Ashok Kumar

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.

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.

With India and the United States having the highest rates of the disease, diabetes mellitus is becoming a global public health concern. In India, which is expected to have the world's biggest diabetic population (more than 101 million by 2023), accessibility and price are major concerns. A significant component of the antidiabetic medication market, which is projected to reach a valuation of USD 1.7 billion in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 3.5% to reach USD 2.01 billion by 2029[1]. The primary treatment for Type 2 Diabetes (T2DM) is still metformin, which is augmented by sulfonylureas, DPP-4 inhibitors, and more recently, SGLT2 inhibitors. With new limitations on illogical fixed-dose combinations, regulatory bodies such as the CDSCO are actively trying to guarantee the safety and effectiveness of pharmaceuticals [2]. Diabetes is a chronic, metabolic disease characterized by elevated blood glucose levels or hyperglycaemia, which results from abnormalities in either insulin secretion or insulin action, or both. According to the report from CDC’s National Diabetes Statistics Report, there are about 37.3 million cases of diabetes in the US which is 11.3% of the US population. The kind of drug most frequently used to treat type 1 diabetes Insulin. Insulin, alpha-glucosidase inhibitors, biguanides, dopamine-2 agonists, DPP-4 inhibitors, GLP-1 receptor agonists, meglitinides and SGLT2 inhibitors, sulfonylureas, thiazolidinediones, and other drugs are commonly used orally to treat type 2 diabetes [3]. Keywords: Antidiabetics, Diabetes Mellitus, Regulatory Bodies, CDSCO, FDA, United States

Parenteral products are currently widely utilized in emergency situations since they provide the highest bioavailability. Parenteral product legislation is crucial as non-sterile, non-pyrogenic products can provide a serious health risk to patients, potentially leading to death. The Central Drugs Standard Control Organization (CDSCO) in India and South African health products regulatory authority (SAHPRA) in South Africa have specified different dosage formats, and this review offers a comparative examination of those requirements. This review explores critical aspects including governing legislation, clinical trial requirements, good manufacturing practices (GMP), quality control, packaging and labelling standards, import and export regulations and recent reforms. As indicated above comparative analysis of regulation and registration process for parenteral dosage from will be valuable regulatory point of view as well as business development point. With this viewpoint industry can unify dossier application in better method, which would aid in lowering time for product to go in market.

The term biosimilar is used for a subsequently launched version of a biologic product which is similar in terms of quality, safety, and efficacy to an already licensed “Reference Biologic” product. The primary purpose of biosimilars is to reduce the healthcare costs associated with the use of biologics and thereby increase access to healthcare. Unlike small molecule generics, the bioequivalence approach is not considered appropriate for the approval of biosimilars. The approval of biosimilars is based on a stepwise comparability exercise with the “Reference Biologic”, starting with a comprehensive physicochemical and biological characterization. The extent and nature of the required nonclinical in vivo studies and clinical studies depend on the level of evidence obtained from the previous steps. Regulations require that the “Reference Biologic” should have been licensed/approved in the same country/region or in other ICH countries based on a full registration dossier. Apart from the comparability exercise, regulations also deal with indication extrapolation, pharmacovigilance, and substitution and interchangeability. This chapter also briefly describes the considerations for exclusivity, market access, and commercialization of biosimilars.

The medical device market in India is a sunrise sector in the pharmaceutical industry and has achieved a milestone in the last few years securing 4th position in the medical device market in Asia with increasing foreign direct investments through governments. Make in India Campaign 2017 and PLI (Product linked incentive) schemes. To enter the medical device market in any country, one has to go through different procedures and regulatory requirements of that country. Medical devices are regulated in India by the DCGI (Drug Controller General of India) under the CDSCO (Central Drug Standard Control Organization). These rules and regulations covers various aspects of device related regulations, including classification, registration, manufacturing and import, labeling, sales, and post marketing requirements, etc. This study is aimed to review and compare the regulatory requirements of South African country with India. Harmonization of medical devices registration across the markets of these two country is essential to overlay way for their easy approval and also in dealing with the withdrawn issues related to quality, safety, and performance.

