Day 3 :
- Track 5: Good Clinical Practices & Good Laboratory PracticesTrack 10: Storage, Distribution, Transportation
Session Introduction
Prakash V Diwan
Anurag Group of institutions, India
Title: Good laboratory Practices:A wake up call for pharmaceutical industries
Biography:
Prakash V Diwan, male Pharmacologist, obtained his PhD from Post Graduate Institute of Medical Education and Research, India in 1980. He served as Assistant Professor in J N Medical College, India and later joined the research and development organization, Indian Institute of Chemical Technology (CSIR) in 1983-2007. He was nominated as the Founder Director, NIPER, Hyderabad in the year 2007. He was awarded with many national awards in the field of pharmacology. He is a Fellow of Royal Society of London (FRSC). To his credit, he has over 200 research publication in national and international journals with an H index 36.00. He has been honoured as a Fellow of Indian Pharmacological Society and Fellow of Andhra Pradesh Academy of Sciences and Fellow of Indian Pharmaceutical association. He has been a Member in Indian Pharmacopeia Commission, Scientific Consultant for various reputed pharmaceutical industries. His contributions are in the field of pharmacology, nanotechnology, clinical researches are laudable. Presently, he holds the responsible positions as Director and Research Scientist in Academia & Research and Development Institutions. He is also a Visiting Scientist at Dr Prabhakar Kore Basic Science Research Center, Belgaum, Karnataka. He has delivered guest lectures and keynote addresses in India and abroad on various challenging areas.
Abstract:
The globe is marching towards perfection. Basically, GLP is a regulation not a guideline. Industry needs greater performance with minimum investments, which is possible only if you adopt GLP. Consumer focuses on and expects quality for a good price. The thalidomide tragedy has opened the new vision for the regulations and has cautioned the world, the extent of toxicity by the drugs. The objective of “Good Laboratory Practice” (GLP) was brought to prevent such a disasters and also poor planning and execution and manipulation of the raw data as manipulation would promote or accelerate approval. GLP aims at: • Securing efforts to generate high quality and reliable data pertaining to protection of man and the environment against various sorts of chemicals and without prejudice against explanation and evaluation of study’s results, • Mutual acceptance of data (MAD) of studies among countries so as to reduce a number of animal tests and trim costs. Good Laboratory Practice (GLP) is a quality system laying down organization, procedures and requirements to plan, implement, document, archive and transfer of non-clinical studies and their results. GLP principles have been developed in the framework of OECD. GLP is the corner stone of the laboratory based activities in any organization. It is not a luxury but essential for the professional laboratories. The GLP assures the quality and integrity and experiments done under GLP are acceptable to countries covered under OECD memberships worldwide. It has the standard operating procedure which is the brain behind the performance which makes it as a system based and not individual based performance. The GLP is a team work consisting of Management, Study Directors, Performer, Quality manager, Archivist and their jobs are well defined. The Study Director is a blue-eyed boy of the management and holds the key of GLP. The management provides resources, Study Director performs and quality assurance units assures the quality and integrity of the study and Archivist preserves the all materials such as study plans, training records, amendments , deviations samples, raw data, etc., in his custody. The documentation is of prime importance. If not documented meaning is not done. There no dearth to prove excellence and meaning well planned is well executed to the satisfaction of sponsor. We need to answer the following: • Do we need GLP? • Can we achieve excellence? • Can we guarantee quality and integrity? • Is it a luxury? • Does it involve risk? • Are there any disadvantages? • GLP is obviously so crucial to modern laboratory operations, but most importantly because good laboratory practice is an essential ingredient for any professional scientist.
Pooja Roy
Vydehi Institute of Medical Sciences and Research Centre, India
Title: Good clinical Practice (GCP) and Declaration of Helsinki
Time : 14:00-14:25
Biography:
Pooja Roy completed her MBBS from Dr B R Ambedkar Medical College, Bangalore and her MD in Pharmacology from Vydehi Institute of Medical Sciences, Bangalore. Currently she is working as an Assistant Professor in Bangalore. She takes active interest in all spheres of the subject and is actively involved in teaching medical students and has several oral papers and poster presentations to her credit.
