Indian Pharmacopoeia Research Articles

Current quality standards of Andrographis Herba of different countries and regions

Andrographis Herba is a commonly used plant medicine, and has been recorded in pharmacopeias of different countries. However, there are some differences in the quality standards. Based on this, this paper compare the quality standards of Andrographis Herba between Chinese Pharmacopoeia, Hong Kong Chinese Materia Medica Standards, United States Pharmacopoeia, European Pharmacopoeia and Indian Pharmacopoeia, including origin, botanical characteristics, identification(microscopic identification and chromatographic identification), content determination, specific test(such as impurities, loss on drying, extractives, pesticides, heavy metals, mycotoxins, and other items) and storage requirements, so as to provide a reference for studying international quality standards of Andrographis.

PHARMACEUTICO-ANALYTICAL STUDY OF SHODHITA SHILAJATU

In the Pharmaceutical process of different forms of medicines raw material & its quality plays an important role. During ancient time Vaidyas were themselves used to collect the raw materials herbs based on their occurrence and organoleptic characters, i.e., typical taste, texture, smell, color, and there types after selection they utilized them in preparing medicines. Based on their own observations, principles of drug processing and ideal quality of finished product, etc., have been documented by them. The principles were developed based upon the scientific parameters prevailing in those days. Materials and Method: Raw Shilajatu was subjected to Shodhana and Shodhita shilajatu was subjected to analytical study. The required materials for the process were collected from the Pharmacy of BLDEA's AVS Ayurveda Mahavidyalaya pharmacy Vijayapur, analytical lab. Raw drugs were purchased from Dorle and Sons retailer from Kolhapur Maharashtra. Shilajatu shodhana was carried out according to reference mentioned in Rasaratna samuchaya. Analytical tests concern Indian Pharmacopeia methods were followed. Result: Raw Shilajatu took 5 ½ hour to 6hour in Shodhan procedure in both batches. Three days for drying. In analytical tests physical constants like pH ash value, solubility, specific gravity, moisture content etc result values were under normal limit.

The Formulation and Evaluation of Gastro-Bilayer Floating Tablets of Losartan Potassium as Immediate Release Layer and Ramipril Hydrochloride as Sustained Release Floating Layer

Objectives: A sustained release Gastro-bilayer floating tablets with reduced dosing frequency and increased drug bioavailability is developed. The dosage form is suitable for the release of two drugs simultaneously in a single dosage unit i.e. Losartan Potassium and Ramipril Hydrochloride. The SeDeM system for selection of powder blend for direct compression gave the parameter index value of ≥0.5 which is considered as best in terms of compression properties. The prepared dosage form provided sustained effect of the drug for 12 hr by Non-Fickian, controlled diffusion and swollen matrix. Peppa’s release model is best suited for the final formulation of batches. Optimized formulation exhibited floating time of 12 hr and floating lag time of less than 1 min. In-vitro dissolution studies shows 96% of the both the drugs release. The swelling and erosion of polymers is studied by Scanning Electron Microscopy. The data obtained from Analysis of variance demonstrated the significance of the model with a P-value of less than 0.05. Methods: SeDeM system was adopted on powder blend before direct compression for preparation of tablet, the hydroxyl propyl methyl cellulose was used as a rate-controlling polymer and a mixture of citric acid and Sodium bicarbonate formed the floating layer. Results: Radius values through SeDeM diagram was plotted and index values are calculated and resulted in an index value of ≥0.5. The pre-compression and post compressional parameters are as per Indian Pharmacopeia specifications. The best formulation for gastric bilayer tablet had a combination of Hydroxy propyl methyl cellulose K15M and Sodium Carboxy methyl cellulose which gave 99.57% drug dissolution within 12 hr. Conclusion: Gastro-Bilayer Floating Tablets of Losartan as Immediate Release layer and Ramipril as sustained-release floating layer are successfully developed. The problem of poor solubility of drugs can be solved by optimization of blend through SeDeM expert System. Hydroxy propyl methyl cellulose K15M, K4M and Carbopol 934 are helpful in achieving the sustained effect of the drug for 12 hr by Non-Fickian, controlled diffusion and swollen matrix. Peppa’s release model is best suited for the final formulation batches based on the drug release mechanisms.

