Informatics Publishing Limited

Veeresh ¹, Pramod Kumar ², V. Rama Mohan Gupta ³

Affiliations
1 Depertment of Pharmacognosy, Smt. Sarojini Ramulamma College of Pharmacy, Mahabubnagar, IN
2 Department of Pharmacognosy, V. L. College of Pharmacy, Raichur, Karnataka, IN
3 Department of Pharmaceutics, Pulla Reddy Institute of Pharmacy, Annaram (V), Hyderabad, IN

Abstract

Trianthema decandra Linn., belongs to family Aizoaceae, commonly known as "Punarnavi" in Sanskrit, "Gadabandi" in Hindi, and "Vellai sharuni" in Tamil . This plant is globally distributed tropical and sub tropical regions. In India it grows in dry-soil lands. It has been known since ancient times for curative properties and has been utilized for treatment of various ailments such as burns and wounds. The ischolar_mains are aperients, and said to be useful in hepatitis, asthma and suppression of the menses. A decoction of the ischolar_main-bark is given as an aperient. The juice of the leaves dropped in to the nostrils relieves one-sided headache. In the present investigation, the detailed Pharmacognostic study of Trianthema decandra ischolar_main is carried out to lay down the standards, which could be useful in future Forensic identification of unknown plant material. The study includes macroscopic, microscopic, preliminary phytochemical screening and physicochemical evaluation. The objective this was to characterize the unknown plant material. Conclusion: In recent years there has been rapid increase in the standardization of selected medicinal plant of potential therapeutic significance. Despite the modern techniques, identification of plant drug by Pharmacognostic study is more reliable.

Keywords

Trianthema decandra Root, Pharmacognostic Study, Phytochemical Screening, Standardization.

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K. Raja Rajeswari ¹, C. H. Sri Durga ¹, V. Rama Mohan Gupta ¹

Affiliations
1 Pulla Reddy Institute of Pharmacy, Affiliated to Jawaharlal Nehru Technological University, Hyderabad, Telangana-502 313, IN

Abstract

Apart from the regular clinical trials, bioavailability/bioequivalence studies are conducted to assess the safety and efficacy of generic drugs, comparing it with a reference listed drug. Clinical trial data is mandatory for further approval of the drug, for it to enter the market. These investigations are strictly regulated by various global and national regulatory authorities. The global clinical trials market is expected to register a Compound Annual Growth Rate (CAGR) of nearly 4.5% during the forecast period, 2018 to 2023. A major challenge for them to achieve the forecasted growth is meeting the increased level of compliance to the regulations. In recent times the research Organizations have been issued an increased number of warning letters with stringent procedures and even subsequent closure of the organizations. This case study conducted by the review of warning letters and other observations pointed out by two major global regulatory authorities, the FDA and EMA and the critical areas were identified. Recommendations were made for the major areas which were critical and repetitive. It was concluded that consistent methods are required to improve the quality of studies to effectively eliminate the challenges in mere future and contribute for the betterment of the drugs’ market.

Keywords

World Health Organization, Food and Drug Administration, Clinical Research Organizations, Quality Management System, Clinical Trials, Regulatory Authorities, Warning Letters, Medical Devices, Drugs, Biomedical Research.

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