Citizens' Issues
Indians as guinea pigs: Clinical trials killed 1,600 people in the past two years; only 22 compensated for fatalities

It took five months for the Directorate General of Health Services (DGHS) to reply to Hisar-based RTI activist Ramesh Verma to tell him the gory truth about how multinational pharmaceutical companies play with the lives of Indians during clinical trials and almost never bother to pay compensation

Here are a few shocking facts that will expose the extent of the rot in the Indian pharma industry, and more important, how multinational (MNC) pharma companies toy around with the lives of Indians.

  • Number of dead between the year 2008 and 2010 due to clinical trials of various drugs by multinational companies in India is 1,600!
  •   The compensation paid by pharmaceutical companies including Merck, Wyeth, Bayer, Pfizer, Amgen, Lilly, Sanofi, PPD, Quintiles and Bristol Myers is for only 22 of the 1,600 who died (as per information, all these 22 people died in 2010). The compensation together, totals to a mere Rs53.30 lakh (at an average of Rs.1.50 lakh to Rs2 lakh. One company by the name of PPD has paid Rs10 lakh—perhaps for the death of more than one person (and this is only an estimate).
  •  288 people lost their lives in 2008; 637 people died in 2009 and 668 died in 2010.
  •  No of registered trials: 11 between July and December 2007; 137 between January and December 2008; 548 between January and December 2009; 806 between January and December 2010 (note the increase in the number of people volunteering for clinical trials over the last three years).

 This shocking information was revealed by the Directorate General of Health Services (DGHS) to Hisar-based RTI (Right to Information) activist Ramesh Verma, who has filed more than 500 RTI applications, most of them pertaining to health issues.
It took five months for the DGHS to finally bow down to transparency after the Central Information Commission (CIC) slammed it for not providing the required information by its PIO (Public Information Officer). Besides giving the PIO a show-cause notice for penalty under Section 20 (1) and (2) of the RTI Act, the CIC ordered that information be given to Mr Verma before 25 September 2011. Accordingly, he was provided information on 23rd September. However, he has still not received complete information and is now filing his complaint again to CIC Shailesh Gandhi.
Verma asked the following queries in his RTI application:
1.    In the past 10 years, approvals for clinical trials have been given for which drugs... Please give names of the drugs, name of the pharmaceutical company, name of the research organisation conducting trials, conditions on which such trials have been approved.
2.    What are the mandatory requirements for the organisation which conducts such clinical trials?
3.    Sample copy of written approval by the member of the family of the person who would be undergoing the clinical trial of the drug.
4.    Details of the compensation paid in case of harm caused to the person during the course of trials. How many people have received how much compensation in the last 10 years?
5.    How many complaints have been received in the last 10 years regarding clinical trials and copy of action taken against such complaints.
6.    How many deaths have occurred during such clinical trials and details of compensation given—along with names of the companies.
 But the shocking fact is that there is no basic figure of financial compensation fixed for monetary compensation for these pharma companies despite the fact that they are playing with the lives and health of people.
Regarding details of compensation, the DGHS in its reply quoted from the Good Clinical Practices Guidelines (GCP) recognised under Schedule Y to the Drugs and Cosmetics Rules issued by the DGHS, Ministry of Health and Family Welfare, which prescribes:

"The compensation for accidental injury for Research subjects who suffer physical injury as a result of their participation in clinical trial... are entitled to financial or other assistance to compensate them equitably for any temporary or permanent or disability subject to confirmation from IEC. In case of death, their dependents are entitled to material compensation.

"Obligations of the sponsor to pay: The sponsor whether a pharmaceutical company, a government or an institution should agree, before the research begins, to provide compensation for any serious physical or mental injury for which subjects are entitled to compensation or agree to provide insurance coverage for an unforeseen injury whenever possible.''
Regarding complaints received from those adversely affected by clinical trials, DGHS replied: "As per available records, one complaint was received from R Rajendran, Sivakasi, regarding clinical trial of Vitreosolve injection in patients with non-proliferative Diabetic Retinopathy. The matter is sub-judice in the High Court of Judicature of Madras at Madurai Bench in Writ Petition (MD) No 9894 of 2010 filed by R Rajendran, son of A Raju…"
Regarding deaths due to clinical trials
, the DGHS provided information only of the past three years and not 10 years as asked by Mr Verma, stating: "Serious adverse events of deaths may occur during clinical trials due to various reasons. These could be disease related deaths like cancer etc or administration to critical or terminally ill patients or side effects or unrelated causes. Such deaths are investigated for causal relationship by investigator and by Medical Monitor of sponsor. The information collated revealed that there were 288 deaths in 2008, 637 in 2009 and 668 in 2010... There were 22 cases of deaths which were related to clinical trial in the year 2010 where compensation has been provided by company."
Regarding the norms of clinical trials, DGHS replies: "[The] number of clinical trials actually conducted in government hospitals/private hospitals is not available with Central Drugs Standard Control Organisations (CDSCO) as prior to 17.11.2008 registration of clinical trial was voluntary. For all clinical trials, permission of which was granted between 17.11.2008 to 14.05.2009, applicants were advised to get the trials registered at ICMR registry at

