News Analysis India

Tag: ICMR

  • ICMR completes clinical trials of world’s first injectable male contraceptive; study claims it’s safe

    By PTI

    NEW DELHI: The Indian Council of Medical Research (ICMR) has completed the clinical trials of the world’s first injectable male contraceptive which showed that it is safe and highly efficacious without any serious side effects.

    The findings of the phase-III clinical trial, which involved 303 candidates aged 25-40 years, were published in the international open-access Andrology journal last month.

    The open-labeled and non-randomized, multi-centre hospital-based phase-III clinical trials were carried out at five different centres (New Delhi, Udhampur, Ludhiana, Jaipur and Kharagpur) and coordinated by the ICMR, New Delhi.

    Permission to conduct phase-III clinical trial was granted by the Drugs Controller General India (DCGI) and approved by the institutional ethical committees of the respective centres.

    As part of the study, 303 healthy, sexually active and married men and their healthy and sexually active wives who came to the family planning clinic and department of urology or surgery for vasectomy or No Scalpel Vasectomy (NSV) were identified.

    The men were injected with 60 mg of Reversible Inhibition of Sperm under Guidance (RISUG).

    “The overall efficacy of RISUG with respect to achieving azoospermia was 97.3 per cent and based on pregnancy prevention was 99.02 per cent without any serious side effect,” the study stated.

    “In the history of contraceptive development, RISUG presents the highest effectiveness compared to all other contraceptives both male and female as they were at the threshold of induction into a mass contraception program,” it said.

    According to the study, with an ever-increasing world population, there is an urgent need to develop modern methods of male contraception for population control.

    Even though vasectomy is quite effective as a contraceptive measure, some major limitations of this method call for the development of improved techniques.

    An ideal male contraceptive approach should have minimally invasive drug delivery system with a one-time injection, long-term effectiveness with negligible side-effects and the option of reversal.

    “To achieve these goals, a novel male contraceptive approach of Reversible Inhibition of Sperm under Guidance (RISUG) has been developed, which has the potential to become for mass use as once injectable and reversible male contraceptive method. Significant features of this method include localized injection and no detectable interaction with other body parts unlike the hormonal injectable contraceptives,” the study said. Follow The New Indian Express channel on WhatsApp

    NEW DELHI: The Indian Council of Medical Research (ICMR) has completed the clinical trials of the world’s first injectable male contraceptive which showed that it is safe and highly efficacious without any serious side effects.

    The findings of the phase-III clinical trial, which involved 303 candidates aged 25-40 years, were published in the international open-access Andrology journal last month.

    The open-labeled and non-randomized, multi-centre hospital-based phase-III clinical trials were carried out at five different centres (New Delhi, Udhampur, Ludhiana, Jaipur and Kharagpur) and coordinated by the ICMR, New Delhi.googletag.cmd.push(function() {googletag.display(‘div-gpt-ad-8052921-2’); });

    Permission to conduct phase-III clinical trial was granted by the Drugs Controller General India (DCGI) and approved by the institutional ethical committees of the respective centres.

    As part of the study, 303 healthy, sexually active and married men and their healthy and sexually active wives who came to the family planning clinic and department of urology or surgery for vasectomy or No Scalpel Vasectomy (NSV) were identified.

    The men were injected with 60 mg of Reversible Inhibition of Sperm under Guidance (RISUG).

    “The overall efficacy of RISUG with respect to achieving azoospermia was 97.3 per cent and based on pregnancy prevention was 99.02 per cent without any serious side effect,” the study stated.

    “In the history of contraceptive development, RISUG presents the highest effectiveness compared to all other contraceptives both male and female as they were at the threshold of induction into a mass contraception program,” it said.

    According to the study, with an ever-increasing world population, there is an urgent need to develop modern methods of male contraception for population control.

    Even though vasectomy is quite effective as a contraceptive measure, some major limitations of this method call for the development of improved techniques.

    An ideal male contraceptive approach should have minimally invasive drug delivery system with a one-time injection, long-term effectiveness with negligible side-effects and the option of reversal.

    “To achieve these goals, a novel male contraceptive approach of Reversible Inhibition of Sperm under Guidance (RISUG) has been developed, which has the potential to become for mass use as once injectable and reversible male contraceptive method. Significant features of this method include localized injection and no detectable interaction with other body parts unlike the hormonal injectable contraceptives,” the study said. Follow The New Indian Express channel on WhatsApp

  • Monsoon fury forces ICMR to issue snakebite cure guidelines for health workers

    Express News Service

    NEW DELHI: As snakebite cases have started rising because of the rains, the ICMR is soon going to roll out a series of educational materials in Hindi, English and Odiya for medical officers in the community and public health centres due to their lack of knowledge on its treatment.

    The educational material for health workers will also be published in other regional languages, especially in the states where snakebite cases are rampant.

    The idea to come out with these educational materials was also to assist ASHAs, Auxiliary Nurse Midwife (ANM) and other health workers to identify snake bites early, provide effective first aid, and timely referrals to the nearest healthcare facility.

    The material has been jointly prepared by the Indian Council of Medical Research-National Institute for Research in Reproductive and Child Health (NIRRH), Mumbai.

    The booklet pictorially depicts the commonly found snake species, signs and symptoms of snakebite envenomation and outlines first aid and preventive measures for the same.

    “We hope this material will help in high-burden areas across India and will prove effective in reducing deaths and disabilities associated with snakebite envenomation,” said Dr Rahul K. Gajbhiye, Scientist D and DBT Wellcome India Alliance, clinical and public health intermediate Fellow, Head Clinical Research Department ICMR-NIRRH.

    “As part of our national snakebite implementation project, we developed medical officers’ flow chart for snakebite treatment. Medical officers in PHC and CHC should be able to treat snakebite cases using the document,” Gajbhiye told The New Indian Express.

    “There was a lack of appropriate IEC material on snakebite and training manual for ANMs, MPW and ASHAS so we developed these educational materials in consultation with snakebite experts, herpetologists, scientists, physicians and community health experts,” he added.

    ALSO READ | Orange alert issued for Uttarakhand till July 18, devastating monsoon continues

    “We are disseminating these educational materials from this month as snakebite cases started rising after the monsoon,” he said.

    It was also felt that this educational material – which also lists the identification of poisonous and non-poisonous snakes, common hiding places for snakes, and symptoms – should be shared with the health workers as they are the first ones to get in contact with the victims.

    But as most of them are unaware of its treatment, the chances of deaths increase.

    Eight states — Madhya Pradesh, Odisha, Uttar Pradesh, Bihar, Jharkhand, Rajasthan, Gujarat, Andhra Pradesh and Telangana — shared the burden of about 70% of snakebite deaths from 2001 to 2014.

    Snakebite envenomation (SBE) is an acute, life-threatening, time-limiting, medical emergency affecting 1.8-2.7 million people with estimated 138,000 deaths annually across the globe.

    India contributes an average of 58,000 deaths annually. India is one of the world’s most affected countries due to the large population engaged in agricultural activities.

    It is estimated that India had 1.2 million snakebite deaths (average 58,000/year) from 2000 to 2019 which is an increase of about 8000 cases/year compared to the earlier estimated survey (2001-2003).

    Gajbhiye said that the majority of the deaths occurred at home in the rural areas with half of the deaths happening between 30-69 years of age, which is a productive age.

