The Seema Rai case of a failed pancreas transplant was discussed on Aamir Khan's Satyamev Jayate. Here is the full story of what went wrong in that case starting from the fact that Fortis did not even have the licence to perform pancreas transplant surgery

The case of Late Seema Rai presented by Major Pankaj Rai on the 27th May episode of Aamir Khan's TV show, Satyamev Jayate, has received a lot of attention during the last few days. Moneylife's article-The Indian Medical Association should indeed sue Aamir Khan! as a response to the above program, has called for reform in the medical sector including the creation of an effective network of accessible medical ombudsman. While the article per se did not focus on Late Seema Rai's case presented in the above show, several comments were received from esteemed Moneylife readers with regard to above case. And to understand the real issues behind the case, Moneylife explored several questions related to the case and these are shared below in question-answer format with necessary evidence and conclusions.
 
A.    As per the law, did the concerned hospital (Fortis) need to have a license to transplant organs such as pancreas in general? If so, did it as a hospital, have the required license for a pancreas transplant?

1.    Fortis did not have a certificate of registration (Form No 12) for performing pancreas transplant surgeries. Please see RTI response from the Government of Karnataka to this effect, given below as Exhibit # 1. The relevant portions are reproduced below
 

EXHIBIT # 1: Furnishing Information under RTI, Government of Karnataka, Dept of Health and Family Welfare Services

2.    The certificate of registration (exhibit # 2) given by the Appropriate Authority for Organ Transplantation to Fortis Hospital is attached and as can be seen from it. The certificate given to Fortis is for transplant of kidney, liver and homograft (permitted usage only).

EXHIBIT # 2: Certificate of Registration for Fortis Hospital  

3.    Please see exhibit # 3 for certificate of registration given to BGS Global which lists Pancreas separately. The certificate given to BGS global is for transplant of Kidney - Liver- Pancreas

EXHIBIT # 3: Certificate of registration for BGS Global received from the Government of Karnataka

4.    Fourth, there was an appeal before the appellate authority and secretary to government, health & family welfare department, vide APPEAL NO: HFW 304 FPR 2011. The appeal was between

M/s Fortis Hospital,            ……………………        Appellant
154/9, Bannerghatta Road,
Opp. I.I.M.B., Bangalore-78.
And

1)    Maj.Pankaj Rai (Retd.)            …………………….        Respondents
No.211, Best Township,
S. Medahalli (Opp. Punjabi Dhaba)
Sarjapur, Attibele Road,
Bangalore-562107

2)    Appropriate Authority under The Transplantation of Human
Organs Act, 1994, Directorate of Health and Family Welfare Services,
Ananda Rao Circle, Bangalore-9.

The Appeal was made under Section 17 of the Transplantation Of Human Organs Act, 1994. And I am quoting from this appeal order, dated 24 November 2011, given by EV Ramana Reddy, appellate authority & secretary to government, health and family welfare department, who notes that:

"3.5  I am of the opinion that the appellant hospital (Fortis) does not have license for transplantation of "pancreas". There is no basis for argument of the Appellant that liver includes pancreas and other abdominal organs. Not only the office of the appropriate authority in Karnataka but also the director general of health services, Government of India, have categorically stated that license granted for liver does not include "pancreas". If it was not specifically rejected under Section 15(2) of the Act, it was not specifically granted also. I agree with the contention of the Respondent-1 (Maj Pankaj Rai Retd) that there is no clause for "deemed approval" if something is not specifically rejected under the Act. Contention of the Appellant that Dr Ramesh, the then Joint Director (Medical) categorically stated that liver includes all other abdominal organs cannot be agreed to. There is no written proof for this and even if the then joint director (medical) were to give it in writing, it is in violation of the Act."

5.    Fifth, the report of the Karnataka Lokayukta (No.Compt/LOK/BCD/621/2010/ARE-1, Bangalore), Dated: 20 May, 2011, notes that:

"The appropriate authority has given permission to Fortis hospital to do transplantation of kidney, liver and homograft usage only (Page # 4)      

Thus the Fortis hospital has registered with the Appropriate Authority to undertake only for kidney, homograft and liver transplantation surgeries only and not for pancreas (Page # 5)

Section 13 of Human Transplantation Act is violated by the Appropriate Authority as the Appropriate Authority has not conducted periodic inspections of the Fortis Hospital and has failed to look at the website of the Hospital.(Page # 6)

The hospital authorities have violated Sec. 9 of the Human Transplantation Act as they have allowed Dr Ramacharan Thaigarajan to perform pancreatic transplantation in spite of not having the permission to undertake pancreatic transplantation surgery in their hospital. (Page # 6)"

B.    The 2nd question is whether Late Seema Rai had registered for a pancreas transplant? If yes, when had she registered and where? A related question is whether a pancreas transplant was done on her along with the kidney transplant? When? Which hosiptal?