Abstract:
The concept of ‘good physician’ is evident by the Hippocratic Oath (460 BC). In the United States, the first landmark in the regulation of drugs was the Food and Drugs Act of 1906. In 1947, the Nuremberg Code was created as a result of the unethical and horrific experiments carried out during World War II at Nazi war camps by German physicians. However, since 1964, the Declaration of Helsinki has stood as one of the world’s most authoritative statements on ethical standards for human research. The Declaration has undergone six major revisions, most recently in October, 2008. For many years the USFDA has required that foreign clinical studies supporting applications for drug licensure comply with the Declaration. However, on Oct 27, 2008, the FDA formally discontinued its reliance on the Declaration and substituted the International Conference on Harmonization’s Guideline for Good Clinical Practice (GCP). Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, and monitoring, auditing, recording, analyses and reporting of clinical trials. GCP provides assurance that the data and reported results are credible and accurate, and that the rights, integrity and confidentiality of trial subjects are respected and protected. However, several authors have criticized GCP and compared between GCP and the Declaration of Helsinki from time to time. It has been put forward that at a time when the volume of overseas trials is increasing, the FDA’s new policy is troubling. Several requirements in latest revision of Declaration of Helsinki have been highlighted which are absent in GCP.
- Young Researchers Forum(YRF)
Session Introduction
Mohidurakshan
Sher-I-Kashmir Institute of Medical Sciences, India
Title: Studies on β-CD complexation of a poorly soluble drug
Time : 11:15-11:35
Biography:
Mohidurakshan is working as a Pharmacist in one of the leading tertiary care hospital of Northern India (Sheri-Kashmir Institute of Medical Sciences, Soura Srinagar). She has fifteen years of experience as a Pharmacist in the said organization. She completed Master’s degree in Pharmaceutics from University of Kashmir with distinction and received merit scholarship and a gold medal. She attended conferences and workshops, has a few publications in hand and is a Freelancer for Pharmaliterati.
Abstract:
Clarithromycin is an oral macrolide antibiotic similar to erythromycin and azithromycin. Clarithromycin penetrates lung tissues and macrophages to a greater degree compared to erythromycin. Clarithromycin is a derivative of erythromycin and it has a methoxy group attached to C6 position of erythromycin. This derivatisation makes clarithromycin more stable towards acid than erythromycin. However, the main problem related with clarithromycin is its practical insolubility in water. Moreover, another problem encountered with clarithromycin is that it is a relatively weak UV absorbing compound as it lacks suitable chromophoric group, hence, absorbance measurements will be unreliable. Here in this study β-CD was chosen for the complexation of clarithromycin to increase its solubility characteristics. Preparation of inclusion complexes of clarithromycin was done using kneading, co-solvent evaporation and solvent blend technique in different ratios. Phase solubility and saturation solubility studies of prepared inclusion complexes were done. The phase solubility behavior of clarithromycin in various concentrations of β-CD was obtained. The inclusion complexes were characterized and their drug CD interactions were studied by means of FTIR, UV and SEM analysis. Dissolution study of different formulations was performed using USP type II dissolution apparatus and the drug content was assayed spectrophotometrically in visible range of UV. Both the solubility and dissolution rate of the drug in these formulations was found to be increased. Drug contents were determined by UV spectrophotometry in visible range.
Khalid Bashir Mir
The University of Kashmir, India
Title: Solubility and dissolution rate enhancement of Aceclofenac by solid dispersion technique
Time : 11:35-11:55
Biography:
Khalid Bashir Mir is pursuing his Ph.D. in Novel Drug Delivery Division (NDDD) at Department of Pharmaceutical Sciences, University of kashmir. He has passed his Masters in Pharmaceutical Sciences with distinction and merit scholarship and a gold medal from university of kashmir for being the 1st Rank holder in M.Pharm. He has attended many congresses, seminars, workshops and communicated his research workings.
Abstract:
The aim of this study is to change the solubility of poorly- water soluble, BCS Class-II drug Aceclofenac via SD technique. Aceclofenac is a non-steroidal anti-inflammatory drug (NSAID) having both anti-rheumatic, anti-inflammatory and analgesic actions. But, one major problem associated with this drug is its poor solubility in biological fluids, which results into low bioavailability after oral administration. The present objective undertaken was achieved by the formulation of solid dispersions of Aceclofenac with various hydrophilic polymers/carriers (like Urea, Mannitol, PEG-4000 and PEG-6000) in different ratios (like 1:1, 1:2 & 1:3) by solvent evaporation method. The saturation solubility profile of formulated SDs and pure drug was done and 4 formulations like FAC-III, FAC-VI, FAC-IX, FAC-XII, out of total 12 formulations showed good solubility profile and out of these 4 formulations, only FAC-IX ( 1:3 drug:urea) showed highest in-vitro dissolution rate carried out in USP Type II Disssolution Apparatus and maximum drug release of 79.3% within 3 hours study was observed in comparison to 31.2% of drug release within 3 hours from marketed immediate release tablet in phosphate buffer (pH 7.4). The pure drug and formulated SDs were charaterized by FTIR, SEM for drug interaction and surface morphology respectively. The selected formulations were evaluated for drug content, wetting time etc.