    In 2019, the World Health Organization (WHO) resolved to halve the global burden of snakebites by 2030.

    Being a major contributor to the existing global burden of mortality, India is taking initiatives at the national and regional level to achieve the WHO target of 2030.

    Snakebite envenoming (SBE) is one of the neglected tropical diseases (NTD) leading to around 81,410 to 137,880 deaths from 1.8 million to 2.7 million cases globally.

    SBE affects around 400,000 people every year causing permanent physical or psychological disabilities including blindness, amputation, and post-traumatic stress disorder.

    It is estimated that in countries with a frail health system and scarcity of anti-venom, one death occurs every five minutes and four more people are disabled permanently due to SBE.

    NEW DELHI: As snakebite cases have started rising because of the rains, the ICMR is soon going to roll out a series of educational materials in Hindi, English and Odiya for medical officers in the community and public health centres due to their lack of knowledge on its treatment.

    The educational material for health workers will also be published in other regional languages, especially in the states where snakebite cases are rampant.

    The idea to come out with these educational materials was also to assist ASHAs, Auxiliary Nurse Midwife (ANM) and other health workers to identify snake bites early, provide effective first aid, and timely referrals to the nearest healthcare facility.googletag.cmd.push(function() {googletag.display(‘div-gpt-ad-8052921-2′); });

    The material has been jointly prepared by the Indian Council of Medical Research-National Institute for Research in Reproductive and Child Health (NIRRH), Mumbai.

    The booklet pictorially depicts the commonly found snake species, signs and symptoms of snakebite envenomation and outlines first aid and preventive measures for the same.

    “We hope this material will help in high-burden areas across India and will prove effective in reducing deaths and disabilities associated with snakebite envenomation,” said Dr Rahul K. Gajbhiye, Scientist D and DBT Wellcome India Alliance, clinical and public health intermediate Fellow, Head Clinical Research Department ICMR-NIRRH.

    “As part of our national snakebite implementation project, we developed medical officers’ flow chart for snakebite treatment. Medical officers in PHC and CHC should be able to treat snakebite cases using the document,” Gajbhiye told The New Indian Express.

    “There was a lack of appropriate IEC material on snakebite and training manual for ANMs, MPW and ASHAS so we developed these educational materials in consultation with snakebite experts, herpetologists, scientists, physicians and community health experts,” he added.

    ALSO READ | Orange alert issued for Uttarakhand till July 18, devastating monsoon continues

    “We are disseminating these educational materials from this month as snakebite cases started rising after the monsoon,” he said.

    It was also felt that this educational material – which also lists the identification of poisonous and non-poisonous snakes, common hiding places for snakes, and symptoms – should be shared with the health workers as they are the first ones to get in contact with the victims.

    But as most of them are unaware of its treatment, the chances of deaths increase.

    Eight states — Madhya Pradesh, Odisha, Uttar Pradesh, Bihar, Jharkhand, Rajasthan, Gujarat, Andhra Pradesh and Telangana — shared the burden of about 70% of snakebite deaths from 2001 to 2014.

    Snakebite envenomation (SBE) is an acute, life-threatening, time-limiting, medical emergency affecting 1.8-2.7 million people with estimated 138,000 deaths annually across the globe.

    India contributes an average of 58,000 deaths annually. India is one of the world’s most affected countries due to the large population engaged in agricultural activities.

    It is estimated that India had 1.2 million snakebite deaths (average 58,000/year) from 2000 to 2019 which is an increase of about 8000 cases/year compared to the earlier estimated survey (2001-2003).

    Gajbhiye said that the majority of the deaths occurred at home in the rural areas with half of the deaths happening between 30-69 years of age, which is a productive age.

    In 2019, the World Health Organization (WHO) resolved to halve the global burden of snakebites by 2030.

    Being a major contributor to the existing global burden of mortality, India is taking initiatives at the national and regional level to achieve the WHO target of 2030.

    Snakebite envenoming (SBE) is one of the neglected tropical diseases (NTD) leading to around 81,410 to 137,880 deaths from 1.8 million to 2.7 million cases globally.

    SBE affects around 400,000 people every year causing permanent physical or psychological disabilities including blindness, amputation, and post-traumatic stress disorder.

    It is estimated that in countries with a frail health system and scarcity of anti-venom, one death occurs every five minutes and four more people are disabled permanently due to SBE.

  • Centre issues fresh advisory on Covid-19: Mock drills on April 10, 11 to check hospital readiness

    Express News Service

    NEW DELHI: The Centre on Saturday issued a fresh advisory to states and union territories and asked them to step up testing as there is a “sustained increase” in Covid-19 cases in the country.

    In a joint advisory issued by Dr Rajiv Bahl, Secretary, Department of Health Research and DG Indian Council of Medical Research (ICMR) and Rajesh Bhushan, Union Health Secretary, said the government plans to hold a nationwide mock drill on April 10 and 11 to check the Covid-19 readiness of all hospitals across the country.

    Health facilities, both public and private, from all districts are expected to participate in the exercise.

    The exact details of the mock drill will be communicated to the states in the virtual meeting scheduled on March 27. 

    The advisory said that a “gradual but sustained increase in the trajectory of Covid-19 cases in the country is being witnessed since mid-February 2023.”

    The letter said that most of the active cases in the country are largely being reported by states like Kerala (26.4 percent), Maharashtra (21.7 percent), and Gujarat (13.9 percent), Karnataka (8.6 percent) and Tamil Nadu (6.3 percent).

    While the rates of hospitalisation and death due to the disease remain low, largely because of the significant coverage achieved in terms of Covid-19 vaccination rates by all states and UTs, this gradual rise in cases needs reinvigorated public health actions to contain the surge, it said.

    The advisory said that in the past several weeks, in some states Covid-19 testing has declined and the current testing levels are insufficient as compared to the standards prescribed by WHO i.e 140 tests/million.

    The letter also asked states and UTs to keep a close watch on the evolving etiologies (causes of diseases) of Influenza like Illness (ILI), especially H1N1 and H3N2, and severe active respiratory illness (SARI) cases.

    The states were also directed to take stock of hospital preparedness including drugs, beds, including ICU beds, medical equipment, medical oxygen, capacity building of human resource on existing guidelines as well as vaccination coverage.

    On Covid-19 testing, the advisory said, “Testing at the level of districts and blocks also varies, with some states heavily relying on the less sensitive rapid antigen tests.”

    “Hence it is critical to maintain optimum testing for Covid-19, equitably distributed (with suitable modifications to address the emergence of a new cluster of Covid cases) across the States. This is especially important to identify any emerging hotspots & take pre-emptive steps to curb virus transmission,” the letter said.

    The states were cautioned that both Covid-19 and Influenza share a number of similarities in terms of mode of transmission, high-risk population, clinical signs and symptoms.

    “While this may present a clinical dilemma for the attending doctors in terms of diagnosis, this also renders both these diseases easily preventable by following simple public health measures like avoiding overcrowding and poorly ventilated settings, using handkerchiefs/tissue while sneezing or coughing, wearing mask in crowded and closed settings, maintaining hand hygiene, avoiding spitting in public places etc.

    On March 22, Prime Minister Narendra Modi had held a high-level meeting to review Covid-19 and Influenza situation as cases soared. He had directed officials to conduct mock drills to ensure that hospitals are prepared for all emergencies.

    A total of 1,161 cases of H3N2 have been reported from January 1 to March 20, 2023, the parliament was informed.