Commentary - A comprehensive safety understanding of granulocyte-colony stimulating factor biosimilars and Intended Copy Biologics in treating chemotherapy associated febrile neutropenia

Filgrastim, human white cell growth factor, Granulocyte colony-stimulating factor (G-CSF), is a core medicine in the WHO list of Essential Medicines. For this reason, recent reporting of statistically significant safety and efficacy differences between reference and Biosimilar brands of filgrastim by Rastogi and the Indian Pharmacopoeia Commission in Toxicology and Applied Pharmacology in 2020 is of great concern [Shruti Rastogi et al. Towards a comprehensive safety understanding of granulocyte-colony stimulating factor biosimilars in treating chemotherapy associated febrile neutropenia: Trends from decades of data. Toxicology and Applied Pharmacology Volume 395, 15 May 2020, 114,976. https://doi.org/10.1016/j.taap.2020.114976]. This commentary shows that the alarming report is a result of incorrect statistical tests misapplied to inappropriate data sets compounded by a further problem relating to the strict regulatory definition of a Biosimilar Medicine as opposed that of an Intended Copy Biologic. In contrast, the body of evidence from more than seven and a half thousand participants in Confirmatory Clinical Studies and Post Approval Clinical Studies as well as the Periodic Safety Update Reports confirms that European approved filgrastim Biosimilars show no meaningful difference in quality, safety or efficacy compared to the reference brand.

Materiovigilance: Concept, Structure and Emerging Perspective for Patient’s Safety in India

There has been an escalation in the number, diversity, and complexity of medical devices. Regulation of these devices has also advanced due to the requirement of better regulatory perspective induced due to elevation in the number of adverse events associated with medical devices. All over the globe, various measures are undertaken to provide better safety to the patients along with attempts to improve the standard of medical devices. The initial and ultimate objective of the concept happens to be unfailingly to ensure patient safety as well as impart required guidance for both manufacturers and adept authorities enabling them to superintend cases coherently and appropriately. Materiovigilance programme of India (MvPI) was launched by the Drug Controller General of India at the Indian Pharmacopoeia commission (IPC) in Ghaziabad in 2015. The main purpose of this initiative is to monitor adverse events associated with medical devices in order to generate safety data, create awareness among the various stakeholders, and prescribe best practices for patient safety. Whilst the reforms in regulations have proposed policies and designs to elucidate, consolidate and accelerate the processes involved in manufacturing and importing medical devices to India, they consistently carry their challenges and limitations. To eliminate such complications the guidelines and regulations are anticipated to be implemented appropriately with the efficacious conclusion. India has been evident in matching with advancements in the World Medical Device regulation scenario, the current review at hand takes upon the question of 'how successful has it been so far'?

In Vitro Dissolution Study of Metronidazole Tablet in Different Fluids

Objective: The plot of this study is to obtain a grasp regarding the effect of different fluids (Gastric medium, simulated gastric fluid without enzyme, ORS solution, rice water, lentil soup, watermelon juice, apple juice, mango juice, pomegranate juice, black and green tea) on dissolution of metronidazole tablet by alteration of different medium. Method: Our study had focused on the in vitro dissolution study of metronidazole in the presence of different fluids (Gastric medium, simulated gastric fluid without enzyme, ORS solution, rice water, lentil soup, watermelon juice, apple juice, mango juice, pomegranate juice, black and green tea) which has been commonly used in diarrheal condition to obtain quickest and profound dissolution for the metronidazole tablet. Different dissolution medium was prepared from 200 ml of fluids and 700 ml of 0.1 N HCl. pH was adjusted to pH 1.2. One commonly available marketed brand is used for the study. Dissolution study was performed as per mentioned in Indian pharmacopoeia. For the analysis of study, we used Graph Pad prism version 8 and Microsoft excel. ANOVA followed by Tukey's test was performed for the comparison of dissolution in different fluids Result: The mean dissolution of metronidazole tablet in Rice water, Lentil soup, Watermelon juice, Mango juice, Pomegranate juice, Black tea and Green tea are significantly different from the dissolution on 0.1 N HCl medium (p 0.05, 95% CI).The highest percentage drug release of Metronidazole was found in apple juice (102.78 ± 2.10). In lentil soup dissolution of Metronidazole doesn’t complies with the IP specification (78.69 ± 1.89). Conclusion: Metronidazole tablet plays a vital role in treatment of diarrhea but before it shows its therapeutic effect on body, it must have to dissolve first. So, dissolution is considered as an important parameter to determine the bioavailability of drug as well as its efficacy. Our study concludes that administration of apple juice can be beneficial on other hand lentil soup can decrease the therapeutic effect of metronidazole tablet.

