October 2025 Issue 5

Different types, specific packaging and labeling regulatory requirements as per CDSCO in India in comparison with Sweden

This project aims to analyze and compare the regulatory requirements related to packaging and labeling of pharmaceutical products in India and Sweden. In India, these regulations are governed by the Central Drugs Standard Control Organization (CDSCO), whereas in Sweden, they fall under the jurisdiction of the Medical Products Agency (MPA), in line with the European Medicines Agency (EMA) directives. The study categorizes the types of pharmaceutical products-such as prescription drugs, over-the-counter (OTC) medicines, biological and medical devices-and examines the specific packaging and labeling requirements for each category. It investigates critical elements such as Language requirements, font size, barcoding, serialization, tamper-evidence features, and safety warnings, highlighting the underlying rationale rooted in patient safety and traceability. Through comparative analysis, the project identifies key differences and similarities between Indian and Swedish regulations. While CDSCO emphasizes local language labeling and rigid compliance with the Drugs and Cosmetics Rules, Sweden follows harmonized European Union (EU) standards with multilingual packaging requirements and Centralized Pharmacovigilance practices. This comparative study provides insights for pharmaceutical companies looking to market their products in both regions, guiding them to navigate regulatory expectations efficiently. The project also highlights potential challenges and opportunities in harmonizing global regulatory practices.

GC-MS Analysis of Phytocomponents In the Ethanolic Leaf Extract of Allium Fistulosum Linn

The present study investigates the phytochemical composition of the ethanolic leaf extract of Allium fistulosum L. (Welsh onion) using Gas Chromatography–Mass Spectrometry (GC–MS). The analysis identified 38 bioactive compounds, including fatty acids, esters, sterols, alcohols, phenolics, and other secondary metabolites. Major constituents detected were n-hexadecanoic acid (27.81%), DL-Proline, 5-oxo-, ethyl ester (10.77%), γ-sitosterol (7.94%), 9, 12, 15-octadecatrienoic acid (4.60%), and phytol (4.22%). These compounds are reported to exhibit various pharmacological activity such as antimicrobial, antioxidant, anti-inflammatory, and potential anticancer activities. The phytoconstituents identified highlight the therapeutic relevance of A. fistulosum and provide scientific support for its traditional medicinal applications. The findings further suggest potential utility of this plant in pharmaceutical, nutraceutical, and cosmetic formulations.

Regulatory Requirements on Pharmacovigilance as Per CDSCO in India Comparison with Japan

Pharmacovigilance (PV) plays an analytical role in ensuring drug safety and public health. This research explores the regulatory frameworks and PV systems in India and Japan, focusing on the Central Drugs Standard Control Organization (CDSCO) and Pharmaceuticals and Medical Devices Agency (PMDA), respectively. Historical developments, adverse drug reaction (ADR) reporting systems, risk management protocols, and international harmonization practices are discussed.1 India's PV system has evolved through programs such as the Pharmacovigilance Program of India (PvPI), whereas Japan’s system emphasizes structured post-marketing surveillance (PMS) and risk management plans (RMPs). Although both systems have made significant progress, challenges such as underreporting in India and regulatory burden in Japan persist. This comparative analysis offers insights into upgrading global pharmacovigilance through interactive learning and harmonization.

Phytochemical Investigation of the Bark of Parkinsonia aculeata and Rotula aquatica: A Comparative Study

The present study investigates the phytochemical profile of the bark of Parkinsonia aculeata and Rotula aquatica, two medicinal plants known for their traditional therapeutic applications. The bark samples were subjected to extraction using alcohol and water, followed by qualitative phytochemical screening to detect the presence of secondary metabolites. The extracts were evaluated for constituents such as alkaloids, flavonoids, steroids, tannins, carbohydrates, and saponins. The results confirmed the rich presence of flavonoids and phenolic compounds in both plants, supporting their ethnomedicinal relevance. These findings contribute to the standardization and quality control of these plants in herbal drug formulations.