    The maximum cases were reported in Delhi at 370, followed by Rajasthan (180) and Karnataka (134). 

    NEW DELHI: The Centre on Saturday issued a fresh advisory to states and union territories and asked them to step up testing as there is a “sustained increase” in Covid-19 cases in the country.

    In a joint advisory issued by Dr Rajiv Bahl, Secretary, Department of Health Research and DG Indian Council of Medical Research (ICMR) and Rajesh Bhushan, Union Health Secretary, said the government plans to hold a nationwide mock drill on April 10 and 11 to check the Covid-19 readiness of all hospitals across the country.

    Health facilities, both public and private, from all districts are expected to participate in the exercise.googletag.cmd.push(function() {googletag.display(‘div-gpt-ad-8052921-2’); });

    The exact details of the mock drill will be communicated to the states in the virtual meeting scheduled on March 27. 

    The advisory said that a “gradual but sustained increase in the trajectory of Covid-19 cases in the country is being witnessed since mid-February 2023.”

    The letter said that most of the active cases in the country are largely being reported by states like Kerala (26.4 percent), Maharashtra (21.7 percent), and Gujarat (13.9 percent), Karnataka (8.6 percent) and Tamil Nadu (6.3 percent).

    While the rates of hospitalisation and death due to the disease remain low, largely because of the significant coverage achieved in terms of Covid-19 vaccination rates by all states and UTs, this gradual rise in cases needs reinvigorated public health actions to contain the surge, it said.

    The advisory said that in the past several weeks, in some states Covid-19 testing has declined and the current testing levels are insufficient as compared to the standards prescribed by WHO i.e 140 tests/million.

    The letter also asked states and UTs to keep a close watch on the evolving etiologies (causes of diseases) of Influenza like Illness (ILI), especially H1N1 and H3N2, and severe active respiratory illness (SARI) cases.

    The states were also directed to take stock of hospital preparedness including drugs, beds, including ICU beds, medical equipment, medical oxygen, capacity building of human resource on existing guidelines as well as vaccination coverage.

    On Covid-19 testing, the advisory said, “Testing at the level of districts and blocks also varies, with some states heavily relying on the less sensitive rapid antigen tests.”

    “Hence it is critical to maintain optimum testing for Covid-19, equitably distributed (with suitable modifications to address the emergence of a new cluster of Covid cases) across the States. This is especially important to identify any emerging hotspots & take pre-emptive steps to curb virus transmission,” the letter said.

    The states were cautioned that both Covid-19 and Influenza share a number of similarities in terms of mode of transmission, high-risk population, clinical signs and symptoms.

    “While this may present a clinical dilemma for the attending doctors in terms of diagnosis, this also renders both these diseases easily preventable by following simple public health measures like avoiding overcrowding and poorly ventilated settings, using handkerchiefs/tissue while sneezing or coughing, wearing mask in crowded and closed settings, maintaining hand hygiene, avoiding spitting in public places etc.

    On March 22, Prime Minister Narendra Modi had held a high-level meeting to review Covid-19 and Influenza situation as cases soared. He had directed officials to conduct mock drills to ensure that hospitals are prepared for all emergencies.

    A total of 1,161 cases of H3N2 have been reported from January 1 to March 20, 2023, the parliament was informed.

    The maximum cases were reported in Delhi at 370, followed by Rajasthan (180) and Karnataka (134).
     

  • Avoid antibiotics unless in case of bacterial infection: ICMR’s revised Covid-19 guidelines  

    By ANI

    NEW DELHI: The Indian Council of Medical Research (ICMR) has issued revised guidelines for Covid-19 in the wake of the surge of cases in the past week across the country.

    “@ICMRDELHI COVID19 National Task Force, @aiims_newdelhi & Dte.GHS revised clinical guidance for management of adult #COVID19 patients. Guideline does not advice use of Lopinavir-ritonavir, HCQ, Ivermectin, Convalescent plasma, Molnupiravir, Favipiravir, Azithromycin, Doxycycline,” Dr Lokesh Sharma, Heath informatics researcher, ICMR tweeted.

    “Antibiotics should not be used unless there is clinical suspicion of bacterial infection. The possibility of coinfection of COVID-19 with other endemic infections must be considered. Systemic corticosteroids are not indicated in mild disease,” revised guidelines said.

    As per the revised Ccovid-19 guidelines, maintain “Physical distancing, indoor mask use, hand hygiene, Symptomatic management (hydration, anti-pyretics, antitussive) Monitor temperature and oxygen saturation (by applying a SpO probe to fingers) Stay in contact with treating physician.

    “Seek immediate medical attention if difficulty breathing, High-grade fever/ severe cough, particularly if lasting for more than 5 days. A low threshold is to be kept for those with any of the high-risk features,” guidelines discussed and prepared in January said.

    Additionally, in moderate or severe diseases at high risk of progression, the guidelines recommend, “Consider Remdesivir for up to 5 days (200 mg IV on day 1 followed by 100 mg IV OD for the next 4 days)”.

    Union Health and Family Welfare Ministry on Thursday wrote to the State governments of Maharashtra, Gujarat, Telangana, Tamil Nadu, Kerala and Karnataka to follow a five-fold strategy of test, track, treat and vaccinations as these states witness a rise in Covid-19 cases.

    India has observed a significant decline in the number of Covid-19 cases during the past few months. However, in the past few weeks a rise in cases has been noted specifically in certain parts of the country with a total of 2,082 cases reported in the week ending March 8, 2023, which rose to 3,264 cases in the week ending March 15, said the Union Home Ministry’s letter.

    There are few States which are reporting a higher number of cases indicating the possible localized spread of infection and there is a need to follow a risk assessment-based approach to prevent and contain the infection, without losing the gains made so far in the fight against the pandemic, said the Union Health Ministry.

    Gujarat has reported an increase in weekly cases from 105 in the week ending March 8, 2023, to 279 in the week ending March 15. Further, the State reported a positivity rate of 1.11 per cent in the week ending March 15 which is higher than India’s positivity rate of 0.61 per cent during the same period, the letter said. 

    NEW DELHI: The Indian Council of Medical Research (ICMR) has issued revised guidelines for Covid-19 in the wake of the surge of cases in the past week across the country.

    “@ICMRDELHI COVID19 National Task Force, @aiims_newdelhi & Dte.GHS revised clinical guidance for management of adult #COVID19 patients. Guideline does not advice use of Lopinavir-ritonavir, HCQ, Ivermectin, Convalescent plasma, Molnupiravir, Favipiravir, Azithromycin, Doxycycline,” Dr Lokesh Sharma, Heath informatics researcher, ICMR tweeted.

    “Antibiotics should not be used unless there is clinical suspicion of bacterial infection. The possibility of coinfection of COVID-19 with other endemic infections must be considered. Systemic corticosteroids are not indicated in mild disease,” revised guidelines said.googletag.cmd.push(function() {googletag.display(‘div-gpt-ad-8052921-2’); });

    As per the revised Ccovid-19 guidelines, maintain “Physical distancing, indoor mask use, hand hygiene, Symptomatic management (hydration, anti-pyretics, antitussive) Monitor temperature and oxygen saturation (by applying a SpO probe to fingers) Stay in contact with treating physician.

