Pharmapedia

REGULATORY ISSUES AND NATURAL PRODUCTS

About Authors:
Sapna Phadtare,* Vaibhav Shinde, Kakasaheb Mahadik
Department of Pharmacognosy, Poona College of Pharmacy,
Bharati Vidyapeeth University, Erandwane,
Maharashtra, Pune-411038
*sapnaphadtare@gmail.com

Abstract
The world is gifted with wonderful and precious resources such as plants, animals and minerals that form the major part of our medical system. We as humans are so dependent on these natural sources that life without them is beyond imagination. Thus it is of prime importance that we look into the conservation and preservation of natural products. The Indian and international government bodies have developed various laws, rules and conventions to ensure sustainability of such natural products. This article reviews the general laws, rules and regulations developed globally for natural and traditional medicine. Various guidelines like WHO, EMEA, TGA guidelines are looked upon. Some difficulties that are faced regarding regulatory issues of herbal medicines are studied. The Acts like Indian patent Act, Plant Variety Protection Act, Farmer’s rights, terms like Biodiversity and Biopiracy are reviewed in this article.

AN REVIEW ON MEDICAL TOURISM: A NEW THRUST AREA FOR TOURISM

About Authors:
Paresh Mohan*, Saurabh Patel, Shobhit Sharma, Mahaveer Prasad Kabra

Department of Pharmaceutics, Kota College of Pharmacy,
S-P-1, RIICO Industrial Area, Ranpur, Jhalawar road,
Kota, Rajasthan, India – 324009.
*pareshmhshwr90@gmail.com

Abstract:
Medical tourism is becoming a new thrust area for tourists across the globe. It is predominantly combined with travel and tourism. The term medical tourism has been coined by travel agencies and the mass media to describe the rapidly growing practice of travelling across all around the world to obtain hi-tech medical care. Various countries like Thailand, Malaysia, India, etc are promoting medical tourism eagerly. The key advantages of India in medical tourism are the following: low cost advantage, strong reputation in the advanced healthcare segment (cardiovascular surgery, organ transplants, eye surgery etc.) and the diversity of tourist destinations available in the country which attracts like culture, food etc.
The most of the people of many countries have long traveled to the developed countries like United States and Europe to seek the expertise and advanced technology available in leading medical centers. This paper focuses on the key issues and opportunities possessed by Indian medical tourism sector that enable it to overcome domestic and international barriers on upgrading its medical services. Finally, this paper analyses and concludes the main reasons why the developing country like India attracts foreign tourists for the medical treatment.

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.

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.

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.

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.

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.

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

INTRODUCTION
The first day of January 2005 marked a dramatic turning point in the history of India. By deliberately excluding pharmaceutical products from patent protection for the previous 34 years, India became a world leader in high-quality generic drug manufacturing. But India’s entry into the global economy at the end of the 20th century, as evidenced by membership in the World Trade Organization (WTO), compelled the nation to once again award patents on drugs. Moreover, India henceforth would have to apply internationally-accepted criteria for granting patents, and the term of its patents would have to extend twenty years beyond filing.
For an emerging superpower still mired in immense domestic poverty and public health crises, these and other fundamental changes to India’s patents regime did not come quickly nor without controversy. Their implementation remains uncertain. It is far too early to empirically establish, for example, whether India’s adoption of stronger patent laws will catalyze a significant shift from generic drug manufacturing to indigenous pharmaceutical innovation[1]. What is clear, however, is that the implications of India’s tumultuous patent system transformation will be felt not only within India but also around the globe. From the perspective of millions suffering worldwide from life threatening diseases, many of whom previously benefited from the low-cost products of India’s thriving generic drug manufacturing sector, the introduction of a pharmaceutical product patents regime in India is viewed as an international healthcare tragedy. That view is the extreme. The true impact of the changes will turn on implementation. Eighteen months into the new patents regime, India is actively exploiting the flexibilities inherent in the WTO’s Agreement on Trade-Related Aspects of Intellectual Property (TRIPS). These flexibilities allow India to balance the need to protect its public from the social costs of stronger patent protection while at the same time provide the necessary incentives for domestic research and development in medicines and healthcare. The transformation of the nation’s patent regime is entirely consistent with a burgeoning domestic pharmaceutical and biotech industry that is beginning to invent rather than merely reverse-engineer. The traditional Indian view of patent protection as a moral wrong antithetical to public health is evolving to a more complex understanding—still in its formative implementation stages, to be sure—that a patent system can be designed and implemented to spur domestic innovation while at the same time maintaining affordable public access to life-saving patented medicines[2]. The first major comparative analysis of India’s newly strengthened patents regime, i.e., the Patents Act, 1970, as last amended in 2005 (hereinafter “India Patents Act, 1970 (2005)”).5 These evaluates the first eighteen months of the new regime’s operation, drawing not only from published literature but also from original fact finding, data gathering, and interviews conducted in India with Indian Patent Office officials, Indian pharmaceutical industry representatives, Indian patent attorneys, and Indian patent law academics.

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)

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