Ashok Kumar

Melasma is a common acquired hyperpigmentation disorder characterized by the development of irregular, symmetrical, and brownish facial patches, which can significantly affect the appearance and quality of life of affected individuals. Methimazole, an antithyroid drug, has been investigated for its potential topical depigmenting activity due to its ability to interfere with melanogenesis. The present study was undertaken to develop and evaluate a methimazole-loaded emulgel intended for topical application in the management of melasma. Pre-formulation studies were carried out to determine the solubility, melting point, ultraviolet absorption maximum, and drug–excipient compatibility. The prepared formulations were evaluated for their physical appearance, homogeneity, pH, viscosity, spreadability, drug content, and in-vitro drug release characteristics. Drug–excipient compatibility was assessed using Fourier-transform infrared spectroscopy, while differential scanning calorimetry was employed to investigate the thermal characteristics of the formulation. The developed emulgels exhibited satisfactory physical characteristics with acceptable pH, viscosity, spreadability, and drug content, indicating their suitability for topical administration. In-vitro drug release studies demonstrated sustained release of methimazole from the emulgel formulations over the studied period. The release data were further analysed to understand the mechanism of drug release. Short-term stability studies were also performed to assess the physical and chemical stability of the prepared formulations. Overall, the study demonstrated the successful development of a methimazole-loaded emulgel with desirable physicochemical properties and controlled drug-release characteristics, suggesting its potential as a topical formulation for further investigation in the management of melasma. Emulgel have several merits like greaseless, easily spreadable, easily removable, emollient and transparency.

Dapsone is a synthetic sulfone with antimicrobial and anti-inflammatory activity, but conventional topical formulations may provide limited skin penetration and short local retention. This study aimed to develop, optimize, and characterize a dapsone-loaded solid lipid nanoparticle (DDP-SLN) polymeric hydrogel for controlled dermal delivery. DDP-SLNs were prepared by hot homogenization followed by probe ultrasonication using glyceryl monostearate (GMS), soya lecithin, and Tween 80. A three-factor, three-level Box–Behnken design using Design-Expert® Version 13 was employed to optimize the formulation based on particle size, entrapment efficiency, and 12-h cumulative drug release. The optimized DDP-SLN dispersion was incorporated into Carbopol 934 hydrogel and evaluated for physicochemical, rheological, drug-release, and stability characteristics. The optimized DDP-SLN showed a particle size of 140.38 nm, PDI of 0.287, zeta potential of −35.0 mV, and entrapment efficiency of 87.93%. The hydrogel exhibited homogeneous texture, pH of 6.23 ± 0.08, viscosity of 8486.67 ± 70.95 cP, and spreadability of 18.42 g·cm/s. Cumulative drug release reached 87.90% over 12 h and followed the Higuchi model (R² = 0.9910), while the Korsmeyer–Peppas exponent (n = 0.612) indicated anomalous transport. The formulation remained stable under the evaluated storage conditions, demonstrating its potential as a topical delivery system for dapsone. The system was designed to enhance drug localization while providing sustained release and hydrogel performance. These findings demonstrate the suitability of combining SLN technology with a hydrogel to improve topical dapsone delivery and maintain formulation quality.

ABSTRACT: Artificial Intelligence (AI) is emerging as a transformative technology in pharmaceutical regulatory affairs, enhancing efficiency, accuracy, and regulatory decision-making throughout the product lifecycle. Recent studies have demonstrated the application of AI and Machine Learning (ML) in regulatory intelligence, dossier preparation, document management, pharmacovigilance, signal detection, and compliance monitoring. Regulatory agencies worldwide are increasingly exploring AI-driven approaches to streamline regulatory submissions and improve review processes while maintaining safety, efficacy, and quality standards. This review aims to evaluate the role of AI in transforming regulatory affairs and to compare the adoption and implementation of AI-enabled regulatory practices by the Central Drugs Standard Control Organization (CDSCO), India, and Health Canada. The study examines current applications of AI in regulatory operations, including automated document review, adverse event monitoring, data analytics, and decision-support systems. Furthermore, it assesses the opportunities, challenges, and regulatory considerations associated with AI integration, such as data governance, transparency, validation, ethical concerns, and workforce readiness. The study concludes that AI has the potential to reshape the future of regulatory science by improving operational efficiency and regulatory effectiveness. Strategic adoption of AI technologies by regulatory authorities can contribute to faster access to safe and effective medicines while maintaining high regulatory standards4.

ABSTRACT: mRNA based therapeutics have evolved emerged as a promising platform in modern medicine because they facilitate provisional production of specific protein within cells. Their applications extend beyond infectious disease vaccines to cancer immunotherapy, protein replacement, gene editing, regenerative medicine, and treating of genetic disorders. Although, the successful development of these products depends on appropriate control of RNA quality, stability, delivery system, manufacturing processes, safety, and efficacy. This research focus on reviewing the regulatory requirements for m RNA based therapeutics in India and Switzerland with particularly focus on the central drug standard control organization (CDSCO) and SWISSMEDIC. The study compares their regulatory framework, approval pathways, manufacturing requirements, quality and storage condition, development criteria. India follow its existing drug and biological product regulatory framework, while Switzerland provide a structured approach for innovative and advanced therapeutics products. The comparative assessment indicates that India has considerable potential for cost effective manufacturing and expanding mRNA research, whereas Switzerland has a highly developed pharmaceutical and research environment. Continued improvement in regulatory guidance, manufacturing capability, product characterization, delivery technologies and safety monitoring may facilitate the wider development and adoption of mRNA-based therapeutics.

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.

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.

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.

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.

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

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.