1.    According to Maj Pankaj Rai (Retd), Late Seema Rai had not registered for a pancreas transplant. Despite this, it was transplanted on her on 2 May 2010 at Fortis Hospital, Bannerghatta Road, Bangalore.

2.    Interestingly, the ZCCK (Zonal Coordination Committee of Karnataka for Transplantation) in a letter (page 1, point 2) to Major Pankaj Rai claims that it was not aware of the fact that Fortis did not have a valid transplant license (to undertake PANCREAS transplantation). The ZCCK also notes (Page 2, point 3) that "There are no rules laid down wherein a patient can be allocated organs even if he/she has not registered for the same". The letter is enclosed as Exhibit # 4 below. This clearly means that when a patient has not registered for transplant of a specific organ, there are no rules under the act to allocate the specific organ to the said patient.

3.    It is also very strange and ironical that ZCCK says that it was not aware that Fortis did not have a valid pancreas transplant license. This is because the Dr Ramcharan T, who is listed as the medical coordinator on ZCCK's letter head also happened to be the transplant surgeon at Fortis (at that point in time). Besides, the fact that Dr Ramcharan T was part of the ZCCK (authorization committee) does show that there was a significant conflict of interest and in fact, his presence in the authorization committee appears to be a violation of the The Transplantation of Human Organs Act (THOA)

4.  Specifically, The Transplantation of Human Organ Rules, 1995
 
Rule 4A talks about the authorisation committee-(1) The medical practitioner who will be part of the organ transplantation team for carrying out transplantation operation shall not be a member of the authorisation committee constituted under the provisions of clauses (a) and (b) of sub-section (4) of section 9 of the Act.

EXHIBIT # 4: Letter from the Zonal Coordination Committee of Karnataka for Transplantation (ZCCK)

To summarise, all of the above clearly establish the following basic facts:

a. FORTIS was required to have a specific certificate of registration (Form No 12)  to undertake PANCREAS transplantation

b. However, FORTIS did not have such a certificate of registration (Form No 12) necessary to undertake PANCREAS transplantation

c. Late Seema Rai had not registered for a PANCREAS transplant and so, there are NO rules under the law to allocate her a PANCREAS according to ZCCK. Yet, the ZCCK allotted her a PANCREAS. In fact, the role of ZCCK in all of this needs to be carefully and thoroughly probed.

d. Despite the lack of a certificate of registration (Form no 12) to perform a PANCREAS transplantation, and despite the fact that Late Seema Rai had not registered for a PANCREAS transplant, it is clear that FORTIS carried out the PANCREAS transplant on Late Seema Rai - on 2nd May 2010 – who unfortunately passed away on 6th May 2010

e. It must also be noted that Late Seema Rai’s death was not reported by FORTIS as required by law within 7 Days

f. While FORTIS Doctors have claimed that they had the patient’s consent (Please see mail from Dr Sreedhara in circulation), Maj Pankaj Rai has refuted the same. He argues that there was no informed consent. The questions that arise here are twofold:

i.   Even if a consent had been obtained from the patient, was this valid given that the PANCREAS transplant done by FORTIS itself was illegal; and

ii.   Put differently, would a patient and/or their family have consented, if they had known that the PANCREAS transplant, to be done by the FORTIS hospital, was being performed illegally?

These and other such issues - like the conflict of interest in the authorization committee and its composition being a violation of the Act - need to be better explored by the law enforcing agencies

g. Overall, the PANCREAS transplantation carried out by FORTIS on Late Seema Rai on 2nd May 2010 does not appear to be LEGAL. Without any doubt, this case certainly merits the highest levels of enquiry (either Judicial and/or by independent bodies like the CBI) for possible lapses on many counts in the law – ranging from illegal transplantation of organs like PANCREAS to functioning and composition of the authorization committees (with huge conflicts of interest and in contravention of the said Act) and even possible negligence by regulators of the relevant Act.

It must be remembered that in recent times, Hon Courts have suggested that strong action must be taken against regulators if they are found to neglect their regulatory duties. I wonder if that has been the case here. Again, only an independent enquiry will reveal the real facts. Therefore, the Government of India and Government of Karnataka should immediately take up the relevant issues and ensure that appropriate action is taken against all those people who violated the law - both in letter and spirit - in the present case.

And before I sign off, a sincere thanks to all those involved in calling attention to this case as it has significant ramifications for organ transplant in India. It is about time that we belled the cat with regard to the rampant corruption in the Medical Profession in India and restore it to the good old days when it was nobility personified.