Curcumin-Non-Aqueous Gel - A Newer Paradigm For The Treatment Of Skin Cancers Via The Topical Route

Curcumin is a novel phytochemical compound proven to be effective in treating many types of cancers, including skin cancer. But its therapeutic applications are limited due to its poor aqueous solubility, stability, and permeability. Methods: To overcome these problems, a novel non-aqueous gel formulation loaded with curcumin was developed for topical administration, using Versagel as the gel base, and its ex vivo permeability characteristics were evaluated. Results: The formulations showed a good spreadability, with 18.6% and 23-40% of the drug released within 24 hours of ex vivo studies. The drug release data were fitted to the Higuchi model and the Korsmeyer-Peppas model. The rate of drug release followed first-order kinetics, and the mechanism of drug release was found to be pure Fickian diffusion. Stability studies revealed that curcumin was stable at room temperature, with a calculated half-life of 1506 days. No skin irritation was observed in the skin irritation test. Conclusion: It is concluded that for drugs unstable in aqueous physiological environments, with poor permeability and oral bioavailability, incorporating them into a non-aqueous topical gel (Versagel) represents a novel approach to enhance their stability and therapeutic efficacy in skin cancers. 

Regulatory Requirements for Paediatric Oncology Drugs As Per CDSCO In India Comparison with United States

Paediatric oncology requires regulatory approaches that balance timely access with child-specific safety. This abstract equates the laws and rules for medicines used to treat childhood cancers in the India and United states. It reviews the regulations created by the Food and Drug Administration (FDA) in the US and the Central Drugs Standard Control Organization (CDSCO) in India focusing on trial design, approval pathways, incentives, ethics, and post-marketing safety. Paediatric oncology is a medical field that deals with diagnosing and treating cancers in children, from babies to teenagers. Children's medicine is different from adult medicine in various ways, such as how medicines are administrated, how metabolism takes place in children body and the way the body functions.  Many medicines given to children are made for adults, so the doses need to be changed to be safe for them. The USA demonstrates structured paediatric mandates (PREA, BPCA, RACE Act) and robust post-marketing mechanisms, while India operates through NDCTR 2019 and ethics-based oversight with fewer formal incentives. Differences exist in trial networks, orphan incentives, and pharmacovigilance capacity.  The article looks at the current state of laws for children's medicines worldwide to show important efforts, difficulties, and progress in this area. These regulations require that medicines are drugged properly for a child's age, tested well in clinical trials, and labelled clearly to avoid misuse. Harmonization, strengthened paediatric trial infrastructure, and targeted incentives in India could accelerate paediatric oncology drug availability while maintaining safety. Cross-border collaboration is recommended. Keywords; Regulatory requirements, Paediatric Oncology, CDSCO, FDA, Pharmacovigilance

Marketing Challenges In Promoting Herbal V/S Allopathic OTC Products

OTC medications are essential for increasing access to healthcare since they allow people to self-medicate for mild ailments. In this project, the marketing difficulties of over-the-counter herbal and allopathic medications are compared. Despite being largely regarded as safe, natural, and culturally acceptable, herbal over-the-counter medications (OTCs) confront several challenges, including slower onset of action, clinical validation, standardization, and regulatory compliance. The strong scientific backing, stringent regulation, and quick therapeutic results of allopathic over-the-counter medications, on the other hand, make them vulnerable to price pressure, restrictions on promotions, and growing customer demand for "natural" substitutes. The study draws attention to variations in pricing policies, promotional restrictions, consumer perception, and regulatory frameworks. Antihistamine, antipyretic, antitussive, and NSAID case comparisons show differences in adverse effects, adherence, and market share. For both herbal and allopathic over-the-counter marketers to be successful in the cutthroat healthcare industry, they must ultimately embrace flexible tactics, guarantee evidence-based claims, and cultivate consumer trust. For both industries to thrive sustainably, patient-centered strategies, innovation, and responsible promotion are crucial.

Regulatory Requirements For Biotechnological Products As Per CDSCO In India Comparison With USFDA

Biotechnological products have transformed modern medicine by providing targeted and innovative therapies, including recombinant proteins, monoclonal antibodies, gene therapies, and vaccines, forming the foundation of precision medicine. However, their biological complexity and structural variability necessitate stringent regulatory oversight to ensure safety, efficacy, and quality. This study presents a comparative analysis of regulatory frameworks governing biotechnological products in India and the United States. In India, the Central Drugs Standard Control Organization (CDSCO) serves as the apex regulatory authority, implementing guidelines under the Drugs and Cosmetics Act of 1940. It mandates rigorous preclinical evaluations, phased clinical trials, adherence to Good Manufacturing Practices (GMP), and robust post-marketing surveillance to ensure product safety and therapeutic benefit. Conversely, the United States Food and Drug Administration (US FDA) regulates biotechnological products under the Public Health Service (PHS) Act and the Food, Drug, and Cosmetic (FD&C) Act. A distinctive feature of the US system is the Biologics License Application (BLA), which requires extensive clinical trials, comprehensive pharmacovigilance, and stringent GMP compliance, reflecting a strong emphasis on scientific validation and patient safety. The comparative analysis highlights key differences in approval timelines, regulatory pathways, clinical data requirements, and pharmacovigilance mechanisms. While CDSCO focuses on accessibility and affordability within India, the US FDA prioritizes exhaustive scientific evaluation and global standardization. Understanding these regulatory nuances is essential for pharmaceutical companies to streamline product development, ensure compliance, and foster public trust. This study underscores the need for harmonization and mutual recognition of standards to accelerate global patient access to life-saving biotechnological therapies.

