International Journal of Drug Regulatory Affairs

Journal Information
ISSN / EISSN: 23217162 / 23216794
Total articles ≅ 247

Latest articles in this journal

Rashmi, Heena
International Journal of Drug Regulatory Affairs, Volume 11, pp 24-30;

Haemovigilance contributes major importance in regard to safe blood transfusions and ensuring patient safety. With coherently scrutinizing adverse events in the transfusion chain, Haemovigilance aids a safer and effective blood donation and transfusion procedures. These days, adverse event tracking, investigation, and analysis create pertinent data for the quality cycle of blood collection facilities, transfusion laboratories, and transfusion institutions. This review article focuses on the requirement of Haemovigilance, the current status of Haemovigilance in India as well as the Haemovigilance Program of India (HvPI) with respect to blood transfusion.
Zuki Patel, Shrikalp Deshpande, Vipul Jambukiya, Hemant Koshia
International Journal of Drug Regulatory Affairs, Volume 11, pp 43-46;

Food & Drug Control Administration (FDCA), can be credited with an iron hand and will of the regulator combined with the strict vigil and a friendly hand holding for all of its stake holders i.e., manufacturers of drugs, wholesalers, retailers, stockiest, C&F agents etc. The enforcement mission targets to fulfill the objective of making available the safe and effective medicines by ensuring that the menace of manufacture of spurious /substandard drugs is eradicated. For the enforcement activities it is vital to have immediate and accurate access to information as well as there is a need to communicate effectively and quickly with the stake holders. Prior to the initiative of implementation of software, SMS alerts etc. the enforcement task was dependent on manual means of actions and communications. Gujarat FDCA implemented web-based software - Xtended Licensing & Laboratory Node (XLN),, with data stored in the central server. The aim behind e-governance was to create a system to bring about transparency, traceability, simplicity, effectiveness, harmonization, speed, accuracy and accountability in various G2G, G2C and G2B functions of the department and to attain & maintain FDCA’s leadership in drug regulations in India.
Solomon Getachew Atsbha
International Journal of Drug Regulatory Affairs, Volume 11, pp 54-60;

The most prevalent infectious cause of blindness is trachoma. Trachoma is the third most common cause of low vision and the second most common cause of blindness in Ethiopia. It is more common in regions where personal and community cleanliness standards are inadequate. This review's objectives are to explore trachoma epidemiology and look at trachoma preventive and control initiatives in Ethiopia. Document review and Pub-med searches were made based on the search items: trachoma, epidemiology of trachoma worldwide and in Ethiopia, and prevention and control program of trachoma in Ethiopia. Trachoma prevalence declined from an average of 26.6% in 2015 to 13.3% in 2020 in Ethiopia, and Trachomatous trichiasis prevalence among those under the age of 15 decreased from 4% to 0.85%. Trachoma continues to be a serious public health issue in the nation despite the persistent efforts that were successful in ending the issue.
Abdoulaye Ousmane, Alhousseini Daouda Maiga, Aminatou Adamou Hassoumi, Maman Sani Falissou Saïdou, Nazifa Ibrahim Yacouba, Samira Abdou Assoumane, Abdoul-Kader Souley Daouda, Mahamat Hassan Sherif, Eric Adehossi, Abdoulaye Djimdé
International Journal of Drug Regulatory Affairs, Volume 11, pp 1-5;

Objective: Malaria is a major public health problem in Niger. It accounts for 28% of all illnesses in the country and 50% of all death records. The objective of our study was to analyze the role played by private pharmacies in the management of uncomplicated malaria. Material and methods: This are a descriptive analytical cross-sectional study, conducted in the form of a survey during the period from May 17 to September 15, 2021 in private pharmacies in Niamey. The study population was composed of incumbent pharmacists, assistant pharmacists, sales agents and customers of private pharmacies. Results: A total of 10 pharmacists, 49 sales assistants and 1000 customers were interviewed. More than 62% of patients did not see a prescriber before coming to the pharmacy. Free access to anti-malarial and knowledge of the disease were the main reasons with 52.09% and 34.56% respectively. Of the sales agents, 76% had attended a training institute. Only 10% of pharmacies have a rapid diagnostic test for malaria and 7 pharmacists or 10% are aware of the existence of national control program. Summary ad conclusion: The pharmacy team had good knowledge of the causative agent of the disease, the signs suggestive of simple malaria. However, the national guidelines for the management of malaria were unknown to pharmacists in private pharmacies.
Kritika Dhiman, Rajiv Kumar
International Journal of Drug Regulatory Affairs, Volume 11, pp 71-75;

