Pharmaceuticals

In December 2019, Wuhan, Hubei Province, China, reported an outbreak of pneumonia of unknown cause. The Huanan Seafood Wholesale Market was found to be associated with instances of pneumonia. Inoculation of respiratory materials into human airway epithelial cells, Vero E6 and Huh7 cell lines, resulted in the isolation of a novel respiratory virus, which was later identified as a novel coronavirus linked to SARS-CoV after genome analysis (SARS-CoV-2). The beta coronavirus SARS-CoV-2 belongs to the Sarbecovirus subgenus.1 Corona virus causes pneumonia, colds, sneezing, and coughing in humans, while it causes diarrhoea and upper respiratory infections in animals. Corona virus spread from person to person or animal to animal through airborne droplets. Corona virus enters human cells via the ACE-2 exopeptidase receptor on the cell membrane. WHO and ECDC recommended avoiding public places and close contact with infected people and pets.

Bundelkhand is located Central part of India with an unique type of climatic condition having stony sandy and rocky soil deficient in water. Gradual climatic change due to acute pressure on land for various developmental activities are regularly increasing the degradation of  biodiversity which is affecting the potential of medicinal plants and invite  needs for the conservation of biodiversity of medicinal plants in the region. During the course of various studies authors have identified the medicinal plants of high value, used in top medical prescriptions and traditional medical practices viz. Acacia catechu (Khadira), Asparagus racemosus (Shatawari), Boswellia serrata (Shalaki), Desmodium gangeticum(Shalaparni), Gymnema sylvestre.(Retz.) R. Br. ex Sm.( Gudmaar), Hemidesmus indicus R.Br.(Anantmoola),Oroxylum indicum (L.) Kurz, Pluchia lanceolata(Rasana),Tribulus terrestris (Gokshuru), Uraria picta (Prishniparni), Withania somnifera (Ashwagandha), Writia tinctoriaetc. Efforts are needed in acclimatizing the medicinal plants in the garden land, nurseries, development of strategy of protection of natural habitat of the medicinal plants of region, developing ago-technical protocols for cultivation of medicinal plants suitable for farmers to enrich their economy as well as biodiversity under Government control is need of the day ensuring effective conservation of these valuable medicinal resources of the country. Cultivation of Cymbopogon flexuosus (Pootika),Saccharum munja (Munja), and Chrysopogon zizanioides (Ushir) is also the need of time for enriching the biodiversity through conserving the medicinal plants. Keywords: Bundelkhand, Agro-geoclimatic conditions, Conservation, Pharmaceuticals, Secondary metabolites.

Drug regulation is totality of all measures- Legal, administrative and technical- which the governments take to assure the quality, efficacy and safety of drugs. With reports of number of tragic adverse events caused by use of drugs, more stringent controls have been imposed upon the procedures for marketing authorization of drugs. The research and development, manufacture, import and export of pharmaceuticals is regulated by different regulatory bodies in different countries with varying levels of regulation stickiness. This review article provides useful information regarding the regulatory framework and Pharmaceutical key role players in many countries which are actively engaged in licensing and approval activities. Key Words: Drug regulation, Drug registration, Drug Approval, EMEA, Pharmaceuticals, USFDA.