TO: Prof. (Dr.

) Sunil Kumar, Director General of Health Services, Ministry of Health and

Family Welfare)

FROM: Indian Orthopaedic Association

DATE: 21/09/21

SUBJECT: Highlighting the Acute Shortage of Locally Processed Bone & Tissue Allografts

Introduction:

India is a global medical powerhouse with a healthcare industry that is slated to reach $372
billion in 2022 and has been growing at the rate of 22.9% CGAR. India has performed the
second largest number of transplants in the world in 2019 after the United States. Yet, it lags
far behind the western nations like Spain (35.1 pmp), United States (21.9 pmp) and United
Kingdom (15.5 pmp) in national donation with a donation rate of only 0.65 per million
population (2019) due to its huge population. 
This unfavorable position is not due to a lack of organ and tissue donors or medical expertise
or adequate facilities needed to perform the necessary transplantation surgeries. India’s large
population should be an asset with donor numbers far exceeding our western counterparts
however this is not the case. And while organ donations in India is a point of concern we
would like to bring to your attention that tissue and bone grafts are virtually nonexistent in
the country given its size and population- less-discussed yet just as important an issue. This
leaves orthopedic surgeons in the vulnerable position of relying almost entirely on artificial
bone graft substitutes that are inferior and expensive or on imported allografts that are
outrageously expensive thereby making them available only to the wealthier patients. We are
writing to you personally as the Transplantation of Human Organs and Tissues Act 1994
enshrines upon you the power to make significant changes in the policy governing
Transplantation of Organs and Tissues that could dramatically address this issue.

Background

Tissues, of which bones are considered a part, are fundamentally different from organs when
discussed from the prism of the transplantation process. Organs can be retrieved only from
donors that have been declared brainstem dead, which happens as a result of traumatic
accidents. Tissues however, can be retrieved from cardiac deaths as well thereby making any
and all deaths potential tissue donors. Additionally, tissues can be donated from living donors
as well, in the case of femoral heads and tibial slices that are normally discarded as medical
residue or even from amputated limbs. 

The second major difference is that unlike with organs, post-retrieval tissues need to be
processed vigorously before they can be transplanted into another person. The processing
removes the immunogenicity of the grafts as well as sterilizes them to prevent any cross
contamination or transmission of diseases. This processing is undertaken in tissue banks. Tata
Memorial Hospital started India’s first tissue bank in 1988 and over the last 30 years, due to
numerous factors including governmental regulations, the total number of tissue banks in
India does not exceed 10. Ganga Hospital in Coimbatore, Ramaiah Hospital in Bangalore and
AIIMS, Delhi are some of the other prominent ones. All these banks largely rely on living
donors and their medical residue rather than deceased donors even though the quality and
range of tissues that can be retrieved from deceased donors are dramatically more as
compared to living donors. 

These indigenous tissue banks have made allografts accessible to the Indian masses, although
their capacity remains seriously limited. Additionally, those patients that use allografts as
opposed to autografts i.e. grafts taken from another part of the patient’s own body, benefit
from the reduced surgical time and lack of a secondary surgical site. This results in faster
patient recovery and shortened hospital stays. All these make for considerable medical
savings and hospital expenses to any patient.

The Law as it Relates to Organ Transplantation and Tissue Banking

Banking of Tissues began in India in 1945 while organ transplantation activities picked up in
the 1970s especially with the help of the IAEA program. However, as scientific development
and demand scaled up, lack of regulation led to organ trading in the 1990s. Government thus
enacted the Transplantation of Human Organs Act (THOA), 1994 to regulate transplantation
of human organs for therapeutic purposes and prevent commercial dealings. The act legalized
the concept of brain death and provided for penalties for commercial dealings. However,
Tissues were left out of its regulatory scope. It was the subsequent Transplantation of Human
Organs (Amendment) Act, 2011  that widened the regulatory ambit to include both organs
and tissues. It set up a National Network to connect recovery and storage centres and a
National Registry for Donors and Recipients.. The Rules of 2014 further prescribed separate
conditions and standards for granting registration to hospitals engaged in organ
transplantation and tissue banks and called for online access of the Registry.

The ‘Bottleneck’
Medico-legal disjoint has led to organs and tissues being governed by the same policies when
they are both fundamentally different with distinct needs, thus disproportionately affecting
tissue transplantations. Regulations like donor-recipient matching registries or follow up
forms are inapplicable to tissues as they do not need to be matched, nor are implanted in a
timely fashion (For example: Grafts can be stored for up to 3 years at a time unlike Kidneys)

The government has set up infrastructure to support organ donations, for instance, road
accident victims are monitored for brainstem death with a panel of doctors ready to declare it
after completing numerous tests. This can only be conducted in a registered transplant
hospital. After the declaration, the transplant coordinator, that needs to be present in every
transplant hospital by law, will approach the next of kin, explain the situation to them,
provide grief counseling and if they are willing, obtain written consent to retrieve the organs.
This infrastructure, however, is not extended to tissue donation. 

