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Journal articles on the topic 'Central Drugs Standard Control Organization stands for central Drugs Standard Control Organization'

Author: Grafiati

Published: 5 June 2025

Last updated: 2 August 2025

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1

Ashok, Kumar P., R. Bharathi, G. P. Darshan, T. S. Rajesh, K. S. Siddaramaiah, and N. Sushma. "Regulatory requirements in the preparation CTD and ECTD as Per CDSCO comparison with Brazil." World Journal of Advanced Research and Reviews 20, no. 2 (2023): 046–53. https://doi.org/10.5281/zenodo.12568310.

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Stringent regulatory standards apply to the creation of Common Technical Documents (CTD) and Electronic Common Technical Documents (eCTD) for regulatory submissions in India, which are overseen by the Central Drugs Standard Control Organization (CDSCO). The essential regulatory considerations affecting the creation of CTD and eCTD submissions in accordance with CDSCO criteria are summarized in this abstract. It emphasizes how crucial adherence to these rules is to ensure the prompt and effective registration of pharmaceutical goods in India. The advantages of eCTD in simplifying the regulatory

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Bandarapalle, Kishore, Rajasekhar K. K, K. Ramesh Reddy, et al. "A review on CDSCO: central drug standard control organization and regulation on medical devices." Future Journal of Pharmaceuticals and Health Sciences 5, no. 2 (2025): 174–80. https://doi.org/10.26452/fjphs.v5i2.754.

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India has served as a central location for overseeing numerous multi-center trials. This evolution may have its roots in the Central Drug Standard Control Organization (CDSCO), which is led by the Drug Controller General of India (DCGI). It oversees the standards for managing clinical trials in India, including trial conduct, Indian regulations, and the quality of data generated. It is imperative that all clinical trials currently carried out in India adhere to the recently updated Schedule Y of the Drugs and Cosmetics Act and the International Conference on Harmonization's Good Clinical Pract

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S., D. Dhole* R. B. Darade. "Indian Pharmaceutical Regulatory Authority: Review." International Journal in Pharmaceutical Sciences 2, no. 5 (2024): 1109–19. https://doi.org/10.5281/zenodo.11235269.

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Central Drug Standard Control Organization is Regulatory Authority in India. CDSCO is responsible for conducting Clinical trials for new drug and provide approval to the new drug. CDSCO also monitors the Rules and Regulation regarding various medicinal practices in India. Functions of CDSCO include ensuring the quality of drugs, Medical Devices and cosmetics sold in the country, approval of new drugs and regulating clinical trials.

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Abhishek, Deshmukh* Tejas Sharma Dr. Shivshankar Mhaske Krushna Tayade kasim Bhuriwale. "CDSCO: pharmaceutical regulatory authority of India." International Journal of Pharmaceutical Sciences 3, no. 2 (2025): 101–6. https://doi.org/10.5281/zenodo.14789469.

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Central Drug Standard Control Organization is Regulatory Authority in India. CDSCO Is responsible for conducting Clinical trials for new drug and provide approval to the New drug. CDSCO also monitors the Rules and Regulation regarding various medicinal Practices in India. Functions of CDSCO include ensuring the quality of drugs, Medical Devices and cosmetics sold in the country, approval of new drugs and regulating clinical Trials

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Ashok Kumar P, Nayana G U, Nithin N, Sharath Kumar N, Sharvari B, and Yashaswini P R. "Regulatory requirements for biosimilars as per CDSCO in India in comparison with Yemen." World Journal of Advanced Research and Reviews 23, no. 3 (2024): 2292–303. http://dx.doi.org/10.30574/wjarr.2024.23.3.2830.

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This study examines the regulatory requirements for biosimilars in India and Yemen, highlighting similarities and differences between the Central Drugs Standard Control Organization (CDSCO) and the Ministry of Public Health and Population (MOPHP). The regulatory landscape for biosimilars is evolving globally, with varying requirements across countries. This comparative analysis examines the regulatory requirements for biosimilars in India, governed by the Central Drugs Standard Control Organization (CDSCO), and Yemen. A comprehensive review of guidelines, regulations, and approval processes re

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Ashok, Kumar P., G. U. Nithin N. Nayana, Kumar N. Sharath, B. Sharvari, and P. R. Yashaswini. "Regulatory requirements for biosimilars as per CDSCO in India in comparison with Yemen." World Journal of Advanced Research and Reviews 23, no. 3 (2024): 2292–303. https://doi.org/10.5281/zenodo.14964641.

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This study examines the regulatory requirements for biosimilars in India and Yemen, highlighting similarities and differences between the Central Drugs Standard Control Organization (CDSCO) and the Ministry of Public Health and Population (MOPHP). The regulatory landscape for biosimilars is evolving globally, with varying requirements across countries. This comparative analysis examines the regulatory requirements for biosimilars in India, governed by the Central Drugs Standard Control Organization (CDSCO), and Yemen. A comprehensive review of guidelines, regulations, and approval processes re

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Singh, Saloni, and Vikesh Kumar Shukla. "Current regulations for Herbal Medicines in India." International Journal of Drug Regulatory Affairs 9, no. 2 (2021): 30–34. http://dx.doi.org/10.22270/ijdra.v9i2.466.

