gnipst bulletin 49.2

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G G G N N N I I I P P P S S S T T T B B B U U U L L L L L L E E E T T T I I I N N N 2 2 2 0 0 0 1 1 1 5 5 5 25 th September, 2015 Volume No.: 49 Issue No.: 02 Vision TO REACH THE PINNACLE OF GLORY AS A CENTRE OF EXCELLENCE IN THE FIELD OF PHARMACEUTICAL AND BIOLOGICAL SCIENCES BY KNOWLEDGE BASED LEARNING AND PRACTICE Contents Message from PRINCIPAL Editorial board Historical article News Update Knowledge based Article Disease Related Breaking News Upcoming Events Drugs Update Campus News Student’s Section Editor’s Note Archive GNIPST Photo Gallery For your comments/contribution OR For Back-Issues, mailto:[email protected] GURU NANAK INSTITUTE OF PHARMACEUTICAL SCIENCE AND TECHNOLOGY Website: http://gnipst.ac.in

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GNIPST Bulletin 49.2

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Page 1: GNIPST Bulletin 49.2

25-09-2015

GGGNNNIIIPPPSSSTTT BBBUUULLLLLLEEETTTIIINNN 22200011155525th September, 2015 Volume No.: 49 Issue No.: 02

Vision

TO REACH THE PINNACLE OF GLORY AS A CENTRE OF EXCELLENCE IN THE FIELD OF PHARMACEUTICAL AND BIOLOGICAL SCIENCES BY KNOWLEDGE

BASED LEARNING AND PRACTICE

Contents • Message from PRINCIPAL• Editorial board• Historical article• News Update• Knowledge based Article• Disease Related Breaking

News• Upcoming Events• Drugs Update• Campus News• Student’s Section• Editor’s Note• Archive

GNIPST Photo Gallery For your comments/contribution OR For Back-Issues, mailto:[email protected]

GURU NANAK INSTITUTE OF PHARMACEUTICAL SCIENCE AND TECHNOLOGY

W e bs i t e : ht t p: / / gni ps t. a c. i n

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MESSAGE FROM PRINCIPAL

"It can happen. It does happen. But it can't happen if you quit." Lauren Dane.

‘We are what we repeatedly do. Excellence then is not an act, but a habit.’ Aristotle

It gives me immense pleasure to pen a few words for our e-bulletin. At the onset I would like to thank the last year’s editors and congratulate the newly selected editors for the current year.

Our first consideration is always in the best interest of the students. Our goal is to promote academic excellence and continuous improvement.

I believe that excellence in education is aided by creating a learning environment in which all learners are supported in maximizing their potential and talents. Education needs to focus on personalized learning and instruction, while promoting an education system that is impartial, universally accessible, and meeting the needs of all students.

It is of paramount importance that our learners have sufficient motivation and encouragement in order to achieve their aims. We are all very proud of you, our students, and your accomplishments and look forward to watching as you put your mark on the profession in the years ahead.

The call of the time is to progress, not merely to move ahead. Our progressive Management is looking forward and wants our Institute to flourish as a Post Graduate Institute of Excellence. Steps are taken in this direction and fruits of these efforts will be received by our students in the near future. Our Teachers are committed and dedicated for the development of the institution by imparting their knowledge and play the role of facilitator as well as role model to our students.

The Pharmacy profession is thriving with a multitude of possibilities, opportunities and positive challenges. At Guru Nanak Institute of Pharmaceutical Science and Technology, our focus is on holistic needs of our students.

I am confident that the students of GNIPST will recognize all the possibilities, take full advantage of the opportunities and meet the challenges with purpose and determination.

Excellence in Education is not a final destination, it is a continuous walk. I welcome you to join us on this path.

My best wishes to all.

Dr. A. Sengupta

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EDITORIAL BOARD

CHIEF EDITOR DR. ABHIJIT SENGUPTA EDITOR MS. JEENATARA BEGUM ASSOCIATE EDITOR MR. DIPANJAN MANDAL

HISTORICAL ARTICLE Ancient history of Indian pharmacy

The study of the ancient history of Indian medicine has recently been revived due to the publication of polyglot translations. However, little is known of ancient Indian pharmacy. Archaeological evidence suggests the Indus people lived a settled life approximately in 2500 B.C. Their cities were enjoying the cleanest and most hygienic daily life with elaborate civic sanitation systems. The whole conception shows a remarkable concern for health. Then, the early Aryans invaded India about 1500 B.C. and the Vedic age started. The Rgveda texts contain the hymns for Soma and those for herbs. The term Ayurveda (i.e., science of life) is found in some old versions of both Ramayana and Mahabharata and in the Atharvaveda. Susruta had the credit of making a breakthrough in the field of surgery. The Ayurveda, a work on internal medicine, gives the following transmission of sages: Brahma-->Daksa-->Prajapati-->Asivinau-->Indra-->Caraka. On the other hand, the Susruta-samhita, which deals mainly with surgical medicine, explains it as follows; Indra-->Dhanvantari-->Susruta Both Caraka and Susruta were medical doctors as well as pharmacists, so they studied more than 1000 herbs thoroughly. The Ayurveda had been used by his devotees for medical purposes. It eventually spread over Asia with the advanced evolution of Buddhism.

