Pharmapedia

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)

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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