    “Seek immediate medical attention if difficulty breathing, High-grade fever/ severe cough, particularly if lasting for more than 5 days. A low threshold is to be kept for those with any of the high-risk features,” guidelines discussed and prepared in January said.

    Additionally, in moderate or severe diseases at high risk of progression, the guidelines recommend, “Consider Remdesivir for up to 5 days (200 mg IV on day 1 followed by 100 mg IV OD for the next 4 days)”.

    Union Health and Family Welfare Ministry on Thursday wrote to the State governments of Maharashtra, Gujarat, Telangana, Tamil Nadu, Kerala and Karnataka to follow a five-fold strategy of test, track, treat and vaccinations as these states witness a rise in Covid-19 cases.

    India has observed a significant decline in the number of Covid-19 cases during the past few months. However, in the past few weeks a rise in cases has been noted specifically in certain parts of the country with a total of 2,082 cases reported in the week ending March 8, 2023, which rose to 3,264 cases in the week ending March 15, said the Union Home Ministry’s letter.

    There are few States which are reporting a higher number of cases indicating the possible localized spread of infection and there is a need to follow a risk assessment-based approach to prevent and contain the infection, without losing the gains made so far in the fight against the pandemic, said the Union Health Ministry.

    Gujarat has reported an increase in weekly cases from 105 in the week ending March 8, 2023, to 279 in the week ending March 15. Further, the State reported a positivity rate of 1.11 per cent in the week ending March 15 which is higher than India’s positivity rate of 0.61 per cent during the same period, the letter said. 

  • Northeast tribals with sickle cell disease are outliving other afflicted tribals: Study

    Express News Service

    GUWAHATI: Tribals in the Northeast with sickle cell disease (SCD) live longer than fellow tribals suffering from the same disease elsewhere in India, a study conducted by Assam’s Bodoland University found.

    SCD (also called sickle cell anaemia) is one of the most prevalent blood genetic disorders which is caused by sickle-shaped haemoglobin and is common among tribals.

    About 2.3 per cent of the world’s population carries this defective haemoglobin. Around 44,000 children are born every year in India with SCD. 

    The Indian Council of Medical Research (ICMR) had entrusted different institutions to conduct a multi-centric study on the disease from 2019 to 2022 in six districts – Udalguri in Assam (Northeast), Kandhamal in Odisha (Eastern India), Mysuru in Karnataka (Southern India), Visakhapatnam in Andhra Pradesh (Southern India), Annupur in Madhya Pradesh (Central India) and Chotaudeypur in Gujarat. 

    In each district, four primary health centre (PHC) areas, predominantly inhabited by tribals, were identified for the study. Two were selected randomly for implementing intervention and the two others were the control area. The intervention was implemented in all villages of two selected PHC areas but the formative research and evaluation surveys were carried out in sampled villages of all four PHC areas. 

    Prof Jatin Sarmah, Head, Department of Biotechnology, Bodoland University, said 42 people were detected with SCD in Udalguri. He said such patients die before attaining the age of adulthood but four-five patients outlived their expected life expectancy.

    “We noticed that even aged SCD patients are still surviving. Ideally, we would like to find out why their foetal haemoglobin survives naturally for long,” Prof Sarmah, who was the principal investigator of the ICMR-sponsored project in the Northeast, said.

    Normally, foetal haemoglobin keeps giving support to SCD patients for 18 to 20 years, he said. “In the cases of these four-five people, we don’t know for what factors they are still getting that support.”

    The biotechnologist also said that no institution in India ever conducted this study but some medical colleges in the US had done so.

    “Saudi Arabia is also conducting a study but our people are different. Indians have different origins and ethnicities,” Prof Sarmah pointed out while stating that the expression of some genetic factors could be behind the Udalguri story. 

    The most common acute events of SCD are pain crisis, acute chest syndrome and lung injury syndrome. With increasing age, chronic end-organ complications begin to appear and they include chronic renal failure, haemorrhagic and non-haemorrhagic stroke, necrosis of bone and pulmonary hypertension.

    The disease is prevalent among tribal populations. Remoteness, language barrier, financial hardships, poor awareness, and lack of trust in the public health care system are the main challenges in its management. 

    The Bodoland University research team’s co-principal investigator was Dr Silistina Narzari.

    Dr Bontha V Babu, Scientist-G and Head, Division of Socio-behavioural and Health System Research, ICMR, was the national coordinator of the multi-centric project.

    The ICMR initiated the country-wide study to develop a model of screening and management of SCD in the primary health care system. The intervention includes increasing awareness and preparing the communities for accessing the government health care system for SCD care and improving the capacity of the primary health care systems.

    GUWAHATI: Tribals in the Northeast with sickle cell disease (SCD) live longer than fellow tribals suffering from the same disease elsewhere in India, a study conducted by Assam’s Bodoland University found.

    SCD (also called sickle cell anaemia) is one of the most prevalent blood genetic disorders which is caused by sickle-shaped haemoglobin and is common among tribals.

    About 2.3 per cent of the world’s population carries this defective haemoglobin. Around 44,000 children are born every year in India with SCD. 

    The Indian Council of Medical Research (ICMR) had entrusted different institutions to conduct a multi-centric study on the disease from 2019 to 2022 in six districts – Udalguri in Assam (Northeast), Kandhamal in Odisha (Eastern India), Mysuru in Karnataka (Southern India), Visakhapatnam in Andhra Pradesh (Southern India), Annupur in Madhya Pradesh (Central India) and Chotaudeypur in Gujarat. 

    In each district, four primary health centre (PHC) areas, predominantly inhabited by tribals, were identified for the study. Two were selected randomly for implementing intervention and the two others were the control area. The intervention was implemented in all villages of two selected PHC areas but the formative research and evaluation surveys were carried out in sampled villages of all four PHC areas. 

    Prof Jatin Sarmah, Head, Department of Biotechnology, Bodoland University, said 42 people were detected with SCD in Udalguri. He said such patients die before attaining the age of adulthood but four-five patients outlived their expected life expectancy.

    “We noticed that even aged SCD patients are still surviving. Ideally, we would like to find out why their foetal haemoglobin survives naturally for long,” Prof Sarmah, who was the principal investigator of the ICMR-sponsored project in the Northeast, said.

    Normally, foetal haemoglobin keeps giving support to SCD patients for 18 to 20 years, he said. “In the cases of these four-five people, we don’t know for what factors they are still getting that support.”

    The biotechnologist also said that no institution in India ever conducted this study but some medical colleges in the US had done so.

    “Saudi Arabia is also conducting a study but our people are different. Indians have different origins and ethnicities,” Prof Sarmah pointed out while stating that the expression of some genetic factors could be behind the Udalguri story. 

    The most common acute events of SCD are pain crisis, acute chest syndrome and lung injury syndrome. With increasing age, chronic end-organ complications begin to appear and they include chronic renal failure, haemorrhagic and non-haemorrhagic stroke, necrosis of bone and pulmonary hypertension.

    The disease is prevalent among tribal populations. Remoteness, language barrier, financial hardships, poor awareness, and lack of trust in the public health care system are the main challenges in its management. 

    The Bodoland University research team’s co-principal investigator was Dr Silistina Narzari.

    Dr Bontha V Babu, Scientist-G and Head, Division of Socio-behavioural and Health System Research, ICMR, was the national coordinator of the multi-centric project.

