Volume : 13, Issue : 08, August – 2026
Title:
EVALUATION OF THE POST-APPROVAL CHANGE REQUIREMENTS FOR PHARMACEUTICALS IN INDIA.
Authors :
N. Vasavi*, Wajid Ali.MD
Abstract :
Post-approval change (PAC) requirements play a critical role in maintaining the safety, efficacy, and quality of pharmaceutical products throughout their lifecycle. In India, these requirements are governed by the Central Drugs Standard Control Organization (CDSCO) and guided by Schedule M, the Drugs and Cosmetics Rules, and emerging harmonization efforts with global regulatory frameworks such as ICH Q12. This study evaluates the regulatory landscape for post-approval changes in India, focusing on the categorization, documentation, and approval pathways for variations in manufacturing processes, formulation, packaging, and analytical methods. The analysis highlights challenges in regulatory timelines, data expectations, and the need for risk-based approaches to streamline change management and ensure continued compliance.
Keywords: Post-approval changes, CDSCO, Schedule M, regulatory compliance, variation filing, lifecycle management, pharmaceuticals, ICH Q12, India.
Cite This Article:
Please cite this article in press N Vasavi et al., Evaluation of the post-approval change requirements for pharmaceuticals in India. Indo Am. J. P. Sci, 2026; 13(08).
REFERENCES:
1. Central Drugs Standard Control Organization (CDSCO). (2017). Draft guidance on post-approval changes for pharmaceutical products. Ministry of Health and Family Welfare, Government of India.
2. Central Drugs Standard Control Organization (CDSCO). (2020). Guidance for industry on submission of applications through SUGAM online portal. New Delhi: CDSCO.
3. Central Drugs Standard Control Organization (CDSCO). (2021). Regulatory guidelines for filing variations to approved pharmaceutical products in India. Ministry of Health and Family Welfare.
4. Central Drugs Standard Control Organization (CDSCO). (2023). National drug regulatory reforms and implementation roadmap for Schedule M (Revised). Government of India.
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13. Food and Drug Administration (FDA). (2023). Guidance for industry: Quality considerations for continuous manufacturing. Silver Spring, MD.
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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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