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NEWS UPDATE World Pharmacists Day 25th September:

All over the world, on Friday 25 September, pharmacists will celebrate World Pharmacists Day. This special day, now in its fifth year, was established by the International Pharmaceutical Federation (FIP), the global federation of national associations of pharmacists and pharmaceutical scientists, which is in official relations with the World Health Organization. Through FIPs 132 member organisations, FIP represents over three million experts in medicines. September 25 was suggested by their Turkish members because it is the date that FIP came into existence in 1912. The purpose of World Pharmacists Day is to encourage activities that promote and advocate for the role of the pharmacist in improving health in every corner of the world. This year’s theme, developed by FIP, is “Pharmacist(s): your partner(s) in health”.

'Remote control' of immune cells opens door to safer, more precise cancer therapies: (24th September, 2015) A molecular "on switch" that allows tight control over the actions of T cells, immune system cells that have shown great potential as therapies for cancer, has been developed by a group of researchers.

Researchers quantify relationship between scientific discoveries, advances in medicine: (24th September, 2015) Scientists have provided a detailed map of how basic research translates into new treatments for deadly diseases. Charting the network of discoveries that led to the development of important therapeutic drugs, the investigators revealed that, up to now, the path to a cure has required thousands of scientists and many decades.

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Newly identified mechanism solves enduring mystery of key element of cellular organization: (24th September, 2015) Scientists have identified a mechanism that plays a key role in cellular organization and function and also offers a possible new treatment strategy for ALS and other degenerative disorders.

New methodology tracks changes in DNA methylation in real time at single-cell resolution: (24th September, 2015) A tool that allows scientists to monitor changes in DNA methylation over time in individual cells has been developed by a group of researchers. Certain diseases, including cancer, cause changes in DNA methylation patterns, and the ability to document these alterations could aid in the development of novel therapies.

Newly identified biochemical pathway could be target for insulin control: (24th September, 2015) Researchers are reporting the identification of a new biochemical pathway to control insulin secretion from islet beta cells in the pancreas, establishing a potential target for insulin control.

Leukemia tumor suppressor identified: (24th September, 2015) A protein-coding gene called hnRNP K has been identified as a tumor suppressor for acute myeloid leukemia (AML), a finding that could be important for investigating how best to target treatment of a blood cancer striking mostly older individuals.

New study reveals neural mechanism responsible for fat breakdown: (24th September, 2015) A breakthrough study shows that fat tissue is innervated and that direct stimulation of neurons in fat is sufficient to induce fat

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breakdown. These results set up the stage for developing novel anti-obesity therapies.

Nanoparticles could boost effectiveness and reduce side effects of allergy shots: (23rd September, 2015) Whether triggered by cats, bees, pollen or mites, allergies are on the rise. And the bad news doesn't stop there. The only current therapy that treats their causes is allergen-specific immunotherapy -- or allergy shots -- which can cause severe side effects. Now, researchers report the development of a potentially better allergy shot that uses nanocarriers to address these unwanted issues.

Chemists design rapid, simple, inexpensive tests using DNA: (23rd September, 2015) Chemists have used DNA molecules to developed rapid, inexpensive medical diagnostic tests that take only a few minutes to perform. Their findings may aid efforts to build point-of-care devices for quick medical diagnosis of various diseases ranging from cancer to allergies, autoimmune diseases, sexually transmitted diseases (STDs), and many others. The new technology may also drastically impact global health, due to its low cost and easiness of use, according to the research team. The rapid and easy-to-use diagnostic tests are made of DNA and use one of the simplest force in chemistry, steric effects – a repulsion force that arises when atoms are brought too close together – to detect a wide array of protein markers that are linked to various diseases.

Neural dysfunction in cognitive control circuits during adolescence could be predictor of psychotic disorders: (22nd September, 2015) Researchers have shown that lower levels of conflict-related brain activity are associated with a higher risk for later psychosis. Their study offers evidence that conflict-related brain activation

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represents an adaptive process that is diminished in individuals at high risk for psychosis, although further study is needed, they say. For detail mail to editor

KNOWLEDGE BASED ARTICLE

Safety of Nanomaterials in Cosmetic Products Nanomaterials are used in a variety of FDA-regulated products because of their unique properties, imparting potential advantages to products considered for development. Such materials, due to their nanoscale size, can have chemical, physical, and biological properties that differ from those of their larger counterparts. Such differences may include altered magnetic properties, altered electrical or optical activity, increased structural integrity, or altered chemical or biological activity. These new or altered properties may affect the performance, quality, safety, and/or effectiveness, if applicable, of a product that incorporates that nanomaterial. The application of nanotechnology may result in product attributes that differ from those of conventionally-manufactured products, and thus may merit particular examination. A. General Framework for Assessing the Safety of Nanomaterials in Cosmetic Products Section 301(a) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 331(a)) prohibits the marketing of adulterated or misbranded cosmetics2 in interstate commerce. The FD&C Act does not subject cosmetics or cosmetic ingredients (with the exception of color additives) to FDA premarket approval in order to be marketed legally in the United States. Except for color additives and those ingredients that are prohibited or restricted from use in cosmetics by regulation, a manufacturer may use any ingredient in the formulation of a cosmetic provided that the use of the ingredient does not otherwise cause the cosmetic to

