Indian Council of Medical Research

ICMR and Forte to begin collaborative research projects in field of ageing & health

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The Indian Council for Medical Research (ICMR) and Forte, the Swedish Research Council for Health Working Life and Welfare, will soon begin collaborative research projects in the field of ageing and health, focusing on developing affordable and appropriate innovative assistive technology for the disabled elderly and methods of home based care interventions for the elderly.

The collaborative research projects will stimulate interdisciplinary, innovative, close to practice research in the field of ageing and health. The main theme of these projects will be Innovative and assistive technology studies; and Models of home-based care. All studies should aim to enhance the understanding of the theme of the call for proposals and should demonstrate potential benefits to Sweden and India. The ICMR and Forte have invited research proposals from eligible scientists for the projects and will deliver significant 2-3 years research funding for internationally competitive and innovative projects.

Proposals could include the development of innovative and assistive technology and services that are affordable and appropriate (culture, gender, age specific) for the elderly. It will include Projects on development of visual assistance, mobility assistance and cognitive assistance of the elderly; Design and provision of technology applicable to working with older adults; and Identify barriers and strategies on older adults’ acceptance of technology and perceptions of learning how to use new tools.

In the area of models of home-based care, proposals could include how the design of housing, living arrangements, effective supportive technologies for functional abilities, and the availability of local communities affect elderly people’s participation, activities and independence. Proposals should address how interventions could prevent or reduce the severity of functional impairment, especially impairments secondary to cognitive decline. It will include interventions aimed at the prevention of functional impairment as well as health promotion in order to reduce the incidence of functional impairment in the elderly; Systems of integrated care designed to address the set of health, social and functional needs of the frail elderly; and community based care models.

Proposals must demonstrate collaboration and include both Swedish and Indian Principal Investigators. Indian applicants must be working in a permanent position in a medical college, research institute or university, anywhere in the country including government, semi-government and registered bodies. Applications from non-governmental agencies and private organizations should provide documentary evidence of registration certificate for research with the Department of Scientific and Industrial Research (DSIR), government of India, previous track record etc.

This call for proposal is open for joint proposals from research teams based in India and Sweden. A Memorandum of Intent (MoI) between ICMR and Forte for cooperation in the field of ageing research and health was signed during the visit of the President of India to Sweden in June 2015. The MoI is based on a planning workshop that was partnered by ICMR and Forte in November 2014 to identify key areas for bilateral cooperation.

With declining fertility and rising life expectancy, there is a rapid increase in the number of elderly persons worldwide. Currently, persons aged 60 years or over comprise 11.5 per cent of the world’s population. This number is expected to surpass the 2 billion mark in 2050 from 841 million in 2013.

India stands to witness 100 million persons aged 60 and above currently as per the latest report from Helpage India. The need for elderly care in India is similar to the global scenario with some factors pertinent to India like a changing family system, a rural urban divide, gender based beliefs, and a lack of facilities that needs to be addressed.

The Swedish national objectives for the policy for the elderly are focused on individual care and treatment. India on the other hand has to put greater stress on the healthcare system to cater to the needs of its elderly population. There is a need to understand and strengthen the mechanisms of provision of care for the elderly and address them through appropriate delivery mechanisms. For this we need to turn to global models of home-based services and remote healthcare delivery through mHealth or telemedicine to understand the nuances of designing and implementing public and private models of elderly care. This will provide an insight into critical success factors as well as challenges in managing elderly care. Through cross national studies, lessons can be learnt on the need for collaboration amongst various stakeholders that can change India’s elderly care landscape, and bring it to a level that is comparable with global standards.

Source: 1, 2


Government looks to fast-track approvals for clinical trials

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As the government reviews an overhaul of the drug regulatory process, rules related to clinical trials may be further eased and timelines for approvals shortened to four to six months from around six to eight months now.

The central drug regulator plans to fast track the approval process for clinical trials while ensuring that the contract research organisations (CROs) involved in the tests comply with stricter quality and compliance checks.

This comes two months after the drug regulatory agency eased rules related to clinical research — a move that was frowned upon by patient rights groups. These rules let investigators undertake as many trials as approved under the watch of the designated ethics committee and could risk patient lives, groups like Swasthya Adhikaar Manch earlier told ET.

