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Regulatory Affairs Courses
  • 21 January 2013

    INDIAN DRUG REGULATORY SYSTEM: MOVING TO A NEW ERA

    About Author:
    Priyank Sharma
    M. Pharm, Drug Regulatory Affairs
    Jaipur National University
    Jaipur, Rajasthan
    Priyank2k4urwith@gmail.com

    Abstract:
    The Pharmaceutical industry represents one of the India’s strength.  The regulation of pharmaceuticals in India is generally seen to be in need of reform, and has been the subject of many official commissions since 1995. Most commentators agree that the state should intervene to prevent untrammeled market forces leading to citizens’ suffering, because adequate information about the costs and benefits of different pharmaceuticals is inaccessible to most users. But in India, a wide range of stakeholders must be considered before changes can be made to the regulatory framework.

  • 23 December 2012
    FOOD CONTAMINANTS: BANGLADESH PERSPECTIVE

    About Authors:
    Zubair Khalid Labu1; AK Mohiuddin1; M.A Bake*2
    1Department of Pharmacy, World University of Bangladesh (WUB), Dhaka-1215, Bangladesh
    *2Product Development officer, Gonoshasthaya Pharmaceuticals Ltd., Mirzanagar, Savar, Dhaka-1344.
    zubairlabu@yahoo.com; *abdul.bake@yahoo.com

    Abstract
    Food is the major source of energy in humans as well as animals. Foods are materials taken into the body by different route which provide nourishment in the form of energy or in the building of tissues. Food contaminants are substances that make food unfit for human consumption. Examples include bacteria, toxic chemicals, carcinogens, teratogens and radioactive materials. The purpose of these studies is to find out the food contaminants which are used in different purposes available in Bangladesh and contaminants detection method. After survey we found that Dhaka is the main city where food contamination by various contaminants in higher percentage. This contamination done by manmade, industrial discharge, poisonous water etc. Government of Bangladesh taking various necessary steps to stop this contamination.

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  • 13 December 2012
    CONCEPT AND PHILOSOPHY OF TOTAL QUALITY MANAGEMENTS

    About Authors:
    Amit A. Patel
    Seth G. L. Bihani S.D. College of Technical Education,
    Institute of Pharmaceutical Sciences and Drug Research,
    Sri Ganganagar, Rajasthan, INDIA.
    amitpatelmx@gmail.com

    ABSTRACT:
    Quality is critical in achieving competitiveness in domestic and global market. Quality is a journey starting from design, to conformance, and ends at better performance. This process considers quality as a ‘never ending’ improvement. The success of TQM mainly depends on the achievement of internal as well as external customer satisfaction. Internal customer satisfaction is a prerequisite to achieve external customer satisfaction.

    If Employees are to identify and correct quality problems, then they have to use some quality tools. Quality circles are also known as work improvement or quality teams. the quality circle is a small group of employees who voluntarily meet at regular times to identify, analyse and solve quality and other problems in their working environment.

  • 30 November 2012
    NEW DRUG APPROVAL PROCEDURE IN INDIA

    About Authors:
    Jatin  Patel*, Krunal Parikh, Dhiren Shah
    Seth G.L. Bihani S.D. College of Technical Education,
    Institute of Pharmaceutical Sciences and Drug Research,
    Sri Ganganagar, Rajasthan, INDIA
    *Patelj313@yahoo.com

    ABSTRACT:
    A regulatory process, by which a person/organization/sponsor/innovator gets authorization to launch a drug in the market, is known as drug approval process. In general, a drug approval process comprises of various stages: application to conduct clinical trials, conducting clinical trials, application to marketing authorization of drug and post-marketing studies. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs.
    This article includes new drug approval process in different countries include India, Australia, European union, China etc.
    New drug approval process in different countries are described in logarithmic representation.

  • 23 November 2012
    STUDIES ON THE THERAPEUTIC ROLE OF VITAMIN B12 AND FOLIC ACID AGAINST ARSENIC INDUCED HEPATIC DAMAGES AT CELLULAR AND DNA LEVEL BY REACTIVE OXYGEN SPECIES

    About Authors:
    Tamal maity
    Institute of pharmacy ,(govt.) ,
    Jalpaiguri and west bengal university of health sciences
    Vidyasagar University
    tamalpharma@gmail.com

