Miscellaneous Articles

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When the domestic pharmacy market is forecasted to touch US$20 billion by 2015, it was essential to do amendments in previous laws directly affecting pharmaceutical market in India. Amendment regulations are drafted by parliamentary counsel’s office for the purpose of excellence in regulation and only published in gazettes. Major change experienced by Indian pharmaceutical market recently is in pharmaceutical pricing policies.

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.

Hepatitis A, an acute, self-limiting liver infection is transmitted through the fecal oral route by a picovnavirus, hepatitis A Virus(HAV) (1). It is the major cause of acute viral hepatitis in children (2). HAV cause asymptomatic infection in young children and symptomatic infection in adults (3). A study shows symptomatic infection in 4-16% of children as compared to 75-95% of adults (1). The symptoms include jaundice, fever, abdominal pain, malaise, anorexia which resolve after onset within 1-2 months.

ABOUT AUTHORS:
Mohit kumar*, Vishal Sachdeva,
Seth G. L. Bihani S. D. College of Technical Education,
Sri Ganganagar (RAJASTHAN) 335001, INDIA
*mohigarg30@gmail.com

ABSTRACT
A well drafted application decides the fate of an invention. Drafting plays a vital role in the success of an invention during its prosecution, management and maintenance during its tenure and turning it into cash. Drafting a patent application is one of the most important and at the same time one of the most difficult process. The applicant or his agent should so draft a patent application that it is granted with an adequate scope or ambit so as to fully serve the business purpose(s) for which the patent is meant to be used. It is here that the importance of drafting the claims in a patent must be fully appreciated, as the drafting of claims must always be done with a clear focus on the exact business needs that are sought to be served by it. That is, a business strategy perspective must inform the thinking of the one who takes up the task of drafting the patent claims. The ultimate purpose of every business strategy is to ensure that a business makes the desired amount of profit to justify the risks taken in making the investments of resources and time. Similarly, the purpose of drafting claims should be to fully serve the business strategy at hand. Even so, only a small number of well drafted patents are actually used by businesses to help them to make or safeguard their profits. (Swarbrick James, 2007).

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