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SOP number: ICMR-NIV/2019-nCoV/Specimens_01
Prepared by: Dr. Y.K. Gurav Reviewed by: Dr. V. Potdar Approved by: Dr. P. Abraham
Date: 19/01/2020 Date: 20/01/2020 Date: 20/01/2020
COVAXINTM, India's indigenous COVID-19 vaccine by Bharat Biotech is developed in collaboration with the Indian Council of Medical Research (ICMR) - Nation... Institute of Virology (NIV). The indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) high containment facility.
The vaccine received DCGI approval for Phase I & II Human Clinical Trials and the trials commenced across India from July, 2020.
After successful completion of the interim analysis from the Phase 1 & 2 clinical trials of COVAXINTM, Bharat Biotech received DCGI approval for Phase 3 clinical trials in 26,000 participants in over 25 centres across India.
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 ... 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.
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 purpos...
British Journal of Medicine & Medical Research
11(4): 1-6, 2016, Article no.BJMMR.21444
ISSN: 2231-0614, NLM ID: 101570965
Published 27th September 2015
Combination file of all the documents related to the national guidelines for accreditation, supervision and regulation of ART clinics in India. Documents included:
... 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
Reliable cause specic mortality statistics are the cornerstone of national health information
systems. They are essential for evidence-based decision making ... monitoring health of
populations, health services planning and delivery, programme implementation, policy development
and epidemiological research.
These Guidelines are intended to provide knowledge to the treating ophthalmologists, pediatricians, ocular oncologists, pediatric oncologists, and general physicians to arrive at an early diagnosis of retinoblastoma in the settings of district hospital, in private clinics and hospitals. The guidelin...
These guidelines will assist the ICMR institutions/ centers/ Hqrs. by providing information on the policies, principles and approaches which should be followed in carrying out procurement of goods and services at their respective institute/ center/ ...
The main objective of these guidelines is to provide guidance on up-to-date, uniform, evidence-informed practices for suspecting, diagnosing and managing various forms of extra-pulmonary tuberculosis (EPTB) at all levels of healthcare delivery. They...
