Lachoo Memorial College of Science and Technology

About Authors: 
Bane Singh Rajput^*
Research Scholar of Lachoo Memorial College of Science & Technology
Pharmacy Wing, Jodhpur (Raj.)
*bnsingh29@gmail.com

Abstract
Drug product recall is an action taken to withdraw or remove a batch or an entire production run of a drug product from distribution or use and return them to the manufacturer. It is usually done due to the discovery of deficiencies in quality, efficacy or safety in the marketed drug products. Defective drug products related to quality includes adulterated or spurious drugs. Safety and efficacy related recalls include serious adverse reactions and death. Recalls also include drugs prohibited under the law and also those products for which product licenses are suspended/ cancelled. In USA, guidelines for drug product recall are described under 21 CFR Parts 7, 107 and 1270.  In Australia, guidelines for drug product recall are described under section 65F of the Trade Practices Act 1974. Sections 2(2), 4, 5 and 7 of the European Communities Act 1972 and Directive 2001/95/EC on general product safety are followed in UK for drug product recall. In India, references for drug product recalls, complaint and adverse reactions are mentioned in Para 27, 28 of Schedule M and conditions of license for defective product recall in Rule 74(j) and Rule 78(i) of the Drugs and Cosmetics Act, 1940 and Rules there under. But no effective and uniform recall procedure and guidelines are formulated yet in India. This paper presents a comparative study of drug product recall guidelines in USA, UK and Australia. Based on this comparative study suggestions are provided to develop regulatory guidelines for drug product recall in India.

About Authors:
PANKAJ MUSYUNI*, PROF. (Dr.) B.P. NAGORI¹, Mr. AKASH MIDHA²
*M. Pharm. (Pharma Management & Regulatory Affairs)
1 Director, Lachoo Memorial College of Science & Technology
2. Lecturer, Lachoo Memorial College of Science & Technology
Lachoo Memorial College of Science & Technology
‘Pharmacy Wing’, Jodhpur, Rajasthan
INDIA

ABSTRACT
Ethics can be explained as branch of philosophy related with the implication of all aspects of human behavior and nature. The purpose of this paper is to present an overview and relevance of business ethics in management and pharmaceutical industry scenario. The rationale of business can not be only illustrated by profit maximization but also by the social concern of the organization. This paper demonstrates the concept of business ethics with various attributes, factors and impact on society and also emphasize on code of ethics and its importance. Present paper also discusses common ethical problems within a pharmaceutical organization. A practical approach as case studies related to pharmaceutical industries will identify the issues and implications for ethical development, advancement and globalization of business ethics. Concept of paper focuses attention on the development of an attitude which should be adopted to understand various terms of ethics and development for social and business concern.

About Author: Naresh Sharma,
M.pharma (Pharmacognosy)
Department of Pharmacognosy, Lachoo Memorial College of Science and Technology,
Jodhpur, India.

ABSTRACT
Due to Lack of knowledge regarding the toxic effects of synthetic compound in mosquito repellents,synthetic mosquito repellents are widely used. The prolong use of synthetic mosquito repellents shows many side effects like neurotoxic hazards, immunotoxic hazards, skin allergy, seizures, eye irritation, insomnia, impaired congnitive function, cough, sneezing, headache, asthma, bronchial irritation, itching,ear, nose and throat pain, dermatitis, reproductive dysfunction, development impairment and cancer, death. Synthetic mosquito repellents contains very toxic compounds such as DEET, picaridin, permethrin, P?Menthane?3, 8?diol (PMD) etc. These draw backs created a pathway for herbal mosquito repellents coil. Large numbers of herbal drugs are used in these mosquito repellents like Neem, Vekhand, Tulsi, Ajowan, Raal, etc along with other natural ingredients. The efforts are made to study the traditional beliefs from scientific approach. The main aim of this product development is to provide employment to the rural youth and to promote the use of herbal mosquito repellent coil as complete safe alternate of chemical repellents.