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India is a major source of herbal plants and medicines. There are substantial numbers of plants and herbs which are used as medicines and people prefer them due to fewer side effects. In India, herbal medicines are regulated by AYUSH, CDSCO (Central Drugs Standard Control Organization), AND D&C Act 1940 & 1945(amendment). About 8000 herbal medicines have been organized in AYUSH systems in INDIA. This article is about how herbal products are regulated in India.

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Sahane, Manish B., and Ganesh D. Basarkar. "A Review of Herbal Regulations and Approval Process in India and Europe." International Journal of Drug Regulatory Affairs 11, no. 4 (2023): 25–33. http://dx.doi.org/10.22270/ijdra.v11i4.629.

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The main suppliers of herbal plants and medications are India and Europe. People prefer using plants and herbs as remedies over synthetic ones since they have fewer adverse effects. In India, AYUSH, CDSCO (Central Drugs Standard Control Organization), AND D&C Act 1940 & 1945(amendment) all control herbal medications. In India, AYUSH systems have been developed to house almost 8000 herbal medications. While in Europe, the European Medicines Agency (EMA) and the Herbal Medicinal Products Committee (HMPC) are in charge of overseeing herbal medications. The regulation of herbal goods in In

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S, Roopalakshmi. "Automated Medical Device Classification." International Journal of Innovative Research in Information Security 11, no. 02 (2025): 106–9. https://doi.org/10.26562/ijiris.2025.v1102.07.

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Manual categorization of medical devices according to regulatory guidelines such as CDSCO (Central Drugs Standard Control Organization) is generally time-consuming, variable, and susceptible to human error. This article describes an automated system of classification based on Microsoft's MiniLM-L12-H384-uncased model, fine-tuned using a dataset of device descriptions, classes, and respective departments. The model is enhanced further by using TF-IDF vectorization and cosine similarity for the determination of the nearest matching device. Experimental evidence shows better classification accura

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Kumar, Devender, Shivali Rahi, and Arpana Rana. "Comparative study of updated Clinical Trial Regulations in India with respect to Australia, Europe, Japan and US." International Journal of Drug Regulatory Affairs 9, no. 1 (2021): 48–61. http://dx.doi.org/10.22270/ijdra.v9i1.455.

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The national regulatory authorities, such as the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), Central Drugs Standard Control Organization and the Australian Therapeutic Goods Administration (TGA), approve every drug that is prescribed for patients around the world. The process of approval undertaken by pharmaceutical companies for drug candidates consists of a series of phases to ensure the product is safe and effective at treating the disease. In this paper, we will compare the clinical trial regulations of India with respect to Australia, Europe, Japan &a

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Amidyala, Lingaiah, S. Amarnath Biradar, and Srinivasarao Bandaru VCS. "AWARENESS OF STAFF NURSES IN CLINICAL RESEARCH: A STUDY FROM YASHODA HOSPITAL." Singapore Journal of Nursing Research 05, no. 01 (2024): 01–09. https://doi.org/10.5281/zenodo.10823499.

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<strong><em>ABSTRACT</em></strong> <strong><em> </em></strong> Clinical research has play vital role in new treatment and to enhance the quality of patient’s care. Nowadays in private and government medical institutions or hospital were conducting clinical research. Nurses are major role in clinical research especially in-patient wards. To investigate clinical research terminology awareness survey in our hospital staff nurses. This study 300 in ward nurses were participated survey at Yashoda Hospitals Hyderabad, and based of work experience nurses were trichotomized, trainee nurse,

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Vaghela, Devanshi, Pragya Sharma, Jai Singh Vaghela, and Kamal Singh Rathore. "Comparison of Regulatory Bodies of Pharmaceutical Industry in U.S. and India." Pharmaceutical and Chemical Journal 8, no. 4 (2021): 1–5. https://doi.org/10.5281/zenodo.13963438.

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The Central Drug Standard Control Organization (CDSCO) is the national administrative body for Indian Pharmaceutical and Clinical Devices. Its headquarters are in New Delhi, India. Its annual budget is USD $ 265,000,000. Inside CDSCO, the Drug Controller General of India (DCGI) manages pharmaceuticals and clinical devices, underneath the extent of Ministry of Health and Family Welfare whereas the Food and Drug Administration (FDA) in United State is responsible for regulating Pharmaceutical drugs for humans and animals, organic products, medical devices, cosmetics, food and substance emitting

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Dukare, Navnath R., Lakshmi PCH, and Somnath Basu. "A Comprehensive Overview of Coronary Stents in India." International Journal of Health Technology and Innovation 3, no. 01 (2024): 21–33. http://dx.doi.org/10.60142/ijhti.v3i01.05.