Firoj A Tamboli
Bharati Vidyapeeth College of Pharmacy, India
Title: Good manufacturing practice (GMP): An overview
Time : 11:55-12:15
Biography:
Firoj A Tamboli is pursuing PhD in Pharmacy from Shivaji University, Kolhapur. He is working as Assistant Professor at Bharati Vidyapeeth College of Pharmacy, Kolhapur. He has more than 15 years of teaching and research experience. He has published number of papers in reputed national and international journals and has been Member of APTI.
Abstract:
Good Manufacturing Practice (GMP) is a set of regulations, codes, and guidelines for the manufacture of drug substances and drug products, medical devices, in vivo and in vitro diagnostic products, and foods. The term GMP is recognized worldwide for the control and management of manufacturing and quality control testing of pharmaceutical products. GMPs is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the Marketing Authorization or product specification. GMP is concerned with both production and quality control. Both industry and regulatory practices will need to be informed by the best techniques of risk assessment and management. “Pharmaceutical cGMPs for the 21st Century” is intended to jump-start progress into this future. The last few years has seen the FDA steer industry further in the direction of a Quality-by-Design (QbD) approach, and away from the Quality-by-Testing (QbT) approach traditionally taken by the pharmaceuticals sector. This move has largely been lauded by business as a sensible move likely to ensure consistent quality of the end product. Quality objective can be achieved only through careful planning and implementation of QA system and practical implementation of GMP. The effective implementation of GMP requires extensive care and knowledge about the different components of GMP that should be incorporated form the inception of the manufacturing building and product development till the production.
Kalaiyarasi Duraisamy
JNTU Hyderabad, India
Title: A validated UPLC/ESI-MS/MS bioanalytical method for the quantification of Perindopril and Amlodipine in human plasma
Time : 12:15-12:35
Biography:
Kalaiyarasi Duraisamy has completed her M.Pharmacy from The Tamilnadu Dr.MGR Medical University and pursuing part time Ph.D., in JNTU, Hyderabad. She is working in a biopharmaceutical company and having more than 5 years research experience in analytical R&D.
Abstract:
BACKGROUND: In the present study, a validated UPLC/ESI-MS/MS method for the determination of combined dosage form of perindopril and amlodipine in human plasma sample was optimized. This method was responsive and an adequate amount to observe the low-dosage PK studies of perindopril and amlodipine in human plasma. METHODS: Chromatographic separation was achieved on a Waters ACQUITY UPLCTM BEH C18 (100.0 mm X 2.1 mm; 1.7µm) column. UPLC analysis consisted of mobile phase A for 0.1% formic acid in MilliQ water and mobile phase B for 0.1% formic acid in acetonitrile, which was degassed. The gradient elution with flow rate at 0.3 mL min-1 of mobile phase was kept and 10 µL of sample was injected in each run. The total chromatographic run time was 5.5 min. Mass spectrometric detection was carried out in multiple reaction monitoring (MRM) mode using electrospray ion source in positive ion polarity to profile the abundances using the transitions m/z 369 → m/z 172, and m/z 409 → m/z 238 for perindopril and amlodipine respectively and the transitions m/z 612.75 → m/z 280.30 for lercanidipine as internal standard. Argon was used as the collision gas at the pressure of 3.5X10-5 Torr. In this developed method, a high recovery of perindopril and amlodipine in plasma samples was proved with improved quality data in terms of increased detection limits and chromatographic resolution with greater sensitivity. CONCLUSIONS: UPLC with MS/MS has the advantage over problems of poor chromatography, wearisome extraction steps, uncertain characterized peak and high injection load. As per FDA guidelines, the method is validated for its accuracy, robustness and reproducibility. Quantification of perindopril and amlodipine dosage forms by this method is time saving, cost effective and it can be used in clinical studies to quantify the drug content in human plasma samples.