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be adulterated (section 601 of the FD&C Act (21 U.S.C. 361)) or misbranded (section 602 of the FD&C Act (21 U.S.C. 362)). Cosmetic product manufacturers must ensure that the product is not misbranded or adulterated. The FD&C Act does not give us the authority to require that safety data be submitted to us or to approve a cosmetic product before it is marketed. Nevertheless, manufacturers or distributors are responsible for obtaining all data and information needed to substantiate the safety of their products before introducing them into the marketplace. In the Federal Register of March 3, 1975 (40 FR 8912 at 8916), we advised that “the safety of a product can be adequately substantiated through (a) reliance on already available toxicological test data on individual ingredients and on product formulations that are similar in composition to the particular cosmetic, and (b) performance of any additional toxicological and other tests that are appropriate in light of such existing data and information. Although satisfactory toxicological data may exist for each ingredient of a cosmetic product, it will still be necessary to conduct some toxicological testing with the complete formulation to assure adequately the safety of the finished cosmetic.” These general principles are applicable to the safety substantiation of cosmetic products whether they contain nanomaterials or conventionally manufactured ingredients. In applying these principles, however, it may be important to give particular consideration to the fact that a material at nanoscale may show changes in, or have novel, physicochemical properties, behaviors, and/or effects that could be different from a larger scale material with the same chemical composition. For example, the small particle size of a nanomaterial has the potential to alter the distribution and bioavailability of that material compared to a larger scale material with the same chemical composition. The small size leads to increased surface area relative to the mass of the particle, which could result in increased biological interactions. In addition, the uptake,

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absorption, and biodistribution of the material may be altered, leading to potential systemic exposure. In some cases, the traditional testing methods that have been used to determine the safety of cosmetic ingredients and finished products may not be fully applicable due to a nanomaterial’s distinctive properties and behavior. Such distinctive physicochemical characteristics or biological interactions may affect the results or interpretation of results obtained from traditional toxicology testing, which form an integral part of safety substantiation. B. Points to Consider in Assessing the Safety of Nanomaterials in CosmeticProducts Just as the traditional safety assessment includes material characterization and toxicology considerations, safety evaluations of cosmetic products containing nanomaterials should also take these considerations into account. Nanomaterials may exhibit new or altered physicochemical properties that may affect biological interactions, which may raise questions about the safety of the product containing nanomaterials. Any such unique properties or biological effects of nanomaterials should be identified and appropriately addressed during safety evaluations. With respect to nanomaterial characterization, safety should be assessed through fully describing the nanomaterial and evaluating a wide range of physical and chemical properties, as well as through the assessment of impurities, if present. The toxicology and absorption, distribution, metabolism, and excretion considerations for nanomaterials in cosmetic products can be informed by addressing the routes of exposure, the uptake and absorption, and toxicity testing. In addition, any distinctive properties and biological behavior of nanomaterials should be considered in determining the suitability of traditional testing methods for toxicity testing of cosmetic products containing nanomaterials. As needed, traditional toxicity testing methods should be modified or new methods developed to address: (1) the key chemical and physical properties that may affect the toxicity

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profile of nanomaterials and (2) the effects of those properties on the function of the cosmetic formulation. The toxicological testing should include consideration of toxicity of both the ingredients and impurities; dosimetry for in vitro and in vivo toxicology studies, if needed; clinical testing, if warranted; and toxicokinetics and toxicodynamics. The overall package of data and information should substantiate the safety of the product under the intended conditions of use. 1. Nanomaterial CharacterizationNanomaterials vary widely in composition, morphology, and other characteristics and cannot be considered a uniform group of substances. These substances may have physical, chemical, or biological properties that are different from those of larger scale material with the same chemical composition. As stated earlier, such differences may include altered magnetic properties, altered electrical or optical activity, increased structural integrity, or altered chemical or biological activity. As discussed in the FDA Task Force report, studies indicate that various attributes of a particular nanoscale material, including increased surface-area-to-volume ratio, morphology, surface features, and charge, can affect the distribution of that material in the body and that material’s interaction with biological systems. Therefore, thorough characterization of nanomaterials can form an integral part of the safety assessment. This would include proper identification of the chemical composition as well as impurities, structure, and configuration of the nanomaterial(s) used in the cosmetic product. In addition, characterization of the nanomaterial(s) as present in the raw material, formulation, test media, and in the relevant biological environment for toxicological testing should be considered to help determine potential biological interactions and effects. In addition, stability of the nanomaterial under testing conditions and in a formulation under intended conditions of use should be determined.

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a. Physicochemical PropertiesAs with any cosmetic ingredient, the nanomaterial should be fully described, including:

• the nanomaterial name,• the Chemical Abstracts Service (CAS) number,• the structural formula,• the elemental and molecular composition including:o the degree of purity, ando any known impurities or additives.

A thorough understanding of the details of the manufacturingprocess will help identify residual additives and impurities, as wellas certain other physical and chemical properties.A wide range of physical and chemical properties should beevaluated to help determine if a substance produced withnanotechnology is safe for the proposed use. Propercharacterization should include, as appropriate:

• measurement of particle size and distribution,• aggregation and agglomeration characteristics,• surface chemistry, including:o zeta potential/surface charge,o surface coating,o functionalization, ando catalytic activity• morphology including:o shape,o surface area,o surface topology, ando crystallinity• solubility,• density,• stability, and• porosity.

