Regulatory affairs (RA) play crucial roles in the pharmaceutical industry because they are concerned with the lifecycle of healthcare products, they offer strategic, tactical, and operational direction, and they support working within the law to hasten the development and delivery of safe and effective healthcare products to people all over the world. The purpose of regulatory affairs is to create and implement a regulatory strategy to guarantee that the combined efforts of the drug development team result in a product that is acceptable to international regulators while also standing out from the competition. Microorganisms play a vital role in every field of drug such as production of antibiotics, antifungal, anticancer, vitamins, vaccines and enzymes etc. These are some examples where microbial products are widely used. In the present work we will discuss various aspects where microorganisms widely used in production of drug and their regulations in US and India.

Diabetes mellitus is a chief cause involved in the morbidity and mortality among the global population (Steppan et al., 2001). The main event of this syndrome includes elevated blood glucose level (hyperglycemia) followed by polydipsia and polyuria. The secondary complications include retinal damage, loss of kidney function and damage to nerves. Further, the diabetes mellitus will also increase the cardiovascular disease progression. Pentacyclictriterpenes are as well one of the compounds occurring in plants. In this group Ursolic acid is a well-recognized compound that is accessible from various sources like seeds as well as fruits and possess many types of activities and is a bright contender for developing novel treatment approaches for treating diseases. Thus, in the current study, ursolic acid a triterpenoid was selected for evaluation of antidiabetic potential by molecular docking. A mechanistic insight for their antidiabetic potential is elucidating by interaction of ursolic acid with target proteins.

The purpose of the current study was to use the solid dispersion approach to improve the solubility of the medication oxcarbazepine, which is only moderately water soluble. The antiepileptic medication oxcarbazepine is used to treat seizures. Due to its high permeability and low water solubility, it falls under BCS class II. To prevent issues of this nature, it was imperative to increase the solubility of oxcarbazepine in accordance with British Pharmacopoeia (BP) solubility criteria since pure oxcarbazepine falls under the category of being only very slightly soluble. Solid dispersion technique has been used to try and increase the solubility of pure oxcarbazepine. Oxcarbazepine is also extensively metabolized by the liver. Attempt has been made to formulate solid dispersions containing oxcarbazepine to improve its solubility and dissolution rate to avoid first pass metabolism; to avoid difficulty.

Preformulation research is a stage that is started before the novel molecule is seeded. In a larger sense, it connects with studies of a molecule's physical, chemical, analytical, and medicinal properties and offers ideas about appropriate modifications that could be made to improve performance. The analysis of preformulation characteristics can contribute to the development of pharmaceutical formulations that are efficient, safe, dependable, and stable. Oxcarbazepine is an antiepileptic drug. It controls seizures or fits by declining the abnormal and excessive activity of the nerve cells in the brain.