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About Authors:
*Parasiya Sachin kumar R., Balamuralidhara V., Pramod Kumar T.M., Rohit Gujarati, Abhisek Shukla, Vandana Kshatri
Pharmaceutical Regulatory Affairs Group, Dept. of Pharmaceutics,
JSS College of Pharmacy, JSS University, S.S Nagar, Mysore-570015, Karnataka, India
*sachin_patel2007@yahoo.com

Abstract
Across Asia, a convergence of economic trends, government policies and greater awareness among the general public of healthcare issues has created an environment that is poised for dramatic growth and change. Taiwan, for instance, can be taken as an example. Taiwan has one of Asia's most highly-praised healthcare systems with excellent provision of healthcare and key health outcomes. Nevertheless, the government is facing new pressures for public healthcare reforms as result of a rapidly ageing population and rising healthcare costs. This paper provides an introductory overview of Taiwan’s sudden changes in its drug regulations due to TFDA (The Taiwan Food and Drug Administration) establishment in 2010, TFDA of the Department of Health (DOH) made an advance announcement about the “amendment draft of the Provisions Governing the Registration and Market Approval of Drugs”, which amends a total of 40 Articles. Without impeding the quality, safety and therapeutic effect of drugs, most of the amended Articles are about simplification of application procedures and loosening of regulations for drug registration and market approval. Regulations loosened are imposed on new drugs, radioactive drugs, allergenic drugs and drugs for export that is intended to accelerate the process to sell new drugs on the market and promote the export of domestically manufactured drugs. As a result of these changes in regulations many pharmaceutical MNCs and local manufacturers explored their business in Taiwan due to quick approval of their NDAs and gained more flexibility in the local market. To support Taiwan's generic drug industry, DOH has also decided to take measures to simplify and reduce the ANDA application time.

About Authors:
Sarepaka a.^*1, Dhamodaran p.¹, Singh a.², Nilani P.¹, Duraiswamy B^1
1Department of Pharmacognosy, JSS College of Pharmacy, Ootacamund, Tamilnadu, India 643001
²Department of Pharmaceutical Chemistry, JSS College of Pharmacy, Ootacamund, Tamilnadu, India 643001
*sarepaka.aparna@yahoo.in

Abstract:
World Health Organisation (WHO) recommends The Directly Observed Treatment Short-course (DOTS) strategy of tuberculosis (TB) treatment which includes a course of first line as well as second line antibiotics. Unfortunately, from nearly the moment drugs became available for the treatment of TB, resistance became a problem.^[1] Also, the price of these medications is high; thus poor people in the developing world have no or limited access to these treatments.^[2] Herbal treatment, however, presents the potential to provide an affordable, available, culturally relevant method to manage tuberculosis. Currently, botanicals are the most competent way to bridge the gap between isolated developing cultures and modern science.^[3] As botanicals attain a more prominent role in modern health care, the quality, safety and activity of these products must be assessed. The tribal medicinal men of Nilgiris district use commonly available plants for the treatment of tuberculosis. In this study, we evaluated five such plants for their antitubercular activity in vitro, namely,Withania somnifera, Allium cepa, Zingiber officinale, Glycyrrhiza glabra andAsparagus racemosus, individually as well as in combination. The results revealed that the combination of these extracts have significant inhibitory effect Mycobacterium tuberculosis growth.

About Authors:
Abhisek Shukla*, Dr. Valluru Ravi
Pharmaceutical Regulatory Affairs group, Dept. of Pharmaceutics,
JSS College of Pharmacy, JSS University,
Sri Shivarathreeshwara Nagar, Mysore-570015, Karnataka, India.
abhishekjsscp@gmail.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. 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. 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. The purpose of this article is to present a concise overview of the drug approval process in Turkey and Canada.

Alternatives to animal testing in drug discovery are primarily based on biochemical assays, on experiments in cells that are carried out in vitro and on computational models and algorithms.

JSS College of Pharmacy is one of the oldest Pharmacy Institutes in the State of Tamil Nadu situated in the beautiful town of Ootacamund, popularly known as Ooty, was established in 1980 with the object of imparting quality pharmacy education in India.

About Authors:
Md. Sofiqul Islam, Madhusudan N. Purohit
Department of Pharmaceutical Chemistry,
JSS college of Pharmacy, Mysore 570015

Quinoline and its derivatives are well  known for their antimalarial and antibacterial propertites. A number of quinoline derivatives are known to possess antimicrobial, antitumor, antifungal, hypotensive, anti HIV, analgesics and anti-inflamatory activites. Application of quinoline derivative are fast spreading from antimalarial drugs to almost every branch of medicinal chemistry. Substitution of halogen group in a suitable position of a bioactive molecule is found to exert a profound pharmacological effect.