    The ICMR initiated the country-wide study to develop a model of screening and management of SCD in the primary health care system. The intervention includes increasing awareness and preparing the communities for accessing the government health care system for SCD care and improving the capacity of the primary health care systems.

  • Counsellors in the dark about usage & health impacts of designer drugs among sex workers, others

    Express News Service

    NEW DELHI: Community health workers, who counsel men having sex with men, transgenders and commercial sex workers, lack knowledge and are ignorant of identifying designer drugs commonly used by this population as a source of enhancing sexual pleasure, reveals a study conducted by the Indian Council of Medical Research (ICMR).

    The study shows community health mobilisers (CHM), drawn from the above-mentioned category and who work with NGOs lack proper knowledge about diseases caused by high-risk sexual behaviours such as sexually transmitted infections (STIs) and other health and psychological illness associated with the daily usage of not only designer drugs but also of sexualised substance use (SSU).

    They also lack knowledge about the impact of these substances in spreading HIV or about prophylactic medications to prevent getting HIV/AIDS.

    A study by HIV Alliance, a Chennai-based non-profit organisation, under the aegis of ICMR, in five states found that these community health workers were also unaware of how these drug users – in the age group of 16 and 40 – were procuring these designer drugs and SSU.

    “We found that there was lack of awareness about various drugs used for chemsex – using drugs as part of your sex life – like ketamine, erectile dysfunction drugs, etc. and latest substance of abuse such as designer drugs,” said Dr Sumit Aggarwal, Scientist and Program Officer at ICMR, who is also one of the authors of the study.

    He said these CHMs were also not aware of the complex health issues associated with SSU, as its daily use leads to violent behaviour, paranoia, hallucinations and confusion.

    “Drug users combine two-three drugs not only to get high but to increase their sexual capacity,” Dr Aggarwal told The New Indian Express.

    He added that erectile dysfunction drugs, ketamine, and gamma-butyrolactone (GBL) are commonly used during chemsex.

    It was found that there was a lack of knowledge among CHMs – working in community-led developmental programmes in Punjab, Gujarat, West Bengal, Delhi and Hyderabad – about online sources for SSU.

    Chemsex is considered a subset of SSU, commonly defined as the use of specific drugs (methamphetamine, mephedrone, gamma-hydroxybutyrate (GHB/GBL), ketamine and cocaine) before or during sexual intercourse, said the study.

    Dr Aggarwal said many drug users – who procured these drugs from medical shops and other places, including at sex parties – turned to SSU because of peer pressure.

    Many also took it to relieve stress, anxiety, and grief, for sexual pleasure, to counteract any guilt, to increase the emotional bond with sex partners, or even to overcome a lack of confidence and even to overcome inhibition for sex work.

    Not only that, craving and dependence on substance abuse caused most users to lose their jobs, leading to financial problems, which further pushed them to illegal activities, including smuggling, theft, and sex work, for quick cash to buy drugs, Dr Aggarwal added.

    The study, published in Brain Sciences, an international, peer-reviewed, open-access journal on neuroscience, was conducted with the aim to assess the knowledge gaps regarding SSU among CHMs. For that, in-depth interviews were conducted with 19 CHMs, the majority being men, followed by transgender.

    ALSO READ | Treat us with dignity, say sex workers

    They were also assessed for their knowledge of HIV, infection prevention, and complex health issues associated with SSU.

    It has been found that chemsex is common among homosexuals, bisexuals, and MSM, who frequently engage in SSU/chemsex because they believe that psychoactive chemicals may boost arousal and stamina, enabling prolonged sex sessions with one or multiple partners.

    Apart from financial problems, these drug users’ relationships with their parents, spouses, and friends suffered due to a lack of concentration. Many users who took it by injecting, sniffing, sublingual and smoking accepted they tried to get rid of the problem and even visited ‘ojhas,’ (a charmer or a wizard).

    Additionally, SSU is also known to have a role in survival sex practices, which includes the selling of sex for subsistence needs such as shelter, food, drugs, or money.

    NEW DELHI: Community health workers, who counsel men having sex with men, transgenders and commercial sex workers, lack knowledge and are ignorant of identifying designer drugs commonly used by this population as a source of enhancing sexual pleasure, reveals a study conducted by the Indian Council of Medical Research (ICMR).

    The study shows community health mobilisers (CHM), drawn from the above-mentioned category and who work with NGOs lack proper knowledge about diseases caused by high-risk sexual behaviours such as sexually transmitted infections (STIs) and other health and psychological illness associated with the daily usage of not only designer drugs but also of sexualised substance use (SSU).

    They also lack knowledge about the impact of these substances in spreading HIV or about prophylactic medications to prevent getting HIV/AIDS.

    A study by HIV Alliance, a Chennai-based non-profit organisation, under the aegis of ICMR, in five states found that these community health workers were also unaware of how these drug users – in the age group of 16 and 40 – were procuring these designer drugs and SSU.

    “We found that there was lack of awareness about various drugs used for chemsex – using drugs as part of your sex life – like ketamine, erectile dysfunction drugs, etc. and latest substance of abuse such as designer drugs,” said Dr Sumit Aggarwal, Scientist and Program Officer at ICMR, who is also one of the authors of the study.

    He said these CHMs were also not aware of the complex health issues associated with SSU, as its daily use leads to violent behaviour, paranoia, hallucinations and confusion.

    “Drug users combine two-three drugs not only to get high but to increase their sexual capacity,” Dr Aggarwal told The New Indian Express.

    He added that erectile dysfunction drugs, ketamine, and gamma-butyrolactone (GBL) are commonly used during chemsex.

    It was found that there was a lack of knowledge among CHMs – working in community-led developmental programmes in Punjab, Gujarat, West Bengal, Delhi and Hyderabad – about online sources for SSU.

    Chemsex is considered a subset of SSU, commonly defined as the use of specific drugs (methamphetamine, mephedrone, gamma-hydroxybutyrate (GHB/GBL), ketamine and cocaine) before or during sexual intercourse, said the study.

    Dr Aggarwal said many drug users – who procured these drugs from medical shops and other places, including at sex parties – turned to SSU because of peer pressure.

    Many also took it to relieve stress, anxiety, and grief, for sexual pleasure, to counteract any guilt, to increase the emotional bond with sex partners, or even to overcome a lack of confidence and even to overcome inhibition for sex work.

    Not only that, craving and dependence on substance abuse caused most users to lose their jobs, leading to financial problems, which further pushed them to illegal activities, including smuggling, theft, and sex work, for quick cash to buy drugs, Dr Aggarwal added.

    The study, published in Brain Sciences, an international, peer-reviewed, open-access journal on neuroscience, was conducted with the aim to assess the knowledge gaps regarding SSU among CHMs. For that, in-depth interviews were conducted with 19 CHMs, the majority being men, followed by transgender.

    ALSO READ | Treat us with dignity, say sex workers

    They were also assessed for their knowledge of HIV, infection prevention, and complex health issues associated with SSU.

    It has been found that chemsex is common among homosexuals, bisexuals, and MSM, who frequently engage in SSU/chemsex because they believe that psychoactive chemicals may boost arousal and stamina, enabling prolonged sex sessions with one or multiple partners.

    Apart from financial problems, these drug users’ relationships with their parents, spouses, and friends suffered due to a lack of concentration. Many users who took it by injecting, sniffing, sublingual and smoking accepted they tried to get rid of the problem and even visited ‘ojhas,’ (a charmer or a wizard).