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Coronary artery diseases (CAD), a non-communicable disease, pose a formidable healthcare challenge globally, particularly in India. Therefore, the demand for advanced medical interventions continues to rise. Coronary stents (CS) play a pivotal role in managing CAD. Coronary stents CS are generally available as bare-metal and drug-eluting varieties. This research delves into the landscape of coronary stents approved in India, leveraging data from the official website of the Central Drugs Standard Control Organization (CDSCO), which is the national Regulatory Authority for Medical Devices in Ind

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Chauhan, Poonam, and Monica Mendonca. "Role of Regulatory Authorities on the Working of Contract Research Organization and Pharmaceutical Company’s Clinical Trials in India." Asia Pacific Journal of Health Management 16, no. 3 (2021): 87–91. http://dx.doi.org/10.24083/apjhm.v16i3.961.

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The evolution of the drug development process and testing its efficacy is a primary responsibility of pharmaceutical companies. The time cost investment involved in identifying a compound suitable to its target disease and making it available to the masses eventually led to the rise of the Contract Research Organization (CRO) in the domain of clinical research. Pharmaceutical companies outsource the research and clinical trials to CRO’s. A CRO has a vital role from drug discovery to the launch and marketing of drugs. India is emerging as attractive location for global clinical trial. It has co

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Pant, Janmejay, Harneet Marwah, Ripudaman M. Singh, and Subhajit Hazra. "An overview of the worldwide master key for pharmacovigilance and its role in India." Journal of Pharmacovigilance and Drug Research 2, no. 2 (2021): 19–26. http://dx.doi.org/10.53411/jpadr.2021.2.2.5.

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Introduction: Pharmacovigilance (PV) is defined as the science and activities related to the detection, assessment, understanding, and prevention of Adverse Drug Reactions (ADRs) and related conditions. Methods: In the 1970s, several significant cases of ADR aided the advancement of the discipline. Between 1989 and 2004, several attempts were made to implement such a program in India, but the scheme was eventually launched in 2010 and is now operating successfully and producing positive results. Results: The pharmacovigilance Program of India (PvPI) contributed different data to th

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Pant, Janmejay, Harneet Marwah, Ripudaman M. Singh, and Subhajit Hazra. "An overview of the worldwide master key for pharmacovigilance and its role in India." Journal of Pharmacovigilance and Drug Research 2, no. 2 (2021): 16–22. https://doi.org/10.5281/zenodo.4904197.

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<strong>Abstract</strong> Pharmacovigilance (PV) is defined as the science and activities related to the detection, assessment, understanding, and prevention of Adverse Drug Reactions (ADRs) and related conditions. In the 1970s, several significant cases of ADR aided the advancement of the discipline. Between 1989 and 2004, several attempts were made to implement such a program in India, but the scheme was eventually launched in 2010 and is now operating successfully and producing positive results. The pharmacovigilance Program of India (PvPI) contributed different data to the World Health Org

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Chaudhry, Sunil. "Fixed dose combinations in India- what a way to go!" Indian Journal of Pharmacy and Pharmacology 10, no. 1 (2023): 45–49. http://dx.doi.org/10.18231/j.ijpp.2023.012.

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Fixed dose combinations (FDCs) are generally considered desirable options in chronic diseases such as tuberculosis, cardiovascular diseases & diabetes, tropical diseases such as malaria & in HIV and in Cancer. FDCs are useful in chronic conditions especially when multiple disorders often co-exist The advantages of the FDC are basically patients compliance, simple dosage schedule, better efficacy, cheaper shipment & packaging activities. The drawbacks of FDCs are (a) Pharmacodynamic mismatch between the two ingredients, one drug having additive/antagonistic effect leading to reduced

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Ashok kumar P, Nikhil HV, Rohith B, Venu T, Vinutha HG, and Sandeep KV. "Regulatory requirement and filling procedure of drug master file in India under central drug standard control organization (CDSCO) in comparison with South Korea." World Journal of Advanced Research and Reviews 23, no. 3 (2024): 2960–68. http://dx.doi.org/10.30574/wjarr.2024.23.3.2940.

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The Drug master file (DMF) is a type of Confidential file that submitted to regulatory authorities about the ingredients, process, packing and storage of any drugs intended to human use. Drug master file plays an important role in production of drug. The Indian regulatory agency is a CDSCO that manages and encourage DMFs in India and in South Korea MFDS manages the DMFs. Unveiling the difference in regulatory requirements and filling procedure of DMF in India and South Korea as per CDSCO and MFDS respectively. Make certain the Protection, Grade, and Effectiveness of Drug Products.

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Ashok, kumar P., HV Nikhil, B. Rohith, T. Venu, HG Vinutha, and KV Sandeep. "Regulatory requirement and filling procedure of drug master file in India under central drug standard control organization (CDSCO) in comparison with South Korea." World Journal of Advanced Research and Reviews 23, no. 3 (2024): 2960–68. https://doi.org/10.5281/zenodo.14982442.

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The Drug master file (DMF) is a type of Confidential file that submitted to regulatory authorities about the ingredients, process, packing and storage of any drugs intended to human use. Drug master file plays an important role in production of drug. The Indian regulatory agency is a CDSCO that manages and encourage DMFs in India and in South Korea MFDS manages the DMFs. Unveiling the difference in regulatory requirements and filling procedure of DMF in India and South Korea as per CDSCO and MFDS respectively. Make certain the Protection, Grade, and Effectiveness of Drug Products.