"However, for all clinical trials permitted on or after 15.06.2009, applicants are being informed that it is now mandatory to register the trial at the said ICMR site before enrolling first patient in the study."
(This is the first part of a two-part series)



Krishnaraj Rao

5 years ago

Life is indeed worthless in India. Brilliant expose of shocking institutionalized negligence. Waiting eagerly for Part II of this article.



5 years ago

Life is very cheap in India. That is why many of the multinational companies are setting their research shop India.
You would note that from the earlier days of manufacturing tie-ups nowadays research-lab tie-ups are increasing because local companies could use their political clout and HUSH-UP things. Recent example that life is cheap in India was the shooting of the personal of toll-booth. The killer is a rich drunkard just trigger happy. Who would sustain the life of the dependant wife and young kid as well as the two mentally deranged brothers dpendant on the poor fellow murdered. BMWs mowing down roadside sleepers by drunkan driving is an ordinary matter in India.


5 years ago

After so called LIBERALISATION of INDIAN ECONOMY many sins in many areas are being practicised. We need thousands of Brave people to dig out the GRAVES.

Set time-frame for preparing mediclaim guidelines: HC to IRDA

Following a PIL filed by social worker Gaurang Damani regarding the hardships faced by such policy holders due to lack of transparency and absence of standard guidelines, the Bombay High Court directed IRDA to state on 17th October by when it would frame the guidelines for settling cashless insurance claims

Mumbai: The Bombay High Court on Tuesday directed the Insurance Regulatory and Development Authority (IRDA) to submit a time-frame by which it would decide on guidelines for settling claims of cashless mediclaim policy holders, reports PTI.

A division bench of chief justice Mohit Shah and Justice Roshan Dalvi was hearing a public interest litigation filed by social worker Gaurang Damani regarding the hardships faced by such policy holders due to lack of transparency and absence of standard guidelines.

The petitioner alleged that there were no standard guidelines for settling such claims, which were handled by Third Party Administrators (TPAs).

He claimed the TPAs received financial incentives from IRDA to reduce claim amount. "Also there is discrimination in settling insurance claims of individual persons and those of corporate clients," Mr Damani said.

The allegations were, however, refuted by IRDA.

The court, while directing the IRDA to state on 17th October by when it would frame the guidelines for settling such insurance claims, also asked Mr Damani to submit to the regulatory authority his complaints about TPAs.

According to the PIL, problems began in July 2010 after public sector insurance companies, acting through TPAs, suddenly stopped offering cashless mediclaim benefits to consumers in top hospitals in the metros.

Mr Damani argued that earlier over 1500 hospitals in Mumbai used to cater to patients having cashless mediclaim policy under which expenses incurred during treatment were taken care of by the insurance companies without patients or their relatives having to bother about payment.

The court was informed that of these only 170 were now offering cashless treatment facilities.


DP World Ports Vallarpadam Container Terminal: The numbers behind point towards another huge scam

By some indications, this is a scam of larger proportions than the Commonwealth Games fiasco. Take a huge unnecessary project, inflate the costs, get your cronies to cover the inflated expenses by bringing in a private player like DP World in this case, and when the project obviously fails, cry wolf, and then get out

We had earlier reported (See: (See: Cochin Port Trust bats for DP World, LBW cabotage ) on how a one-sided contract between Cochin Port Trust and DP World Ports Vallarpadam Container Terminal, its tenant, had sparked off intense lobbying over cabotage rules. Now we dig a little deeper.

Nothing works better towards getting the truth than digging out the dirt by actually going onsite and sifting through the sediment as well as getting a first-hand grip on matters.