Ibel C Fredy
PES College of Pharmacy, India
Title: Adverse Drug Reaction Reporting – A Retrospective Analysis
Time : 12:35-12:55
Biography:
Ibel C Fredy is doing his VI year Doctor of pharmacy (Pharm D) Intern from PES College of Pharmacy affiliated to Rajiv Gandhi University of Health sciences, Bangalore. He is an active research scholar. He has published over 6 research papers in international journals and been a co-author in several research articles. He is working on other research related activities.
Abstract:
INTRODUCTION: Pharmacovigilance also known as drug safety is defined as the science and activities relating to the collection, detection, assessment, monitoring and prevention of adverse effects or any other drug-related problems. The occurrence of adverse drug reaction is a price that patients have to pay for the benefits produced by modern medicine. METHODOLOGY: The study was a retrospective observational study. Each documented ADRs was assessed for its causality by using the Naranjo’s scale. The severity by modified Hartwig and Siegel scale. Preventability by modified Shamrock and Thornton scale. Results were analyzed using Microsoft Excel RESULTS: Our study showed that gender predominance occurs based on the population included under study and common age groups affected were above 40 yrs. most of the ADR’s was probable, followed possible and less of highly probable and unlikely. Adverse drug reactions reported were commonly moderate followed by mild with a few severe reactions. Majority of the reactions was not preventable followed by probably preventable with only less number of them were definitely preventable. Commonly associated drugs with ADRs were Analgesics, Cephalosporins, followed by chemotherapeutic agents and Quinolones. Retrospective analysis of ADRs reported from 2009-2015 shows significant variations in number of ADRs reported which was maximum during the active pharmacovigilance studies. CONCLUSION: This study strongly suggests that there is greater need for streamlining of hospital based ADR reporting and monitoring system to create awareness, to promote the reporting of ADRs among healthcare professionals and to encourage ADR based studies in hospital which have significant outcome in the ADR reporting.
Khwaja Amtul Raouf Qazi
MRM College of Pharmacy, India
Title: 3G system in pharmacy practice with vigilance
Time : 12:55-13:15
Biography:
Khwaja Amtul Raouf Qazi has completed her MPharmacy (Pharmacology) from Jawaharlal Nehru Technological University, Hyderabad, with a First Class with Distinction.
Abstract:
India is a hub of global clinical trials and a destination for drug discovery & development. However, whether patients in India receive safe drugs or not is still very much in question. Rapid induction of high tech pharma products in the market throw up the challenges of monitoring Adverse Drug Reaction (ADRs). The complete safety data commonly is captured through Pharmacovigilance. True challenge lies in recognizing the importance & applying current 3G system in pharmacy, i.e., Good Manufacturing Practices, Good Laboratory Practices & Good Pharmacy Practices with vigilance in order to improve public health. This article mainly highlights on Medwatch program & its goal and patient safety. It mainly focuses on adverse effect reporting & producing new safety information to patients. Medwatch is the FDA reporting system for an adverse effect, aimed to detect safety hazard signals for medical products. It deals with pre-market review and approval & post-market monitoring for safety. It also determines the benefit and limitation of clinical trials. It focuses on adverse event monitoring and new drug safety problems. Approaches like–Yellow Card Scheme for ADR reporting in the UK should also are encouraged worldwide to identifying new information about hazards associated with medicines. Even, mandatory reporting is required by manufacturer to submit the reports to the healthcare provider & post-authorization safety experience should be conducted to ensure the benefits of use of drugs. Thus, it generates a great way towards a safe medical practice.
Vineela Nekkanti
Rajiv Gandhi University of Health Sciences, India
Title: Challenges in Implementing Good Clinical Practice (GCP) Guidelines and their Mitigations
Biography:
Vineela Nekkanti has completed her Pharm.D at the age of 24 years from Rajiv Gandhi University of Health Sciences, Bengaluru. She was class topper in all the years of Pharm.D and a University Rank holder as well. She did her internship in BGS Global Hospital, Bengaluru and is further interested in pursuing MS in Clinical Research from United States. She has presented four poster presentations at National and International Conferences and published one research article in International Journal. She is also a co-founder of “Care N Share India” Trust, conducting several health related activities for underprivileged people.