“(There will be) changes to the (regulations) to make it both easy and stringent,” a senior health ministry official told ET, speaking about the government’s upcoming move on the condition of anonymity.

According to the official, the changes include a reduction in processing and approval time for clinical trials here while ensuring that companies adhere to higher quality standards.
The government has so far halved the clinical trial processing and approval timeline which previously would, in some cases, take up to a year and half, said the official. “The target is to reduce (the entire process) further by 30-40%.” Clinical trial regulations will also be tightened on quality parameters, focusing on aspects like the profile of the recruited patients and the CROs enrolling them, said the official. For this purpose, CROs across the country will be inspected for compliance withGood Clinical Practice (GCP) standards, the official added.

The government has reduced the timeline by measures like increasing the frequency of meetings of the committees granting the approvals and waivers, said another senior ministry official who also preferred to remain anonymous. The Subject Expert Committee, for instance, now meets once a month as compared to once every three months.

It has also introduced an online system to receive and process clinical trial applications faster.

Clinical trial sites currently also have to comply with strong quality measures like GCP standards and the Indian Council of Medical Research ethical guidelines, said the official. “There is no compromise in the quality requirements.” The industry feels the government’s latest decision is much needed to spur pharmaceutical research.

According to Indian Society for Clinical Research president Suneela Thatte, the process can be made more efficient by restricting certain requirements like a three-tiered review process of new drug applications to only special cases. Training and orientation of experts overseeing the entire process would also help speed up the process, she added.
“Other countries don’t have multi-tiered reviews like India does,” she said. Additional investment in governance and infrastructure is also required to ensure compliance with the new regulations, said Naz Haji, Quintiles IMS’ CRO head for India, Singapore, Malaysia and Indonesia.

India’s approval timeline is much longer than timelines of leading clinical research hubs, according to Meir Perez Pugatch, managing director of research consultancy Pugatch Consilium. “In Singapore, for instance, clinical trial applications are usually processed within a timeframe of 30 days, and small-scale clinical trials … are processed within a timeframe of only 15 days.”
Source: 1

TB epidemic in India larger than what was previously estimated: WHO

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Tuberculosis epidemic in India is “larger” than what was previously estimated, the World Health Organisation (WHO) today said while asserting that the country was one of six nations which accounted for 60 per cent of the new cases in 2015.

The Global Tuberculosis Report 2016 which was released today, however, said the number of TB deaths and incidences rate continue to fall globally as well as in India.

“The TB epidemic is larger than previously estimated, reflecting new surveillance and survey data from India. However, the number of TB deaths and the TB incidence rate continue to fall globally and in India,” WHO said.

It said that in 2015, there were an estimated 10.4 million new (incident) TB cases worldwide, of which 5.9 million (56 per cent) were among men, 3.5 million (34 per cent) among women and 1.0 million (10 per cent) among children while people living with HIV accounted for 1.2 million (11 per cent) of all new TB cases.

“Six countries accounted for 60 per cent of the new cases – India, Indonesia, China, Nigeria, Pakistan and South Africa. Global progress depends on major advances in TB prevention and care in these countries,” the global health body said in its report.

It said worldwide, the rate of decline in TB incidence remained at only 1.5 per cent from 2014 to 2015 and stressed the need for it to accelerate to a 4–5 per cent annual decline by 2020 to reach the first milestones of the End TB Strategy.

“In 2015, there were an estimated 480000 new cases of multidrug-resistant TB (MDR-TB) and an additional 100000 people with rifampicin-resistant TB (RR-TB) who were also newly eligible for MDR-TB treatment.

“India, China and the Russian Federation accounted for 45 per cent of the combined total of 580000 cases. There were an estimated 1.4 million TB deaths in 2015, and an additional 0.4 million deaths resulting from TB disease among people living with HIV. Although the number of TB deaths fell by 22 per cent between 2000 and 2015, TB remained one of the top 10 causes of death worldwide in 2015,” it said.

WHO said that in 2015, 6.1 million new TB cases were notified to national authorities and reported to WHO while notified TB cases increased from 2013–2015, mostly due to a 34 per cent increase in notifications in India.

