incidence of indigenous cases) of a specified malaria parasite species in a defined geographic area; continued measures are required to prevent re-establishment of transmission.

Malaria eradication is defined as the permanent reduction to zero of the worldwide incidence of malaria infection caused by all species of human malaria parasites. Once eradication has been achieved, intervention measures are no longer needed.

Path to malaria elimination

Countries are situated at different points along the road to elimination. The rate of progress will depend on the strength of the national health system, the level of investment in malaria control and a number of other factors, including biological determinants; the environment; and the social, demographic, political and economic realities of a particular country.

Issue:

Beginning next year, the World Health Organisation will begin pilot tests of the injectable malaria vaccine RTS,S (or Mosquirix) on 750,000 children aged 5-17 months in Ghana, Kenya and Malawi.

Any decision on wider use will be taken based on the results of the pilot tests in the three countries.
- If the vaccine does indeed prove to be ready for large-scale use, it will be a milestone in the fight against malaria.
- Although the number of cases globally and in the African region came down by 21% between 2010 and 2015, in 2015 itself the number of deaths worldwide on account of the disease was as high as 429,000.
According to WHO estimates, Africa accounted for 92% of these deaths, and 90% of the 212 million new cases that year.
- The vaccine, given in four doses, protects against Plasmodium falciparum, which is the most prevalent malaria parasite in Africa.
- The three countries have been chosen as they have settings with moderate-to-high transmission of malaria and already have in place malaria control programmes such as the use of bed-nets, rapid diagnostic tests and combination therapy. Each country is to decide where precisely to run the pilots.
Given the low protection efficacy of the vaccine even in tightly controlled clinical settings, the pilot tests will be useful in evaluating the likelihood of replicating the immunisation schedule in the context of routine health-care settings.
Also, the extent to which the vaccine reduces the all-cause mortality has to be evaluated as this was not “adequately addressed” during the trial.
There is, specifically, a need to ascertain if excess cases of meningitis and cerebral malaria seen during the trials are causally related to the vaccination.
Unlike other vaccines, the less-than-optimum protection offered by this vaccine would mean that existing malaria intervention measures will have to be used in conjunction to reduce the incidence of the disease.

Conclusion:

A disease like malaria if successfully eliminated can have long term benefits for African countries and also India. It is important that we closely monitor the studies and work in synergy to ensure best possible outcomes can be replicated. Health outcomes have spillover benefits in multiple sectors of the economy and society.

Connecting the dots:

Analyse the impact of epidemics on the health profile of the country. Elaborate on the need to increase health expenditure keeping global norms in mind.

HEALTH

TOPIC: General Studies 2

Government policies and interventions for development in various sectors and issues arising out of their design and implementation.

Issues relating to development and management of Social Sector/Services relating to Health

Development processes and the development industry the role of NGOs, SHGs, various groups and associations, donors, charities, institutional and other stakeholders

Prescribing medicines under generic names. Is it practical?

Introduction:

The Prime Minister’s recent announcement on making it mandatory for doctors to prescribe only the generic name, and not brand name of a drug, has generated a heated conversation in the media and in the pharma industry.

If enacted, the move will make it illegal for Indian doctors to write out a prescription for the trademark of the drug, forcing them to mention the chemical name instead.

What are Generic Drugs?

A generic drug is identical--or bioequivalent--to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. Although generic drugs are chemically identical to their branded counterparts, they are typically sold at substantial discounts from the branded price.

They are medicines on which patents have expired. They are sold either as branded products or as unbranded products under their generic names. These generic names are internationally agreed short names called International Non-Proprietary Names. For example, paracetamol is the name for a pain relieving and fever reducing medication and Crocin is one brand name of paracetamol.

Why Generic Drugs?

One of the main reasons for advocating generic drugs by the Government was due to the significant price difference between generic and branded drugs, i.e. products sold as unbranded generic medicines are cheaper than others.
Other prime reason to popularise generic drug by the Government is to make drugs and medicines affordable for people, who cannot otherwise afford the expensive branded medicines and the private hospitals. As it is, more than 70% of India’s population lives in the rural areas, out of which around 35% is either below the poverty line or close to it.
Another reason for the use of generic drugs is to reduce the unethical practices of doctors who deliberately prescribe branded drugs over generic drugs. It is rumoured that private doctors would prescribe branded drugs because there are incentives or kickbacks from the pharma companies.
The use of generic drugs, which are no different from the branded ones, will reduce the rising cost on healthcare and the poor people can benefit.

What the doctors say about generic drugs?

There is a difference of opinion regarding this. Most of the doctors are not sure about the quality of generic drugs. According to a doctor in AIIMS, “there are certain generic medicines that don’t work like the branded ones”.

Whether there is a difference in quality between generic drugs and branded ones is difficult to answer by the entire medical fraternity be it the doctors, chemists, pharmaceutical representatives. Some say that they are as good and same as branded ones while others feel that they are not of good quality. Some others say that they are less effective. Doctors are more sure about the availability of the branded drugs rather than the generic ones as there is no advertising and marketing of generic drugs.