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Surbhi, H. Makvana Shrikalp Deshpande Maitreyi Zaveri. "Comparative Analysis Of Drug Labeling Requirements In The USA And India: Regulatory Frameworks And Compliance Standards." International Journal in Pharmaceutical Sciences 2, no. 6 (2024): 701–7. https://doi.org/10.5281/zenodo.11620505.

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The pharmaceutical industry is heavily regulated worldwide, with drug labeling being a critical aspect of ensuring patient safety and effective usage. Drug labeling is a crucial aspect of pharmaceutical regulation, ensuring that essential information about a medication's safety, efficacy, and usage is communicated effectively to healthcare professionals and patients The Food and Drug Administration (FDA) in the USA and the Central Drugs Standard Control Organization (CDSCO) in India are the primary regulatory bodies responsible for ensuring drug safety and efficacy through labeling. This study

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Mitra, Satabdi. "Acute kidney injury and severe septicemia: toll of over-the-counter availability of drugs." International Journal Of Community Medicine And Public Health 8, no. 4 (2021): 2038. http://dx.doi.org/10.18203/2394-6040.ijcmph20211277.

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Non-steroidal anti-inflammatory drugs (NSAIDs) act mainly on peripheral pain mechanisms and on the central nervous system to raise the pain threshold. Their usage is widespread and many of these drugs are available over-the-counter (OTC) and hence self-medicated and abused. Drugs and Cosmetics Act is quiescent on this issue. Literature review has shown that, nimesulide, a preferential COX-2 inhibitor group of NSAID is notorious to produce hepatic and renal damage besides gastric mucosal injury which surpass its benefits. Here a case has been reported on life-threatening condition faced on cumu

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Garg, Ram Ishwar, Gladson David Masih, and Bikash Medhi. "Nanoformulation and Fixed Dose Combination." International Journal of Pharmaceutical Sciences and Nanotechnology(IJPSN) 18, no. 2 (2025): 7897–901. https://doi.org/10.37285/ijpsn.2024.18.2.1.

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Nanoformulation refers to the design of drug delivery systems at the nanoscale to enhance solubility, stability, and bioavailability. According to the U.S. Food and Drug Administration (FDA), nanoformulation refers to the design and development of drug delivery systems with components in the nanoscale range (typically 1-100 nanometers), where the unique physiochemical properties at this scale are leveraged to enhance therapeutic efficacy, improve bioavailability, and enable targeted delivery1. FDC (Fixed-Dose Combination) combines two or more drugs in a single dosage form. As defined by the Ce

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Ashok Kumar P, Bharathi R, Darshan G P, Rajesh T S, Siddaramaiah K S, and Sushma N. "Regulatory requirements in the preparation CTD and ECTD as Per CDSCO comparison with Brazil." World Journal of Advanced Research and Reviews 20, no. 2 (2023): 046–53. http://dx.doi.org/10.30574/wjarr.2023.20.2.2076.

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Stringent regulatory standards apply to the creation of Common Technical Documents (CTD) and Electronic Common Technical Documents (eCTD) for regulatory submissions in India, which are overseen by the Central Drugs Standard Control Organization (CDSCO). The essential regulatory considerations affecting the creation of CTD and eCTD submissions in accordance with CDSCO criteria are summarized in this abstract. It emphasizes how crucial adherence to these rules is to ensure the prompt and effective registration of pharmaceutical goods in India. The advantages of eCTD in simplifying the regulatory

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Nagothu, Harshitha, Koushik Yetukuri, and Rama Nadendla. "Comparitive Study of Pharmacovigilance System in India and USA." Journal of Complementary Medicine Research 14, no. 2 (2023): 129. http://dx.doi.org/10.5455/jcmr.2023.14.02.20.

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A system of pharmacovigilance is a field of pharmacological sciences that deals with the Adverse Events Reaction reporting produced by medical devices and or drugs. One of the possible public health problems is an adverse event, which needs ongoing recording, assessment, and surveillance. Drug regulations have improved and got stronger since the 1937 sulphanilamide tragedy and the1960 thalidomide disaster. As such response, a Pharmacovigilance System was developed, which is capable of receiving, diagnosing, evaluating, monitoring, and mitigating harmful effects of medical products. The Central

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Mourouguessine, Vimal, Nishanthi Anandabaskar, and Kagne Rajendrakumar Nivaratirao. "Experiences on the path to achieving SIDCER recognition of an Ethics Committee." Bangladesh Journal of Bioethics 13, no. 3 (2022): 53–60. http://dx.doi.org/10.62865/bjbio.v13i3.45.

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Ethics Committees (ECs) are endowed with the responsibility of ensuring ethical conduct of biomedical research and human research participants’ protection. Although mandating its registration with central regulatory agency/agencies like Department of Health Research or Central Drugs Standard Control Organisation helps to improve its quality of functioning, further progress in achieving highest standards of ethical review is facilitated by undergoing various recognition/accreditation programs. One such is the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) recognition pr

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Soni, Navdha N., and Dilip G. Maheshwari. "CURRENT REGULATION OF MEDICAL GASES IN INDIA AND FUTURE ASPECTS." International Journal of Drug Regulatory Affairs 6, no. 1 (2018): 35–40. http://dx.doi.org/10.22270/ijdra.v6i1.226.