Surveillance has recently been expanded to include the safety of herbal and cosmetic products. A new phrase has emerged characterizing industry monitoring known as “Kosmetonadzor” to ensure the safety of cosmetic products. Wigan (1997) was the first in the literature to use the term to refer to the safety management of cosmetic products. It is now recognized as a public health concept worldwide. As there is no systematic reporting system, side effects or side effects of cosmetics are relatively insignificant or overlooked. There is a follow-up management system for preparation. In India, market surveillance is usually focused on drug side effects. As a result, more emphasis has been placed on medical devices, blood products, biologics, natural products, and special diets, and less on related side effects. To sum up, Cosmetology refers to the monitoring of cosmetic products that have recently entered the market. Conclusions Cosmetic surveillance is a new approach to regulating the safety of cosmetic products. It is an important component of public health initiatives. As post-sale surveillance of cosmetics becomes more and more common worldwide, malfunctions in these items can be detected and corrected, so safety can be achieved. Physicians Family doctors and general practitioners play an important role in detecting ADRs caused by cosmetic items and, as a result, urge patients to report ADRs. Raising awareness of this new notion will be an important contribution to global public health. In general, the Cosmetovigilance system can avoid both significant and minor adverse effects. Because the notification procedure is critical to the system, healthcare workers must be taught and supported as part of the Cosmetovigilance feedback system. Some regulation modifications are required to keep up with Turkey's developing cosmetics business. In general, cosmetic monitoring systems can prevent both serious and minor side effects. As the reporting process is a key element of the system, medical professionals must be educated and supported in terms of cosmetic oversight within the feedback system. Some regulatory updates are needed to keep pace with the changing Turkish cosmetics market.
Kaustubh Navnath Pawar, Rohit Tukaram Gore, Samiksha Rohidas Palekar
International Journal of Drug Regulatory Affairs, Volume 11, pp 61-70;

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 the Drugs and Cosmetics Act, Central Drugs Standard Control Organization (CDSCO) oversees approving drugs, conducting clinical trials, setting standards for drugs, monitoring the quality of drugs imported into the nation, and coordinating the efforts of state drug control organizations by offering professional advice to ensure uniformity in the application of the Drugs and Cosmetics Act. The US Food and Drug Administration (FDA), a single agency, oversees the regulation of a trillion dollars’ worth of goods, or about 25 cents of every dollar spent, including 80 percent of the food supply in the US, all medical devices, and prescription drugs, animal products, cosmetics, and even the production of tobacco products. The FDA's Center for Devices and Radiological Health regulates companies that produce, repackage, re-label, and/or import medical devices sold in the United States (CDRH). Also, CDRH is in charge of overseeing the regulation of lasers, x-ray machines, ultrasound equipment, microwave ovens, and color televisions, among other electronic gadgets that generate radiation for both medical and non-medical purposes. The IMDR, which was published in January 2017 and became effective in January 2018, was produced by the Medical Devices and Diagnostics Division of CDSCO and is a set of structured regulations for medical devices. In February 2020, the "Medical Devices (Amendment) Regulations, 2020" were established, and they became effective in April 2020. The 2020 amendment now includes a new clause called "registration of specific medical equipment."
Hirishita Dhawan, Priyanka Gupta
International Journal of Drug Regulatory Affairs, Volume 11, pp 47-53;