Abstract:
Good Clinical Practice (GCP) is a set of guidelines for biomedical research, which encompasses the design, conduct, termination, audit, analysis, reporting and documentation of the studies involving human subjects. It primarily establishes the two main principles i.e. Protection of rights of human subjects and authenticity of biomedical data generated. After the breach of subject rights during human experiments such as Nazi war crime, Human radiation experiments and Thalidomide tragedy, these guidelines came into existence in 1996, which are ubiquitously implemented in clinical research. Though the regulatory bodies maintain stringent norms to implement these guidelines, there are many discrepancies associated with it such as lack of professional training, safety reporting, Informed Consent Document (ICD) administration and record keeping, which thereby depleting the standards of Clinical trials and authenticity of data generated. Hence to overcome such limitations, certain measures have to be taken for the proper conduct of clinical trials.
Bhusnure O G
Channabasweshwar Pharmacy College, India
Title: Zebrafish as a model system for drug target screening and validation
Time : 15:10-15:30
Biography:
Will be updated Soon
Abstract:
From ancient times to today, drug discovery transitioned from serendipity to rationality over its long history. Drugs are a physician’s most powerful weapon to combat disease. The discovery of new drug targets is the basis of new drug development and examination of new drug mechanisms. Proper drug target selection and validation are crucial to the discovery of new drugs. Zebrafish have recently entered the fray as a model animal for some human diseases. The fish are more affordable, easier to keep, and faster to raise than mammals, giving a higher-throughput system. Zebrafish being a non-mammalian, drugs can also be tested for toxicity and their potential therapeutic activity against the target more easily than in mammals. Perhaps, surprisingly, genes that cause disease in zebrafish are similar to those in humans, for example in angiogenesis, inflammation and insulin regulation. Presently, the research using zebrafish is expanding into areas such as pharmacology, clinical research as a disease model and interestingly in drug discovery. The use of zebrafish in pharmaceutical research and discovery and drug development is mainly target screening, target identification, target validation, morpholino oligonucleotide screens, assay development for drug discovery, physiology based drug discovery, Quantitative Structure-Activity Relationship (QSAR) and Structure-Activity Relationships (SAR) study and drug toxicity study. In last few years, the use of zebrafish (Danio rerio) in scientific research is growing very rapidly. Initially, it was popular as a model of vertebrate development because zebrafish embryos are transparent and also develop rapidly. The zebrafish embryo has become an important vertebrate model for assessing drug effects. It is well suited for studies in genetics, embryology, development, and cell biology. Zebrafish embryos exhibit unique characteristics, including ease of maintenance and drug administration, short reproductive cycle, and transparency that permits visual assessment of developing cells and organs. Compounds on various organs, including the heart, brain, intestine, pancreas, cartilage, liver, and kidney, were observed in the transparent animals without complicated processing, demonstrating the efficiency of toxicity assays using zebrafish embryos. The use of animal models allows researchers to investigate disease states in ways which would be inaccessible in a human patient, performing procedures on the non-human animal that imply a level of harm that would not be considered ethical to inflict on a human. Using zebrafish, it is possible to obtain results quickly at lower costs. “Reducing failures early in the development is far more important than filling a pipeline with poorly chosen late-stage products likely to fail, and fail expensively” says Szymkowski.
Varaprasad Adepu
JNTU Kakinada, India
Title: Estimation of Ramelteon in Bulk And Tablet Dosage Form By HPLC
Time : 15:30-15:50
Biography:
I have completed M Pharm and pursuing PhD in JNTU, Kakinada. I has published more than 5 papers in national and international journals and presented more than 4 papers in national, international conferences.
Abstract:
A simple, accurate and precise reverse phase HPLC method was developed, described and validated for the determination of ramelteon in bulk and tablet dosage form. Chromatography was carried on an ODS column using a mixture of acetonitrile and 0.05Mphosphate buffer, pH 6.8 (in the ratio 40:60 v/v) as the mobile phase at a flow rate of 1.2 mL/min with detection at 285 nm by ultraviolet detector i.e. incorporated in HPLC. The retention time of the drug was found to be 7.0 min. The method validation proofs were carried out as per the ICH guidelines. The developed method was validated for linearity over a range of 500µ g/mL to 1500µ g/mL, with a correlation coefficient of 0.999, which shows the method is quite linear. Further precision, ruggedness, accuracy were validated. The %RSD for system precision was observed to be 0.7, whereas the method precision was observed to be 0.5. And for ruggedness the observations were found to be 0.5 and 0.4 respectively. The average recovery of 100.0% indicates the capability of the method, and finally no significant differences in % RSD values w.r.t retention time prove the robustness of the method. As per ICH guidelines, method validation results are in good agreement. The proposed approach is effective and can be applied for the estimation of ramelteon in bulk and tablet dosage form.
