Comparative Study on Law Relating to Orthopedic Implants in India, United States and European Union with Case Study

Background: The article provides brief discussion on the comparative regulations on orthopedic implants in India, United States and European Union. Orthopedic implants are tone of the high risk medical devices manufactured to substitute or replace a missing or damaged joint or bone or to support a damaged bone or joint and to improve the quality of life of patients. Thus, there is a need to regulate the import, manufacture, clinical investigation; sale and distribution of orthopedic implants to ensure that all orthopedic implants that were brought to market are safe, quality and performance. The orthopedic implants industry is adversely affected by lack of awareness on proper regulatory practices, lack of awareness on the current regulatory practices, separate consistent standards, separate lawful requirements, and proper guidance on quality system etc. Conclusion: The objective of this article is to harmonize the regulatory requirements at par with the internationally accepted regulations and to develop ecosystem in the country to boost the Indian orthopedic device sector, and that will make India more productive for orthopedic device development to encourage national and multinational orthopedic implants industries to manufacture their orthopedic implants in India.

Regulatory Aspects of Personalised Medicines

: The advent of big data analysis, genetic engineering and epigenetics has transformed the healthcare system by shifting the strategy for diagnosis, prevention and treatment of diseases from “one-size-fits-all” approach to “personalised” approach. Identification of biomarkers from molecular diagnosis has made tailoring of the medical treatment possible. Optimization of treatment decreases the costs related to the ineffective treatments and help in avoiding possible side effects and adverse drug reactions. The efficient development of personalised medicine is largely dependent on the tools, sequencing techniques used and regulatory policies related to the personalised medicine products, tests and companion diagnostics. The uncertainties around regulations governing personalised medicine should be eliminated and specific guidelines should be laid down by the respective regulatory authorities to bridge the emerging tools and technologies with the regulatory policies. Also, proper regulatory approval pathways for companion diagnostics will resolve the complications of organized development of therapeutic products and diagnostic tests.

Pharmacy professionals’ awareness and attitudes towards counterfeit medicines in Harar town, Eastern Ethiopia: a cross-sectional study

Background: Awareness and opinion of health care providers, particularly pharmacy professionals, play a pivotal role in avoiding circulation of counterfeit drugs. Therefore, the aim of present study was to assess pharmacy professionals’ awareness and attitudes towards counterfeit medicines in Harar town, Eastern Ethiopia. Methods: A cross-sectional study was conducted among pharmacy professionals working in community drug retail outlets found in Harar town, Eastern Ethiopia. A total of 92 pharmacy professionals participated in the study, and data were collected through self-administered structured questionnaires developed after reviewing similar surveys. The collected data were coded, entered and analyzed using Statistical Package for Social Sciences (SPSS, version 21). Descriptive statistical analysis was performed, and variables with p value < 0.05 were considered as statistically significant. Results: Among pharmacy professionals participated in the study, 65.2 % of them were males. About 75 % of the study respondents were also druggists. Nearly 83 % of participated pharmacy professionals had information on the circulation of counterfeit medicines in the pharmaceutical market. Half of the study respondents described counterfeit medicine as a medicine without active ingredient or with reduced amount of active ingredient. 45.7 % of the pharmacy professionals reported that antibiotics are at high risk for counterfeiting, and only 28.3 % of them aware of the efficacy associated problems of counterfeit medicines. In addition, 51.1 % of the study respondents said that counterfeit medicines can be identified by visual inspection and laboratory analysis. In connection to the attitudes of the participants, 93.5 % of them agreed on the item dispensing and prescribing counterfeit medicines are illegal. 55.4 % of the study participants believed that counterfeit medicines are cost effective, and 65.2 % of them believed that pharmacy professionals deliberately dispense counterfeit medicines to obtain a big profit. 77.2 % of the participants responded that the law against counterfeit medicines and its implementation should be strengthened. Furthermore, all attitude items were not significantly associated with demographic variables (P value > 0.05). Conclusion: Drug regulatory bodies and concerning bodies must play an active role appropriate strategies should be instilled to enhance pharmacy professionals’ awareness and attitude towards CFM.