    Additionally, SSU is also known to have a role in survival sex practices, which includes the selling of sex for subsistence needs such as shelter, food, drugs, or money.

  • Monkeypox remains global health emergency: WHO

    Express News Service

    NEW DELHI: The World Health Organisation (WHO) has said that monkeypox, the zoonotic viral disease, which has been reported in over 100 countries, including India, is still a global health emergency of concern.

    The WHO announcement came at its third meeting of the International Health Regulations (2005) (IHR) Emergency Committee regarding the multi-country viral disease outbreak.  The WHO labels public health emergency of international concern (PHEIC) to convey a coordinated global response in not only collaboration on sharing vaccines and treatments but also in unlocking funds.

    According to Dr Pargya Yadav, a top scientist at the National Institute of Virology, Pune (NIV)-Indian Council of Medical Research (ICMR), India is fully prepared and has already trained Viral Research and Diagnostic Laboratories (VRDL) facilities to screen samples for monkeypox.

    In India, 20 monkeypox cases, including one death, have been reported. While Kerala reported six cases – all had travelled from UAE – including the youth who died, Delhi reported the maximum number with 14 monkeypox cases.

    “In this situation when monkeypox virus is showing mutation, it is important to keep monitoring and do the testing and sequencing for suspected cases,” Dr Yadav, who has been successful in isolating the monkeypox virus from the clinical specimen of a patient, paving the way for the development of diagnostic kits and vaccines against the disease, said on WHO continuing to declare monkeypox as a global health emergency. 

    Dr Yadav, who headed the team that developed Covaxin, India’s first indigenous Covid-19 vaccine, said Covid had taught us to be vigilant during an outbreak till we are sure about the endgame of the disease.

    Globally, there have been 77,092 cases in 106 countries as of October 31, while 36 deaths have been reported. 

    “The Emergency Committee acknowledged that some progress has been made in the global response to the multi-country outbreak of monkeypox since the last meeting, including the emerging information on the effectiveness of behavioural interventions and vaccines,” the WHO said.

    WHO Director-General, Dr Tedros Adhanom Ghebreyesus, said there had been a promising decline in global cases. “The number of reported cases has dropped for eight straight weeks. This is very encouraging.”

    ALSO READ | ‘Vax paucity led to Monkeypox surge’: Researchers from ICMI

    Though in the meeting some progress was acknowledged, it was felt Public Health Emergency of International Concern should continue.

    In July, the WHO said the rapidly spreading monkeypox outbreak represented a global health emergency.

    Since early May 2022, cases of monkeypox have been reported in countries where the disease is not endemic and continue to be registered in several endemic countries. 

    Most confirmed cases with travel history reported travel to countries in Europe and North America rather than West or Central Africa, where the monkeypox virus is endemic. 

    This is the first time that many monkeypox cases and clusters have been reported concurrently in non-endemic and endemic countries in disparate geographical areas.

    Most reported cases so far have been identified through sexual health or other health services in primary or secondary healthcare facilities. They have involved mainly, but not exclusively, men who have sex with men, according to WHO.

    NEW DELHI: The World Health Organisation (WHO) has said that monkeypox, the zoonotic viral disease, which has been reported in over 100 countries, including India, is still a global health emergency of concern.

    The WHO announcement came at its third meeting of the International Health Regulations (2005) (IHR) Emergency Committee regarding the multi-country viral disease outbreak.  The WHO labels public health emergency of international concern (PHEIC) to convey a coordinated global response in not only collaboration on sharing vaccines and treatments but also in unlocking funds.

    According to Dr Pargya Yadav, a top scientist at the National Institute of Virology, Pune (NIV)-Indian Council of Medical Research (ICMR), India is fully prepared and has already trained Viral Research and Diagnostic Laboratories (VRDL) facilities to screen samples for monkeypox.

    In India, 20 monkeypox cases, including one death, have been reported. While Kerala reported six cases – all had travelled from UAE – including the youth who died, Delhi reported the maximum number with 14 monkeypox cases.

    “In this situation when monkeypox virus is showing mutation, it is important to keep monitoring and do the testing and sequencing for suspected cases,” Dr Yadav, who has been successful in isolating the monkeypox virus from the clinical specimen of a patient, paving the way for the development of diagnostic kits and vaccines against the disease, said on WHO continuing to declare monkeypox as a global health emergency. 

    Dr Yadav, who headed the team that developed Covaxin, India’s first indigenous Covid-19 vaccine, said Covid had taught us to be vigilant during an outbreak till we are sure about the endgame of the disease.

    Globally, there have been 77,092 cases in 106 countries as of October 31, while 36 deaths have been reported. 

    “The Emergency Committee acknowledged that some progress has been made in the global response to the multi-country outbreak of monkeypox since the last meeting, including the emerging information on the effectiveness of behavioural interventions and vaccines,” the WHO said.

    WHO Director-General, Dr Tedros Adhanom Ghebreyesus, said there had been a promising decline in global cases. “The number of reported cases has dropped for eight straight weeks. This is very encouraging.”

    ALSO READ | ‘Vax paucity led to Monkeypox surge’: Researchers from ICMI

    Though in the meeting some progress was acknowledged, it was felt Public Health Emergency of International Concern should continue.

    In July, the WHO said the rapidly spreading monkeypox outbreak represented a global health emergency.

    Since early May 2022, cases of monkeypox have been reported in countries where the disease is not endemic and continue to be registered in several endemic countries. 

    Most confirmed cases with travel history reported travel to countries in Europe and North America rather than West or Central Africa, where the monkeypox virus is endemic. 

    This is the first time that many monkeypox cases and clusters have been reported concurrently in non-endemic and endemic countries in disparate geographical areas.

    Most reported cases so far have been identified through sexual health or other health services in primary or secondary healthcare facilities. They have involved mainly, but not exclusively, men who have sex with men, according to WHO.

  • Dr. Rajiv Bahl appointed as ICMR Director General 

    By PTI

    NEW DELHI: Dr Rajiv Bahl was on Friday appointed as Director General of the Indian Council of Medical Research (ICMR) and Secretary of the Department of Health Research for a period of three years.

    Bahl is currently the Head of Research on Maternal, Newborn Child and Adolescent Health cum-Newborn Unit Head, Department of Maternal Newborn Child and Adolescent Health and Ageing, at the World Health Organization (WHO) in Geneva.

    “The Appointments Committee of the Cabinet has approved the appointment of Dr Rajiv Bahl to the post of Director General, ICMR-cum-Secretary Department of Health Research for a period of three years, with effect from the date of assumption of charge of the post or until further orders, whichever is earlier,” according to an order issued by the Department of Personnel and Training.

    His predecessor, Dr Balram Bhargava’s extended tenure as Director General of ICMR and Secretary of the Department of Health Research ended in July.

    Bhargava was appointed to the post on April 16, 2018 for four years.

    NEW DELHI: Dr Rajiv Bahl was on Friday appointed as Director General of the Indian Council of Medical Research (ICMR) and Secretary of the Department of Health Research for a period of three years.

    Bahl is currently the Head of Research on Maternal, Newborn Child and Adolescent Health cum-Newborn Unit Head, Department of Maternal Newborn Child and Adolescent Health and Ageing, at the World Health Organization (WHO) in Geneva.

