T.M. Pramod Kumar

Pharmaceutical R&D is failing with an era of triple obstacles – increased timelines for approval, high cost and even higher failure rates. The world around us is constantly putting pressure on creating completely new solutions for about 4000 diseases with known molecular basics and many other diseases without basic intellect. There comes a need to remove the wide gap in innovation showcasing a challenge for drug discovery. The shockingly tedious drug development process is forcing us to find more effective solutions and drug repurposing can be a starting point where the clear understanding of the de novo pathway for an existing drug essentially unlocks the full potential for repurposing a drug for other diseases. Drug repositioning (also known as drug repurposing, re-profiling, re-tasking or therapeutic switching) is the application of known  drugs and compounds to new indications (i.e., new diseases). This idea dates back with cases like Viagra, Thalidomide, and Aspirin etc. There are a number of approaches to drug repurposing, but these are ultimately an expedition into new area. Scientists have to justify examining a compound in a different disease state, so they often make a hypothesis based on possible associations between mechanisms. A significant advantage of drug repositioning over traditional drug development is that since the repositioned drug has already passed a significant number of toxicity and other tests, its safety is known and the risk of failure for reasons of adverse toxicology are reduced. The possibilities are endless, and animal models are elevating drug repurposing's potential.

To describe the various adverse donor reactions and determine the frequency of their occurrence in whole blood donors.  A retrospective review of all the no of donor Reactions reports of 19 blood banks of Kerala from 01/01/2014 to 31/12/2015 was done. The total number of donations were 246092(94.34%) and the Donors rejected were 14752(5.66%) 1174(0.48%) had an adverse reaction of which 999(0.41%) were vasovagal related and 175(0.07%) were needle injuries. Donor safety is an essential prerequisite to increase voluntary blood donation. AE analysis helps in identifying the blood donors at risk of AE, applying appropriate motivational strategies, pre-donation counseling, care during and after donation, developing guidelines and hemovigilance programme in countries with limited resources. Strict adherence to the rules is essential to ensure donor safety.  Also  it would have detrimental effects on return of donors for subsequent donations and rate of complications resulting in long-term morbidity and disablement is not negligible.

The objective of this paper is to give insight and better understanding of the regulatory requirements for changes done for an approved New Drug Application (NDA) in United States (US). For technical advancements, there may be situations which demand/ necessitate modifications for an approved NDA. The changes must be in conformance with the regulatory requirements of the Food and Drug Administration (FDA), the ultimate authority for the Drug related approvals in US. The changes must be systematically reported to the regulatory authorities in the recommended formats, termed as “Post approval changes for an NDA”. Section 506A of Federal Food, Drug, and Cosmetic Act, provides requirements for making and reporting manufacturing changes to an approved application and for distributing a drug product made with such changes. The FDA has revised its regulations on supplements and other changes to an approved application (21 CFR 314.70) to conform to section 506A of the Act. The changes can be major, moderate or minor depending on the changes likely to affect the quality, safety and efficacy of the product. Irrespective of the category of the changes, every change is to be brought to the notice of the US FDA in stringent, structured and stipulated format that are recommended for the regulatory advancements. If manufacturers are to achieve the much-heralded desired state, it is essential to allow some manufacturing changes. Firms would still be responsible for ensuring product quality. The goal is well known, the components needing change are well understood and characterized and the process well defined. Key words: NDA, USFDA, Post approval changes, Regulatory Authorities

Surrogacy is an arrangement in which a woman carries a pregnancy and gives birth to a baby for another woman. Surrogate motherhood is one of many currently available forms of Assisted Reproductive Technologies (ARTs) that have developed in response to the increasing number of individuals/couples who find themselves unable to conceive a child on their own. The main aim of this study is to give an overview of legal aspect of surrogate mother. Surrogacy is gaining popularity as this may be the only method for a couple to have their own child and also because adoption process may be long. India is leading in this business because of the easy availability of surrogates at comparatively less cost. Many agencies have come forward with the intention of outsourcing pregnancy to foreign countries. In India this process had been regulated by the law from 2002. Though the regulation have been initiated, they are not so stringent when compare to other countries hence many foreigners are coming to India for surrogate mother. It may be concluded that Assisted Reproductive Technology (ART) Bill 2010 has provided for single parenthood by allowing “unmarried couples” and “single persons” from India and abroad to have children using ART procedure and surrogate mothers in India.