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Generally medical gases are administered or supplied directly to the patients. They should be manufactured and transferred with the highest quality possible as per standards and limits decided by the different regulatory authorities. In India medical gases are regulated by Ministry of Commerce and Industry and central drug standard control organization. Along with these various act are available for better regulation that are Explosives act 1884, Gas cylinder rules 2004, Drugs and Cosmetics Act and specifications of medical gases are given in Indian pharmacopoeias. Various facilities and requi

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Rushikesh, Kale* Sakshi Kape Rohit Karne Satwik Kanade Kalyani Kale. "New Drug Application (NDA) Documentation: A Comprehensive Review from A Quality Assurance Perspective." International Journal of Pharmaceutical Sciences 3, no. 4 (2025): 3351–55. https://doi.org/10.5281/zenodo.15304832.

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The New Drug Application (NDA) process is a critical component of drug approval, This review discusses the NDA process, key aspects from a quality assurance&ensp;perspective, the need for contextualized documentation and regulatory frameworks, and the role of quality assurance in enabling successful drug approvals. The New Drug Application (NDA) is the principal regulatory&ensp;pathway to gain approval for new pharmaceutical products before they can be marketed. It guarantees that a drug adheres to the rigorous safety, efficacy, and quality standards mandated by regulatory authorities, includi

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Gupta, Urvashi, Ashwin Kamath, and Priyanka Kamath. "A descriptive study of new drug approvals during 2017–2021 and disease morbidity and mortality patterns in India." Perspectives in Clinical Research 15, no. 2 (2023): 66–72. http://dx.doi.org/10.4103/picr.picr_109_23.

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Abstract Aim: Studies show the presence of a mismatch between drug research and disease burden. A study conducted in the European Union found that new drug development was restricted to certain diseases. A study of biosimilar approvals in India found that 87% of drugs were for treating noncommunicable diseases. This study aimed to determine the new drugs approved in India from 2017 to 2021 and the top ten causes of morbidity and mortality and detect the presence of any discordance between these. Methods: A descriptive study was conducted using data on new drug approvals accessed from the Centr

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Uppal, Shivangi, and Navjeevan Dadwal. "Product and process development compliance in the Indian biopharmaceutical industry: Challenges and innovations." Environment Conservation Journal 25, no. 4 (2024): 1085–91. https://doi.org/10.36953/ecj.28462883.

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This study explored product and process development in the Indian biopharmaceutical industries, crucial in developing, manufacturing, and distributing biopharmaceutical products. Quality by Design (QbD) is a fundamental approach guiding product development, integrating scientific principles, and risk management throughout the lifecycle of biopharmaceutical products. Compliance, desired by regulatory bodies such as the Central Drugs Standard Control Organization (CDSCO), the U.S. Food and Drug Administration (FDA), the European Medicines Evaluation Agency (EMEA), and the International Organizat

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Pathak, Rahul, Rajat Singal, Sandip Mitra, Sanjay Koul, and Supriya Sharma. "Unlocking the benefits of Drug Master File filing in the Indian pharmaceutical industries." Indian Journal of Pharmacology 56, no. 5 (2024): 342–47. https://doi.org/10.4103/ijp.ijp_297_23.

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Abstract Ensuring the safety and quality of drugs is a crucial component for the development of any pharmaceutical industry. This requires stringent regulation in the process of drug manufacturing and marketing. A Drug Master File (DMF) serves as a comprehensive document containing information about the quality, safety, and manufacturing procedure/facility of a drug or drug substance. Many countries with highly regulated markets use the DMF system extensively to protect their intellectual property rights while providing accurate and detailed information about their products to regulatory bodie

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Gadhade, Jyoti B., Rajesh S. Hiray, Rekha Y. Aherkar, and Kalpana U. Shah. "Pharmacovigilance programme of India: revival of the renaissance." International Journal of Basic & Clinical Pharmacology 7, no. 11 (2018): 2281. http://dx.doi.org/10.18203/2319-2003.ijbcp20184338.

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Adverse drug reactions (ADRs) are the fourth leading cause of morbidity in the world. In order to safeguard the health of the community, Pharmacovigilance Programme of India (PvPI) is implemented as the monitoring body by Indian Pharmacopoeia Commission (IPC). It is leading national authority. National Coordinating Centre (NCC) PvPI works as the World Health Organization (WHO) collaborating centre for pharmacovigilance. Adverse drug reactions are reported to NCC PvPI which are then directed towards WHO Uppsala Monitoring Centre (UMC) Sweden which is the global monitoring centre for worldwide d

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Devani, Harsh, and Avani Khristi. "Gene Therapy in India: Current Landscape and Future Prospects." Research Journal of Biotechnology 20, no. 4 (2025): 210–14. https://doi.org/10.25303/204rjbt2100214.

