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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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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These guidelines have been developed specifically to address ethical issues of conducting research in children.
In order to streamline and effectively control compounding of medicinal products in hospitals and pharmacies, these Guidelines for Production of Extemporaneous and Hospital Based Sterile Preparations has been crafted. The purpose of these guidelines therefore is to assist pharmacists in ...discharging their legal and professional obligations to patients in the area of extemporaneous dispensing. This guidance will help to assure the safe and appropriate preparation and supply of extemporaneously prepared medicinal products to patients, where
the supply of such products is necessary.
Extemporaneous and hospital based sterile preparations are critical for patients whose clinical needs cannot be met by registered medicinal products. The guidelines outline the principles and application of the concepts of Good Manufacturing Practice (GMP) requirements for premises, equipment, personnel, storage, quality management system, quality control, compounding processes as well as documentation.
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Manual on Hospital Infection Control Guidelines prepared by the Indian Council of Medical Research Antimicrobial Stewardship Program. The document covers the basic principles of infection control, role of heath care workers, bio-waste management and elaborates on the steps to be followed for setting... up of an effective infection control in hospitals.
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Claims for refugee status related to situations of armed conflict and violence under Article 1A(2) of the 1951 Convention and/or 1967 Protocol relating to the Status of Refugees and the regional refugee definitions
UNHCR issues these Guidelines on International Protection pursuant to its mandate,... as contained in, inter alia, the Statute of the Office of the United Nations High Commissioner for Refugees, namely paragraph 8(a), in conjunction with Article 35 of the 1951 Convention relating to the Status of Refugees, Article II of its 1967 Protocol, Article VIII(1) of the 1969 OAU Convention Governing the Specific Aspects of Refugee Problems in Africa, and Commitment II(e) of the 1984 Cartagena Declaration on Refugees.
These Guidelines clarify paragraph 164 of the UNHCR Handbook on Procedures and Criteria for Determining Refugee Status under the 1951 Convention and otherwise complement the Handbook. They are to be read in conjunction with UNHCR’s other Guidelines on International Protection.
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This new edition and fully updated publication replaces the 2012 UCG and is being circulated free of charge to all public and private sector prescribers, pharmacists, and regulatory authorities in the country
Document No. : FDA/SMC/SMD/GL-RAR/2013/01