Although a wide range of analytical techniques are available formeasurement of physicochemical properties of materials, many ofthese methods have not been validated for the evaluation of

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nanomaterials in cosmetic products. Therefore, appropriate analytical methods suitable for the specific nanomaterial and the cosmetic product formulation should be chosen, and results obtained from such tests appropriately interpreted and reported for adequate characterization of the material. b. ImpuritiesAs with any cosmetic ingredient, a change in the starting material used to prepare a formulation will likely result in altered composition of the final product, which may result in different impurities. Variables such as altered purity or changes in the starting material should be considered. A manufacturer should assess the identity and quantity of impurities and how they may affect the overall safety of the end product. It is also important to understand how the nanomaterial is manufactured. Nanoscale impurities may arise from the manufacturing process. Changes in the manufacturing process, including use of different solvents, time/temperature conditions and changes to the starting chemicals (e.g., alternative starting materials, different purity levels or different concentrations of the chemicals used in the process) may change the types and/or quantities of impurities in the final product. Additional agents, such as dispersing agents and surface modifiers, are often used in the manufacture of nanomaterials. These additional agents and impurities should be considered in the safety substantiation for nanomaterials in cosmetic products. 2. Toxicology ConsiderationsThe appropriateness of toxicological testing depends on the intended use, exposure levels, and degree of concern for potential toxicity of an ingredient or formulation. In determining what toxicological testing may be appropriate, manufacturers should consider each ingredient’s chemical structure and composition, and physicochemical properties, purity/impurities, agglomeration and size distribution, stability, conditions of exposure, uptake and absorption, bioavailability, toxicity, and any other qualities that may affect the safety of the product for its intended

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use. Manufacturers should address both short-term and long-term toxicity of nanomaterials, and consider the need to evaluate the possibility of ingredient-ingredient interactions or ingredient-packaging interactions. Where traditional toxicity test methods are used, manufacturers should consider the applicability of the test methods and, as needed, modify them with respect to such factors as appropriate solvents and dosing formulations, solubility, agglomeration and aggregation of particles, and stability conditions associated with the cosmetic product containing nanomaterials. For example, whether a nanomaterial is soluble, insoluble, or partially-soluble may affect the suitability of a traditional toxicity test method. Some traditional in vivo test methods may be suitable for only soluble nanomaterials. Some traditional in vitro and in vivotest methods may need to be adjusted for testing insoluble or partially-soluble nanomaterials. These considerations are important because nanoparticles tend to stick to each other to form larger agglomerates/aggregates that may be insoluble. Therefore, in a dosing or test medium, nanomaterials may be present as a nano-dispersion rather than in solution. Agglomeration and aggregation of particles is another factor that may affect the suitability of traditional toxicity testing methods, and manufacturers should ensure that testing appropriately reflects the range of free particles and any aggregates or aggolomerates found in the cosmetic product formulation. Toxicological testing may need to be conducted separately on the free nanoparticles and the agglomerated/aggregated nanoparticles because they will likely have different chemical and biological properties. Due to their high surface energy, nanomaterials may also interact with the testing medium or bind to different substances, including proteins, in the test medium, resulting in an altered biological activity. Thus, manufacturers should consider and make necessary adjustments to traditional toxicity testing methods, taking into account the specific characteristics of the nanomaterial as it is intended to be used in the cosmetic product. In instances where traditional

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toxicity testing methods cannot be satisfactorily modified, FDA recommends developing new methods to adequately assess the toxicity of the nanomaterial in the cosmetic product and ensure the product is safe. It is also important to mention that the dose metrics currently used for toxicological testing of conventionally manufactured chemicals (measured and expressed in mass, volume or number of particles such as mg/kg, or mg/L) may not be appropriate for nanomaterials because of their large surface area per particle mass or volume. In addition to weight/volume metrics, evaluations of the safety of nanomaterials should also consider alternative metrics, such as weight/volume concentration, particle number concentration and surface area, until suitable parameters for dose metrics become available. a. Routes of ExposureThe safety of an ingredient is based in part on the potential for exposure and the relevant routes of exposure that are determined by its intended use and its application. Although most cosmetic products are applied directly to the skin, some products may be applied by spray presenting the possibility of inhalation exposure. Additionally, some cosmetic products are applied in an area where there is the possibility of oral exposure. Additionally, systemic absorption can result from dermal, inhalation, ocular and oral exposures. Therefore, for nanomaterials, the dose to the primary exposure organs as well as the dose to any secondary target organs should be considered in developing or modifying toxicological testing methods and for evaluating the test data. b. Uptake and AbsorptionAs stated above, some nanomaterials have unique physicochemical properties that may alter the potential toxicity of a compound (e.g. reduction in particle size could increase the ability for the compound to be absorbed). Therefore, the safety assessment should address whether there will be an increase in uptake, absorption, transport into cells, and transport across barriers (e.g. blood-brain barrier) or altered bioavailability or biological half-life.