So when my reports on the whole Cochin Port Trust, DP World Ports Vallarpadam Terminal and ICTT (International Container Trans-shipment Terminal) at Kochi started doing the rounds (see link above) and were being quoted—amongst other places, at the Ministry of Shipping and elsewhere, I felt it was time to actually go down to Ground Zero and take a look.

Obviously, it is not easy to get an entry into such high-security areas, but then, where there is a will, there is a way, and the report  was too important to be abandoned half-way just because the follow-up needed some solid hard work.
This was not really planned, it was supposed to just be a short detour in life to go back on a ship for a few months, but as things turned out, of all things, I found myself working on a ship, dredging the bottom of the sea right off the Vallarpadam Terminal in Kochi, at times just metres away from the jetty. And more importantly, working with people who knew every inside secret of what was really happening there, and the real games involved. But we get ahead of the report.
Go to Kerala today and talk to most anybody even remotely connected with shipping, and many of them will make it sound as though the removal of cabotage is the ultimate and only way to ensure the development of Kerala, every other logical argument or reason is put aside. And towards that, the reasoning trotted out is that the DP World's Vallarpadam Container Terminal's sheer survival is directly connected to Kerala's industrial development, and that in turn will not happen without cabotage being withdrawn. An issue of national importance and security is to be forsaken because, it is argued by those who push this in Kerala for their UAE-based masters, the commercial and technical importance of Vallarpadam is just too brilliant for the Nation.
That is the major flaw, but like the emperor who wore no clothes, nobody will tell the Chief Minister and his cohorts this. There are those, of course, who know the realities and are now beginning to come out. Speaking to some of them involved the usual "off-the-record" aspect, so, in this article, we present some simple facts, without attributing sources, but which can be easily re-verified.
a) The Vallarpadam Container Terminal even at its best-projected levels will simply not be feasible for 4th Generation and upwards container ships. Third generation container ships are midgets compared to the 6th Generation mainline container ships swinging past through Colombo on their East-West runs. These ships will not be able to enter the Cochin Harbour channel itself, leave alone the Port and the Vallarpadam terminal. A good explanation of the various generations of container ships is given here: and you can see that even today, Panamax-sized 3rd Generation ships can hardly call Cochin Port. Still, to give the devil his due, to start with even a 3rd Generation container ship of the 3,000-4,000 TEU (twenty-foot equivalent unit) capacity level at Kochi is very welcome.
To break even, Vallarpadam will need to do between 3 million and 5 million TEUs per annum. As of now, it is doing about 0.3 million through 0.4 million TEUs. Where is this massive jump going to come from? Will shippers from the north suddenly lose interest in Gujarat ports and Mumbai/JNPT to come all the way to Kerala? Will those from the eastern parts abandon Chennai or Tuticorin (or Thoothukudi, as it is called now)? Here's a reality check—which ports are more customer-friendly, and have better rail linkages? The answers are there, clear to see.
b) The Vallarpadam Container Terminal is not going to be commercially feasible as a mainline container port for multiple reasons. For one, the hinterland is seeing development for a variety of reasons—none of which are really industrial—Kerala's economy is growing more due to tourism, remittances and some agriculture than any heavy industries. Sure, there is consumption, but one-way inbound traffic cannot sustain a mainline port—it has to be two-way.

And there is simply not much outward traffic. The terminal, even now, appears to be full of empty containers awaiting repositioning back to the north and west of India, or abroad.
c) Another myth is that Cochin Port is just 10 miles off the main sea-lanes. This would be true for coastal traffic or for ships hugging the Indian coast for whatever reason—mobile phone signal, piracy avoidance, or specifically heading for Indian ports or the Persian Gulf. But a fast container ship with high freeboards and guards on board would use what is called the 8-degree Channel, or other options, well south of Kochi by about 80 miles or even more if it were headed for Colombo, Singapore or Malaysia, to run what is called the "pendulum" between the Red Sea on one side and the Malacca Straits via Colombo on the other.
d) This is not substantiated because like in all things pertaining to shipping, the real numbers never seem to be emanate, but Colombo Port is supposed to be about 2.5 times as efficient in terms of speed of container handling and one-quarter of the price in terms of cost to shipping line, when compared to Cochin Port and its tariff structure.

