Editorial Applied Clinical Research, Clinical Trials & Regulatory Affairs, 2019, Vol. 6, No.

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EDITORIAL

Regulatory Traits - Relevance to Contemporary Healthcare Environment (Part-I)

The impression that health and access to drugs is the key in human’s life and it is changed into axiomatic across
our journey. A considerable amount of the newest work has been centered on accessing drugs/pharmacological ac-
tions/research and development. Nonetheless, negligible amount of work/research has been done on the regulative
systems, so as to confirm the worth of any drug by appreciating quality, safety, and effectiveness. This is often a
notable forum in terms of obtaining the newest insights through articles within the space of regulative traits. We
need to grasp why pharmaceutical laws/regulations area unit therefore significant? What are the variations among
pharmaceutical laws/regulations, however bridging is done by appreciating and understanding evolution, a way to
empower economic process of rules, question arises that what are the hurdles to be encountered in implementation
of rules, what are the measures for social control of pharmaceutical laws/regulations? what number of violations
happened and what are corrective preventive actions taken? is there any audit mechanism to validate?

It is incessantly overwhelming to be conversant in all the spirited rules that unfold the health care environment.
It is exciting to pinpoint the administrative/regulatory bodies, who are blamed for not executing necessities to ap-
preciate compliance and the way it happens as per modern move. Because, health care regulations, values and stan-
dards are becoming indispensable to warrant all of us safe health care. The latitude and complexness of health care
regulation can be outlined with the understanding of elementary logic behind the deep regulative network, recent
advancement, suggestions, critiques, caselets. On the other hand, the user has no clue to measure the quality of the
drug. Because it is accessed through varied channels viz. sales representative, doctors, nurse, patients, etc. There-
fore, chances are there that serious adverse effects can be encountered and may be prolonged until death for misap-
propriation of usage. The pharmaceutical regulations are witnessing intense makeover always. These kind of inputs
from the forum is bringing the opportunity to determine review, approve, evaluate and manage the rising RA sys-
tem. So, now we all realize and cannot disagree even how much vital role directives/regulations plays within the
health care environment.

Dhiman et al., “Partnership Efforts – Their Potential to Reduce the Challenges that Confront Regulators and
Pharmaceutical Industry” discussed that two imperative pillars of healthcare sectors are pharmaceutical industry
and health regulatory authorities [1]. There is a growing need for these parties to come together on common plat-
forms and collaborate. The success of the strategies and approaches intended to deal with these challenges depends
upon strategic-level leadership and new ways of collaborative working, which creates a room for potential syner-
gies. Arora et al., “Therapeutic Potential of Probiotics: A Ray of Hope or Nightmare?” emphasizes the role of vari-
ous probiotic microorganisms with a particular impact on their therapeutic use in human health and disease [2]. The
authors also highlighted the progression of probiotic research related to therapeutic potentials of probiotics, clinical
trials on probiotics, risks and regulatory concerns associated with probiotics and their use. Akhtar and Pathak in
“Hair Care Cosmetics Regulation in Different Countries – A Comparative Study” pointed that manufacturers across
the globe are conducting safety analysis to ensure the safety, non-irritating potential of these products and that the
product should not cause any allergic reaction [3]. The authors manifests that the several regulatory as well as clini-
cal aspects of hair cosmetics governing the use of hair products worldwide and stressed that the products safety
should be observed in market-place via consumer comments and complaints. Mohit et al., “Comparison of Regula-
tory Requirements for Registration of Pharmaceutical Drugs in ASEAN and GCC Regions”, made an attempt to
focuses on general regulatory requirements of registration of pharmaceuticals in ASEAN and GCC region [4]. Ban-
sal and Dhiman “Line of Progression: Indian Regulatory Framework for Nutraceuticals and Dietary Supplements”,
manifests the progression of Indian food product regulations over the years mainly emphasizing on regulations of
nutraceuticals and dietary supplements. The authors stressed that the implement of guidelines in ensuring the safe
and nutritious food, a robust system and a better coordinated action is required [5].

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6 Applied Clinical Research, Clinical Trials & Regulatory Affairs, 2019, Vol. 6, No. 1 Editorial

We express our sincere thank and appreciation all, who generously contributed, patiently waited for the peer-
reviewed, and revised the manuscripts for this special issue to uphold the high quality of this journal. Spell bound to
acknowledge sincerest thanks to the editorial board’s constructive and timely reviews and all the support to shape
this special issue. We owe special thanks to Ms. Iqra Shafi for untiring hard work to get this special issue a reality.
We hope that all of you will enjoy this special issue.

REFERENCES
[1] Dhiman SK, Gummadi V, Dureja H. Partnership efforts – Their potential to reduce the challenges that confront regulators and phar-
maceutical industry. Appl Clin Res Clin Trial Regul Aff 2019; 6(1): 7-17.
[2] Arora M, Kaur N, Bansal P, Baldi A. Therapeutic potential of probiotics: A ray of hope or nightmare? Appl Clin Res Clin Trial Regul
Aff 2019; 6(1): 18-33.
[3] Pathak K, Akhtar N. Hair care cosmetics regulation in different countries- A comparative study. Appl Clin Res Clin Trial Regul Aff
2019; 6(1): 34-45.
[4] Mohit, Deep A, Khurana G, Kumar J, Monga A. Comparison of regulatory requirements for registration of pharmaceutical drugs in
ASEAN and GCC regions. Appl Clin Res Clin Trial Regul Aff 2019; 6(1): 62-70.
[5] Bansal R, Dhiman A. Line of progression: Indian regulatory framework for nutraceuticals and dietary supplements. Appl Clin Res
Clin Trial Regul Aff 2019; 6(1): 46-61.

Mr. Swagat Tripathy Prof. Harish Dureja

(Guest Editor) (Guest Editor)
Project Manager M. Pharm. (Pharmaceutics), Ph.D. (Gold-Medalist),
Aurobindo Pharma Limited Professor, Department of Pharmaceutical Sciences
Hyderabad – 500 084 Director, Intellectual Property Right Cell
Telangana, India Director, Professional Consultancy Services
E-mail: swagat.tripathy7@gmail.com Convener, Institute Innovation Council
M. D. University, Rohtak, 124001–India
E-mail: harishdureja@gmail.com

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