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Gene therapy has emerged as a revolutionary approach in the field of medicine, offering potential cures for genetic disorders and other diseases. This review provides an overview of the current status of gene therapy in India, highlighting recent advancements and future prospects. The study encompasses key developments, regulatory frameworks and promising clinical trials, shedding light on India's role in the global gene therapy landscape. The regulatory oversight, primarily administered by the Central Drugs Standard Control Organization (CDSCO), plays a crucial role in ensuring the safety and

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Hudha, V. A.*1 Sherin Kunjumon2. "A Review on Medical Device Reporting: Navigating Voluntary Reporting System in Us FDA & India CDSCO." International Journal of Pharmaceutical Sciences 3, no. 4 (2025): 2384–95. https://doi.org/10.5281/zenodo.15245527.

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Medical device reporting (MDR) plays a critical role in ensuring the safety and efficacy of medical devices by identifying and addressing potential risks in a timely manner. While mandatory reporting is often emphasized, voluntary reporting serves as a complementary mechanism that enhances post-market surveillance by capturing adverse events and device malfunctions that might otherwise go unreported. This review provides a comprehensive analysis of voluntary medical device reporting systems in two major regulatory frameworks: the United States Food and Drug Administration (US FDA) and the Cent

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S., Kishore M., and Shashikala S. Konnur. "A study on drug induced cutaneous adverse drug reactions at a tertiary care hospital, Mysore, India." International Journal of Basic & Clinical Pharmacology 8, no. 4 (2019): 777. http://dx.doi.org/10.18203/2319-2003.ijbcp20191116.

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Background: Drugs, however safe and efficacious, are associated with risk of adverse reactions. Adverse Drug Reactions (ADRs) are one of the leading causes of morbidity and mortality. ADRs was rated as the fifth leading cause of death among all diseases. Consequences of ADRs range from diminished quality of life, increased physician visits, hospitalizations, and even death. The objectives of the study were to obtain information about drug induced cutaneous adverse reactions and to establish the causal relationship.Methods: Observational cross sectional study, a total of 76 patients were recrui

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Kumar, Mal Dipak, Samrat Chakraborty, and Biswajit Mukherjee. "FEEBLE REGULATORY AFFAIRS WEAKEN THE BACKBONE OF INDIAN DRUG INDUSTRIES." International Journal of Drug Regulatory Affairs 2, no. 4 (2018): 1–13. http://dx.doi.org/10.22270/ijdra.v2i4.10.

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India is emerging as a global outsourcing power house in almost all fields including Drugs and Pharmaceutical sector.Now it becomes a hub to conduct clinical trials and contract researches. Pharmaceutical industry currently opts fortotal quality management as primary criteria to prevent sub-standard products which do not fall under officialspecifications. However, there are many areas where immediate regulatory measures are desired. Central DrugsStandard Control organization (CDSCO) is the prime regulatory authority for the purpose of enforcement accordingto the Drugs and Cosmetic Act 1940 and

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Daulat, More Pankaj, Ambika Abhishake V. J., Prabhakar Singh, and Bhupendra Raj. "A prospective study of adverse drug reactions in a tertiary care teaching hospital." International Journal of Basic & Clinical Pharmacology 7, no. 10 (2018): 1965. http://dx.doi.org/10.18203/2319-2003.ijbcp20183931.

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Background: Adverse drug reactions (ADRs) have become frequent cause for hospitalization and are coming up as an economic burden on health systems. Identification of ADRs and their reporting pattern can provide useful information for their management.Methods: This was an observational and prospective study. ADR reports of 130 patients were collected of the inpatient department of various clinical departments of Sanjay Gandhi Memorial Hospital, Rewa, Madhya Pradesh (M.P.) The ADRs were collected during October 2014-September 2015, with ADR reporting form of Central Drugs Standard Control Organi

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Pawar, Kaustubh Navnath, Rohit Tukaram Gore, and Samiksha Rohidas Palekar. "A Review on Approval Process and Regulation of Medical Devices as per US FDA and CDSCO." International Journal of Drug Regulatory Affairs 11, no. 1 (2023): 61–70. http://dx.doi.org/10.22270/ijdra.v11i1.586.

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Regulatory affairs play a significant role in the pharmaceutical industry, it is “the process of gathering, reviewing, and monitoring the existing regulatory environment and creating regulatory plans and gaining a competitive edge for securing regulatory approvals required more than just acquiring facts”. A medical device is a treatment instrument that "does not work on or in the human body in a way that is primarily intended by pharmacological, immunological, or metabolic mechanisms”. In other words, a medical device is essentially any medical product, not a medicine or biological product. By

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R., Nalini, Mansoora Shahiba R., Ezhil Ramya J., and Kannan S. M. "Prescribing pattern and adverse drug reactions of cardiovascular drugs in out-patient department of a tertiary care hospital." International Journal of Basic & Clinical Pharmacology 8, no. 4 (2019): 767. http://dx.doi.org/10.18203/2319-2003.ijbcp20191114.

