Volume : 13, Issue : 08, August – 2026
Title:
STUDY ON THE ROLE OF ECTD SUBMISSIONS IN EXPEDITING DRUG APPROVALS IN INDIA
Authors :
A Vidya Sagar*, Dr. R. Narasimha Rao, Dr. T. Vijaya Kumari
Abstract :
This topic aims at reviewing the drug filing and different aspects of obtaining United States Food & Drug Administration (USFDA) and European Medicines Agency (EMA) approval for a drug in order to get a Marketing Authorization in US & Europe and their effective role in improving the standards laid down by them. All new / generic drug products must be approved by the respective regulatory agency governing the respective market before a particular product can be introduced into the market. By law, all new drugs must first be shown to be safe and effective before they can be approved by the respective regulatory agency for marketing. USFDA is the regulatory agency which is responsible for safety regulation of the food and drug products in US. EMA is the regulatory agency/ decentralized body which is responsible for safety regulation of the food and drug products in Europe. Drug approval process in USFDA involves submitting of an Investigational New Drug Application, followed by submission of New Drug Application. The applications are reviewed and agency officials examine the drug’s safety and efficacy data and the drug is approved. EU establishes 4 different drug approval processes:
1) Centralized Procedure
2) Decentralized Procedure
3) National Procedure
4) Mutual Recognition Procedure
Keywords: Drug Approval, EMA, USFDA.
Cite This Article:
Please cite this article in press A Vidya Sagar et al., Study on the role of ECTD submissions in expediting drug approvals in India.,, Indo Am. J. P. Sci, 2026; 13(08).
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Volume : 13, Issue : 08, August – 2026
Title:
EVALUATION OF ANTIHYPERLIPIDEMIC ACTIVITY OF SAPINDUS EMARGINATUS IN RATS
Authors :
Chinthala Jamima*, Dr.R.narasimha Rao, Dr.N. Raghunandhan
Abstract :
Obesity and hyperlipidemia have become major disorders predominantly causing prevailing cardiovascular diseases and ultimately death. The prolonged use of anti-obesity drugs and statins for reducing obesity and blood lipid levels is leading toward adverse effects of kidneys and muscles, specifically rhabdomyolysis. The objective of this study is to evaluate potential of seeds of Sapindus emarginatus against hyperlipidemia. In this model of Hyperlipidemia, 30 adult male wistar rats (200-250gms) were evenly divided into 5 groups in both groups. Group-1 and Group-2 served as untreated and model controls respectively, while Group-3, 4 and 5 were the treatments groups which were simultaneously treated with standard, 100 and 200 mg/kg extract respectively along with High Fat Diet. On last day, blood samples for biochemical parameters, were obtained under inhaled diether anaesthesia. The outcomes of this study were expressed as mean standard error and data were evaluated by using analysis of variance followed by multiple comparisons. Oral administration of 100 mg/ kg and 200mg/kg body weight of Methanolic extract residual fraction of Moringa oleifera. Leaves exhibited a significant reduction (P < 0.01) in serum lipid parameters such as triglycerides, total cholesterol, low density lipoprotein (LDL), very LDL and increase in high density lipoprotein in hyperlipidemic rats when compared with hyperlipidemic control in both models. Our results demonstrated that Methanolic extract fraction of Sesbania grandiflora. Possessed significant antihyperlipidemic activity.
Keywords: Sesbania grandiflora, Cholesterol, LDL, triglycerides and antihyperlipidemic activity.
Cite This Article:
Please cite this article in press Chinthala Jamimaet al., Evaluation of Antihyperlipidemic activity of Sapindus Emarginatus in rats,, Indo Am. J. P. Sci, 2026; 13(08).
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