Miscellaneous Articles

ABOUT AUTHOR
Kunal Roy
NSHM Group of Institutions Knowledge campus,
Department of Pharmaceutical Analysis & Quality Assurance
Kolkata-700053
kunal.roy17@gmail.com

ABSTRACT:
Counterfeit Culture is a one of the most important and dangerous crime in the world of drugs and its related products  and  explores the dangerous and sometimes deadly world of fake, fraudulent, and faux products. The pharmaceutical  industry has a has history of peddled knock-off  dosage forms, medical devices   but during the last 15 years, it has mushroomed into a global phenomenon.
The range of counterfeit goods now being produced includes pharmaceuticals. The traffic in counterfeit goods is now estimated at a staggering $350 billion representing nearly 10% of all global trade. This illicit and highly profitable criminal enterprise continues to grow unabated and has been linked to organized crime syndicates around the world.

We need to thanks to the new digital platforms like social media where technology is reinforcing people to create, participate, and share content on the Web, we can have meaningful conversations around events, places, people, news, brands, and products through blogs, micro-blogging sites like Twitter, Social bookmarking, and sharing sites like Digg, social networking sites such as Facebook, social forums and review sites. Virtual worlds like YouTube, Second Life, and podcasts are a few new age tools to name.

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.