    “The Appointments Committee of the Cabinet has approved the appointment of Dr Rajiv Bahl to the post of Director General, ICMR-cum-Secretary Department of Health Research for a period of three years, with effect from the date of assumption of charge of the post or until further orders, whichever is earlier,” according to an order issued by the Department of Personnel and Training.

    His predecessor, Dr Balram Bhargava’s extended tenure as Director General of ICMR and Secretary of the Department of Health Research ended in July.

    Bhargava was appointed to the post on April 16, 2018 for four years.

  • ICMR isolates monkeypox virus; may pave way for development of diagnostic kits, vaccines

    By PTI

    NEW DELHI: The National Institute of Virology (NIV) in Pune under ICMR has isolated monkeypox virus from the clinical specimen of a patient which can pave the way for development of diagnostic kits and vaccines against the disease, officials said on Wednesday.

    With India isolating the virus, the Indian Council of Medical Research also invited expression of interest (EOI) from experienced vaccine manufacturers, pharma companies, research and development institutions and in-vitro diagnostic (IVD) kit manufacturers for joint collaboration in development of vaccine candidate against monkeypox and diagnostic kits for the infection.

    The virus isolation enhances India’s capacity to do research and development in many other directions, Dr Pragya Yadav, a senior scientist at NIV, said. The development comes amid India reporting four cases of monkeypox — three from Kerala and one from Delhi — so far.

    “The National Institute of Virology has successfully isolated monkeypox virus from the clinical specimen of a patient which can help in the development of diagnostic kits and also vaccines in future. For smallpox live attenuated vaccine was successful for mass immunisation in the past. Similar approaches on new platforms can be tried for making vaccines. The virus isolation enhances India’s capacity to do research and development in many other directions,” Dr Yadav said.

    At present, fluid inside the lesions on the skin are being used for virus isolation as they have the highest viral titre. Dr Yadav said monkeypox virus is an enveloped double-stranded DNA virus having two distinct genetic clades — the central African (Congo Basin) clade and the west African clade.

    “The recent outbreak which has affected several countries leading to a worrisome situation is caused by the West African strain which is less severe than Congo lineage reported earlier. The cases reported in India are also of the less severe West African lineage,” she told PTI.

    The EOI documents states that ICMR is willing to make available monkeypox Virus strain/isolates for undertaking research and development validation as well as manufacturing activities using characterized isolates of monkeypox virus under the joint collaboration in the public-private partnership mode for development of vaccine candidate against monkeypox disease and diagnostic kits for diagnosis of the infection.

    “The ICMR is in possession of characterised monkeypox virus isolates/strain and is thereby willing to collaborate with experienced vaccine manufacturers as well as the in-vitro diagnostics (IVD) manufacturers on Royalty basis on fixed term contract condition for undertaking R&D and manufacturing activities for Joint development and validation of 5 potential vaccine candidate against monkeypox disease, development of diagnostic kit (IVD), for detection of the monkeypox virus leading to product development,” the EOI document said.

    “The firm(s)/organisation(s) would be granted rights to undertake further R&D, manufacture, sell, and commercialise the end product(s) ‘vaccine candidate/IVD’ against the Monkeypox disease under defined Agreement,” the document said.

    ICMR reserves all the Intellectual Property Rights and Commercialisation rights on the Monkeypox virus isolates and its method/ protocols for purification, propagation and characterisation, the EOI document stated.

    The World Health Organisation (WHO) on Saturday declared monkeypox a global public health emergency of international concern.

    Globally, over 16,000 cases of monkeypox have been reported from 75 countries and there have been five deaths so far.

    According to WHO, monkeypox is a viral zoonosis, a virus transmitted to humans from animals, with symptoms similar to smallpox although clinically less severe. Monkeypox typically manifests itself with fever, rash and swollen lymph nodes and may lead to a range of medical complications. It is usually a self-limited disease with symptoms lasting for two to four weeks.

    The ‘Guidelines on Management of Monkeypox Disease’ issued by the Centre, stated that human-to-human transmission occurs primarily through large respiratory droplets generally requiring prolonged close contact. It can also be transmitted through direct contact with body fluids or lesions, and indirect contact with lesion material such as through contaminated clothing or linen of an infected person.

    Animal-to-human transmission may occur by bite or scratch of infected animals or through bush meat preparation. The incubation period is usually from six to 13 days and the case fatality rate of monkeypox has historically ranged up to 11 per cent in the general population and higher among children.

    In recent times, the case fatality rate has been around three to six per cent.

    The symptoms include lesions which usually begin within one to three days from the onset of fever, lasting for around two to four weeks and are often described as painful until the healing phase when they become itchy. A notable predilection for palm and soles is characteristic of monkeypox, the guidelines stated.

    NEW DELHI: The National Institute of Virology (NIV) in Pune under ICMR has isolated monkeypox virus from the clinical specimen of a patient which can pave the way for development of diagnostic kits and vaccines against the disease, officials said on Wednesday.

    With India isolating the virus, the Indian Council of Medical Research also invited expression of interest (EOI) from experienced vaccine manufacturers, pharma companies, research and development institutions and in-vitro diagnostic (IVD) kit manufacturers for joint collaboration in development of vaccine candidate against monkeypox and diagnostic kits for the infection.

    The virus isolation enhances India’s capacity to do research and development in many other directions, Dr Pragya Yadav, a senior scientist at NIV, said. The development comes amid India reporting four cases of monkeypox — three from Kerala and one from Delhi — so far.

    “The National Institute of Virology has successfully isolated monkeypox virus from the clinical specimen of a patient which can help in the development of diagnostic kits and also vaccines in future. For smallpox live attenuated vaccine was successful for mass immunisation in the past. Similar approaches on new platforms can be tried for making vaccines. The virus isolation enhances India’s capacity to do research and development in many other directions,” Dr Yadav said.

    At present, fluid inside the lesions on the skin are being used for virus isolation as they have the highest viral titre. Dr Yadav said monkeypox virus is an enveloped double-stranded DNA virus having two distinct genetic clades — the central African (Congo Basin) clade and the west African clade.

    “The recent outbreak which has affected several countries leading to a worrisome situation is caused by the West African strain which is less severe than Congo lineage reported earlier. The cases reported in India are also of the less severe West African lineage,” she told PTI.

    The EOI documents states that ICMR is willing to make available monkeypox Virus strain/isolates for undertaking research and development validation as well as manufacturing activities using characterized isolates of monkeypox virus under the joint collaboration in the public-private partnership mode for development of vaccine candidate against monkeypox disease and diagnostic kits for diagnosis of the infection.

    “The ICMR is in possession of characterised monkeypox virus isolates/strain and is thereby willing to collaborate with experienced vaccine manufacturers as well as the in-vitro diagnostics (IVD) manufacturers on Royalty basis on fixed term contract condition for undertaking R&D and manufacturing activities for Joint development and validation of 5 potential vaccine candidate against monkeypox disease, development of diagnostic kit (IVD), for detection of the monkeypox virus leading to product development,” the EOI document said.

    “The firm(s)/organisation(s) would be granted rights to undertake further R&D, manufacture, sell, and commercialise the end product(s) ‘vaccine candidate/IVD’ against the Monkeypox disease under defined Agreement,” the document said.

    ICMR reserves all the Intellectual Property Rights and Commercialisation rights on the Monkeypox virus isolates and its method/ protocols for purification, propagation and characterisation, the EOI document stated.

