Foreign companies stop clinical trials in India after government amends rules on compensation

Several US and Canadian companies have stopped clinical trials in India following an amendment to the rules, which they say, could lead to "unreasonable claims" by subject-patients. The new rules, brought in by the Directorate General of Drugs Control in India, make it mandatory for companies and educational institutions to meet all medical expenses of those who volunteer for clinical trials.

The new regulations--Drugs and Cosmetics (First Amendment) Rules, 2013-- for clinical trials has some problematic clauses, according to the researchers. One clause states that for an injury/illness, occurring to a clinical trial subject, he or she shall be given free medical management as long as required. "This does not specify what type or cause of injury. Thus a trial participant may be involved in a traffic accident or assaulted by someone, but under the open-ended clause, the trial sponsor has to cover all costs. This is unreasonable," said Suneela Thatte, President of Indian Society for Clinical Research.

Scientific agencies in the US such as the National Institute of Health have stopped trials in India. "For the research community in India it will now be near impossible to carry out trials of important low cost drugs, which may have an adverse impact on healthcare in the country. A number of such companies have now excluded India for clinical trials."
A reputed hospital and research centre in Bangalore was shocked when it received a letter from its research partners in Canada, asking the institute to halt all clinical trials with immediate effect.

"An international trial to test two cheap medicines --aspirin and clonidine-- which can reduce the risk of heart attacks after surgery was on in India. This study was sponsored by McMaster University in Canada. But it was stopped after the new regulations," said Prem Pais, dean and head, clinical research/training at St. John's Medical College here.

"Another trial to test an anti-clotting drug - Rivraroxaban- was sponsored by Bayer. In earlier trials, India was included, but the company withdrew after the new regulations. The health ministry needs to have a relook at the amended rules after consultation with researchers involved in clinical trials," Dr Pais said.

Researchers argued that the clause is "unethical" as it's an inducement for people to participate in a trial, even if it is risky, merely to get what amounts to "free health insurance". "Another clause calls for financial compensation to be paid over and above costs of medical management in the case in the event of any illness, considered trial-related. But there is no clarity on what constitutes trial-related injury. Again any medication cannot work all the time. A person whose cancer was not stopped from progressing may claim compensation under this clause even though the treatment was effective during the trial,'' said the ISCR chief.

"We must also make a distinction between death of a patient during a clinical trial and death due to clinical trial. Patients who participate in clinical trials already have a disease which could be mild or serious. The death of a patient in a clinical trial could be due to various reasons, including a natural progression of the disease, new diseases, age-related disorders, or an unrelated complication. Patients who participate in a clinical trial receive greater degree of medical care than they would have under regular treatment because of the high level of investigations and patient management that a clinical study protocol requires,'' Thatte said.

According to the ministry of health, 89 deaths were attributed to clinical trials between 2005 and 2012 of which compensation was paid in 82 cases.

* Number of clinical Trials in India

2009: 391

2010: 500

2011: 325

2012: 262

(*Source: Central Drugs Standard Control Organisation)

WHAT ARE CLINICAL TRIALS

A prospective drug has to go through a long process before being available in the market. The molecule is first born in a biochemistry laboratory where biochemists synthesize a large number of molecules, tailored to fit into receptors in human cells- normal or abnormal or cells of disease causing germs to promote their function, decrease their function or destroy them.

Molecules that seem promising are then tested in animal models to see if they behave as expected and to study how a living body handles the molecule, its side effects at various doses and to estimate what doses would be likely to be useful in humans. The few molecules which pass this phase, enter the phase of clinical trials. Initial human trials are in a few normal volunteers to test human handling of the molecule at various doses and any side effects. After this phase, a series of trials are carried out in patients suffering from the disease to test whether the drug is safe and effective.

Phase 3 trials are required by the drug regulatory agencies before a new drug can be approved. The usual requirement is for a double blind placebo-controlled trial. 'Controlled' means that there will be at least two groups - one which receives the new treatment and the other a 'comparison control group'. Randomisation ensures that a trial subject enters the experimental or control arm randomly to ensure the arms are truly comparable. A 'double blind trial' is one in which neither the subject nor the doctor knows which treatment the participant is getting using drugs which are identical in appearance. Finally a placebo is a tablet/injection which looks like the trial medicine but is inactive and inert.

A DAY IN MY COLLEGE

I never forget my first day in my pharmacy graduation we all were introduced to teachers and seniors it was all amazing on our first lecture we were first time introduced to pharmacopeia let me tell you all about Pharmacopeia

Well it was that day and it is till now that nobody of my batch spells it wrong. It’s not due to teachers it’s all due to the senior’s coz at every point of our ragging the question was same can you spell pharmacopeia.

On that very day I was also introduced to one of my favourite subject i.e. Pharmaceutics I can define pharmaceutics as

It was not my favourite subject due to the teacher but it was my favourite subject coz it was easy enough for me to understand 

During a class that was the time when we used sit at first bench in front of teachers filled with enthusiasm and passion I suddenly dared to look back I found a lot loves an emotions all over the classroom well that love reminds my another subject that was pharmaceutical chemistry well I was never good at chemistry all my graduation chemistry followed me like an ghost and kept running as I ran away from love.