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For example, there may be an increase in the dose delivered to sensitive tissues due to the increased ability of the nanomaterial to pass through the blood-brain barrier. Nanomaterials used in cosmetic products can be divided into two groups: (1) soluble and/or biodegradable nanoparticles, which disintegrate into their molecular components (e.g. some liposomes and nanoemulsions) upon application to skin and thus may not raise safety questions, and (2) insoluble, sufficiently stable and/or biopersistent nanoparticles (e.g. titanium dioxide (TiO2), fullerenes, and quantum dots). Some insoluble, partially-soluble or sufficiently stable nanomaterials, particularly those in the lower nanoscale range and with certain surface characteristics, may be able to cross biological membrane barriers (Ref. 25) and may have harmful effects due to the potential interaction with organs and cellular compartments. Thus, when there is evidence of systemic exposure to nanomaterials, manufacturers should consider including absorption, distribution, metabolism, and excretion (ADME) parameters in safety assessments of the nanomaterial in the cosmetic product. For exposure via dermal absorption, studies should be conducted with both intact skin and impaired skin (e.g. sunburned, atopic, eczematous, psoriatic, or systematically damaged skin) to address the possibility of an increased rate of penetration and ability of the ingredient to become systemically absorbed. The passive transport of many nanomaterials may not occur through intact skin, but there is an increased probability for entry of nanomaterials through skin with an impaired barrier layer. The use of aerosolized cosmetic products can also result in exposure to nanomaterials via the respiratory tract. The deposition of nanomaterials in the respiratory system depends on their aerosol properties and interactions with respiratory epithelium. The soluble nanoparticles may be dissolved, metabolized and transported to other organs and blood whereas the insoluble nanoparticles may be either retained in the airways and result in pulmonary effects or swallowed by coughing and

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cleared. The physical characteristics, including surface properties of nanomaterials, are important factors that warrant careful attention, particularly for inhaled nanoscale particles. Studies have indicated that decreasing the size of particles and increasing the surface area can result in potential adverse effects not only in the respiratory system, but also in the heart and blood vessels, the central nervous system, and the immune system. Exposure via the oral route is generally limited to those products that are introduced into or applied near the mouth (e.g., mouthwash, lipsticks). Limited evidence suggests that the uptake of nanomaterials and systemic absorption depends on their size, surface charge, and surface ligand modification. Additional studies have indicated that nanomaterials have limited uptake in the gastrointestinal tract, but the translocation to certain regions of the intestinal barrier can be substantially increased. Therefore, we recommend that the safety assessment process for nanomaterials include the issues of toxicokinetics and toxicodynamics with reference to different exposure routes. c. Toxicity TestingThe initial step in the evaluation of the safety assessment of cosmetic products is to conduct toxicity testing based on a toxicological profile of the ingredients and their routes of exposure. There are several guidelines for conducting toxicity testing (tiered testing strategy) of chemicals that can be used as a starting point in evaluating toxicity of nanomaterial ingredients. Consistent with the guidelines issued by the Cosmetic, Toiletry and Fragrance Association (CTFA) and the Organization for Economic Co-operation and Development (OECD), at a minimum, testing for acute toxicity, skin irritation, ocular irritation, dermal photoirritation, skin sensitization, mutagenicity/ genotoxicity, repeated dose (21-28 days) toxicity, and subchronic (90 days) toxicity. Phototoxicity testing for a cosmetic product that is intended to be used on sun-exposed skin. Results obtained from this basic test battery may indicate a need for additional

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testing. Where available, other relevant data, such as toxicological data on individual ingredients that are similar in composition to the nanomaterial or data on a larger scale material with the same chemical composition as the nanomaterial, can also be considered.

As stated previously, in designing tests for use with nanomaterials in cosmetics products, manufacturers should consider modifying traditional toxicity testing with respect to such factors as appropriate solvents and dosing formulations, agglomeration of particles, purity and stability conditions, and other variables. New methods may also need to be developed if traditional tests cannot be modified satisfactorily. For example, the Ames test, recommended as part of a battery of genotoxicity testing for conventional chemicals, may not be suitable for insoluble or partially-soluble nanomaterials used in cosmetic products because the bacterial cell wall may create a possible barrier for many nanomaterials. Toxicity testing in vivo has long been considered indispensable for obtaining information on translocation, biodistribution, accumulation, and clearance. As mentioned earlier, while conducting in vivo toxicity testing for nanomaterials, careful attention should be paid to the issue of dose metrics (mass, volume or number of particles). The manufacturer should consider the surface area and number of particles, as well as mass concentration in the study design of in vivo toxicity testing. For in vivo studies via the dermal route of administration, the test substance should be applied directly to the skin, and for the oral route of administration, the test substance should be given either by gavage or in the diet. Agglomeration or aggregation characteristics of nanomaterials in the topical vehicle, gavage or feed matrix are other important factors to assess prior to conducting these studies for safety assessment. Additionally, the potential for nanomaterials to penetrate through the skin or be absorbed through the gut and becoming available for biodistribution, should be addressed while

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estimating the risks associated with the exposure to nanomaterials. There has been recent emphasis on the development of validated methods for in vitro testing of cosmetic products by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and the European Center for the Validation of Alternative Methods (ECVAM). The seventh amendment to Directive 2003/15/EC of the European Parliament and of the Council instituted a ban on animal testing of cosmetic products in 2004 and a ban on certain animal tests with validated alternatives in March 2009. We recommend validation of in vitro methods for safety testing of cosmetic products and ingredients and optimizing these models for nanomaterials, with particular attention being paid to the issues of cytotoxicity and precipitation of insoluble ingredients. Nanomaterials can settle, diffuse, and aggregate differentially according to their size, density, and surface chemistry. Thus, the assessment of the agglomeration or aggregation of nanomaterials in the media used in the in vitro system should be addressed. Alternative testing methods currently under consideration that can be optimized for a specific nanomaterial and might be useful to help determine ingredient safety include:

1. Reconstructed human skin such as EpiskinTM and Epiderm TMfor skin irritation and corrosion testing;

2. Phototoxicity testing via 3T3 NRPT (3T3 fibroblasts neutral reduptake phototoxicity testing) applicable to ultra violet (UV)absorbing substances;

3. Human/pig skin in a diffusion cell for dermal absorption;4. Bovine Corneal Opacity and Permeability (BCOP) and the Isolated

Chicken Eye (ICE) for ocular irritation; and5. Genotoxicity testing using a battery of recommended tests

covering the endpoints of gene mutation, and structural andnumerical aberrations. While conducting genotoxicty tests, thenanomaterial’s specific properties should be taken into account tounderstand the mechanism of nanomaterials’ genotoxic effects .

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In vivo studies may be more suitable for nanomaterials with limited solubility properties.

Jeenatara Begum Assistant Professor

GNIPST

DISEASE RELATED BREAKING NEWS Middle East respiratory syndrome coronavirus

(MERS-CoV) – Kuwait: (23rd September, 2015) On 19 September 2015, the National IHR Focal Point of Kuwait notified WHO of 1 additional fatal case of Middle East respiratory syndrome coronavirus (MERS-CoV) infection. Read more

UPCOMING EVENTS 3rd International Conference and Exhibition on Pharmacognosy,

Phytochemistry & Natural Products will be held on 26th to 28th October, 2015 at Hydrabad.

DRUGS UPDATES FDA Approves Lonsurf (tipiracil and trifluridine)

for Advanced Colorectal Cancer: (22nd September, 2015) The U.S. Food and Drug Administration approved Lonsurf (a pill that combines two drugs, trifluridine and tipiracil) for patients with an advanced form of colorectal cancer who are no longer responding to other therapies. Read more

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CAMPUS NEWS INDOOR BATTLE 2015

On 24th September, 2015 GNIPST organised the Indoor games (Table Tennis, Carrom, Chess for both Boys and Girls) Indoor Battle 2015. Congratulations to all winners and participants. The Winners are:

Table Tennis (for Boys): 1st: Soumen Dhara (M.Pharm, 2nd year [Pharmacology]) 2nd: Ratul Banduri (B.Pharm, 3rd year) 3rd: Sneham Sen (B.Pharm, 3rd year) Table Tennis (for Girls): 1st: Sweta Saha (B.Sc [BT], 3rd year) 2nd: Moutan Roy (B.Pharm, 2nd year)

Carrom (for Boys): 1st: Sk. Sajjat Ali (B.Pharm, 4th year) and Sk. Abdul Aslam (B.Pharm, 3rd year) 2nd: Sourabh Saha (B.Pharm, 4th year) and Rajib Singha Roy (B.Pharm, 4th year) 3rd: Arnab Banerjee (M.Pharm, 2nd year [Pharmaceutics]) and Achinta Banerjee (M.Pharm, 2nd year [Pharmaceutics]) Carrom (for Girls): 1st: Sreyashee Mitra (B.Pharm 4th year) and Rituparna Das (B.Pharm 4th year) 2nd: Rinita DasBhowmik (B.H.M, 1st year) and Tania Datta (B.H.M, 1st year) 3rd: Sushmita Sen (D.Pharm, 2nd year) and Keya Das (D.Pharm, 2nd year)

Chess (for Boys): 1st: Sayantan Dutta (B.Pharm, 3rd year) 2nd: Tanmoy Das Biswas (B.Pharm 4th year)

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Chess (for Girls): 1st: Rituparna Das (B.Pharm 4th year) 2nd: Suchetana Dutta (B.Pharm 4th year) 3rd: Krishnakali Basu (B.Pharm 4th year) SAGAR DUTTA MEDICAL COLLEGE FEST-ASTERICA 2015

WINNER: The students of GNIPST stood first in the FASHION SHOW competition of Sagar Dutta Medical College Fest: Congratulation to the participants- Souvik Ganguly (B.H.M 2nd year) Riya Taran (B.Pharm 4th year) Moktar Hossain (B.Pharm 4th year) Chandrika Saha (B.Pharm 4th year) Swaranjeet Banik (B.Pharm 4th year) Sampita Pal (B.Pharm 3rd year) Ranit Kundu (M.Pharm 1st year) Susmita Kar (B.Pharm 2nd year) Md. Nadeem Shah (B.Pharm 4th year) Sreyashee Mitra (B.Pharm 4th year) Sunanda (M.Pharm 1st year) Best Male Model of ASTERICA 2k15: Souvik Ganguly (B.H.M 2nd year) Best Female Model of ASTERICA 2k15: Sampita Pal (B.Pharm 3rd year) Anchor: Sreejita Roy (B.Sc ) Solo Singing competition: Sayantan Goswami (B.Pharm 4th year):winner Arpita (B.Sc) :2nd runner up

CARNIVAL OF CANVASS: On 4th September the Students of GNIPST celebrated the freshers party for Masters degree students. On 4th September the students of GNIPST celebrated Teachers’ Day.

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Page 22: GNIPST Bulletin 49.2

25-09-2015

ESPERANZA: On 21st August, 2015 the 1st year students of GNIPST were welcomed in the Freshers Welcome Programme ‘ESPERANZA’.