In 2019 there were over 800 deceased organ donors in India, all of whom had to be obtained
exclusively from road traffic accidents that left the victims brain dead, which in itself is an
arduous process. Comparatively, there were over 91,000 deaths in the city of Mumbai alone
in 2019, all of whom could have been potential tissue donors without requiring additional
tests to declare brainstem death. 

The lack of awareness and misconception alongwith absence of a clear process for potential
donors to reach the correct entities is another major impediment in India. This had led to
barely any deceased tissue donations taking place. Since most tissues and bones can only be
retrieved from deceased donors, it leads to loss of a valuable medical resource that could save
lives. Adding further to the complexity is the Opt-In system followed in India that mandates a
formal informed consent from the next of kin for donation.
___________________________________________________________________________

Cost-Benefit Analysis of Locally Produced Allografts vs Importing Grafts

A complete lack of availability of locally produced quality allografts forces orthopedic

surgeons to be largely reliant on American produced grafts; as the USA is the only country
that produces grafts in quantities that enable them to export. It is also one of the few countries
whose grafts are considered reliable and safe as cross-contamination and transmission of
diseases is the number one focus of all tissue banking. However, the costs of these grafts are
astronomical when compared with Indian produced grafts. (Table 1)

Table 1: 2019 price list from MTF Biologics, the largest tissue bank in the USA.
ConMed is their distributor for India. Their prices have been compared to that of the
Tata Memorial Hospital’s Tissue Bank in Mumbai.
 A comparison
points to the
dramatic price
difference with
Indian costs being
on average 95
percent cheaper.
However, it is
important to note
that the TMH
Tissue Bank,
Mumbai is a
government-funded
entity that is heavily
subsidized with the
goal to cater to low-
income and below
poverty line patients. In Spite of that, the cost differences are so large that even independent
tissue banks that do not rely on government funding are able to comfortably provide cost
savings of up to 80 percent.

Proposed Recommendations: 

1. Minor changes by amendment of THOTA 1994 to legalise the difference between

requirements of Organs and Tissues by definition.
2. Overhaul Consent Mechanism from Opt-in to Opt-out system, while also allowing direct
submission of Medical Residue from Hospitals and clinics to legally registered Tissue Banks.
3. Set up a National Network leveraging NGO-private organisational strength to capture deaths
in real-time and connect it to regional network as per geo-location to procure tissues
efficiently which will complement the current NOTTO-SOTTO-ROTTO structure. It would
inadvertently, require the Hospitals and clinics to mandatorily record and report deaths to the
Connectors.

Strategic Recommendation:

Design a policy to differentiate Organ-Tissue procedures and shift to Opt-out system of

Consent while developing a network of which would track deaths in real-time.

Rationale for Policy Recommendation:

Firstly, The differentiating of Organs and Tissue in legality will untangle procedural
constrictions ailing tissue banking and enable specific protocols pertaining to differential
needs to be developed based on Expert Committee recommendations.
 Secondly, India has an Opt-In system for organ and tissue donation that requires strict written
consent from the next of kin in the case of deceased donors- regardless of the actual donor’s
pledges or wishes. An Opt-Out system is one wherein every citizen is by default
understanding considered to be a donor unless they specifically decide to opt-out. Spain is a
brilliant case study that leads the world with over 40 donations per million as compared to
India’s paltry 0.34 per million despite its large population.
(https://onlinelibrary.wiley.com/doi/full/10.1111/ajt.14104) 

Thirdly, Femoral heads from hip replacements and tibial slices from knee replacements are
medical residue that is usually discarded which could be utilised efficiently if legally
registered tissue banks are enabled to sign MOUs with hospitals and clinics that are then
mandated to direct the tissue samples straight to those banks.

Fourthly, An absence of a clear process from when a death occurs in a hospital in India to
organ procurement leads to missing the golden-hour opportunity. Our inspiration for the
National Network is the United States system under the National Organ Transplant Act
(NOTA),1984 which created a network of Organ Procurement Organisations (OPOs) to keep
track of all deaths that occur in the country and provide the next of kin with adequate
information, as well as connect potential donors to the relevant tissue banks. There are 57
OPOs that cover all the USA. (https://jamanetwork.com/journals/jamasurgery/article-
abstract/2773525) 