“However, globally there was a 4. 3 million gap between incident and notified cases, with India, Indonesia and Nigeria accounting for almost half of this gap. The crisis of MDR-TB detection and treatment continues.

“In 2015, of the estimated 580000 people newly eligible for MDR-TB treatment, only 125000 (20 per cent) were enrolled.

Five countries accounted for more than 60 per cent of the gap – India, China, the Russian Federation, Indonesia and Nigeria,” it said.

WHO said that the upward revisions to estimates of the burden of TB disease in India for the period 2000–2015 follow accumulating evidence that previous estimates were “too low”.

“This evidence includes household surveys, a state-wide TB prevalence survey, studies of anti-TB drug sales in the private sector, notification data and new analysis of mortality data.

“Since India accounts for more than one quarter of the world’s TB cases and deaths, these revisions have had a major impact on global estimates. Estimates for India are considered interim, pending a national TB prevalence survey scheduled for 2017/2018,” WHO said.

It said that in the African Region where the burden of HIV-associated TB is highest, 81 per cent of notified TB patients had a documented HIV test result.

“The proportion of known HIV-positive TB patients on ART was above 90 per cent in India, Kenya, Malawi, Mozambique, Namibia and Swaziland,” it said.

Giving out details about India, WHO said mortality (HIV+TB only) was 37 per thousand while incidence (HIV+TB only) was 113 per thousand.

Estimated TB incidence in India in 2015 in the age group of 0-14 years for both males and females was 255 per thousand.

Commenting on the report and the disease in the South East Asian Region which also includes India, WHO Regional Director (SEARO) Poonam Khetrapal Singh said TB remains a serious problem across the region and requires the fullest attention and strongest commitment of governments.

“As outlined in WHO’s new global report on TB, a number of countries in the region are among the world’s highest TB burden countries, while revised estimates based on increased case-reporting and enhanced surveillance show that the TB caseload is higher than previously projected.

“TB is the single largest cause of death of any infectious disease in the region, and remains responsible for incalculable suffering, premature mortality, impoverishment and foregone development,” she said.

She said though countries have been making efforts to end TB and the number of TB deaths and its incidence rate continues to fall, at the current trend the region would not be able to achieve the SDG targets.

“A newer and bolder approach is needed to bend the curve faster and sharper to achieve the global targets. This means intensifying measures to ensure early diagnosis and treatment, such as active case-finding and enhancing access to cutting-edge diagnostic tools.

“Adopting newer approaches of case diagnosis, community based treatment and treatment of latent infection. It means integrating TB programmes with existing health systems, thereby amplifying the effect these interventions have,” she said.

Singh also said that funds must be allocated accordingly, while political commitment must be fortified and both must occur at national and international levels.

Source: 1

Union Cabinet approves amendments to HIV and AIDS (Prevention and Control) Bill, 2014

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The Union Cabinet under the chairmanship of Prime Minister Narendra Modi has given its approval to introduce official amendments to the HIV and AIDS (Prevention and Control) Bill, 2014 which has been drafted to safeguard the rights of people living with HIV and affected by HIV.

The Bill seeks to address HIV-related discrimination, strengthen the existing programme by bringing in legal accountability and establish formal mechanisms for inquiring into complaints and redressing grievances. The Bill seeks to prevent and control the spread of HIV and AIDS, prohibits discrimination against persons with HIV and AIDS, provides for informed consent and confidentiality with regard to their treatment, places obligations on establishments to safeguard rights of persons living with HIV and create mechanisms for redressing complaints. The Bill also aims to enhance access to health care services by ensuring informed consent and confidentiality for HIV-related testing, treatment and clinical research.

The Bill lists various grounds on which discrimination against HIV positive persons and those living with them is prohibited. These include the denial, termination, discontinuation or unfair treatment with regard to employment, educational establishments, health care services, residing or renting property, standing for public or private office, and provision of insurance (unless based on actuarial studies).  The requirement for HIV testing as a pre-requisite for obtaining employment or accessing health care or education is also prohibited.