Bilayer floating tablets of Drotaverine HCL were developed by direct compression method. Immediate release layer contains 20 mg of drug and super disintegrant sodium starch glycolate, serves the purpose of loading dose. Sustained release layer contained HPMC K100, natural polymers like xanthan gum, guar gum, karaya gum release the drug for 12 hours’ time. Sodium bicarbonate and citric acid are used to produce effervescence. Floating lag time of optimized tablet is 92 sec, whereas floating duration is more than 12 hours. FTIR results revealed that there was no interaction between drug and HPMC K100 / xanthan gum. The post compression parameters of developed tablets were found to be satisfactory. In this study, it was confirmed that the formulations containing HPMC K100, have shown better floating properties and finally the formulation containing a combination of HPMC K100 and xanthan gum in 3:1 ratio, has exhibited decent sustained drug release properties. The release kinetics of optimized formulation prepared with the combination of HPMC K100 and xanthan gum followed zero order kinetics.

A novel periodontal film for the treatment of periodontitis was developed by using herbal drug Quercetin, it is a plant flavanol from the flavonoid group of polyphenols. It is found in many fruits, vegetables, leaves, seeds and grains; capers and red onions. It has a bitter flavour and is used as an antimicrobial agent and effective against infecting microorganisms in the periodontal pocket. Calibration curves for Quercetin was developed in phosphate buffer PH 6.6, FT-IR studies was performed, which revealed that no interaction between the selected drug and polymers. Differential scanning calorimetry was performed to the identification of various physical properties and thermal transitions of drug and the polymeric materials. Periodontal films were prepared by solvent casting technique using Eutragit  and HPMC as polymers Dibutyl phthalate as plasticizers and PEG as surface active agent. The formulated periodontal films were evaluated for their folding endurance, percent moisture loss, surface pH, viscosity, thickness, uniformity of weight, content uniformity, and in-vitro release. Scanning electron microscopy was done to study the surface characteristics of the patch on placebo and optimized formulation F3 before dissolution and after dissolution. SEM analysis revealed that the drug was uniformly distributed in patch and drug was released by diffusion. Data of In-vitro release from the formulated periodontal films were fit to different equations and kinetic models to explain release kinetics. Kinetic models used were zero first-order equations and Higuchi models. The release mechanism was understood by fitting the data to Korsemeyer-Peppas model.

The main objective of this study is to improve the physicochemical stability, swelling and drug release pattern of the polymers in biological condition by Hybridization. In this study, interpenetrating polymer network (IPN) of acrylamide grafted ghatti gum (Am-g-GG) and poly vinyl alcohol (PVA) was developed by emulsion crosslinking method. Glutaraldehyde was used as the crosslinking agent. Experiments were performed according to a 23 factorial design to evaluate the effects of GG:PVA ratio, Glutaraldehyde and drug loading percentage on the percent Drug entrapment efficiency, percentage of Swelling at pH 1.2 & pH 6.8 and percentage Cumulative drug release. The effect of the three independent variables on the response variables was studied by response surface plots and contour plots generated by the Design-Expert software. The desirability function was used to optimize the response variables. The compatibility between Miglitol and the excipients was confirmed by differential FTIR spectroscopy analysis. The prepared IPN microspheres showed well controlled release characteristics and continued to drug release following a diffusion-controlled release pattern. The drug release was for a prolonged time without collapsing the IPN matrix. The observed responses taken were in good agreement with the experimental values. Thus, Miglitol IPN microspheres were produced with fewer experimental trials, and a patient compliant product with good stability was achieved with the concept of formulation by design.

The objective of this research work was to carry out design and evaluation of sustained release matrix tablets of Itopride by use of natural and synthetic polymers.  Matrix tablets were prepared by wet granulation technique by using natural polymers like Carbopol 934, Tamarind poly saccharide, Locust bean gum, Ethyl cellulose, HPMC K 100 as matrix forming agent and excipients such as Lactose, Starch 1500, Magnesium stearate, MCC and talc were used. The dissolution medium consisted of 900 ml of 0.1 N HCl for first 2 hours and then 7.4 phosphate buffer for remaining 10 hours. The release of Itopride from matrix containing lactose, micro crystalline cellulose and starch 1500 as diluents. The drug release rate was found in order of lactose> micro crystalline cellulose>starch 1500. The formulation was optimized on the basis of acceptable tablet properties and in-vitro drug release. The release data were fit into different kinetic models (zero-order, first-order, Higuchi’s equation and Korsmeyer-Peppas equation). Optimized formulation was tested for their compatibility with Itopride by FT-IR studies, which revealed that there is no chemical interaction occurred with polymer and other excipients. The drug release profile of the best formulation was well controlled and uniform throughout the dissolution studies.