Volume : 13, Issue : 08, August – 2026
Title:
SIMULTANEOUS ESTIMATION OF NEW ANALYTICAL THE ROLE OF THE CDSCO IN ENSURING GMP COMPLIANCE IN INDIAN PHARMACEUTICAL FACILITIES.
Authors :
V. Harika*, Dr. G. Anil kumar
Abstract :
The Central Drugs Standard Control Organization (CDSCO) plays a pivotal role in regulating and ensuring the quality, safety, and efficacy of pharmaceuticals in India. As the national regulatory authority, CDSCO is responsible for implementing and enforcing Good Manufacturing Practices (GMP) across Indian pharmaceutical facilities. Through a combination of guideline development, routine inspections, licensing, and compliance monitoring, the organization seeks to maintain high standards of drug manufacturing. CDSCO inspections focus on critical areas including documentation practices, facility hygiene, quality control systems, and personnel training, aiming to prevent deviations and ensure data integrity. Non-compliance may lead to regulatory actions such as warning letters, product recalls, or suspension of manufacturing licenses. This review highlights CDSCO’s regulatory framework, inspection mechanisms, and enforcement strategies, emphasizing its role in safeguarding public health and maintaining India’s credibility in global pharmaceutical markets.
Keywords: CDSCO, Good Manufacturing Practices, GMP compliance, Indian pharmaceutical industry, regulatory inspections, quality assurance, drug safety, manufacturing standards, compliance monitoring, public health.
Cite This Article:
Please cite this article in press V Harika et al., The role of the CDSCO in ensuring GMP compliance in Indian Pharmaceutical Facilities. Indo Am. J. P. Sci, 2026; 13(08).
REFERENCES:
1. Central Drugs Standard Control Organisation (CDSCO). About Us and Functions. Government of India official portal. CDSCO
2. Guidance Document for Risk Based Inspection of Drugs. CDSCO. CDSCO
3. G.S.R. 127(E) — Application Form A for extension of Revised Schedule M compliance. The Gazette of India. CDSCO
4. CDSCO Circulars on Revised Schedule M and WHO GMP/COPP. CDSCO
5. Schedule M — Revised Good Manufacturing Practices details. Schedule M.com. Schedule M
6. The Drugs & Cosmetics Act, 1940 and Drugs & Cosmetics Rules, 1945. Government publications (India). IJRASET
7. CDSCO Workshop on GMP Training (CDSCO WHO GMP workshop document). CDSCO
8. Bakliwal, K. Regulatory Framework in Pharmaceutical Industry (SSRN). SSRN
9. Assessment of Quality Standards and GMP Compliance of Pharmaceutical Formulations in India. International Journal of Pharmaceutical Sciences. IJPS Journal
10. Generic Drugs in India: Regulations, Challenges, and Reforms. (LWW Journals). Lippincott Journals
11. A Review on the Role of CDSCO in Regulatory Oversight in India (IJRASET Review Article). IJRASET
12. Reforming India’s Pharmaceutical Regulation: Structural Gaps and Drug Safety (ResearchGate/ IJSR 2025). ResearchGate
13. Shukla, A., et al. Current Good Manufacturing Guidelines for Medicinal Products (Semantics Scholar). Semantic Scholar
14. Clinical Research Regulation in India — History & Development (PMC). PMC
15. Singh T. D. & Reddy P. The Truth Pill: The Myth of Drug Regulation in India (book on drug regulation issues). Wikipedia
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).
REFERENCES:
1. Amit G, Vandana S, Sidharth M. HYPERLIPIDEMIA: An Updated Review. Inter J of Biopharma & Toxicol Res 2011;1:81-89.
2. Virchow RP, Thrombose IG. In Gesammelte Abhandlungen zur Wissenschaftlichen Medicin. Frankfurt-am-Main, Meidinger Sohn & Company 1856, S 458-564.
3. Ankur rohilla, Nidhi Dagar, Seema Rohilla, Amarjeet Dahiya, Ashok Kushnoor. HYPERLIPIDEMIA- a deadly pathological condition. Inter J Curr Pharma Res 2012;4:15-18
4. Ross R, Glomset JA. The pathogenesis of atherosclerosis. N Engl J Med 1976;295:369-77.
5. Grundy SM, Vega GL. Hypertriglyceridemia: causes and relation to coronary heart disease – Semin. Thromb. Hemost 1988;14:249-64.
6. Dargel R. Lipoproteins and the etiopathogenesis of atherosclerosis. Zentralbl Allg Pathol 1989; 135: 501-504.