HOMAGE TO FORMER PRESIDENT DR A P J ABDUL KALAM: On 31st July, 2015 all the students and teachers of GNIPST paid their homage for our former president Dr. A P J Abdul Kalam. ALUMNI ASSOCIATION:

GNIPST has been certified by the Alumni Association under the West Bengal Societies Registration Act, 1961. FAREWELL PROGRAMME:

On 15th May 2015 GNIPST celebrated the farewell programme ‘Sesh Chithi’ for the final year students of M.Pharm, M.Sc, B.Pharm, B.Sc and BHM. JIS SAMMAN 2015

On 11th May, 2015 GNIPST attended the JIS SAMMAN 2015. JIS SAMMAN Awards: • Best College (Non Engineering):

GNIPST• Best Principal:

Dr (Prof.) Avijit Sengupta• Best HOD:

Mr. Jaydip Ray• Best Faculty:

Mr. Debabrata Ghoshdastidar (Pharmacy)Dr. Swati Chakraborty (Life Sciences)

• Best faculty since inception:Mr. Jaydip Ray

• Best Office Staff:Ms. Jaya Banerjee

• Best technical Assistant:Mr. Somnath Majhi

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Page 23: GNIPST Bulletin 49.2

25-09-2015

• College Blue:Avik Paul

• Highest DGPA of 2014:B.Pharm:Purbali Chakraborty (4th year)Diksha Kumari (3rd year)Aishika Dutta (2nd year)Sampita Paul (1st year)M.Pharm:Aritra Mukherjee (Pharmaceutical Chemistry)Mounomukhar Bhattacharya (Pharmacology)B.Sc (Biotechnology):Papiya Saha (3rd year)Shomasree Das (2nd year)Ayanita Basak (1st year)B.Sc (Microbiology):Bonhisikha Chatterjee (3rd year)Riaz Hossain (2nd year)Soumi Chowdhury (1st year)BHM:Bishal Roy (3rd year)Shreyabhanja Chowdhury (2nd year) Recitation:

Udita Majumder Debate:

Srijita Roy Poushali Ganguly Quiz:

Arani Ray Dipayan Nath Band:

Syantan Ghoswami Anurag Ghosh Atanu Mondal

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Page 24: GNIPST Bulletin 49.2

25-09-2015

Arka Khamaru Ritobroto Paul Abhirup Dasgupta

Fashion: Md. Nadeem Shah Koustav Sarkar Shaksar Saha Avirup Dasgupta Ranit Kundu Namrata Ganguly Shreyasee Mitra Chandrika Saha Debopriya Chatterjee Riya Taran

Innovative Modeling: Ankit Chowdhury Kartik Koley Mudasar Manna Dipan Chaterjee Abhishek Singh Kaustav Pal Manojit Dutta SPIRIT JIS 2015

On 03th to 05th April, 2015 JIS organised SPIRIT JIS 2015. GPAT 2015 Result:

The following B.Pharm. final year students have qualified, GPAT-2015. We congratulate them all. Diksha Kumari Rupanjay Bhattacharya Avik Paul Xtasy 2015: GNIPST is going to organize the Tech Fest ‘Xtasy 2015’ from 30th March, 2015 to 1st April, 2015.

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Page 25: GNIPST Bulletin 49.2

25-09-2015

FINISHING SCHOOL TRAINING PROGRAMME: The FINISHING SCHOOL TRAINING PROGRAMME was organized by the Entrepreneurship Development Cell and Training & Placement Cell, GNIPST in collaboration with Indian Pharmacy Graduates’ Association (IPGA), Bengal Branch from 21st February to 11th April, 2015 at GNIPST Auditorium. On 21

st February, 2015 the Finishing School Training Programme of

GNIPST was inaugurated by Sri Soumen Mukhopadhyay, Deputy Director, Drug Control Office, Goutam Kr. Sen, President, IPGA, Mr. Subroto Saha, Asst. Directorate, Drug Control Office, Mr. Ranendra Chakraborty, Sales Manager and Associate Director Dr. Reddys Laboratory. On 28th February, 2015 Dr. D. Roy, Former Deputy Drug Controller, Mr. Sujoy Chakraborty, divisional Therapy Manager, Cipla and Mr. Vikranjit Biswas, Senior Manager, Learning & Development, Cipla delivered their valuable lectures in the 2nd day

FINISHING SCHOOL TRAINING PROGRAMME of GNIPST. On 14th March, 2015 Mr. Milindra Bhattacharya, Senior Manager, QA & QC, Emami Ltd. and Mr. Joydev Bhoumik, Manager, Operation, Ranbaxy Laboratory Limited delivered their valuable lectures in the 3rd day FINISHING SCHOOL TRAINING PROGRAMME of GNIPST. On 21st March, 2015 Mr. Tridib Neogi, Associate Vice-President (Quality Assurance), Albert David Ltd. delivered his valuable lectures in the 4th FINISHING SCHOOL TRAINING PROGRAMME of GNIPST. On 28th March, 2015 Dr. Gautam Chaterjee, an Alumni of Jadavpur University and presently associated with NIPER delivered his valuable lectures in the 5th FINISHING SCHOOL TRAINING PROGRAMME of GNIPST. On 11th April, 2015 the closing ceremony of the FINISHING SCHOOL TRAINING PROGRAMME was held in GNIPST Auditorium.

