Volume : 13, Issue : 08, August – 2026

Title:

REGULATORY IMPLICATIONS OF DATA INTEGRITY ISSUES IN INDIAN PHARMACEUTICAL MANUFACTURING.

Authors :

Shireesha Mulkala*, Ch. Rajveer

Abstract :

Data integrity is a foundational element of Good Manufacturing Practices (GMP) and a critical determinant of product quality, patient safety, and regulatory compliance in pharmaceutical manufacturing. In the Indian pharmaceutical sector, data integrity issues have emerged as a significant regulatory concern, particularly in the context of increasing global scrutiny from agencies such as the Central Drugs Standard Control Organization (CDSCO), the United States Food and Drug Administration (US FDA), and the European Medicines Agency (EMA). Common challenges include incomplete or inaccurate documentation, inadequate control of electronic and paper-based records, manipulation or deletion of data, lack of audit trails, and insufficient adherence to ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available).
Regulatory implications of data integrity lapses are severe and multifaceted, ranging from warning letters, import alerts, product recalls, and suspension or cancellation of manufacturing licenses to reputational damage and loss of market access. For Indian manufacturers, particularly small and medium-sized enterprises (SMEs), such regulatory actions can significantly impact export capabilities and long-term sustainability. The evolving alignment of India’s Schedule M with WHO-GMP guidelines further underscores the heightened regulatory expectations for robust data governance systems, validated computerized systems, and a strong quality culture.
This abstract highlights the regulatory consequences of data integrity failures in Indian pharmaceutical manufacturing and emphasizes the need for systemic corrective and preventive actions, regulatory harmonization, workforce training, and technological modernization to ensure sustained compliance and global competitiveness.
Keywords: Data Integrity; Indian Pharmaceutical Manufacturing; Good Manufacturing Practices (GMP); Schedule M; WHO-GMP; ALCOA+ Principles; Regulatory Compliance; CDSCO; US FDA; EMA

Cite This Article:

Please cite this article in press Shireesha Mulkala et al., Regulatory implications of data integrity issues in Indian pharmaceutical Manufacturing. Indo Am. J. P. Sci, 2026; 13(08).

REFERENCES:

1. Central Drugs Standard Control Organization (CDSCO). (2023). Guidance document on good manufacturing practices. Ministry of Health and Family Welfare, Government of India.
2. Drugs and Cosmetics Act, 1940 & Rules, 1945. (Latest amended edition). Government of India.
3. World Health Organization. (2014). WHO good manufacturing practices for pharmaceutical products: Main principles (WHO Technical Report Series No. 986). WHO Press.
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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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