    Abstract:
    In an attempt to develop new therapeutics, Vitamin B12 & Folic acid was used to screen the effect on arsenic-induced hepatic toxicity in female rat of Wistar strain. Sub chronic exposure to sodium arsenite (0.4 ppm/100 g body weight/day via drinking water for a period of 28 days) significantly increased activities of hepatic. A notable distortion of hepatocellular histoarchitecture was prominent with a concomitant increase in DNA fragmentation following arsenic exposure. A marked elevation of in hepatic tissue was also evident from the hepatic accumulation of antioxidant enzymes such as superoxide dismutase, Catalase, Xanthine Oxidase, DNA Fragmentation & Histological views. However, co-administration of Vitamin B12 & folic acid (200 µl/100 g body weight/day for a period of 28 days) was found to significantly prevent the arsenic-induced alteration of hepatic function. Moreover, the degeneration of histoarchitecture of liver found in arsenic-treated rats was protected along with partial but definite prevention against DNA fragmentation induction. Similarly, generation of reactive oxygen species and free radicals were found to be significantly less along with restored activities of antioxidant like Vitamin B12 & Folic acid co-administered group with comparison to arsenic alone treatment group. The present investigation offers strong evidence for the hepato-protective and antioxidative efficiencies of Vitamin B12 & Folic acid against oxidative stress induced by arsenic.

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  • 5 November 2012
    PROBLEM: ENVIRONMENTAL POLLUTION AND GLOBAL WARMING IDEA TO IMPLEMENT GREENERY IN INDIA

    The main problem which we are facing is the Global warming because of the polluted atmosphere. My idea can reduce the global warming and can bring back the polluted free environment

    MAIN OBJECTIVE:
    Converting the brown economy to green economy can be done very easily and fastly only by the Indian youth by starting an effective campaign by name “earth warriors” or some other easy feasible name so that everyone in India can understand the theme of the program easily unlike the other programs that we had earlier like great power race or carbon credit race etc., which takes time for the people to understand the theme of the campaign.

  • 9 August 2012
    A study on Financial Implication on Working Capital of Wockhardt Limited after Implementation of Patent Product 2005 In India

    About Authors:
    Manthan Shah
    D.Pharm, B.Pharm, MBA(Marketing & Finance)
    Assistant PMT
    Sohm India Pvt Ltd
    manthanshah.leo@gmail.com

  • 9 July 2012
    READ ONCE | POWER CORRUPTS : ABSOLUTE POWER CORRUPTS ABSOLUTELY

    About Author:
    Mr. Jagmohan Rai Agarwal,
    M.Pharm (1968), Industrial experience SSI sector, nearly 37 years,
    retired from own Industry (2004),
    Founder President of M.P.Pharmacy Graduates’ Association (MPGA),
    Ex President: M.P.Pharmaceutical Manufacturers’ Organisation (MPPMO),
    Founder President : M.P. Small Scale Drug Manufacturers’ Association (MPSDMA),
    Ex President Indian Pharmaceutical Association, M.P. State Branch, Indore (IPA),
    Ex Vice Chairman Confederation of Indian Pharmaceutical Industries (SSI) (CIPI)
    Recently submitted thesis for award of  Ph.D. on title “Enforcement of Drug Laws-Globalization vis-à-vis Indian Drug Laws”
    (Email: sharda_jollo@yahoo.co.in)

  • 6 June 2012
    Aspirin and Prevention of Cancer

    Dr.

  • 24 May 2012
    Must Read Article: PHARMA, JOURNEY TO……. JAIL

    About Author:
    Mr. Jagmohan Rai Agarwal,
    M.Pharm (1968), Industrial experience SSI sector, nearly 37 years, retired from own Industry,
    Founder President of M.P.Pharmacy Graduates’ Association,
    President: M.P.Pharmaceutical Manufacturers’ Organisation,
    Founder President : M.P. Small Scale Drug Manufacturers’ Association,
    President Indian Pharmaceutical Association, M.P. State Branch, Indore,
    Recently submitted thesis for award of  Ph.D. on title “Enforcement of Drug Laws-Globalization vis-à-vis Indian Drug Laws”
    (Email: sharda_jollo@yahoo.co.in)

    Quality of Pharmaceuticals has been a concern of the World Health Organisation (WHO) since its inception. The setting of global standards is requested in Article 2 of the WHO constitution which sites as one of the organisation’s functions that it should develop, establish and promote International standards with respect to food, biological, pharmaceuticals and similar products.

    Campbell (US FDA) was the first leading architect of the present Federal Food, Drug and Cosmetics Act passed in 1938. He differed sharply with ‘Willey’ in his belief that Court proceedings were not the only proper way to secure compliance.

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