Evaluation of Therapeutic Potential of Medicinal Plant in the Management of Diabetes

Diabetes mellitus is a chronic metabolic disorder that has become a major global health burden due to its progressive complications and rising prevalence. It is associated with long-term damage to vital organs, including the heart, kidneys, eyes, and nerves, thereby contributing significantly to morbidity and mortality worldwide. Although several synthetic anti-diabetic are currently available, their long-term use is often accompanied by adverse effects such as hypoglycemia, gastrointestinal disturbances, and reduced therapeutic efficacy. These limitations highlight the urgent need for safer, more effective alternatives to improve diabetes management. In this context, medicinal plants have emerged as promising candidates, as they not only help regulate blood glucose but also offer additional health benefits with fewer side effects compared to conventional drugs. Among the medicinal plants investigated for antidiabetic potential, Cinnamomum cassia and Terminalia catappa have attracted considerable attention. These plants are rich in bioactive phytochemicals such as cinnamaldehyde, flavonoids, tannins, and terpenoids, which demonstrate hypoglycemic, antioxidant, and β-cell rejuvenate properties. Animal model studies have shown that these plants can effectively lower blood glucose and enhance insulin sensitivity, thereby protecting against diabetes-induced complications. The growing interest in medicinal plants reflects their potential as safer and multifunctional therapeutic options. By integrating these natural agents into diabetes management strategies, it may be possible to achieve better glycemic control while minimizing adverse effects. These results strongly indicate the potential of medicinal plant as complementary therapeutic agents, supporting progressive efforts to combine medicinal plants into diabetes management strategies.

Regulatory requirements for stem cell therapy as per CDSCO in India comparison with Brazil

Stem cells are fundamental units of every multicellular organism because they have the ability to differentiate into many kinds of mature cells. Stem cells have the characteristic of totipotency and also self-renewal. Adult stem cells possess multipotency with differential plasticity, which can be exploited for future generations of therapeutic options, though very early embryonic stem cells show totipotency. Fortunately, scientists did discover regulators in terms of pleuripotency, such as the oct-4 & Nanong protein. Stem cells occur in all of us, ranging from the initial stages of human development to the terminal stage of life. Stem cells are not specialized cells that become specialized cells, which comprise the various types of tissue in the human body. The ability of stem cells to regenerate and repair tissue is very promising. Stem cell therapy is a unique medical treatment that can use donor (allogeneic) or the body's own cells (autologous) to repair and regenerate damaged tissues. It has only been now that scientists have known stem cells well enough to consider the prospects of culturing them outside the body for extended periods.

Assessment of Effectiveness of Self-Instructional Module (SIM) on Knowledge Regarding Stress Management among Nursing Officers Working in ICU in Selected Hospital at Hassan

Nursing is a highly demanding and stressful profession that requires the ability to cope with critically ill or dying clients and medical emergencies. Nurses often encounter tough situations that demand dedication, sound academic knowledge, clinical skills, and time management to complete multiple tasks effectively. Coping strategies and resilience are essential to maintain well-being and ensure quality patient care. The objectives of present works are To assess pre-existing knowledge regarding stress management among ICU nursing officers in a selected hospital at Hassan. To evaluate the effectiveness of a self-instructional module (SIM) on stress management. To determine the association between pre-test knowledge scores and demographic variables. An interventional one-group pre-test post-test pre-experimental design was adopted. Forty participants were selected using purposive sampling. Data was collected through a structured knowledge questionnaire. The SIM was administered after the pre-test, and the post-test was conducted after 7 days. Data was analyzed using descriptive and inferential statistics. The mean post-test knowledge score (72.18%) was significantly higher than the pre-test score (36%) (Paired t = 21.915, df = 39, p < 0.001). Pre-test knowledge levels were significantly associated with number of children. The study concluded that the self-instructional module was effective in improving knowledge regarding stress and its management among ICU nursing officers.

