Glenmark Pharmaceuticals under regulatory scrutiny for alleged misconduct


Glenmark Pharmaceuticals Ltd is under regulatory scrutiny for alleged misconduct in carrying out clinical trials recently in Jaipur.

The Central Drugs Standard Control Organisation (CDSCO) has allegedly found that fake identities were used in clinical trials, as well as evidence of substantial departures from good clinical practice (GCP), in what could be the latest blow for India’s drug-testing industry, which has run into a series of problems with international regulators in recent years.

The alleged misconduct on the part of the company has triggered a tough response from India’s apex drug regulatory authority, which has sent a show cause notice to the company for failing to ensure that clinical trial was conducted in accordance with the Drug and Cosmetics Act, 1940 and Rules 1945, GCP guidelines. The regulatory body has sought an explanation about the alleged irregularities within 10 days. Glenmark has, however, denied any wrongdoing.

The company came under the scanner following reports that several people were deceived into participating in an ongoing trial for pain medication to treat osteoarthritis at a  Multispeciality Hospital in Jaipur. A total of 38 kits were supplied by the company, of which only three were issued to the enrolled patients on April 6. Glenmark has suspended the trials.

CDSCO, which had initiated the inquiry and sent a team from its head office on 22 April to the site, found inadequate and inconsistent patient identification. According to the investigations, the enrolment of subjects was “falsified” and “cannot be relied upon”.

The team also found that out of three patients mentioned in the informed consent form (ICF), two were related to each other and did not visit the hospital in the last six months.

 

Death of radio executive TANIA: result of misplaced priorities of media in civic negligence: hundreds healthy deaths vs one in hospital due to disease


        Just Compare the media  projection, burden of negligence and accountability of  hundreds of healthy deaths by civic negligence   with one hospital death by disease. In fact the burden of   negligence here in healthy deaths is massive and  these deaths are unpardonable. But reality is opposite. It is just to compare how  a naked “negligence  in deaths of healthy people” in such cases   to the  “alleged and perceived negligence ( with no proof and no investigation )  in death of someone already having disease  and death in hospital”  during treatment  is projected by our society and  media. 

An unfortunate incident   of untimely death of a young and talented person happened yesterday due to civic negligence.  The family lost their dear daughter due to an incident which was totally preventable . Another recent incident was of unlicensed school vans being driven rashly, again leading to  entirely preventable loss of lives. These incidents bring fore to my mind the misplaced priorities of media and society  which too have  contributed to  some extent to these unabated ongoing preventable   deaths  of  hundreds of  healthy people.

An open drain and a poorly lit road claimed the life of a young executive in Noida in the early hours of Wednesday. The victim, Tania Khanna was driving  car that plunged into the eight-foot-wide drain. Such a huge drain has been left uncovered and there is no proper mechanism of streets lights in the area. There is also no CCTV camera installed there. Noida Authority officials did not respond to requests for a comment.

An open drain next to a road with no barrier or signage and not even street lighting is a recipe for disaster. No civilized part of the world would allow such a situation to exist. That this particular area is still in the process of being developed is beside the point. Whether an area is fully developed or is being developed, there should either be no open drain or if there is one that has not yet been covered, it must be clearly separated from the road and pavements by barriers. There should also be clear signs warning people of the potential danger and lighting to ensure they can see it. That this is not done amounts to negligence by the civic authorities, for which individual accountability must be fixed and action taken.

Multiple  Deaths  in healthy people by civic negligence :

Large numbers of death and morbidity happen amongst absolutely healthy population due to preventable causes like open manholes, drains, live electric wires, water contamination, dengue, malaria, recurring floods  etc. Which somehow are never made as headlines or breaking news by media due to lack of sensational substance. These deaths  of people are in thousands, and are almost entirely of healthy people, who otherwise were not at risk of death. In fact the burden of   negligence here is massive and  these deaths are unpardonable.  It’s time media took it upon itself to bring to fore these issues so that many innocent lives of  many more healthy people like Tania can be saved.

