Valluru Ravi

The present study deals with the elaborated overview of comparative study of in-process and finished product quality control tests for parenteral products taking compendia specifications of Indian Pharmacopoeia (IP), British Pharmacopoeia (BP), United States Pharmacopoeia (USP), European Pharmacopoeia (EP) and Japanese Pharmacopoeia (JP) into consideration. When it comes to most sensitive parts of body i.e.; veins, a high degree of precautions should be taken during and after production of product for it to avoid any hitches. The sterility of these parenteral products, as well as accuracy in the calculation and preparation of doses is of great importance and a must in terms of compliance. The high graded quality product always refers to a product which is within the compendia limits. This article focuses on the comparison of Pharmacopoeial specifications of parenteral preparations, the procedures that are employed to maintain the quality and sterility of these ophthalmic products. This covers specifications and limits of different dosage forms according to different Pharmacopeia (like IP, BP, USP, JP etc.) which helps in comparative study of specifications provided in different Pharmacopeia as well as highlighting the differences in standards and also focussing on the specifications of different nations. Different regulatory requirements of the respective countries demand products with different specific limits so this comparative study will help in meeting all the requirements of all the pharmacopoeias and later the regulatory requirements of that particular country.

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.

Biomarkers and surrogate endpoint largely replaced the clinical trials which are needed to be carried out before drug approval in regular approval process under FDA (Food and Drug Administration), a governing pharma regulatory body in USA and as a result approval process can be accelerated. It can be said that surrogate endpoint and biomarker are substituting the clinical trials and decrease the duration of product development phase as well as decrease the entry time period of novel products in the market. The article enlightens the extent to which the biomarkers and surrogate endpoint have benefited the pharma industry for expediting the entry of their products into the market at the earliest to get the maximum benefit of the product during the patent period. Simultaneously article also throws light on the history of risk factors of surrogate endpoint which are likely to jeopardize the interest of the human beings involved. It may conclude that Biomarkers and surrogate endpoints play pivotal role in accelerating approval process for drug approval in USA and the usage of these parameters to minimize the casualty of human lives who are suffering from serious life threatening diseases by providing recent research products which have caliber to cure or improving the quality of life. Key words: Clinical trial, Biomarker, Surrogate end point, Accelerated approval, Caliber to cure, Casualty of human lives.