India: Health Ministry Releases New Draft Policy On Prevention And Control Of Hemoglobinopathies For Public Consultations

On August 07, 2018, the Ministry of Health and Family Welfare (MoHFW) released the new draft policy for Hemoglobinopathies (Thalassemia, Sickle Cell Disease and variant Hemoglobins) in India1.

Thalassemia, and Sickle Cell diseases are two common genetic disorders that are chronic, life restricting and require long and specialized treatment. India has the largest number of children with Thalassemia major in the world – about 150,000. There are almost 42 million carriers of - thalassemia trait, and about 10,000 to 15,000 babies with β-thalassemia major are born each year..  Hb E is variant hemoglobin that significantly contributes to the disease burden of hemoglobinopathies. The prevalence of sickle cell disease is variable, with very high percentage in many tribal communities. For sickle cell disease there are about 25, 00, 000 carriers of the gene (Hemoglobin AS), and about 1, 25,000 patients of sickle cell disease.

About Hemoglobinopathies

Hemoglobinopathies are genetic disorders with Mendelian pattern of inheritance. Genes are, therefore, the primary determinants of the disease with environmental, nutritional and infectious factors playing only a limited modifying role at best. Hemoglobinopathies are disorders with autosomal recessive inheritance and thus, have equal prevalence in males and females. Every person carries two copies of a gene, one inherited from each parent. In autosomal recessive disorders, parents are carriers. They are individuals with only one abnormal gene, the other being normal; while in the patients both copies of the gene are abnormal. Thalassemia major, Thalassemia intermedia, Sickle cell disease and Hb E, occurring singly or in combination, are the major clinical syndromes causing socio economic burden of - hemoglobinopathies in India.

Challenges in developing a plan for treatment and prevention of Hemoglobinopathies in India.

The epidemiological data is incomplete, and the precise burden of these disorders is unknown. Treatment consists mainly of giving repeated blood transfusions, bringing with it the challenges of motivating donors to give blood, and avoiding the transmission of infections such as HIV, hepatitis B and C. The excess iron that gets into the body through the blood transfusions needs to be removed by use of the expensive chelators. Bone marrow transplant as a curative treatment requires a HLA matched donor, specific infrastructure and trained doctors and nurses. The physicians need specialized training to treat the affected patients, as well as monitor and manage the complications of therapy. Treating sickle cell disease is equally challenging, especially as patients are often living in remote areas, and have poor socio-economic status. The management of pain and vaso-occlusive crises is difficult.

Recognizing the great socio-economic burden of these disorders, the government constituted a technical committee comprising of experts and representatives of parent organizations to formulate a policy on hemoglobinopathies, which aimed at informing and providing broad guidance on prevention and management of these disorders. The policy encompasses the public health goal by providing:

  1. Affordable and quality care treatment to all patients with Hemoglobinopathies (affected population), and
  2. Reduce the prevalence of hemoglobinopathies through carrier screening and prenatal diagnosis
  1. Affordable and quality care treatment to all patients with Hemoglobinopathies
  • Strengthening treatment centres in Central Government institutions and States in all districts to provide access to affordable and quality services for the management of patients with Thalassemia major by regular and safe blood transfusions and iron chelation therapy; treatment for Sickle Cell Disease with penicillin prophylaxis, immunizations and hydroxyurea, monitor for early detection of any complications, and for their optimal management to prevent morbidity and mortality. 
  • Setting up National/Regional Centres of Excellence as referral and training centres for hemoglobinopathies.
  • Strengthening facilities for separation of blood components and blood storage.
  • Initiation of newborn screening for Sickle Cell Disease where required, and institute prophylactic antibiotic therapy to improve survival rates and reduce morbidity.
  • Establishing facilities for bone marrow transplants in tertiary care institutions.
  • Setting-up of central Hematopoietic Stem Cell donor registry, to facilitate bone marrow transplants in, appropriately identified, patients lacking sibling donors. .
  1. Reduce the prevalence of hemoglobinopathies through carrier screening and prenatal diagnosis
  • Extensive awareness and education programmes in the community, schools and colleges.
  • Inclusion of basic knowledge about genetics, inheritance and prevention of thalassemia major and sickle cell diseases in the school curriculum. 
  • Strengthening laboratories at the District level for facilitating and supporting screening and diagnosis of carriers, including extended family members of patients with thalassemia and sickle cell. 
  • Screening for carrier status of β-thalassemia, HbS and HbE in adolescent students in schools and colleges, to empower them to make informed decisions regarding marital and reproductive choices in future.
  • Screening of pregnant women, preferably in the first trimester, for carrier status, and for those who test positive, screen their husbands and enable the at-risk couples to avail services for prenatal diagnosis to prevent the birth of an affected child.
  • Strengthening facilities for prenatal diagnosis in Medical Colleges and selected tertiary care hospitals in the State.
  • Screening of new born children for early detection of sickle cell disease and provide appropriate intervention followed up by counselling of families.  
  • Cascade screening of blood relatives of those affected with thalassemia major or sickle cell disease, as well as screen subjects in high risk communities.
  • In the rural areas, 'Ashas' are envisaged to be trained to identify subjects with severe anemia which could be likely to be due to thalassemia major or sickle cell disease and counsel such patient to enable contact multipurpose worker (Female) for referral to the primary health centre for further testing and confirmation.

Research and innovation in the area of hemoglobinopathies

The policy advocates promoting research to develop innovative treatments for thalassemia major and sickle cell disease, and devise new diagnostic methods, keeping in mind the continuously evolving technology in this field. The policy also suggests requirement of international collaboration, as many countries in the West have been running successful control programs and treatment centers for hemoglobinopathies for several years. India has much to gain from their experience, so that mutual collaborations and discussions would be extremely useful for the success of the program in India. Thalassaemia International Federation (TIF) expertise may be used.

Additional aspects of treatment related issues that need to be implemented

The Policy advocates for provision of medicines, including iron chelating agents, hydroxyurea, leukocyte filters and infusion pumps free of cost to the poor patients. In line with 'Make in India' initiative, the policy advocates for promotion of manufacture of the equipment and chemicals in India, including waiver of GST and custom duties to reduce cost of treatment for the affected families The policy recommends setting up of a patient registry for thalassemia and sickle cell disease to obtain information on the number of persons affected and the number of carriers to estimate patients who require various services.

Note – This policy on hemoglobinopathies covers the prevention strategy, and empowers prospective parents to exercise their right not to have a child with a serious genetic disorder, and protects the rights of an affected child to have access to optimal care. The policy also advocates promoting research to develop innovative treatments for thalassemia major and sickle cell disease, and devise new diagnostic methods, keeping in mind the continuously evolving technology in this field.

Footnote

1 https://mohfw.gov.in/sites/default/files/drft%20policy.pdf

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
 
In association with
Related Topics
 
Related Articles
 
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Mondaq Sign Up
Gain free access to lawyers expertise from more than 250 countries.
 
Email Address
Company Name
Password
Confirm Password
Position
Industry
Mondaq Newsalert
Select Topics
Select Regions
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions