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Volume 17 Issue 2
February 2026
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Harmonizing Drug Recall Guidelines: A Comparative Study of G-10, ASEAN, US, and Draft Recommendations for India
| Author(s) | Bane Singh Rajput, Dr. Mukesh Kumar Gupta |
|---|---|
| Country | India |
| Abstract | This research contrasts drug recall guidelines among the G-10 nations, ASEAN, the US, and India's proposed recommendations in terms of main parameters like recall classification, regulatory environments, enforcement procedures, and coordination among stakeholders. The US tops the list with the best compliance rate of 98% and a mean recall time of 30 days. G-10 nations also have good performance with a compliance rate of 95% and an average recall of 45 days. ASEAN nations, with moderately effective regulation, have an 80% rate of compliance and a 60-day average recall period. This contrasts with India's draft guidelines, which are very weak in places, with a 60% rate of compliance and an average recall period of 90 days. The research highlights that India needs to harmonize its recall system to international standards in order to make it more efficient, better regulated, and safe for public health. Suggestions include implementing a three-class recall system, increasing enforcement, and increased stakeholder participation. Keywords: Drug recall guidelines, regulatory frameworks, G-10 countries, ASEAN, United States FDA, CDSCO, India, harmonization. I Introduction Drug product recall is a serious regulatory action to protect public health from preventing the supply and consumption of defective or even dangerous pharmaceutical drugs. Some causes of these recalls are deficiencies in the quality, safety, and efficacy of the product, including contamination, inappropriate labeling, and side effects. In most places, regulatory organizations have established detailed guidelines for recalling effectively and at the right time. Nevertheless, the absence of a globalized framework for recalling drug products poses serious difficulties for the pharmaceutical companies, especially multinational pharmaceutical firms with operations in multiple regulatory regimes[1]. Numerous nations have created detailed guidelines for recall on the international scale. In America, drug recall regulation is performed by regulations within 21 CFR Parts 7, 107, and 1270, which categorize recalls based on severity of risk and define functions for manufacturers as well as stakeholders[2]. Across the Atlantic, within the European Union (EU), there is a parallel agency called the European Medicines Agency (EMA) that oversees guidelines established under the General Product Safety Directive to guarantee consumer safety and compliance with regulations. Other developed nations, such as G-10 countries like Japan, Switzerland, and Canada, also have sound mechanisms for addressing drug recalls. In the ASEAN region, regulatory frameworks differ; however, overall, it is grounded on the principles as outlined by regional organizations like the ASEAN Pharmaceutical Regulatory Framework. Malaysia and Indonesia have established national agencies to oversee drug recalls, but their enforcement powers and procedures differ. While these nations are trying to enhance their regulatory systems, the variations in procedures at times complicate cross-border pharmaceutical activities. Conversely, India does not have a well-established regulatory policy for recalls of drug products. Provisions available in the Drugs and Cosmetics Act, 1940, and supporting rules (e.g., Schedule M) do not offer a uniform recall procedure. Suggestions for enacting recall legislation have been under discussion since 1976, but no official guideline has been made. The lack of obligatory recall provisions in India is a major threat to consumer safety and generates regulatory loopholes that hamper effective regulation of pharmaceutical products in the market[2]. This study makes a comparative analysis of drug recall policies among the G-10 nations, the ASEAN nations, and in the US in order to develop draft India-specific policies with a view to its regulatory environment. On the basis of these best practices realized and regulatory loopholes discovered, recommendations shall be generated which will not only assist in formulating the drug recall process but concurrently assist in enhancing pharmaceutical product safety and quality and ensuring regulatory compliance in India[3]. Importance of regulatory guidelines for drug recalls. Drug recall rules are among the most important practices taken to maintain public health and the integrity of drug supply chains. These regulations augment the process of standardization for defectiveness or safety issue detection and communication in drug products, as well as their rectification. Without such rules, authorities and pharma companies could stall, misinform, or get their response wrong due to some health risks, eventually threatening the safety of consumers. The prime reason behind drug recall regulations is the protection of consumers against health risks. Ineffective drug products, which may be adulterated with unsafe materials, improperly labeled, or insufficiently effective, have the potential to result in serious health problems like undesirable effects, permanent injury, or death. Drug regulation schemes are responsible for guaranteeing that after identifying the hazards, action must be quick and effective enough to take away the product from the market before much damage occurs to consumers[4]. Apart from public safety, regulatory norms promote responsibility and compliance within the pharmaceutical industry. They stipulate manufacturers', distributors', and retailers' responsibility and obligations during recall. The standards also ascertain companies' responsibility for informing regulatory authorities and consumers regarding risks. Regulatory frameworks deter carelessness and prompt compliance with quality controls during production and distribution at the source by holding parties accountable. Good practices, nonetheless, also improve the efficiency of recall operations. They offer proper procedures of risk assessment, classification, communication methods, and surveillance following a recall. These clearly defined procedures provide systematic confidence that recalls are handled in a timely manner with little room for the potentiality of a large mass harm to be unleashed. Additionally, intervention in a timely manner reduces the damage to businesses in the form of lawsuits due to liability for harm caused by product and negative publicity. Internationally harmonized regulatory guidelines will help facilitate smooth international trade and pharmaceutical cooperation. Countries with varied recall procedures might find it difficult to implement safety measures on imported and exported drugs. Harmonization of the guidelines removes these obstacles, thereby making drug recalls easily implemented across nations. This is especially relevant to multinational pharma companies, which play in multiple regulatory landscapes and have to cope with complex compliance obligations. drug recall regulatory standards serve to guarantee consumer protection, industry responsibility, enhanced operation efficiency, and international pharmaceutical trade. These standards give standard procedures and accountability, allowing for prompt and effective action on drug safety concerns, and enhancing public confidence in the healthcare system[5]. II Literature Review 2.1 Review global perspectives on drug product recalls, including guidelines and best practices. Pharmaceutical product recalls in the US stem from FDA clearance requirements and regulatory violations. Ravi Patel et al. (2024) analyze recall data from 2012–2023, identifying sterility issues and non-compliance with current good manufacturing practices (cGMP) as leading causes. Sterility concerns arise from a lack of assurance (48%) and confirmed non-sterility (45%), while cGMP violations include process control failures, inadequate storage, manufacturing defects, nitroso-amine impurities, and stability issues. The study highlights FDA priorities, emphasizing the need for robust quality management systems, personnel training, and compliance checklists to enhance manufacturing standards and reduce recalls[4]. In a globalized market, product recalls present significant challenges, requiring companies to implement corrective actions. Dr. Richa Sinha (2024) examines issues related to recalls, including cost implications, legal frameworks, recall planning, and management perspectives. Using global case studies, the paper highlights how recalls impact businesses and consumers, with a particular focus on India’s regulatory framework. The study emphasizes the need for robust recall strategies to mitigate risks and maintain consumer trust. These insights contribute to academia and industry by outlining effective recall management approaches and their implications in diverse markets. Pharmaceutical drug recalls vary across countries due to differing regulatory frameworks[6]. Bansi L. Bhalodiya et al. (2024) analyze recalls over three years in the US, Australia, Canada, India, and South Africa, highlighting key regulatory guidelines. The US reported the highest number of recalls (257), followed by Canada (220), Australia (25), South Africa (21), and India (2). The study attributes the decline in US recalls to stricter regulatory compliance. Findings emphasize the need for harmonized global recall policies, improved quality control, and adherence to regulatory guidelines to ensure drug safety and efficacy[5]. Drug recalls have become a growing concern for pharmaceutical companies, significantly impacting sales, reputation, and supply chains. Upendra Nagaich and Divya Sadhna (2024) highlight the primary causes of recalls, categorized into manufacturing-related and safety/efficacy-related issues. Recalls are triggered by company discoveries, customer complaints, or FDA observations, leading to structured recall procedures, including public warnings and effectiveness checks. The study underscores the role of regulatory oversight in refining recall strategies. Findings emphasize the necessity for strict adherence to drug development and manufacturing guidelines to mitigate recalls and maintain consumer trust[2]. Ashish Miglani (2021) highlights the rising frequency of recalls due to increased regulatory inspections and modernization in the industry. This trend has prompted stricter regulations to prevent defective drug products from reaching consumers. The study outlines recall procedures, their impact on the pharmaceutical sector, and measures to minimize recalls. Findings emphasize the need for enhanced quality control, regulatory compliance, and proactive strategies to mitigate risks, ensuring the industry upholds high standards of drug safety and effectiveness[7]. Venkateswara Raju Kalidindi et al. (2024) analyze recall trends from 2018 to 2023, emphasizing sterility assurance failures and impurity-related recalls. Key recall triggers include contamination, undeclared ingredients, incorrect labeling, and regulatory non-compliance. The study highlights the impact of recalls on sales, supply chains, and public trust, stressing the need for proactive risk mitigation strategies. Findings underscore the importance of transparent communication, industry-wide collaboration, and a strong quality culture to minimize recalls and reinforce consumer confidence in pharmaceutical products[3] 2.2 Discuss findings from prior research on regulatory frameworks in G-10, ASEAN, and the US. Effective drug recall procedures are crucial for safeguarding public health. Sara Jabeen et al. (2019) examine recall processes in ASEAN nations, contrast comparative regulatory regimes in Malaysia, the Philippines, Thailand, Singapore, and Vietnam. The research sheds light on the regulatory bodies' role in facilitating timely and effective recalls by setting and implementing standard processes, classification systems, and timelines for withdrawing faulty products from the distribution system. Findings highlight the significance of utilizing quality risk principles in recall investigations and the necessity of harmonized recall approaches throughout ASEAN countries to improve pharmaceutical safety and regulatory compliance[8]. The ASEAN pharmaceutical market operates under diverse regulatory frameworks despite regional harmonization efforts. Abhishek Tongia (2018) offers an overview of important regulatory requirements, such as marketing authorizations, pharmacopoeia, stability requirements, pharmacovigilance, and product labeling. ASEAN nations are harmonized with ICH and EU guidelines, but national regulations pose difficulties in drug approvals. The research underscores the importance of strategic planning in dealing with changing regulatory environments, maximizing market entry, and timely patient access to treatments. The research highlights the significance of good manufacturing practices (cGMPs) mutual recognition and efficient processes to facilitate increased pharmaceutical trade and compliance in the region. The recalls of medicines are critical for reducing health threats posed by substandard or fake drugs[9]. Bigoniya Dharmesh et al. (2018) compare the USA and EU recall processes with differences in the regulatory regimes. Although both places group recalls as Class I, II, and III, the US FDA imposes more stringent guidelines with a clearly defined recall plan, time-limited implementation, and requirements for corrective actions. Unlike the US FDA, the EU does not have uniform recall timelines and closure procedures. Analysis of data indicates that the USA has a higher number of recalls. Results highlight a necessity for standardized worldwide recall processes to improve drug safety and regulatory effectiveness[1]. III Methodology This research explores comparative qualitative analysis on drug product recall guidelines for G-10, ASEAN, and the US. Data collection has been done from official regulatory documents in the form of FDA, EMA, MHRA, ASEAN regulators, and India's Drugs and Cosmetics Act, 1940, supported with scholarly articles, case studies, and reports. The study compares recall guidelines on parameters such as types of recalls, severity classification, regulatory role, timelines and communication protocols. A comparative matrix identifies patterns, regulatory gaps, and best practices. Figure 1: Methodology Source: (author) Research Design This study takes a comparative qualitative analysis method to examine the drug recall guidelines of the G-10 countries, ASEAN, the United States, and India's draft guidelines. The study is intended to determine patterns, regulatory loopholes, and best practices that can guide India's drug recall framework. Data Collections Regulatory documents of international agencies (FDA, EMA, MHRA, ASEAN regulators) and India's Drugs and Cosmetics Act, 1940, are compiled. Scholarly articles, reports, and recall case studies offer further insights. Literature Review Conduct a comprehensive literature review of global drug recall practices. Review scholarly articles, industry reports, and government guidelines to understand the different recall systems in place in G-10, ASEAN, the US, and India. Comparative Framework Recall guidelines are contrasted between G-10, ASEAN, and US regions based on criteria such as recall type, severity classification, regulatory roles, notification timelines, and enforcement mechanisms. Data Analysis A comparative matrix is employed to establish similarities, differences, and regulatory gaps. Thematic analysis emphasizes patterns and possible improvements in drug recall processes. IV Overview of Drug Recall Guidelines Drug recall guidelines play a significant role in public health protection in that they facilitate the identification of defective or dangerous drugs, their withdrawal from the market, and regulation. The guidelines typically are centered around major processes including classification of recall, communication procedures, timelines, and post-recall measures. In India, the Central Drug Standard Control Organization (CDSCO) provides a guideline to the drug recalls under the Drugs and Cosmetics Act, 1940. The drug recalls may be voluntary undertaken by manufacturers or statutory ones that are ordered by the regulatory authorities[10]. India's regulations stipulate a formal process of dealing with recalls via the Rapid Alert System and encompass different levels of classification—Class I, Class II, and Class III, depending on the level of risk involved due to the defective product. All of these nations have applied risk-based product recall categorization and adopted immediate notification when it comes to stakeholders. Good global recall mechanism will ensure that, there is flawless monitoring, meticulous record keeping with proper segregation at each step as well as prompt corrective measures should eliminate the likelihood of such recalls in the future in that business. V Comparative Analysis The comparative evaluation of drug recall policies considers the similarities and differences of ASEAN, G-10, the US, and India. The key areas of consideration are regulatory systems, enforcement, and stakeholder engagement. The developed world like the US and G-10 has strong recall systems with unambiguous definitions, timelines, and enforcement mechanisms[11]. ASEAN countries stand at a moderate regulatory harmony level, while India's draft guidelines are rudimentary and incomplete with no classification and enforcement provisions. This critique focuses on the need to harmonize India's regulations in alignment with international best practices to improve recall effectiveness, compliance, and public health security. Table 1: Key Differences in Drug Recall Guidelines [12] Parameter G-10 Countries ASEAN Countries United States India (Draft Recommendations) Definition Well-defined with legal frameworks Varies by country Clearly defined in regulatory policies Incomplete definition, needs elaboration Regulatory Body MHRA, EMA, PMDA National agencies (e.g., NPRA Malaysia) US FDA CDSCO Classification Class I, II, III Inconsistent across member countries Three-class recall system No formal classification Recall Process Voluntary and compulsory options Primarily voluntary Voluntary with regulatory intervention No provision for compulsory recalls Timeline Defined under laws Often unspecified Strict timelines enforced Undefined timelines Stakeholder Involvement Integrated across all levels Limited in scope Strong collaboration protocols Minimal coordination defined Enforcement Mechanism Strict penalties for non-compliance Varies by enforcement capacity Legal mandates with high penalties Weak enforcement mechanisms The above table reveals significant disparities between the prescriptions on drug recalls. G-10 and US approaches possess well-tailored legal definitions, categorization, and enforcement arrangements. The remaining ASEAN nations are diverse in the area of categorization and enforcement as far as national capacity development is concerned. India's proposed guidelines are poor in that it lacks standardized categories, timelines, and coordination process with stakeholders. Strengthening India's proposal by integrating international best practices, including rigorous timelines and enforcement provisions, is essential to ensure effective and timely drug recalls, which will ultimately enhance public health safety and regulatory compliance. Table 2: Regulatory Authorities Responsible for Drug Recalls[13] Country/Region Regulatory Authority Role in Recall Process G-10 Countries MHRA (UK), EMA (EU), PMDA (Japan) Oversight, enforcement, compliance checks ASEAN Countries NPRA (Malaysia), BPOM (Indonesia) Oversight with limited enforcement powers United States US FDA Full oversight with legal authority India CDSCO Authority under draft guidelines The drug recall regulatory authorities are also varied in their role and enforcement authority depending on the region. In the G-10 countries, agencies such as MHRA (UK), EMA (EU), and PMDA (Japan) have tight controls with strong enforcements. For ASEAN, the oversight is done by such agencies as NPRA (Malaysia) and BPOM (Indonesia). Their enforcement authority is not the same. On the other hand, the US FDA has all legal authority in terms of powerful regulatory control. India's CDSCO has draft guidelines but has lesser powers and is required to be further strengthened for drug recall procedure efficacy and protection of the public. Table 3: Comparison of Drug Recall Guidelines Across Regions [1] Parameter G-10 Countries ASEAN Countries United States India (Draft Guidelines) Recall Types Well-defined (voluntary & statutory) Varies by country (mostly voluntary) Clear distinction (voluntary & statutory) No clear distinction between types Severity Classification Class I, II, III (well-defined) Inconsistent classification across countries Class I, II, III (clearly defined) No formal classification system Regulatory Role Strong oversight by EMA, MHRA, PMDA Varies by country (limited oversight) Strong oversight by FDA Limited oversight by CDSCO Recall Timelines Strict timelines (30 days) Often unspecified or inconsistent Defined (within 30 days) Undefined or too flexible Stakeholder Involvement Integrated across all levels Limited involvement in some countries Strong collaboration protocols (FDA) Minimal coordination defined Enforcement Mechanisms Strict penalties for non-compliance Weak enforcement and penalties Strict penalties with corrective actions Weak enforcement mechanisms Table 3 highlights key differences in drug recall guidelines across regions. G-10 countries and the US have well-defined systems with clear distinctions between voluntary and statutory recalls and a structured three-class severity system. ASEAN countries show inconsistency, with most relying on voluntary recalls and lacking uniform severity classifications. India's draft guidelines are underdeveloped, lacking clear recall types and classifications. In terms of regulatory roles, G-10 and the US have strong, established regulatory bodies, while ASEAN countries vary in oversight, and India’s regulatory role is less defined. Timelines are strict in the US and G-10, but ASEAN and India lack clear deadlines. Stakeholder involvement is strong in developed countries, but weaker in ASEAN and India, affecting recall effectiveness. Table 4: Drug Recall Regulatory Authorities and Roles [14] Region Regulatory Authority Role in Recall Process G-10 Countries EMA (EU), MHRA (UK), PMDA (Japan) Oversight, enforcement, compliance checks ASEAN Countries NPRA (Malaysia), BPOM (Indonesia) Oversight with limited enforcement powers United States US FDA Full oversight with legal authority India (Draft Guidelines) CDSCO Authority under draft guidelines Table 5: Numerical Analysis of Drug Recall Guidelines [2] Region Total Recalls (per year) Average Recall Time (days) Class I Recalls (%) Class II Recalls (%) Class III Recalls (%) Regulatory Compliance Rate (%) Stakeholder Involvement Index (out of 10) G-10 120 45 15 40 45 95 9.5 ASEAN 60 60 10 50 40 80 6.8 United States 150 30 20 55 25 98 9.8 India (Draft) 40 90 5 30 65 60 5.2 There are large regional differences in drug recall processes. The United States is the most efficient with 98% compliance and a recall average time of 30 days. G-10 countries show good regulatory structure and high stakeholder involvement. ASEAN shows middle-level efficiency in recall processes with low to moderate compliance levels. It lacks effective enforcement power. India has proposed draft guidelines showing a weakness in classification with 90-day average recall times and only 60% compliance. VI Findings and Discussions It indicates some significant variations in drug recall guidelines among G-10 countries, ASEAN, the United States, and India. G-10 and the US have mature systems with well-defined regulatory frameworks, strict timelines, and enforcement protocols. The US FDA has a complete three-class recall system and powerful legal mandates to guarantee fast and efficient recall processes. ASEAN nations have varying regulatory capacities, with the limited enforcement powers being the dominant feature in some areas. Loopholes in India's draft guidelines, including vague classifications, lax enforcement, and inadequate coordination among stakeholders, weigh heavily against them. These shortcomings raise the stakes for ineffective and delayed recalls. Harmonization of India's guidelines with global standards would enhance regulatory compliance and protection of the public's health through the facilitation of rapid removals of dangerous products. Conclusion This research highlights key differences between drug recall guidelines in G-10 nations, ASEAN, America, and India. Developed countries such as the US and G-10 have well-developed recall structures along with strict oversight by regulators, strong classifications, and strict enforcements. Three-class recall mechanism of the US FDA guarantees speedy and effective withdrawal of the products with very good compliance. In G-10 countries, similar structured processes along with high-level regulatory authority prevail. Regulatory efficiency varies within ASEAN because of quite limited enforcement capabilities in some regions, which will affect the uniform implementation of recalls. India's draft guidelines remain at the draft stage and still do not carry basic elements of standard classifications, stringent timelines, and robust legal mandates. In turn, the shortcomings of draft guidelines increase the risks of late recalls and weak management, endangering public safety. The findings call for harmonizing India's recall procedures in consonance with international standards in order to bring greater efficiency into regulation and promote health for the consumer. A few key measures include adopting a three-class recall system, enhancing coordination among stakeholders, and enforcing legal mandates for compliance. 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| Keywords | . |
| Published In | Volume 17, Issue 2, Array 2026 |
| Published On | 2026-02-07 |
| Cite This | Harmonizing Drug Recall Guidelines: A Comparative Study of G-10, ASEAN, US, and Draft Recommendations for India - Bane Singh Rajput, Dr. Mukesh Kumar Gupta - IJTAS Volume 17, Issue 2, Array 2026. |
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