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Background: The main objective of prescription pattern analysis is to assess the rationality of drug use. It has been found that cardiovascular disease is the most frequent cause of morbidity and mortality throughout the world. This study is to estimate the prescribing pattern and adverse drug reactions in patients with cardiovascular diseases.Methods: This prospective observational study was conducted for a period of 2 months in cardiology outpatient department.100 patients who fulfilled the study criteria were observed. The central drug standard control organisation (CDSCO) reporting forms w

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Kumar, Nitesh, Mukesh Darshan, and Farzana Islam. "Ensuring global health: a comprehensive review of vaccine regulation with a focus on the Indian perspective." International Journal Of Community Medicine And Public Health 11, no. 2 (2024): 989–93. http://dx.doi.org/10.18203/2394-6040.ijcmph20240295.

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The regulation of vaccines is crucial for ensuring public health and safety. A global perspective on vaccine regulation, with focus on the Indian approach in vaccine regulation, was analysed. The historical evolution of vaccine regulation, highlights significant events that shaped regulatory systems. The role of National Regulatory Authorities (NRAs) in ensuring the safety, efficacy, and quality of vaccines is discussed, along with the pivotal role of the WHO through its prequalification program. The stages of the regulatory review process, including pre-licensure review and post-licensure sur

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Singh, Narinder, Geeta Sharma, Rahat Kumar, and Vikram Bhandari. "Pharmacovigilance in India and its Impact in Patient Management." AMEI's Current Trends in Diagnosis & Treatment 1, no. 1 (2017): 27–33. http://dx.doi.org/10.5005/jp-journals-10055-0006.

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ABSTRACT Pharmacovigilance is the pharmacological science relating to the detection, assessment, understanding, and prevention of adverse effects, particularly the long-term and short-term adverse effects of drugs or treatment. The World Health Organization (WHO) established pharmacovigilance Programme for International Drug Monitoring in response to the thalidomide disaster detected in 1961. India joined the WHO adverse drug reaction (ADR) monitoring program based in Uppsala, Sweden, in 1998. The Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, unde

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Srivastava, Rohan, and N. D. Kantharia. "Evaluation of rationality of fixed dose combinations of antimicrobials available in Indian market." International Journal of Basic & Clinical Pharmacology 11, no. 2 (2022): 128. http://dx.doi.org/10.18203/2319-2003.ijbcp20220411.

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Background: The antimicrobial resistance is alarming at present. One of the important factors for resistance is use of irrational fixed dose combinations. Thus, objective was to critically analyze the rationality of FDCs of antimicrobial agents currently available in India.Methods: The FDCs of AMAs enlisted in Indian Drug Review 2019 were analyzed by 8 point criteria tool. Analysis includes number of active pharmacological ingredients, approval by central drug standard control organization, listing in world health organization model list of essential medicines (2019) or Government of India nat

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Ashok Kumar P, Lakshmi S, Bhavana K P, Anusha B, Preeti Basavaraj Dayasagar, and M Kavitha. "Regulatory requirements for the approval of anti-cancer drugs as per CDSCO in India comparison with Singapore." World Journal of Advanced Research and Reviews 23, no. 3 (2024): 2969–78. http://dx.doi.org/10.30574/wjarr.2024.23.3.2941.

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This study examines the regulatory requirements for anticancer medications in Singapore and India are compared in this abstract. It draws attention to the frameworks set up by Singapore's Health Sciences Authority (HSA) and India's Central Drugs Standard Control Organization (CDSCO). The procedures for clinical studies, approval schedules, and post-marketing surveillance are among the main distinctions. Singapore places a strong emphasis on strict safety and efficacy criteria, whereas India stresses a quicker clearance process to address pressing healthcare needs. The investigation highlights

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Menon, Vidya. "Regulatory gaps in India’s medical device framework: The case of Johnson and Johnson’s faulty hip implants." World Journal of Orthopedics 15, no. 12 (2024): 1124–34. https://doi.org/10.5312/wjo.v15.i12.1124.

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The Johnson and Johnson faulty hip implant case represents one of the most significant crises in medical device history, impacting nearly 93000 patients worldwide. In response to alarming failure rates and a global recall in August 2010, countries such as Australia, the United States, and the United Kingdom quickly implemented revision surgeries and reimbursement programs to protect patient safety. In stark contrast, India's response was alarmingly delayed; defective implants continued to be sold even after the global recall. By the time the import license was revoked, and the Central Drugs St

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Dhiman, Kritangni, and Navjeevan Dadwal. "Implementation of hazard analysis and critical control points (HACCP) in Indian biopharmaceutical industries: A field study." Environment Conservation Journal 26, no. 1 (2025): 84–90. https://doi.org/10.36953/ecj.28512885.

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People widely accept the HACCP principles as an effective approach to ensuring product safety. Internationally recognized, these principles serve as a tool for managing safety hazards in the manufacturing domain. HACCP is a crucial component in biopharmaceutical industries. It is vital in maintaining consumer safety, sustaining biopharmaceutical product quality, improving risk management, and promoting continuous improvement. This study revolves around the crucial domain of the HACCP system, which falls under Good Manufacturing Practices (GMPs), established by regulatory bodies such as the CDS

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Ashok, Kumar P., S. Lakshmi, K. P. Bhavana, B. Anusha, Basavaraj Dayasagar Preeti, and Kavitha M. "Regulatory requirements for the approval of anti-cancer drugs as per CDSCO in India comparison with Singapore." World Journal of Advanced Research and Reviews 23, no. 3 (2024): 2969–78. https://doi.org/10.5281/zenodo.14982496.