Policy Provision, Implementation and Analysis

1. The policy would be called ‘ National Organ and Tissue Transplantation Policy’
2. It will identify the differential needs of organs and tissues and thus, do away with Form 14
requirement of waiting list prior to registration of Tissue Banks (Rules 2014)
- Once, the rules are approved by The Ministry of Health and Family Welfare; States will
be encouraged to implement these Rules as inter-state coordination and uniformity will
aid the system.
- Private Tissue banks will be encouraged to fill in the demand-supply gap
- Government shall subsidise treatment of BPL recipients ( insert cost) (emulating the
Tamil Nadu Model reference?)
3. Change Donor System from Opt-In to Opt-Out wherein consent is the default.
- The sensitive and intimate nature surrounding Consent and donation will be
dealt with by caution. One year period after approval must be earmarked to
invite public opinion and expert advice. During this period, heavy media
campaign will be undertaken by the government to advertise the change and
its beneficial outcomes
- An ethics committee will be constituted to study the implications of the system overhaul.
4. Medical Residue must be directed to registered Tissue banks by Hospitals and Clinics
according to the MOUs signed between them. Similarly, the opt-out system will be applicable
here.
5. An online National and state portal (National Organ and Tissue Transplantation portal?
Suggest name!!) will be built to track real-time information on all deaths that occur in the
country.
 Inadvertently, Every hospital would be mandated by law to inform and register all
relevant information regarding all deaths that take place with ROTTO. 
 ROTTO would be responsible for maintaining the online portal, qualifying the
recently deceased personal medical history.
 If found viable, ROTTO would inform the hospital to have their transplant
coordinators and grief counsellors approach the next of kin for consent.   
 Upon receiving consent, the ROTTO would then connect the closest relevant tissue
bank to the hospital and donor so that an orderly and timely retrieval could take
place. 
 ROTTO would also maintain the follow-up forms that are filled after a processed
graft has been transplanted. These are important to maintain traceability in case of any
adverse effects post-surgery. 

6. Extend the mandate for TCs to include tissue donations as well. Grief counselling training
will be mandatory for TCs and even Connectors as they undertake the delicate interaction
with the relatives of the deceased patient for the donation of organs. This can push up organ
donation by as much as 30 percent (Dixit 2002)
7. Tissues would be allowed to be retrieved for research & educational purposes and not just for
therapeutic purposes so long as informed consent is obtained. This is currently prohibited by
law. 
8. Constitute an expert committee to advise states on matters related to tissues and most
importantly to set clear standards for Tissue Banks and Technicians related issues (Rules
2014, 28 (2) with an expert on Tissue Transplantation.
9. IEC (Information Education Communication) activities must be rigorously undertaken to
dispel myths and misconceptions related to organ and tissue donation
- Short Movies like ‘ Phir Zindagi’ will be encouraged.
-organise Organ donation week ( organothon)
-advertisement on OTT platforms and TV channels
- Social media will be extensively used.

POLICY ANALYSIS:

Table 2: Cost-benefit Analysis

Potential
Cost-Benefit Outcomes USA India Difference Savings
Average Cost 120,182 4,667 96% 115515
Number of grafts transplanted in a Over Less than
year 1Million 20k 98% 11,320 Cr
(Figures taken from https://www.cdc.gov/transplantsafety/overview/key-facts.html )
Outcomes Matrix:

Policy Political Capital Projected Roll

Option Needed Cost Out Time Rank
3 months to notify
Minimal, minor and align all
alterations to None, only policy changes government
1 existing policies required. functionaries 3
Maximum, huge 1 year to advertise
political will and cascade
needed to all new rules and
implement such a Administrative costs as well as regulations
seismic media campaign costs needed to to all healthcare
2 policy shift educate the public. stakeholders 2
Medium, as new
burdens will be
imposed on 2 years for the
healthcare platform to be
professionals built, tested, and
and new 5 Cr (approx) rolled out to all
government project to set up levels and
spending would the national platform hospitals across
3 be required. to track deaths the country. 1

All the 3

 Option 1 standalone, is the most cost and time effective option

 Option 2 however would entirely alter the landscape of organ and tissue donation in
India. It is expected to be a jarring change to the socio-cultural sentiments
surrounding passing of a loved one and would depend significantly on the political
courage and will to adopt such a policy especially since financial cost would not be
much. 
 Without Option 3, that is a network to effectively manage the expected expanded
donor pool, the above two options won’t make sense.
 In 2019 the GOI implemented the National Organ Transplant Programme with a
budget of 149.5 crores. The current organizational hierarchy is already funded and
would only need approvals to direct small portion of these same funds for activating
data collection and portal set-up.

Thus, a combination of the three solutions as a policy is our strongest

recommendation. While incurring a cost, the financial amount required is hardly
 prohibitive. That coupled with the fact that it does not disrupt the socio-cultural
manner in which our society functions leads it being a relatively achievable yet
consequential change therefore it is regarded as the most preferential. 

Conclusion 

The tissue transplantation field in India is still at a nascent stage in spite of existing vast
medical expertise and infrastructure. The policy proposals suggested would act as a catalyst
enabling the country to leverage its large population under the Opt-Out policy shift as proven
world over. (https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-014-0131-
4) .The policy will not only vault India to the ranks of other developed nations but would
radically improve the lives of millions by improving patient care and resulting in cost savings
of thousands of crores over the next decade. This is not only the right but also the necessary
thing to do to bring about a just and equitable society for all. We urge you to take the
necessary steps to implement the policy at the earliest.