Efficacy of Topical Formulations in Healing of Caesarean Scars Using NonInvasive Devices: A Controlled Trial

Background: Despite the availability of many topical formulations for scar treatment, an objective evaluation of their effect is lacking. Objective: To assess the physiological, structural, and mechanical parameters of scar healing by a scar ointment (MEBOScar). Methods: 45 patients from the Department of Obstetrics at Al Ain Hospital, UAE, with recently acquired Pfannenstiel scars were recruited into this prospective, open-label, controlled study. Scar ointment was applied to a lateral third of the scar; positive control (silicone gel based topical) to the other lateral third; the middle third was left untreated (negative control). The scars were evaluated at 4 time points up to 12 weeks using non-invasive devices and a scar questionnaire. Results: In comparison with silicone gel, there was a significant reduction in trans epithelial water loss at weeks 2,4,8, and 12 (p<0.001) and scar area at weeks 4, 8 and 12 (p<0.001) with scar ointment. The skin elasticity at week 4 was significantly increased by scar ointment (p=0.007). By week 12, gross colour mismatch of the scar was described by 9% patients with scar ointment (24% with silicone gel, 42% with no treatment; p<0.001). There was significant improvement in scar texture with scar ointment by week 12 (p<0.001). Conclusions: Scar ointment has beneficial effects on objective and subjective patient-reported parameters of Pfannenstiel scars.

A Comprehensive Review of Regulatory Requirements and Registration Process of Pharmaceutical Drug Products in CIS Countries

Background: The CIS region has a potential market for India. The registration of the drug products in CIS regions is a challenging task because these countries have no harmonized regulatory organization. The CIS region includes 12 countries such as Russia, Kyrgyzstan, Ukraine, Uzbekistan, Kazakhstan, Tajikistan, Turkmenistan, Armenia, Azerbaijan, Belarus, Georgia and Moldova, which require different regulatory guidelines for medicinal product registration as per their FDA guidelines. The different guidelines for the same region become a challenging task for the manufacturer and exporter. The registration of the same product for different countries of CIS is not possible with the same dossier due to the lack of their regulatory harmonization. These countries obey their country-specific dossier format, so to target these market manufacturers and exporters needs to submit different dossier documents for different countries. But Ukraine and Kazakhstan have harmonization and it varies in Uzbekistan and Tajikistan. Ukraine and Kazakhstan are also imposing strict rules and expecting USFDA level documents for approval. Conclusion: The overall conclusion is that harmonization in CIS is highly imbalanced, which affects both time and cost for product registration. Harmonization is the need of the era for easy product registration, and it will be beneficial for the manufacturer, regulator, importer, exporter, and to access medicines of high public health value.

Raw Data Management and Data Integrity in Pharmaceutical Product Development

In pharmaceuticals, raw data management is a tedious process that comprises of obtaining the data, affirming the validity, and preserving the required data to make certain of the quality, accuracy, and timeliness of the one who is using the data. Raw data management makes processing, validation, and other essential functions simpler and less time intensive. It provides actual information, i.e., the information which has not undergone any processing either manually or through an automated system. Raw data are managed by looking into integrity issues, such as document falsification, failure to provide adequate controls, and taking appropriate measures for its prevention. Also, access to the computer system should be restricted to authorized personnel only. There should be shared just-read client accounts that will stop the sharing of important data to personnel other than the authorized one. Prevention and management include training, good documentation practice, self-inspection, management strategy, and global corrective and preventive actions. Also, a good moral practice should be taught to the employees who are into documentation work.

EU IVDR Regulatory Changes: An Overview of Requirements in (EU) 2017/746

IVDR is the new regulatory basis for placing IVDs in the market, making them available and putting them into service in the European market. EU IVDR regulation is much bigger than the impact of EU IVDD, which is a bold statement to make, considering the significant industry- wide impact as it presents challenges to the manufacturer. Rather, it is largely a revision that contains guidance on how to fulfill the existing IVDD requirements. IVDR focused on the IVD-specific provisions therein regarding classification, performance evaluations, clinical data, conformity assessments and notified bodies. IVDR presents enormous change to the IVD industry, not only because it needs a significant change in technical documentation and Quality management system, but also because it changes the relationship with the economic operator and their responsibilities.

