Miscellaneous Articles

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.

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.

About Authors:
Ritul bapna
LMC of science and technology,
Jodhpur
*bapnaritul89@gmail.com

1. Introduction
The principal law for patenting system in India is the Patents Act, 1970. Initially, according to the provisions of this law no product patent but only process patents could be granted for inventions relating to food, drugs and chemicals. However, since 2005 product patenting is allowed in India. India being a member country of World Trade Organization (WTO) signed TRIPS (Trade Related Aspects of Intellectual Property Rights) Agreement in laws to be followed by each of its member countries. India being a signatory of the TRIPS agreement was under a contractual obligation to amend its Patents law to make it compliant with the provisions of the agreement. The first amendment in this series was in the form of the Patents (Amendment) Act, 1999 to give a pipeline protection till the country starts giving product patents. It laid down the provisions for filing of applications for product patents in the field of drugs and agrochemicals with effect from 1st January1995 as mailbox applications and introduced the grant of Exclusive Marketing Rights (EMRs) on those patents. To comply with the second set of TRIPS obligations India further amended the Patents Act, 1970 by the Patents (Amendment) Act, 2002.Through this amendment provision of 20 years uniform term of patent for all categories of invention was introduced. The third set of amendments in the patent law was introduced as the Patents (Amendment) Act, 2005. Through this amendment product patent regime was introduced in India. To implement its TRIPS obligations, India passed changes to its patent law in 2005 so that medicines could now be patented. However, the new law also contained the flexibilities. India has one of the best patent laws in the world in terms of giving some space to its producers to make generic medicines.

About Authors:
Ram Chandra*, Abhimanyu, Dr. Ashutosh Aggarwal
Seth G.L. Bihani S.D. College of Technical Education,
Institute of Pharmaceutical Sciences and Drug Research,
Sri Ganganagar, Rajasthan, INDIA
*rcgedar@gmail.com

1.        Introduction
Biostatistics is contraction of biology and statistics, sometimes referred to as biometry or biometrics, is the application of statistics to a wide range of topics in biology. The science of biostatistics encompasses the design of biological experiments, especially in medicine and agriculture; the collection, summarization, and analysis of data from those experiments; and the interpretation of, and inference from, the results. Hypothesis testing determines the validity of the assumption with a view to choose between two conflicting hypotheses about the value of a population parameter. Hypothesis testing helps to decide on the basis of a sample data, whether a hypothesis about the population is likely to be true or false. Statisticians have developed several tests of hypotheses (also known as the tests of significance) for the purpose of testing of hypotheses which can be classified as:- (a) Parametric tests or standard tests of hypotheses, and (b) Non-parametric tests or distribution-free test of hypotheses. Parametric tests usually assume certain properties of the parent population from which we draw samples. Assumptions like observations come from a normal population, sample size is large, assumptions about the population parameters like mean, variance, etc., must hold good before parametric tests can be used. But there are situations when the researcher cannot or does not want to make such assumptions. In such situations we use statistical methods for testing hypotheses which are called non-parametric tests because such tests do not depend on any assumption about the parameters of the parent population. Besides, most non-parametric tests assume only nominal or ordinal data, whereas parametric tests require measurement equivalent to at least an interval scale. (Bolton Sanford 2004, Jakel James et.al. 2001)

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.