These guidelines have been developed for scientific purpose with the main aim to guide the regulatory authority for evaluating probiotic products in our country.
The guidelines reiterate that the general principles of ethics for biomedical research involving human participants shall also be applicable. In addition, the guidelines specify unique provisions for stem cells, because of their inherent property for unlimited proliferation, differentiation to cells... of the germ layers, oncogenic potential, unrecognised toxicities and possible involvement in pre-implantation stages of human development. The guideline therefore focuses on: 1. Monitoring mechanism and regulatory pathway for basic, clinical research and product development based on categories of research and level of manipulation. 2. Procurement of gametes, embryos and somatic cells for derivation and propagation of any stem cell lines, their banking and distribution. 3. Other important areas like international collaboration, exchange of cell/lines and education for stakeholders and advertisement.
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Original text from 2008, updated in 2012. This document marks the beginning of a structured approach to safety assessment of GE foods, which are yet to be approved in our country. It is understood that many changes will become necessary and will be incorporated as we progress. This document will ho...wever, remain an important milestone in the process towards safety evaluation of food derived from GE plants in India.
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These guidelines have been developed specifically to address ethical issues of conducting research in children.
These guidelines are applicable to all biomedical, social and behavioural science research for health conducted in India involving human participants, their biological material and data.
The purpose of such research should be: i. directed towards enhancing knowledge about the human condition while ...maintaining sensitivity to the Indian cultural, social and natural environment; ii. conducted under conditions such that no person or persons become mere means for the betterment of others and that human beings who are participating in any biomedical and/or health research or scientific experimentation are dealt with in a manner conducive to and consistent with their dignity and well-being, under conditions of professional fair treatment and transparency; and iii. subjected to a regime of evaluation at all stages of the research, such as design, conduct and reporting of the results thereof.
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Combination file of all the documents related to the national guidelines for accreditation, supervision and regulation of ART clinics in India. Documents included:
National Guidelines for Accreditation, Supervision & Regulation of ART Clinics in India | Preliminary Pages | Corrigendum | Chapter 1 ...- Introduction, Brief history of ART and Requirement of ART Clinics | Chapter 2 - Screening of Patients for ART - Selection Criteria and Possible Complications | Chapter 3 - Code of Practice, Ethical Considerations and Legal Issues | Chapter 4 - Sample Consent Forms | Chapter 5 - Training | Chapter 6 - Future Research Prospects | Chapter 7 - Providing ART Services to the Economically Weaker Sections of the Society | Chapter 8 - Establishing a National Database for Human Infertility | Chapter 9 - Composition of the National Accreditation Committee | Bibliography
| Members of the Expert Group for Formulating the National Guidelines for Accredation, Supervision and Regulation of ART Clinics
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Antibiotics use with care
The infectious disease burden in India is among the highest in the world. A large amount of antibiot-ics are consumed in fighting infections, some of them saving lives, but every use adding to antibiotic resistance in bacteria. Antibiotic use is increasing steadily (table 1), particularly ... certain antibiotic classes (beta-lactam antibacterials), most notably in the more prosperous states. Resistance follows in lock-step.
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India is experiencing rapid demographic and epidemiological transitions with NCDs causing significant disability, morbidity and mortality both in urban and rural populations and across all socioeconomic strata. According to the ICMR State Level Disease Burden Initiative, in 2016, NCDs accounted to a...n estimated 6.0 million deaths, constituting 62% of the total mortality of that year.
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The intent of these guidelines is to develop a holistic, coordinated, proactive and technology driven strategy for management of biological disasters through a culture of prevention, mitigation and preparedness to generate a prompt and effective response in the event of an emergency. Th...e document contains comprehensive guidelines for preparedness activities, biosafety and biosecurity measures, capacity development, specialised health care and laboratory facilities, strengthening of the existing legislative/
regulatory framework, mental health support, response, rehabilitation and recovery, etc. It specifically lays down the approach for implementation of the guidelines by the central ministries/departments, states, districts and other stakeholders, in a time bound manner.
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The Global guidance framework for the responsible use of the life sciences: mitigating biorisks and governing dual-use research (the framework) aims to provide values and principles, tools and mechanisms to support Member States and key stakeholders to mitigate and prevent biorisks and govern dual-u...se research.
The framework adopts the One health approach and focuses on the role that responsible life sciences research can play in preventing and mitigating risks caused by accidents, inadvertent or deliberate misuse with the intention to cause harm to humans, nonhuman animals, plants and agriculture, and the environment.
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SOP- Quality Assurance of Malaria Diagnostic Tests
The National Strategic Plan for HIV/AIDS and STIs 2017-2024 spells out the objectives and targets that we have jointly committed to achieve. The plan describes the strategies and activities that will need to be implemented on the ground across India's 36 States and Union Territories with the help of... AIDS Control Societies, District AIDS Prevention and Control Units, Regional Institutes, communities, development partners and the private sector. We must urgently scale up our efforts to avert new HIV infections and provide care and treatment to people living with HIV to materialise our commitment of ending AIDS in India by 2030.
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Previous advocacy efforts have achieved tangible goals in terms garnering political commitments
to increase financing for TB—as seen at the 2018 UN High-Level Meeting on TB. The challenge
now is to ensure that these commitments are actually met within a global biomedical research
ecosystem that... is designed and incentivized to prioritize the health needs of wealthy populations
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