Every HIV infected or affected person below the age of 18 years has the right to reside in a shared household and enjoy the facilities of the household. The Bill also prohibits any individual from publishing information or advocating feelings of hatred against HIV positive persons and those living with them. The Bill also provides for Guardianship for minors. A person between the age of 12 to 18 years who has sufficient maturity in understanding and managing the affairs of his HIV or AIDS affected family shall be competent to act as a guardian of another sibling below 18 years of age to be applicable in the matters relating to admission to educational establishments, operating bank accounts, managing property, care and treatment, amongst others.

The Bill requires that “No person shall be compelled to disclose his HIV status except with his informed consent, and if required by a court order”. Establishments keeping records of information of HIV positive persons shall adopt data protection measures. According to the Bill, the central and state governments shall take measures to prevent the spread of HIV or AIDS; provide anti-retroviral therapy and infection management for persons with HIV or AIDS; facilitate their access to welfare schemes especially for women and children; formulate HIV or AIDS education communication programmes that are age appropriate, gender sensitive, and non-stigmatizing; and lay guidelines for the care and treatment of children with HIV or AIDS. Every person in the care and custody of the state shall have right to HIV prevention, testing, treatment and counseling services. The Bill suggest that cases relating to HIV positive persons shall be disposed’ off by the court on a priority basis and duly ensuring the confidentiality.

There are no financial implications of the Bill. Most of the activities are being already undertaken or can be integrated within the existing systems of various Ministries under training, communication and data management, etc. The Bill makes provision for appointment of an ombudsman by state governments to inquire into complaints related to the violation of the Act and penal actions in case of non-compliance. The ombudsman need not be a separate entity, but any existing state government functionary can be deputed or given additional charge.

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ICMR issues consensus document for management of non-Hodgkin’s lymphoma

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The Indian Council of Medical Research (ICMR) has issued the consensus document for management of non-Hodgkin’s lymphoma (high grade) which will provide guidance to practicing doctors and researchers for the management of patients suffering from non- Hodgkin’s lymphoma – high grade and also focusing their research efforts in Indian context.

Lymphoma is a type of cancer that develops in the lymphatic system, the body’s disease fighting network. It is estimated that around 1,000 people worldwide are diagnosed with lymphoma every day. Globally the incidence of disease is 385741 cases with mortality of 199650 cases. India accounts for 23801 cases with a mortality of 16597 cases.

This document will help practicing doctors, clinicians, researchers and patients in complex decision making process in management of the disease. It represents the current thinking of national experts on subject based on available evidence.

The ICMR had earlier constituted sub-committees to prepare consensus document for management of various cancer sites. This document is the result of the hard work of various experts across the country working in the area of oncology. This consensus document on management of non- Hodgkin’s lymphoma – high grade summarizes the modalities of treatment including the site-specific anti-cancer therapies, supportive and palliative care and molecular markers and research questions. It also interweaves clinical, biochemical and epidemiological studies.

The purpose of this document is to revamp recommendations for evaluation, staging and response assessment of patients with non-Hodgkin’s lymphoma. The availability of more effective therapies for lymphoma and the increasingly sensitive and specific technologies has made this consensus the need of hour. However, good clinical judgement, a careful history and physical examination are the cornerstones of patient follow up. The objective of this guideline is to provide healthcare professionals with clear guidance on the management of patients with Non Hodgkin Lymphoma – High Grade. The guidance may not be appropriate for all patients with NHL but this compilation of Indian Data gives us an insight to best practice. This disease strata is currently undergoing extensive investigations and it is likely that paradigms will shift over the next several years.

Lymphomas are a very complex group of diseases with differing behaviours and treatment options. It is typically classified into two groups, Hodgkins lymphoma (HL) and non-Hodgkins lymphoma (NHL). NHL’S are subclassfied as low grade (indolent) and high grade. The high grade NHL is generally curable with cytotoxic therapy while the low grade lymphomas are controllable for long periods.

While lymphoma is potentially fatal, some forms are curable and a patient’s survival may be greatly enhanced by early diagnosis. Almost all lymphoma types can be cured or managed as a chronic disease, but its complexity and variation do not allow for a one-size-fits-all treatment approach. Instead, it necessitates highly specialized and individualized approaches. The cause of the majority of lymphoma cases is unknown, however, there could be several factors that may influence one’s risk of developing lymphoma. The relative effects of these factors in any given case of cancer vary and are very difficult to determine with accuracy at present.

Source: 1, 2