During the lunchtime of that at the same day at the local canteen (In Hindi I will say at our adda ) I found a simple girl who seems to be interesting and I was attracted toward her there it reminded me the subject that first attracted me then distracted me and again after some time I found it interesting it was Pharmacology 

And believe me the same thing happened to my feelings to the girl also  I was first attracted to her then again distracted and then attracted it all affected me lot and I became a blogger……….

And once there was there was a time when I was in love. And when a person is in love he is the luckiest buddy in the world everything seems to be bright, green and natural and it all pushed me to one more subject which was luckiest for me well it’s also natural like love i.e. Pharmacognosy 

I was an average student and was also average by nature and when an average person gets attracted to something interesting or new he follows it like an passion and till then bunking classes was my passion but as all know bunking is inversely proportional to attendance my attendance fell down to 50% and I was ordered to deans cabin and there I was introduced to the rules and regulations of colleges which were as boring as Pharmaceutical Jurisprudence  

And that incidence made us more analytical and after that our every bunk was pre analysed and we all started to calculate attendance and in this way I started analysing and managing my bunks and that analysing leads me to one more subject that is Pharmaceutical analysis

The main talks that I miss the most is about the cell phones, software’s and girls with all my friends all of us talked can even discuss the whole day about these topics and all that developed our interest in marketing and it is also one of our subjects .

I remember all that crystal clear in my mind. May be I have missed few of subjects but what I want to share is my college life it was all too much interesting .As we all want to complete the course,have job and settle down but what that is left behind is your friendship, college and even sometime the course  and I know that this is not a day as per my heading but that four years seem to be vanished in a day  

High Cholesterol May Be Particularly Bad for Middle-Aged Men

Middle-aged men with high cholesterol levels are at greater risk for a first heart attack than similar women are, Norwegian researchers report.

Cholesterol blood tests are done to help assess your risk of developing heart disease or stroke. If your risk is high then you will usually be advised to take a statin medicine to lower your cholesterol level. Lowering your cholesterol level reduces your risk, even if your cholesterol level is normal. Other factors that can reduce your risk include: not smoking, choosing healthy foods, a low salt intake, regular physical activity, keeping your weight and waist size down and drinking alcohol in moderation. Ensuring your blood pressure level is not raised (or taking medication to lower it if it is high) is also important.

What is cholesterol?

Cholesterol is a lipid (fat chemical) that is made in the cells in your body. Many different cells make cholesterol but cells in the liver make about a quarter of the total. Although many foods contain cholesterol, it is poorly absorbed by the gut into the body. Therefore, cholesterol that you eat in food has little effect on your body and blood cholesterol level. A certain amount of cholesterol is present in the bloodstream. You need some cholesterol to keep healthy. Cholesterol is carried in the blood as part of particles called lipoproteins. There are different types of lipoproteins, but the most relevant to cholesterol are:

• Low-density lipoproteins carrying cholesterol - LDL cholesterol. This is often referred to as bad cholesterol. This is the one mainly involved in forming atheroma. Atheroma is the main underlying cause of various cardiovascular diseases (see below). The majority of cholesterol in the blood is LDL cholesterol, but how much varies from person to person.
• High-density lipoproteins carrying cholesterol - HDL cholesterol. This is often referred to as good cholesterol. This may prevent atheroma forming.

What are atheroma and cardiovascular diseases?

Patches of atheroma are like small fatty lumps that develop within the inside lining of arteries (blood vessels). Atheroma is also known as atherosclerosis and hardening of the arteries. Patches of atheroma are often called plaques of atheroma.

Over months or years, patches of atheroma can become larger and thicker. So in time, a patch of atheroma can make an artery narrower. This can reduce the blood flow through the artery. For example, narrowing of the coronary (heart) arteries with atheroma is the cause of angina.

Sometimes, a blood clot (thrombosis) forms over a patch of atheroma and completely blocks the blood flow. Depending on the artery affected, this can cause a heart attack, a stroke, or other serious problems.

Cardiovascular diseases are diseases of the heart (cardiac muscle) or blood vessels (vasculature). However, in practice, when doctors use the term cardiovascular disease they usually mean diseases of the heart or blood vessels that are caused by atheroma.

In summary, cardiovascular diseases caused by atheroma include: angina, heart attack, stroke, transient ischaemic attack (TIA) - sometimes called mini-stroke - and peripheral vascular disease. In the UK, cardiovascular diseases are a major cause of poor health and the biggest cause of death.

Who should be treated to reduce their cardiovascular health risk?

Treatment to reduce the risk of developing a cardiovascular disease is usually offered to people with a high risk. That is:

• People with a risk assessment score of 20% or more. That is, if you have a 2 in 10 chance or more of developing a cardiovascular disease within the next 10 years.
• People with an existing cardiovascular disease (to lower the chance of it getting worse, or of developing a further disease).
• People with diabetes. If you have diabetes, the time that treatment is started to reduce cardiovascular risk depends on factors such as: your age, how long you have had diabetes, your blood pressure and if you have any complications of diabetes.
• People with certain kidney disorders.

