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Regulatory Affairs Courses
  • HOMEGROWN DRUG COMPANIES FACING HEAT IN THE US MARKET

    “ Domestic drug firms are facing a lot of regulatory issues in the US market with the US health regulator pulling them up for non-compliance of manufacturing norms.

  • FERMENTATION COSMETICS

    ABOUT AUTHOR:
    Vinay Kumar Singh
    General Manager-Technical,
    Mikasa Cosmetics Limited,
    Ahmedabad, Gujarat
    vinay.s@mikasacosmetics.com

    Before refrigerators, Korea developed fermentation techniques that enable food to be stored safely for long periods. Many traditional medicines and cosmetics used by women at the royal court used similar knowhow. With interest growing in traditions of the past, there are now more cosmetics made using old techniques.

    The latest trend in Cosmetics particularly Skin Care is fermented beauty products. This concept, originated in Korea, basically involves fermentation of natural ingredients like black tea, ginseng, seaweed, bamboo sap extract, red clove flower, hibiscus, snow lotus and various herbs and flowers.

  • Improvement in drug manufacturing standards: an initiative of government of India

    Editorial, Mar 2015 issue

    “ Globalization of the pharmaceutical industry has the potential to rapidly spread poor-quality medicines worldwide. This is due to lack of expertise, poor manufacturing practices. It influence public

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  • ANTIBIOTIC POISONING AND FOOD POISONING THROUGH CHICKEN

    { DOWNLOAD AS PDF }

    ABOUT AUTHOR
    Suman Pattanayak
    Department of Pharmaceutical Analysis,
    Vijaya Institute of Pharmaceutical Sciences for Women,
    Enikepadu, Vijayawada, AP, India
    suman6982@gmail.com

    Chicken is one of the most popular foods. There can’t be many people who do not enjoy chicken curry, chicken pakoda, roast chicken, stew or barbecued chicken on a Sunday. This includes children as well as adults who both enjoy the taste and versatility of chicken. Since the 1940s, antibiotics have played a critical role in protecting the public’s health, and are responsible for saving millions of human lives. About 90% of antibiotics produced in the world are given to farm animals. The use of low doses of antibiotics by the modern food animal industry is responsible for drug-resistant bacteria emerging on farms which reach the general population through human or animal carriers, and through the food consumers eat. The chicken is one of the worst offenders when it comes to food poisoning. Many of us have either experienced this first hand or know someone who has suffered from this nasty illness.

  • BREAKTHROUGHS IN EPIGENETICS

    { DOWNLOAD AS PDF }

    ABOUT AUTHORS:
    Shashi Shekhar Anand, Navgeet, Balraj Singh Gill*
    Centre for Biosciences,
    School of Basic and Applied Sciences,
    Central University of Punjab, Bathinda, India
    gillsinghbalraj@gmail.com

    ABSTRACT
    The word ‘epigenetic’ was first coined by Conrad Waddington in 1946. It deals with functionally relevant modifications to the genome that do not include a change in the nucleotide sequence. Till date observation has focused on the functions of genome sequences and how their regulation occurs. The emerging epigenetic changes and the interactions between cis-acting elements with protein factors  plays a central role in gene regulation as well as give insight to various diseases. To evaluate the crosstalk of DNA and protein by taking account of the whole genome, one new evolving technique which is called as ChIP-chip, works on the principle of combining chromatin immunoprecipitation with microarray. ChIP-chip has been recently used in basic biological studies and may be improved further and can be useful for other to aspects, like human diseases. Now a days large amount of discoveries by ChIP-chip and other high-throughput techniques like this   may be connected with evolving bioinformatics to add to our knowledge of life and diseases.

  • Ayurvedic Cosmetics

    ABOUT AUTHOR:
    Vinay Kumar Singh
    General Manager-Technical,
    Mikasa Cosmetics Limited,
    Ahmedabad, Gujarat
    vinay.s@mikasacosmetics.com

    To understand Ayurvedic Cosmetics one must think as to what is the synergy between Ayurveda and Cosmetics. The word ‘cosmetics’ is derived from the Greek word ‘kosmeticos’ which means skill decoration or skill in arranging in order or correcting the deformities. Cosmetics is applied topically to skin and its appendages to cleanse, decorate, beautify, alter the appearance and ultimately to enhance confidence of user.

  • Advance technology in skincare

    ABOUT AUTHOR:
    Vinay Kumar Singh
    General Manager-Technical,
    Mikasa Cosmetics Limited, Ahmedabad

    Skin care market in India is estimated to be more than Rs 7,000 crore as per Euro monitors report of 2013. Skin care is rapidly growing segment in India. Demand for skin care products will continue to rise as consumers start paying more attention to their skin. Consumers of all age groups look for benefits including wrinkle-free, smooth and glowing, and healthy skin.With changing life styles, increase in disposable incomes, greater product choice and availability, and influence of satellite television, internet, more people are taking interest in personal grooming. The facial skin care market is booming. Products are competing with one another to take shelf space in the retail stores. Facial skin care products have become an essential part of the beauty market. Like western countries, creams and potions are applied in India also, in an effort to remove the pimples and the acne, fight stress and worry lines, and to remain young..The trend is driven further by the launch of new products with additional benefits which persuades consumers to buy these brands. As a result, skin care witnessed growth by a value CAGR of 8% at constant 2013 prices.

  • Drug price control: Should be win-win situation for Patients and Industries

    Editorial, Feb 2015 issue

    “ Getting access for patented formulation or molecule by poor patients is a bigger healthcare challenge. As we are aware that developing a new molecule cost in billions to pharmaceutical companies and it takes at least 12 years to reach the milestone.

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  • Why to wait for jobs? Pharmacy students need to be entrepreneurs.

    Editorial, Jan 2015 issue

    “ Entrepreneurship means not to develop drug molecule in campus in four years. It means to make students able to generate jobs not only for themselves but for others too. They may imagine some products in FMCG category like oral hygienic, maternity and nursing products, herbal formulations, OTC products…

  • PHARMACY: BOON OR BANE

    { DOWNLOAD AS PDF }

    ABOUT AUTHOR:
    Pranita Pradip Dharmadhikari
    Department of Phrmacology,
    N.D.M.V.P. College of Pharmacy, Nashik
    2009pranitadh@gmail.com

    “Pharmacy is the health profession that links the health science with the chemical science and it is charged with ensuring safe and effective use of pharmaceutical drugs.” That’s how the Wikipedia defines it. For a student it is a career, an ambition and of a course a learning process.

    Pharmacy education in India was initiated by Medical College; Madras in 1860, the purpose was to develop pharmaceutical skills of students of medical degree or diploma course or of that pursuing hospital assistance. From 1860 to 2014 the pharmacy profession shows a tremendous growth in India, it shows that pharmacist is one of the major fraternities of health care system around the world. As a pharmacist, I must say that pharmacy is profession which benefits to the world. But certain area in pharmacy are consistently points the pharmacist as towards negative aspects. Hence it’s a pharmacist’s duty to focus on wrong practices to make a profession as boon for world.[1]

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