Introduction: During the COVID-19 pandemic, surgical masks have become a crucial protective measure to prevent the spread of the virus. While they are regulated as medical devices to ensure their effectiveness, the high demand for masks has led to an increase in counterfeit products that pose a threat to public health. Materials and methods: In Chandigarh, India, a cross-sectional study was conducted with 350 individuals aged 15 and above who had access to social networks. An online questionnaire consisting of 20 questions on knowledge, practice, and demographics was used to collect data through convenience sampling with a chain-sampling method. Descriptive statistics and correlation and linear regression analysis were performed using SPSS version 29.0 to find a statistically significant relationship between knowledge, practice, and demographic variables. Result: Of 350 participants in the survey 26.0% were aged 15-29, 32.6% were aged 30-39, 13.4% were aged 40-49, and 28.0% were aged 50-80. In terms of gender, 49.1% were male and 50.9% were female. The majority had a master's degree (45.7%) and were employed in the private sector (49.4%). Education had a significant impact on knowledge (t-value of 11.375, significance level < .001), but job type did not (t-value of -1.740, significance level .083). Participants' knowledge and practice had a strong positive correlation (Pearson Correlation coefficient of 1.000, significance level < .001). The constant (intercept) was significant in predicting practice, while age, gender, and job were not (significance levels > .05). Conclusion: The study found that the community had satisfactory awareness and practice of using certified and licensed surgical masks. However, there is a need for reinforced education on the topic. The researchers recommend mass media campaigns and strict government regulation to ensure the use of certified masks and prevent the use of counterfeit ones. Continuous education is also necessary to help the public understand the importance of using certified and licensed masks for maximum protection.
Jayaprakash Munirathnam, Gowri Radhakrishnan
International Journal of Drug Regulatory Affairs, Volume 11, pp 6-14;

The objective of this study is to emphasis on the importance of the chromatographic testing methods updates to evaluate the quality of drug products and drug substances. Indian pharmacopeial monographs compared with United States pharmacopeia and British pharmacopoeia monographs for the critical testing parameters. The monographs of most commonly prescribed or sold Tablets like Paracetamol, Amoxycillin, Co-amoxiclav, Losartan potassium and its drug substances were selected for this comparative study. The comparison was made to the critical tests like assay and related substances for drug substances; assay, dissolution and related substances tests for drug Products. It has been observed that the Indian pharmacopoeia assay and dissolution tests are comparable with other pharmacopoeias, however related substances methods of analysis need to be updated as per current requirement. The comparative study suggests that Indian Pharmacopoeia need to strengthen testing procedure and specification limits to improve the quality of pharmaceutical products.
Neha Meshram, Suankit Harane, Vinita Kale, Dinesh Biyani, Milind J. Umekar
International Journal of Drug Regulatory Affairs, Volume 11, pp 31-42;

Most clinical studies were carried out in the United States, Europe, and Japan up until 1995. In 1995, the first assessment of research in India was completed. A 2004 article suggested that India lacked the ideal research environment that the majority of clinical researcher’s demand. Clinical trials carried out in India significantly increased in 2009. A public interest litigation (PIL) was filed in 2012 accusing government, non-governmental, and independent investigators of conducting clinical studies improperly. The Drugs and Cosmetics Rules of 1945's Schedule Y, which govern clinical trials, were previously followed (D&C Rules). The Drugs and Cosmetics Act, 1940 (D&C Act) is the legal framework for the New Drugs and Clinical Trials Rules, 2019, or "NDCT Rules," which put an end to the protracted process of codifying the regulations that apply to clinical trials. Clinical trials, studies on bioequivalence and bioavailability, ethics committees, and investigational novel medications for human use will all be subject to the new regulations. As of 13-01-2o22, the Union Health Ministry has published a final notification revising the New Drugs and Clinical Trials (ND&CT) Rules, 2019 to include cell derived products as well as stem cell derived products under the definition of new medication.
Sandhya Jaiswal, Parshant Sharma, Heena Qureshi
International Journal of Drug Regulatory Affairs, Volume 11, pp 15-23;

A study relating to the regulation for nasal products has been conducted for the current review. The analysis emphasized the significance of classifying nasal products. Nasal products are challenging to manufacture in India due to regulatory and logistical issues. In addition to the production guidelines established by the USFDA and EU, the study analyses the prospects for nasal products in the future. Some common policies held by the 2 major international agencies have been shown in this review. The current evaluation focuses on how nasal product production should be done in conjunction with other product production and will examine the fundamental recommendations made by the USFDA and EU, as well as whether or not there is a specific category of recommendations for nasal products. Conclusions The article demonstrates the USFDA and EU guidelines, and it was found that there were not major differences between the guidelines of the two. Instead, there are only minor differences between the infrastructures of the two agencies related to nasal products.
Back to Top Top