Biography:
Kalaiyarasi Duraisamy has completed her M.Pharmacy from The Tamilnadu Dr.MGR Medical University and pursuing part time Ph.D., in JNTU, Hyderabad. She is working in a biopharmaceutical company and having more than 5 years research experience in analytical R&D.
Abstract:
BACKGROUND: In the present study, a validated UPLC/ESI-MS/MS method for the determination of combined dosage form of perindopril and amlodipine in human plasma sample was optimized. This method was responsive and an adequate amount to observe the low-dosage PK studies of perindopril and amlodipine in human plasma. METHODS: Chromatographic separation was achieved on a Waters ACQUITY UPLCTM BEH C18 (100.0 mm X 2.1 mm; 1.7µm) column. UPLC analysis consisted of mobile phase A for 0.1% formic acid in MilliQ water and mobile phase B for 0.1% formic acid in acetonitrile, which was degassed. The gradient elution with flow rate at 0.3 mL min-1 of mobile phase was kept and 10 µL of sample was injected in each run. The total chromatographic run time was 5.5 min. Mass spectrometric detection was carried out in multiple reaction monitoring (MRM) mode using electrospray ion source in positive ion polarity to profile the abundances using the transitions m/z 369 → m/z 172, and m/z 409 → m/z 238 for perindopril and amlodipine respectively and the transitions m/z 612.75 → m/z 280.30 for lercanidipine as internal standard. Argon was used as the collision gas at the pressure of 3.5X10-5 Torr. In this developed method, a high recovery of perindopril and amlodipine in plasma samples was proved with improved quality data in terms of increased detection limits and chromatographic resolution with greater sensitivity. CONCLUSIONS: UPLC with MS/MS has the advantage over problems of poor chromatography, wearisome extraction steps, uncertain characterized peak and high injection load. As per FDA guidelines, the method is validated for its accuracy, robustness and reproducibility. Quantification of perindopril and amlodipine dosage forms by this method is time saving, cost effective and it can be used in clinical studies to quantify the drug content in human plasma samples.
- Workshop
Session Introduction
Ravi Kumar Tummalacharla
Cleanrooms Containments, India
Title: How to prevent outbreaks in endemic countries?
Time : 10:00-11:00
Biography:
Ravi Kumar Tummalachalra is a Graduate Mechanical Engineer. Expert in Design& construction of Bio-Containment projects (BSL-3 Ag, BSL-3, BSL-2 facilities), Cleanrooms, HVAC systems. He has 16 yrs of experience on Cleanrooms, Biocontainment’s, Vivariums (Animal facilities), Eco toxicology labs, Microbiology, Virology, Bacteriology, Analytical, Instrumentation labs. In the past worked for Bharat Biotech, Biovet and Voltas ltd. Founder and CEO of Cleanrooms Containments since 2011. Presented few topics on Bio-Containments, Cleanrooms on various national and international seminars. Exclusively working on Cleanrooms and Bio-Containments. Going to present another talk at IVBWG at Geelong-Australia on Nov 3rd 2015. Member of ABSA (American Biological Safety Association), ASHRAE (American Society for Heating, Refrigeration& Air-Conditioning Engineers), Society for bio-Safety of India, CCSI (Contamination Control Society of India). Actively involved in organizing ASHRAE programs.
Abstract:
The presentation shall give an over view of Bio-Containments, CDC/NIH guidelines, how to select suitable containment, how to stop outbreaks by developing effective, energy efficient, safe new research and manufacturing facilities to prevent outbreaks. Few points on Bio-security also discussed. Presentation shall cover methods and technologies implemented globally for Bio-containments, Research facilities, safety measures to follow while handling infectious organisms. Constructional features of these facilities, some typical layouts, material of construction of these facilities, HVAC requirements, and various primary, secondary and tertiary containment methods are discussed in detail. There are Life science research Bio-containments and Pharmaceutical containments also and both are slightly different. It is explained appropriately. What are the adverse effects of outbreaks, economic loss to nation are also discussed. India is endemic to many infectious diseases. DBT& DST formed some Bio-Safety guidelines for India, but there is a necessity to form a committee to develop and release complete guidelines for the nation. A Govt. certifying body to certify the certifying companies. These companies in turn to certify the bio-containments all over India after construction of new facilities and for re-qualification every year. Bio-containments are for Bio-safety, they are different from Cleanrooms. Major consideration shall be for Personnel and Environmental safety rather than product safety in bio-containment facilities.