Comparison of Maternal and Neonatal Outcomes in Case of Primary Cesarean Section Done During Late vs. Early Labor

Background: Cesarean section (CS) done before the onset of labor is called an elective and done during labor is called an emergency CS. During labor, CS may be needed in early(1st) or late(2nd) stages. Earlier studies have shown more maternal and fetal complications when a cesarean is done for the first time in the late stages. Objective: Our objective was to find out whether the maternal and fetal outcomes differ when primary CS is done in the first stage of labor compared to the second stage of labor for various indications and how. Methods: This was a retrospective observational study on women who underwent primary CS during active labor and to link the maternal and fetal outcomes related to the stages of labor. The study population was patients admitted to the Labor ward of Saqr hospital, Ras Al Khaimah, UAE, between 1st January 2017 till 31st December 2017, but had to undergo primary CS during labor for various indications at 1st and 2nd stages of labor. Data was collected from maternal and neonatal electronic case records. Results: A total of 135 case records were studied. Most cesarean sections were in the early stage of labor. The most common indications were fetal distress and prolonged labor. The maternal and fetal complications were higher in 2nd stage of labor than in 1st stage which includes uterine atonia (p=.001), postpartum hemorrhage (p=.006), postoperative hematuria(RR=3.46), problems with breastfeeding (p=0.001) and fetal injuries (p<.001). Conclusion: Primary CS in late labor is associated with increased maternal and neonatal complications compared to CS in early labor.

Self-Emulsifying Drug Delivery System (SEDDS) and its Pharmaceutical Applications

Poor aqueous solubility, oral bioavailability, inter, and inter-subject variability, and physical stability have always been a concern for pharmaceutical formulation scientists while formulating an oral dosage form. Self-Emulsifying Drug Delivery System (SEDDS) is a promising new approach to mitigating those potential problems. The main advantages of SEDDS are that it increases the solubility and decreases the bio-degradation of lipophilic drugs. Mostly BCS II & IV Class drugs are preferable. SEDDS is an admixture of drugs, oil, surfactants, cosolvents, and stabilizers. With little energy input, they form (o/w) microemulsion within the G.I. lumen. The present review discusses the various formulations of SEDDS, selection criteria for surfactants, oils, Patentable SEDDS dosage forms, solidification technique, characterization, and future approaches.

Safety and Quality of Nutraceuticals: Have FSSAI Guidelines been Able to Blaze the Trail?

The nutraceutical industry has three main segments, including herbal/- natural products, dietary supplements and functional foods. The dietary supplements market is preliminarily driven by the paradigm shift towards preventive health management practices, amid rising healthcare costs and increasing burden of lifestyle diseases. Rise in healthcare expenditure, increased usage of nutraceuticals product as a substitute to prescription and OTC drugs and augmented demand for the nutritional diet are the major factors driving the global nutraceuticals market. Many individual laws were devised to govern its manufacturing and sale. However, increasing regulatory formalities from multiple agencies and laws, complicate the development, testing and marketing of these substances and hamper the growth of the nutraceutical market. Globally, the regulatory authorities are aware of the changing needs of consumers and proactively protect consumers by amending existing laws to accommodate changes. Market entry requirements of nutraceuticals, functional foods and supplements vary from country to country. The global regulatory guidelines aim at regulating various aspects of the nutraceutical and dietary supplements market, focusing on its manufacture, testing, labeling, sale and registration to assure safety and quality of the product. The major change that was introduced was the ban on marketing Nutraceuticals as medicinal products. This review has been performed to provide a comprehensive understanding of the global regulatory requirements with critical analysis of the Indian regulatory guidelines to explore the lacunae and suggest the need of further amendments in the form of recommendations that can be incorporated into regulatory body guidelines to make it more competitive for national & international trade.