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Page 26: GNIPST Bulletin 49.2

25-09-2015

JOBS: All the students of Final Year B. Pharm and M. Pharm are hereby informed that an interview will be conducted on 23rd May, 2015 by Standard Pharmaceuticals Ltd. GSK for post: Production, QA, QC. All the students of Final Year B. Pharm and M. Pharm are hereby informed that an interview will be conducted by GSK for sales and marketing job. Details given below:

Date: 27.03.2015Time: 09:45 amVenue : GSK Consumer Healthcare Limited, Unit No. 208,

2nd Floor, Ecospace Campus B (3 B), New Town, Rajarhat, 24 Pgs (N). Kolkata-700156.

THYROCARE provisionally selected 15 students from JIS Group. Amongst these, 3 students of B. Sc (H) Biotechnology and M. Sc Biotechnology have been selected. Ipsita Mondal (M. Sc Biotechnology)Debriti Paul (M. Sc Biotechnology)Debopriya Chatterjee {B. Sc (H) Biotechnology}

The final year students of B.Pharm (31 students) and B.Sc (11 students) attended the pooled campus drive of Abbott India Ltd. on 10th March, 2015 at Jadavpur University. Among them 17 students have gone through to the final round of this pooled campus drive and short listed for final selection.

ACHIEVEMENT: Congratulations to Anurag Chanda, student of B.Pharm final year

who have got the 1st prize in poster presentation event in Prakriti 2015 at Department of Agricultural and Food engineering, IIT, Kharagpur.

OTHERS: On 24th and 25th February, 2015 Swamiji of Gourio Math wasdelivered some motivational lectuers in GNIPST.

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Page 27: GNIPST Bulletin 49.2

25-09-2015

The students of GNIPST participated in the 4th Sardar JodhSinghTrophy organised by NIT on 20th February, 2015. On 8th February, 2015 Gnipst celebrated the Reunionprogramme“Reminiscence Reloaded 2015”.

STUDENTS’ SECTION WHO CAN ANSWER FIRST????

"Strength's Origin is in Science" is themotto of which Indian organization?

Answer of Previous Issue’s Questions: Fear of Injection

Identify the person

Answer of Previous Issue’s Image: J manjula, dedo head

Send your thoughts/Quiz/Puzzles/games/write-ups or any other contributions for Students’ Section& answers of this Section at [email protected]

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Page 28: GNIPST Bulletin 49.2

25-09-2015

EDITOR’S NOTE It is a great pleasure for me to publish the 2nd issue of 49th Volume of GNIPST BULLETIN. All the followers of GNIPST BULLETIN are able to avail the bulletin through facebook account ‘GNIPST bulletin’ I am very much thankful to all the GNIPST members and readers who are giving their valuable comments, encouragements and supports. I am also thankful to Dr. Abhijit Sengupta, Director of GNIPST for his valuable advice and encouragement. Special thanks to Dr. Prerona Saha, Mr. Debabrata Ghosh Dastidar and Mr. Soumya Bhattacharya for their kind co-operation and technical supports. Thank you Mr. Soumya Bhattacharya for the questionnaires of the student section. An important part of the improvement of the bulletin is the contribution of the readers. You are invited to send in your write ups, notes, critiques or any kind of contribution for the forthcoming special and regular issue.

ARCHIVE The general body meeting of APTI, Bengal Branch has been

conducted at GNIPST on 15th June, 2012. The program started witha nice presentation by Dr. Pulok Kr. Mukherjee, School of NaturalProducts, JU on the skill to write a good manuscript forpublication in impact journals. It was followed by nearly two hourlong discussion among more than thirty participants on differentaspects of pharmacy education. Five nonmember participantsapplied for membership on that very day.

GNIPST is now approved by AICTE and affiliated to WBUT forconducting the two years’ post graduate course (M.Pharm)in PHARMACOLOGY. The approved number of seat is 18.

The number of seats in B.Pharm. has been increased from 60 to120.

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Page 29: GNIPST Bulletin 49.2

25-09-2015

AICTE has sanctioned a release of grant under ResearchPromotion Scheme (RPS) during the financial year 2012-13toGNIPST as per the details below:a. Beneficiary Institution: Guru Nanak Institution of PharmaceuticalScience & Technology.

b. Principal Investigator: Dr. LopamudraDutta.

c. Grant-in-aid sanctioned:Rs. 16,25000/- onlyd. Approved duration: 3 years

e. Title of the project: Screening and identification of potentialmedicinal plant of Purulia & Bankura districts of West Bengal with respect to diseases such as diabetes, rheumatism, Jaundice, hypertension and developing biotechnological tools for enhancing bioactive molecules in these plants.

Activity Clubs of GNIPST: Name of Club Member Faculty SPORTS Mr. Debabrata GhoshDastidar LITERARY AND PAINTING Ms. Jeenatara Begum SCIENCE AND INNOVATIVE MODELLING

Mr. Samrat Bose

ECO Ms. Sumana Roy SOCIAL SERVICES Dr. Asis Bala PHOTOGRAPHY Ms. Sanchari Bhattacharya CULTURAL Ms. Priyanka Ray DEBATE AND EXTEMPORE Mr. Soumya Bhattacharya

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