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This study examines the regulatory requirements for anticancer medications in Singapore and India are compared in this abstract. It draws attention to the frameworks set up by Singapore's Health Sciences Authority (HSA) and India's Central Drugs Standard Control Organization (CDSCO). The procedures for clinical studies, approval schedules, and post-marketing surveillance are among the main distinctions. Singapore places a strong emphasis on strict safety and efficacy criteria, whereas India stresses a quicker clearance process to address pressing healthcare needs. The investigation highlights

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Chawan, Vihang S., Sagar V. Badwane, Kalpesh V. Gawand, Abhishek M. Phatak, and Madhura S. Naik. "Analysis of randomized clinical trials leading to new drug approvals in India and USA." International Journal of Clinical Trials 3, no. 2 (2016): 68. http://dx.doi.org/10.18203/2349-3259.ijct20161413.

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<p class="abstract"><strong><span lang="EN-US">Background:</span></strong>To analyse the number of randomized clinical trials and subsequent new drug approvals in India and USA.</p><p class="abstract"><strong>Methods:</strong> Data was collected for completed randomized clinical trials done by multinational in India and USA from www.clinicaltrials.gov during the period from 1/1/2009 to 31/08/2014 and the subsequent new drug approvals from 1/1/2010 to 31/10/2015 for India obtained from Central Drugs Standard Control Organization (CDSCO) (www

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Badar, Vandana, Vidisha Vivek Parulekar, and Priti Garate. "A surveillance study of cutaneous adverse drug reactions in a tertiary care teaching hospital in India." International Journal of Basic & Clinical Pharmacology 7, no. 12 (2018): 2439. http://dx.doi.org/10.18203/2319-2003.ijbcp20184862.

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Background: Skin is one of the most common targets of adverse drug reactions (ADRs) The practice of pharmacovigilance all over the world is 5% whereas in India, it is below 1%. Hence, the purpose of our study is to monitor and analyze the suspected cutaneous adverse drug reactions (ACDRs) reported at our tertiary care teaching hospital, to characterize the nature and predictability, severity and preventability of ACDRs and identify most common drugs causing cutaneous ACDRs so that they can be given cautiously and with keen surveillance.Methods: An observational study was conducted in patients

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Evans, Valerie, Peter Roderick, and Allyson M. Pollock. "Adequacy of clinical trial evidence of metformin fixed-dose combinations for the treatment of type 2 diabetes mellitus in India." BMJ Global Health 3, no. 2 (2018): e000263. http://dx.doi.org/10.1136/bmjgh-2016-000263.

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There is growing national and international concern about the drug regulatory system in India. Parliamentary reports have highlighted the presence of high numbers of unapproved medicines and irrational combinations of both approved and unapproved drugs in the Indian market-place. Fixed-dose combinations (FDCs) are a peculiar feature of the Indian pharmaceutical landscape. Although metformin is a first-line treatment, FDCs for diabetes in India account for two-thirds of all diabetes medicine sales, and some have not been approved by the Central Drugs Standard Control Organization (CDSCO). This

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Patel, Royal, Anupam Kumar Sachan, Sanjana Chaohan, et al. "Present era of drug safety in India: An overview." Journal of Pharmacovigilance and Drug Research 2, no. 1 (2021): 1–8. http://dx.doi.org/10.53411/jpadr.2021.2.1.1.

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Introduction: Common Adverse Drug Reactions (ADR), evaluated by drug clinical trial studies, whereas an individual or specific population might suffer reactions after prolonged dormancy. Pharmacovigilance (PV) is a scientific investigation dealing with and keeping regular vigil on the drugs being used. Methods: The Indian Pharmacopoeia Commission (IPC) and other regulatory authorities like a National Coordination Committee (NCC) via the Central Drug Standard Control Organization (CDSCO) manage PV activity in synchronicity. Indian Pharmacovigilance (PV) system requires carving, therefore

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Ahmed, H. Shafeeq. "Evaluating the validity of the national list of essential medicines 2015 for medicines affecting blood in 2022: An observational cost analysis." Journal of Hematology and Allied Sciences 2 (October 29, 2022): 91–95. http://dx.doi.org/10.25259/jhas_19_2022.

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Objectives: The study aims at evaluating the validity of the national list of essential medicines (NLEM) 2015 for medicines affecting blood in 2022. The study essentially aims at conducting a cost analysis that mainly compares the cost variation between the highest and lowest priced branded variants of the same. Material and Methods: The study takes into account the aforementioned two classes of “Medicines Affecting Blood,” which is 10.1–antianemia medicines and 10.2–medicines affecting coagulation. Data were collected from MedGuideIndia, a database of medicines marketed in India. Both cost ra

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