Steps to promote generic drugs

One way is to reduce illicit medical practices.
The Medical Council of India has already given strict instructions to doctors to prescribe generic medicines. But very few private practitioners usually do this. So strict measures should be adopted so that the doctors are compelled to prescribe generic medicines.
More steps are needed to be taken to strengthen the Jan Ausadhi scheme.
Measures should also be taken to end the doctor-big pharma nexus.
The MCI needs to provide more practical guidelines.
Also the Government should take measures to increase awareness of generic drugs to the general public.
The Jan Ausadhi stores that are available today are either run by the hospital’s administration or some NGOs in the Government hospitals and public healthcare centres. Steps should be taken to encourage more and more private companies or individuals to open generic drug stores.
In 2008, the government launched a chain of pharmacies called Jan Aushadhi to supply inexpensive generic medicines. In the last nine years, only a few such stores have been operational and they often have had stockouts and other problems. India has seven lakh retail pharmacy shops and still many rural areas are underserved. There are fewer than 10,000 Jan Aushadhis.
The Government should control the MRP of drugs, generic or branded, so that benefits reach the common man.
The IMA should also take measures to ensure quality, safe, affordable generic drugs.

Whether all generic medicines in India are of equal quality?

The U.S. and the European Union have ensured that generic drugs are therapeutically equal to the innovator drug by making bioequivalence (BE) testing compulsory. In other words, generic formulations are tested on healthy volunteers to ensure that they have the same physiological characteristics as their innovator counterparts. Once bioequivalence is established, a generic drug is legally certified to be of the same quality to replace the innovator product and can therefore be interchanged for the innovator product.

Even the World Health Organisation (WHO) and Médecins Sans Frontières (MSF) purchase only bioequivalent drugs for their programmes.

However, until earlier this month, India mandated bioequivalence (BE) studies for only those formulations seeking approval within four years of the innovator product getting approval. As a result, most generic drug manufacturers sought marketing approval from the fifth year onwards, effectively evading the requirement of conducting BE studies.

A welcome move - On April 3, 2017, the Ministry of Health finally amended the Drugs & Cosmetics Rules to make BE testing of all highly soluble drugs compulsory.

Doctors and pharmacists are unaware about the quality of generics approved prior to April 3 as there is no proof of bioequivalence and hence doctors should not be forced to make this choice of prescribing only the generic name. Therefore, if the government wants to make the prescription of generics compulsory, it needs to put in place a legal mechanism to guarantee that all generics, especially those introduced prior to April 3, are bioequivalent to the innovator product.

At the very least, the government should require companies to self-certify their drugs to indicate whether they are in fact bioequivalent. A simple logo on the drug’s packaging to indicate whether a drug has been tested for proof of bioequivalence, along with the trial ID number listed on the Clinical Trials Registry India, should be made mandatory.

Even presuming successful BE studies, a drug can fail for a variety of reasons. It may lack stability and break down due to heat or humidity. These substandard drugs are a dangerous problem, especially in government-run hospitals.

Drug quality in India

According to the government’s most recent survey of the quality of drugs in India, 10% of all drugs from ‘government sources’ tested NSQ, or not of standard quality. A NSQ drug will compromise patient health. These numbers are shocking.

An earlier report of the Comptroller and Auditor General had revealed that the Armed Forces Medical Stores Depot, which serves armed forces personnel, had reported the percentage of locally procured drugs that were substandard at as high as 32% in one year!

The challenge for the government is to balance its policy objectives of taking the power of the doctor away to prescribe brand name drugs with the reality that generic drugs in India are of questionable quality. The solution does not lie in more laws, but in providing more information to the consumer.

Drug regulators in India have a vast trove of information on substandard drugs which they need to release into a searchable database. Especially the laboratory test report, investigation report by drug inspectors of drugs which have failed testing, and the criminal complaint filed in court against the manufacturer along with the final judgment of the court.

If this information is made available over the Internet, the government will truly empower hospital procurement officers, pharmacists and patients with information required to avoid products of manufacturers with a poor quality record.

The government must seriously consider using IT tools to network all 36 drug regulators — one for each State/Union Territory and the Central regulator - into one integrated national database. This can then be accessed by every citizen over a smartphone. This will protect them from substandard drugs.

To actually have better access to medicines, we need, at the minimum, the following:

All formulations, representation and dosages of an enlarged list of essential and life-saving drugs to be put under price control.
The market must be rid of all currently licensed irrational fixed dose combinations and useless and/or harmful medicines.
The method of fixing price control in Drug Price Control Orders 2013 must be changed to a cost-based ceiling price determination. The current simple average formula legitimises high margins of up to 3000% over the cost of the product. So, methods of price control also need much more fine tuning.
Laws for enabling substitution of generic and branded equivalents by pharmacists need to be introduced.
A free medicine and diagnostics scheme in all states on the lines of such programmes in Tamil Nadu and Rajasthan.
A fully functioning public health system with free healthcare for all like in the United Kingdom, Canada and Scandinavian countries.
No brands for medicines that are out of patent as is the practice in well regulated countries.
Briefer officially approved trade names for all rational fixed dose combinations so that doctors do not have to painfully write out the generic names of their multiple constituents.
Creative use of government use compulsory licence provisions in the Patents Act to ensure competition in costly patented drugs and thereby make them less costly.

Connecting the dots:

Critically analyze the Government’s move to make it mandatory for doctors to prescribe only the generic name. Is it practical?
What are generic drugs? Why generic drugs are essential for a developing country like India?
Link: http://iasbaba.com/2017/03/synopsis-iasbabas-tlp-2017-27th-feb-day-31/