Regulatory Requirements on Parenteral Dosage Forms – A Comparative Analysis of CDSCO (INDIA) and DDF (CAMBODIA)

Parenteral products enter directly into the bloodstream or other sterile body cavities; any failure in sterility or pyrogen control can therefore be fatal. India’s Central Drugs Standard Control Organization (CDSCO) and Cambodia’s Department of Drugs and Food (DDF) impose distinct—but increasingly convergent—regulatory frameworks to safeguard these medicines. Using document analysis of primary statutes, 2023-2025 draft amendments and technical guidance, this study compares nine domains: dossier structure, good manufacturing practice (GMP), quality control, labelling, pharmacovigilance, clinical data, timelines, user fees and intellectual-property protection. CDSCO’s reviewed Schedule M introduces ISO-class cleanrooms, media-fill twice yearly and real-time environmental monitoring, whereas DDF relies on ASEAN Common Technical Dossier (ACTD) and WHO-GMP while fast-tracking import licenses to bolster access. India mandates local bioequivalence (BE) for most generic injectables and endotoxin limits , while Cambodia grants BE waivers for well-established therapeutic classes to attract investment. Timelines average nine months in India and twelve in Cambodia, but Cambodian fees remain lower. Alignment opportunities include mutual GMP recognition and a shared e-submission portal. Findings assist manufacturers in dossier planning and support regulators in harmonizing approvals without flexible patient safety.

Integrating Real-World Evidence (RWE) in Oncology Drug Regulation: A Comparative Analysis of CDSCO and Health Canada

Cancer remains a major global health challenge, necessitating continuous innovation in oncology therapeutics. While randomized controlled trials (RCTs) are the traditional gold standard for evidence generation, they often lack applicability to diverse real-world populations. This has fuelled growing interest in incorporating Real-World Evidence (RWE), derived from Real-World Data (RWD), into regulatory decision-making processes, especially in oncology. This study aims to compare how RWE is integrated into oncology drug regulation by two key regulatory bodies, Health Canada and India’s Central Drugs Standard Control Organization (CDSCO), in order to identify lessons and opportunities that can support India's evolving regulatory framework. A qualitative comparative analysis was conducted using regulatory documents, guidance frameworks, and real-world case examples. Canada’s CanREValue initiative was explored in depth, alongside an assessment of India’s emerging digital health infrastructure and policy efforts. Health Canada has established a mature RWE framework supported by multi-stakeholder collaborations and pilot projects, facilitating dynamic regulatory decisions in oncology. In contrast, CDSCO is in the early stages of RWE adoption, with limited formal guidance. However, initiatives like the Ayushman Bharat Digital Mission (ABDM) and national health registries offer promising pathways. Canada’s regulatory progress offers valuable insights for India. Strengthening digital infrastructure, developing national RWE frameworks, and fostering collaboration could transform India’s oncology regulatory ecosystem. This study highlights the potential of RWE to improve evidence-driven decision-making and enhance access to cancer therapies.

Targeted Gene Bisulfite Sequencing Identifies Changes In P21 Methylation by the Nephrotoxicant Bromate

This study aimed to evaluate site-specific changes in the methylation of the nephro-protective gene p21 (CDKN1a) after exposure to nephrotoxicants using a targeted bisulfite sequencing approach. A targeted gene bisulfite sequencing (TGBS) method was developed using the Illumina MiSeq platform and Bismark bisulfite mapper. Human embryonic kidney (HEK293) cells and freshly isolated human proximal tubular cells (hPT) were analyzed, and 5-aza-2’-deoxycytidine (5-Aza), a DNA methyltransferase inhibitor, served as a positive control. Methylation differences between human and rat p21 were also investigated. TGBS analysis identified a methylation-sensitive site in the p21 promoter region, sis-inducible element-1 (SIE-1), which regulates p21 expression via transcription factor binding. Treatment with 5-Aza altered methylation at this site, whereas nephrotoxicants cisplatin and bromate (BrO3?) did not, despite increasing p21 protein expression. No SIE-1 site was detected in normal rat kidney cells (NRK), indicating species-specific differences. Cisplatin and BrO3? exposure did not decrease promoter methylation in either HEK293 or NRK cells. These findings reveal species-specific differences in basal p21 promoter methylation and indicate that nephrotoxicant-induced changes in p21 expression are independent of promoter DNA methylation. The study also demonstrates the utility of TGBS for rapid analysis of locus-specific DNA methylation.

Marketing development of Affordable Medicines