    The World Health Organisation (WHO) on Saturday declared monkeypox a global public health emergency of international concern.

    Globally, over 16,000 cases of monkeypox have been reported from 75 countries and there have been five deaths so far.

    According to WHO, monkeypox is a viral zoonosis, a virus transmitted to humans from animals, with symptoms similar to smallpox although clinically less severe. Monkeypox typically manifests itself with fever, rash and swollen lymph nodes and may lead to a range of medical complications. It is usually a self-limited disease with symptoms lasting for two to four weeks.

    The ‘Guidelines on Management of Monkeypox Disease’ issued by the Centre, stated that human-to-human transmission occurs primarily through large respiratory droplets generally requiring prolonged close contact. It can also be transmitted through direct contact with body fluids or lesions, and indirect contact with lesion material such as through contaminated clothing or linen of an infected person.

    Animal-to-human transmission may occur by bite or scratch of infected animals or through bush meat preparation. The incubation period is usually from six to 13 days and the case fatality rate of monkeypox has historically ranged up to 11 per cent in the general population and higher among children.

    In recent times, the case fatality rate has been around three to six per cent.

    The symptoms include lesions which usually begin within one to three days from the onset of fever, lasting for around two to four weeks and are often described as painful until the healing phase when they become itchy. A notable predilection for palm and soles is characteristic of monkeypox, the guidelines stated.

  • Covaxin booster safe, necessary as it ensures persistent immunity: ICMR study

    By Express News Service

    NEW DELHI: The Covaxin booster dose is safe and necessary as it ensures persistent immunity that minimises breakthrough Covid infections, said a new Indian Council of Medical Research (ICMR) study.

    Published in the Nature – Scientific Reports Journal, the study said no serious adverse events were observed, except pain at the injection site, itching and redness.

    With the government pushing for precaution doses in the country, as only eight per cent of the population in the over 18 years of age group has taken booster doses, the study said it is well known that neutralising antibodies induced by Covid-19 vaccines wane within six months of vaccination leading to questions on the effectiveness of the two-dose vaccination against breakthrough infections.

    The study said that the administration of the third dose of BBV152 increased neutralisation titers against both homologous (D614G) and heterologous strains (Alpha, Beta, Delta, Delta Plus and Omicron) with a slight increase in B cell memory responses.

    The study said that a booster dose of Covaxin, India’s indigenous Covid-19 vaccine developed by Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV), showed an 18.5-fold increase in neutralisation antibody titers against the Omicron variant, as compared with the non-booster does recipient.

    ALSO READ | Covid vaccine protects people of all body weights: Lancet

    “Thus, seroconversion rate remains high in boosted recipients compared to non-booster, even after six months, third post dose against variants,” said Dr Pragya Yadav, one of the authors of the study, ‘persistence of immunity and impact of the third dose of inactivated Covid‐19 vaccine against emerging variants’.

    Seroconversion rates are one of the methods used for determining the efficacy of a vaccine. “Hence, these results indicate that a booster dose of BBV152 is safe and necessary to ensure persistent immunity to minimise breakthrough infections of COVID-19 due to newly emerging variants,” the study added.

    The report said that, in addition, sera collected after six months post a third dose was also evaluated for neutralisation efficiency. Results showed that Covaxin generated higher neutralisation efficiency against D614G, Delta and Omicron variants, and the antibody titers are persistent even after 12 months of primary vaccination.

    Yadav, a top scientist at ICMR-NIV who was also awarded for her work on vaccine development, said that the emergence of SARS-CoV-2 variants of concern had raised questions about the durability of the neutralising antibody responses.

    “Diminished vaccine effectiveness against variants of concern such as Alpha, Beta, Delta and Omicron has been reported for several authorised vaccines with two doses of vaccination,” she said.

    Understanding the persistence of neutralising antibody responses against variants of concern has become vital to assess the need for additional booster doses, said the lead author, Krishna Mohan Vadrevu, director with Bharat Biotech International Limited (BBIL).

    The researchers assessed the persistence of immunogenicity up to six months after two or three doses of Covaxin and the safety of a booster dose in an ongoing phase 2, double-blind, randomised controlled trial.

    For the booster dose trial, around 184 from the parent study were re-enrolled to receive the preventive dose or placebo.

    A decline in antibody levels after the second dose of Covaxin was found.

    However, more than 75 per cent of participants who followed up six months after the amount still had detectable neutralising antibody responses to the homologous SARS-CoV2 strain D614G, the study said

    NEW DELHI: The Covaxin booster dose is safe and necessary as it ensures persistent immunity that minimises breakthrough Covid infections, said a new Indian Council of Medical Research (ICMR) study.

    Published in the Nature – Scientific Reports Journal, the study said no serious adverse events were observed, except pain at the injection site, itching and redness.

    With the government pushing for precaution doses in the country, as only eight per cent of the population in the over 18 years of age group has taken booster doses, the study said it is well known that neutralising antibodies induced by Covid-19 vaccines wane within six months of vaccination leading to questions on the effectiveness of the two-dose vaccination against breakthrough infections.

    The study said that the administration of the third dose of BBV152 increased neutralisation titers against both homologous (D614G) and heterologous strains (Alpha, Beta, Delta, Delta Plus and Omicron) with a slight increase in B cell memory responses.

    The study said that a booster dose of Covaxin, India’s indigenous Covid-19 vaccine developed by Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV), showed an 18.5-fold increase in neutralisation antibody titers against the Omicron variant, as compared with the non-booster does recipient.

    ALSO READ | Covid vaccine protects people of all body weights: Lancet

    “Thus, seroconversion rate remains high in boosted recipients compared to non-booster, even after six months, third post dose against variants,” said Dr Pragya Yadav, one of the authors of the study, ‘persistence of immunity and impact of the third dose of inactivated Covid‐19 vaccine against emerging variants’.

    Seroconversion rates are one of the methods used for determining the efficacy of a vaccine. “Hence, these results indicate that a booster dose of BBV152 is safe and necessary to ensure persistent immunity to minimise breakthrough infections of COVID-19 due to newly emerging variants,” the study added.

    The report said that, in addition, sera collected after six months post a third dose was also evaluated for neutralisation efficiency. Results showed that Covaxin generated higher neutralisation efficiency against D614G, Delta and Omicron variants, and the antibody titers are persistent even after 12 months of primary vaccination.

    Yadav, a top scientist at ICMR-NIV who was also awarded for her work on vaccine development, said that the emergence of SARS-CoV-2 variants of concern had raised questions about the durability of the neutralising antibody responses.

    “Diminished vaccine effectiveness against variants of concern such as Alpha, Beta, Delta and Omicron has been reported for several authorised vaccines with two doses of vaccination,” she said.

    Understanding the persistence of neutralising antibody responses against variants of concern has become vital to assess the need for additional booster doses, said the lead author, Krishna Mohan Vadrevu, director with Bharat Biotech International Limited (BBIL).

    The researchers assessed the persistence of immunogenicity up to six months after two or three doses of Covaxin and the safety of a booster dose in an ongoing phase 2, double-blind, randomised controlled trial.

    For the booster dose trial, around 184 from the parent study were re-enrolled to receive the preventive dose or placebo.

    A decline in antibody levels after the second dose of Covaxin was found.

    However, more than 75 per cent of participants who followed up six months after the amount still had detectable neutralising antibody responses to the homologous SARS-CoV2 strain D614G, the study said