In any case, the relationship between the corporate entities that operate Colombo Port and Cochin Port are deep to say the least, and they can easily play one off against the other if required. However, as of now, Colombo has dozens of cranes and over six deepwater jetties, while Cochin has only four cranes and two jetties-of which one jetty, the eastern one, is surrounded by extremely shallow water where the port appears to have now realised that the bottom is rock & shale, which will have to be cut out and then dredged. At a very high cost.
e) There has been constant dredging of silt going on for years in Kochi harbour now, and a short stint onboard one of these dredgers reveals that it would be a joke, if it were not for the fact that it is the taxpayer who is paying for this joke. Literally, these dredgers are in the hands of bandicoots and bedbugs, who simply transport some silt and more water from the port to the dumping ground about 10 miles outside, but probably in the interest of prolonging their engagement, are playing some really stupid games which consist of the same silt, sediment and water going in and out of the port. A bit too technical to explain—but you can imagine the process is akin to taking water from Cochin Port, dumping it into the Arabian Sea, and then coming back for more.
f) The side-effect of these silt- and water-movement games is what is known as the 'littoral' effect. This is impacting the beaches, and especially the strips near, for example, Fort Cochin and the famous fishing nets. These areas are being effected, as well as the beaches in and beyond the gut which leads to Vypeen (one of the islands that form part of the city of Kochi), and Fort Cochin. There is every chance that after the beaches, which have already been eroded, the next to go will be the beachfront properties themselves. Either that, or look for huge expense in building retaining walls, rising waters due to climate change adding to the complications.
g) Kochi Refineries Limited (KRL) realised this years ago, its report on this exists and was ignored by the powers-that-be when greedily swallowing the bait for Vallarpadam of heavy capital expense and all that went with it, and so it decided to move out of Cochin Port. Since it made for almost 90% of the revenue and movement, it was persuaded to stay back, and at a huge cost—a new tanker & gas terminal which could easily have been an offshore SBM (Single Buoy Mooring) anywhere along the coast, with deepwater, is coming up along the northern shore outside Kochi harbour. Needless to say, more dredging and port works, as well as deepening of the channel is going to be in order here too—when there were ample less environmentally-sensitive spots all along the Kerala coast which could have been made into deepwater ports for tankers and gas carriers, at much lower cost and disruption.
For some people I spoke to, the whole DP Ports/Vallarpadam Terminal is a scam of larger proportions than, for example, the CWG scam. Take a huge unnecessary project, inflate the costs, get your cronies to cover the inflated expenses by bringing in a private player like DP World in this case, and when the project obviously fails, cry wolf, and then get out.

Whether it is really a huge scam or not, time only will tell, but as of now, the taxpayer has largely paid the bill for a port terminal going nowhere.
The bets are out in Kochi, the money is on DP World likely abandoning the Vallarpadam project and leaving the Government of India with a huge bill paid for a terminal that is going nowhere, and continuous high-cost maintenance dredging at great environmental cost a side-effect. The whole noise about cabotage is just humbug dreamt up to divert real attention.
If anything, a full & proper enquiry should be done on how this
high-cost white elephant came into being in the first case. There is room for good Kerala cuisine in Tihar Jail, too.
In the next article, we will come up with a detailed analysis of the few numbers available for this project.
You might also want to read:

Why are overage ships with improper documents being chartered for Indian ports?




4 years ago

Hi malQ,

I'm disappointed in knowing about increasing cost of dredging in ICTT area. I have to agree on this alone. Apart from that I don't agree with ur claim that lack of Rail-Road connectivity is the real reason for ICTT's current mess.
The function of ICTT is just tranship containers from mother ships calling @ it to smaller ships which would take them to other ports were it is intended to as you said the might metros wherever in India. Only a small portion need to be taken on road or rail to say may be a Bangalore or Coimbatore. No one will insist on transporting containers intended for places like Punjab or Delhi or somewhere in North via roads from Kochi, rather they will be transhiped from Kochi to nearby ports like Mumbai or port. See all job is to substitue the work done by Colombo even they don't have expressways and freight trains connecting to Indian ports.
Its for the greater good of nation! NONE of INDIA's existing ports will anyway suffer due to ICTT @ Vallarpadam. Its only going to benefit through lesser transport time & cost saved.
Ok I agree if u say Kochi may still not match with Columbo with craines or freight stations (more stations are coming up fasts) or with the pace or even what you claim of it can't take a 4th gen ship of full capacity. Well this is the beginning Columbo/ Dubai/Singapore have been enjoying the India market from ever since it's there its got the advantage all the money is flowing which we could have saved.