The following people should also have medication to lower their cholesterol level, regardless of any calculated risk. The risk calculator may not necessarily take these people into account who have a high risk of developing atheroma:

• People with a total cholesterol (TC) to HDL ratio of 6 or more (TC/HDL = 6 or more).
• People with inherited lipid disorders.

DECLINE IN NEW DRUG LAUNCH :MYTH OR REALITY

As per current scenario theres is wide increase pharmaceutical research and development ,times,cost and spending but there are concerns that these efforts are not reflected in the no of new drugs being brought to the market it is widely reported that there is a decline in no of new drugs in market .well there can be various reasons for that ,but as per the heading i will talk with facts .
The exact no of drugs approved till now in india 
The exact no of drugs that are approved till now in india are given as 
From 1971 - AUGUST 2013 

Total no of drugs approved from 1971 to August 2013

YEAR	NO OF DRUGS APPROVED
1971-1981	351
1982-1992	321
1993-1998	157
1999	23
2000	28
2001	41
2002	56
2003	39
2004	76
2005	122
2006	161
2007	188
2008	264
2009	208
2010	221
2011	79
2012	43
August 2013	23
TOTAL NO OF DRUGS TILL NOW	2401

well this as this data shows there is a decline in no of new drugs approved in year 2011,12 and if we talk about year 2013 it is also dont have a hope of crossing the no hundred 

it is clearly visible from the above data that how the new drug development has declined from year 2010 India’s population is just over 1.2 billion at present and projected to rise to 1.7 billion by 2050 and India will become the world’s most populous country.This projection shows that the demand of drugs will rise in coming years. There is a need, at national level to acquire an expertise in the field of R&D and to develop the technology to build up capacity in innovation and production of the drugs to ensure that essential drugs at affordable prices are available to the vast population. The reasons for this downfall can be given as follows
THE NEW GOVERNMENT POLICIES
The new government policies are widely affecting the new drug launch policies of the company. the total focus of the government is on the generic drugs but we should must not neglect the fact that new disease needs new drug and development of new drugs is the only policy which can help us to gain control over wide spreading diseases.
THE NEW PATENT REGIME IN INDIA
While the large firms are gearing up to face the challenges of the patent regime, the small scale segment of the Indian pharmaceutical industry suffers from various inadequacies including lack of expertise, training and finance for technological upgradation and adoption of good manufacturing practices (GMP) to meet global quality standards; limited exposure and expertise on IPR issues; limited adoption of information technology (IT) techniques in production and processes.
THE LEAST INVESTMENT IN R&D SECTOR
The total no of investment in the new drug development has also decreased these years ow or negligible R&D  expenditure which affects the ability of SMEs to offer innovative solutions; and the inability of SMEs to access finance on easy terms for import of capital goods and undertaking advertising and marketing activities.
THE DRUG PRICE CONTROL 
price control tends to reduce the market shares of both domestic and foreign companies, and this factor by
itself should not cause the relative share of foreign companies to decline. At the same time, it needs to be noted that in certain ways, domestic companies are able to offset to some extent the adverse effect of price control on their market share.

Most of the MNCs pharma companies have stopped launching latest products in India after 1995 though they have been introducing them in other parts of the world. 
Overall, it seems there are no immediate danger of price rise due to the new patent system, especially because much of these patented applications/drugs are very similar to the off-patent drugs and offer possibilities of substitution. However, there may be some medium to long run price effects of the new patent system, when far superior patent protected drugs come into the market, whether from Indian or foreign firms. And, this may result in significant loss of consumer welfare.

Table shows number of Anatomical Therapeutic Chemical (ATC) groups Approvals (1999-2011)

Anatomical Therapeutic Chemical (ATC) groups	Number of Approvals
A - Alimentary tract and metabolism	192
B - Blood and blood forming organs	39
C - Cardiovascular system	186
D – Dermatologicals	108
G - Genito urinary system and sex hormones	56
H - Systemic hormonal preparations (excluding sex hormones and insulins	10
J - Antiinfectives for systemic use	204
L - Antineoplastic and immunomodulating agent	102
M - Musculo-skeletal system	145
N - Nervous system	232
P - Antiparasitic products, insecticides and repellents	20
R - Respiratory system	115
S - Sensory organs	74
V – Various	23

THE FOCUS ON GENERICS 
One man named AAMIR KHAN just showed on his show how generics are important and rest of india started believing  his words well i am not saying that generics are not important but the fact is that you can never kill innovation on the name of generics and now a days even the establish companies are looking through the option of generics by sacrificing there  research

THERE ARE MANY MORE COUNTRIES WHICH DON'T RECOGNIZE PATENT 
Countries like south korea Switzerland and Italy don't even have patent law till 1960 and 70 but they have to introduce the law becoz there local investors were looking forward to get their patent by other countries which caused sudden shortage of new drugs throughout the countries.

well these were my views. As in my last post also i didn suggested any of the solution  and same is also here becoz i want to know the suggested answers from my viewers .......... so please come forward and answer the questions