 

       Single  Death in Hospital due to disease:

The  media has always, instead, focused on the stray  and occasional incidents of perceived alleged negligence  in hospital deaths which could have occurred due to critical medical condition of patient. However an impression is created as if the doctors have killed a healthy person. It is assumed without any investigation that it was doctor’s fault.  Media has been responsible for  creating a misunderstanding about the whole process of treatment . The patient coming to hospital already is diseased and some are critical and have a finite percent chance of death. The doctor tries his best to treat him but  may not always succeed. Making an issue out of a hospital death of a sick patient despite the doctors’ best efforts may get some high viewership to the paper but is it right?  No. They have ignored other important things like civic negligence and has instead trained their entire energy in  blaming the doctors  in an effort  to get something sensational out of nothing.

The whole blame  is cleverly put  on doctors. Even after doing everything possible, doctor may be running for his life, trying to save himself from goons. He may be an object for revenge. He may be running after lawyers, if a medical lawsuit is filed. He may have to stand like a culprit in front of relatives of deceased, who can abuse or threaten him in the language they choose, in garb of emotional outburst. Doctors are advised in such situations to be calm and suffer silently or just apologize, as it is thought to be correct in front of relatives stuck with grief. Even if court give the judgement after decades in favor of doctor, harassment of the doctor is permanent and irreversible damage is  done  to doctor. He is already punished.

Here it will be seen later, whether some one can be punished or not.

Point to ponder-Misplaced priorities:

Who is to be  blamed for  the deaths of healthy people which occur because of civic negligence? Here relatives may be helpless and  the vital questions  may go unanswered or taken as a routine.  There are no punching bags like doctor  for revenge. Any stray incident of death of an already ill patient is blown out of proportion by media forgetting the fact that thousands of patients are saved everyday by  doctors. But media instead chose to defame medical profession by igniting the emotions of people by sensationalising death of diseased and ill,  who probably were already at risk of death and did not give due importance to highlighting prevention of healthy  and absolutely 100% preventable deaths.

      Is  it due to a misplaced priorities of  the media or in an effort to create sensational news? Had media made an appropriate noise about right  issues and scratched the right pole for  preventing  death of healthy people , Tania might have been alive today and thousands more.

Hospital, Doctors fined for unfair trade practices: Doctors “ be clinically and legally correct so as to save themselves”


 

Since Hannurabi times  1750BC, medical profession or health care has been regulated. For thousands of years, attempts  have  been made, laws enacted  to regulate or control medical treatments or doctors. It has never been perfect.  In today’s time, where medico-legal issues have become as important as much as treatment, it is strange to find such practices, where transplant was done without valid license. More importantly, it was done in a well known hospital in Delhi and not in unknown location.

Going by the news item,  Jaipur Golden Hospital New Delhi conducted renal transplant without having a valid license for the same in 2006. It could have gone unnoticed, in case  everything had gone well. But  in today’s scenario, no one accepts even small and routine  complications. So doing a procedure like transplant without license  is asking for trouble.

Medical fraternity is clear that there are no treatments without complications.  Even simple procedures can get complicated. Therefore, doing anything which is   legally not correct, can be a blunder.  Consequences of even little mistakes can be disastrous in current environment, which is not very supportive to doctors.  Temptation  for  doing procedures without being legally correct  can be many, like holding  a license previously, or just to maintain a continuity of performing a special surgery. Money generated may  or may not be a great incentive in such circumstances . Reason can be as simple as to continue doing procedure while license is awaited and take  temporary invalidity of licensing requirements lightly.

Legalities should be taken in correct perspective always.  Doctors can save themselves by just following well laid protocols and  legal requirements. This is not right  for doctors   doing  procedures against the law or without legal permissions. Because  no one, including patient will not support the doctor in adverse circumstances.

Doctors  can save themselves by   doing procedures, which are clinically and legally correct.

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