Joby Mathew

5 years ago

This is a different perspective on the Terminal and and its development. Its good that the there is an alternate to jingoistic and subjective news reports.

I am no expert on port and ship matters, but a bit of research on the net brought out an interesting news. Please see this link According to this (and according to the Terminal Website), a a 4th gen post panamax ship called on the Vallarpadam Terminal. So maybe not all is lost.

It was good to understand the dredging issues and the associated cost but then isn't it also true that the benefit to Kochi, Kerala and ultimately India is not only revenue from the terminal or port, but also from associated business that a large port brings?

I don't think anyone in Kochi or Kerala expects the state to industrialize because of the Terminal but certainly there is improved infrastructure (witness new roads and bridges connecting the island to the city) and improved commercial activity.

Lets hope the loss on account of dredging will be offset by other gains to the city and the state.



In Reply to Joby Mathew 5 years ago

Thank you for writing in, Joby - yes, the MAERSK SEMBAWANG did make one call to Cochin, but she came in very "light" or partially loaded, and not on a typical mainline voyage. A loaded 4th generation ship would be another issue - in "light" condition, even a bigger 5th or 6th generation ship could come to Cochin, but what would it achieve?

The bigger issue here is that it is being projected as though it is only cabotage which is ruining the operational issues of Valarpadam - when it is a host of other parameters and aspects, all linked to terrible planning.

Nobody doubts that better infrastructure yields results - but there has to be some thought applied behind it, before putting public money on the spending block.

Humbly submitted/VM


5 years ago

As a avid watcher of major dredging and port projects in India, I can assure you that more than any financial scam, Vallarpadam ICTT mess is due to shoddy planning and no foresight.

There were many study reports available on the silting pattern in the Kochi harbour. Difficulties in maintaining deeper dredged levels could have been easily identified at the planning stage itself. Now after the ICTT is inagurated, Kochi Port has formed a team to study this aspect. SInce Maintenance Dredging is in the scope of the Port, they will never be able to make any net profit from this PPP project. Moreover, DP World will also claim for idling charges on account of delay in maintenance dredging. Anyway, completion of the ongoing Capital Dredging is itself doubtful.

The Cabotage issues are all secondary.



In Reply to Prakash 5 years ago

Thank you, Prakash, for your comments.

Those in governance and spending public money do not have the luxury or excuse of losses thanks to shoddy planning and no foresight - though rightly pointed out as the reasons by you.

I was able to study the silting patterns, as well as the total lack of any sort of supervision or accountability wrt the capital dredging currently underway at Cochin Port, in some detail. There is also the simple fact that despite everything, the old school types onboard modern dredgers are still proceeding with the "number of trips" rather than "amount of sediment" method for production, with little control or expertise ashore to correct this. Furthermore, quietly releasing some amount while in channel itself to prevent muddying the vessel due to rolling as well as to reduce dumping time, and then carrying some amount back to reduce dredging time, appears to be an accepted practice with all the Dredger Masters there.

The cabotage issue is simply an eyewash.

Humbly submitted/VM


In Reply to malQ 5 years ago

Thanks. Watch this space for another major blunder being committed at JNPT capital dredging project of 40 km channel. The work involves large quantity of rock blasting in busy channel. FYI, Maharashtra state is blessed with 20 m waters hardly 3 km from coast in Sindhudurg district. They can easily build a ICTT which can take 6G container vessels. But the politicians are more keen on 2G, 3G, CWG and real estate scams.


In Reply to Prakash 5 years ago

Thank you for writing in, Prakash, and yes, you are correct, the whole Mumbai/JNPT dredging project is going to be another spending fiasco.

The Indian Navy has already moved much of its West Coast resources to Karwar. New ports like Mundra in Gujarat as well as other ports in Kutch and Khambat as well as Saurashtra coast have natural deep water access - likewise Gangavaram in AP and maybe Dhamra in Orissa. They also have better rail and road connectivity.

World over, old port cities are losing their ports, whether it is London or New York, to other activities. But here, we keep trying to flog the same old same old, when the rules of the game have changed.

The result is increasingly evident - more commercial traffic through the heart of cities like Mumbai and Chennai (Kolkata Port has more or less died a natural death anyways) and a high-c0st white elephant of a container terminal in Cochin.

Thanks again for writing in/vm

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