DEVELOPMENT OF pH-DEPENDENT CHRONOMODULATED DELIVERY SYSTEMS OF 5-FLUOROURACIL AND OXALIPLATIN TO TREAT COLON CANCER

Objective: To develop two different oral formulations such as 5-fluorouracil (5-FU) tablets and oxaliplatin (OX) microspheres which were further filled into capsules and coated with pH-sensitive polymer (eudragit S-100) for the chronotherapeutic treatment of colon cancer (Fluorouracil: Oxaliplatin regimen) to perform as a substitute for intravenous (IV) route based chronomodulated chemotherapy.
 Methods: The 5-FU tablet formulation was prepared with alginate and guar gum polymers in varied concentrations using wet granulation technique in two varieties such as granules coated and tablet coated formulations using eudragit RSPO as coating material to achieve controlled drug release. Alongside OX microspheres were formulated using the ionotropic gelation methodology in combination with alginate and chitosan polymers in varying concentrations to accomplish a time-controlled drug release. Prepared formulations were evaluated for pre-compression and post-compression parameters, percentage yield, percentage drug entrapment, Fourier transformed infrared spectroscopy (FT-IR), Differential scanning calorimetry (DSC), Scanning electron microscopy (SEM), In vitro and Ex vivo dissolution studies.
 Results: Pre-compression and post-compression parameters for 5-FU tablets were satisfied with Indian pharmacopeia specifications. The entrapment efficiency of OX microspheres were increased due to the elevated concentration of polymers up to a certain level as seen in A7M, further greater the concentration of polymer resulted in a decline of entrapment efficiency as seen in A4M and A8M. The optimized formulations A14T and A14M were shown in vitro drug release of 90.36 % by 24 h and 79.63 % by 9 h respectively.
 Conclusion: The two different oral formulations of 5-FU (Tablets) and OX (Microspheres) were found to be successful in controlled drug release. Therefore they can be efficiently used to control the rate of drug release to the colon in synchronization with the circadian timing system in the belief of improved therapeutic efficacy, tolerability and overall survival rate of cancer patients. Hence it is promised to be a better alternative for intravenous route based chronomodulated chemotherapy.

Pattern of adverse drug reactions occurring at department of neurology of a tertiary care hospital in India

Background: The objective of the study was to study the pattern and trends of adverse effects of drugs used in department of neurology in a tertiary care hospital.Methods: A prospective, observational study was carried out for a duration of 12 months from November 2018 to October 2019 at Department of Neurology and Department of Pharmacology and Therapeutics, G.S.V.M. Medical College, Kanpur after getting an approval from institutional ethical committee. Data was collected by analyzing OPD prescription slip, treatment charts and investigation reports. All relevant information regarding adverse drug reactions (ADRs) were collected as per norms of Indian Pharmacopoeia commission (IPC).Results: During the study period, a total of 130 ADRs reported. Most of the ADRs were reported due to antiepileptic drugs followed by antiparkinsonian drugs. Dizziness was the most frequent ADR reported. Most of the ADRs were reported due to phenytoin. Other ADRs observed were drowsiness, nausea/vomiting, weakness, joint pain, dyskinesia.Conclusions: Most of the ADRs were due to anti-epileptic drugs. Most of the reactions were of mild severity.

Formulation and Evaluation of Fast Dissolving Oral Films of Cetirizine Hydrochloride

Introduction: Fast-dissolving oral delivery system is a solid dosage form, which is used as a novel approach, as it dissolves rapidly in the mouth and directly reaches the systemic circulation. This facilitates rapid absorption and reduces first-pass effects. These films provide better utilization without the need to chew and do not require the need of water for administration. Fast-dissolving oral films might be useful in special patients like those with swallowing difficulties and in that in chemotherapy. This study was aimed to formulate and evaluate the fast dissolving oral films of Cetirizine Hydrochloride.
 Methods: Oral films of Cetirizine Hydrochloride were prepared using Hydroxy Propyl Methyl Cellulose (HPMC), Polyvinyl alcohol, glycerol, aspartame in different concentrations by the solvent casting method. Films were evaluated for different physical Films were subjected to USP dissolution studies.
 Results: The drug content of the nine formulations was found to be in the range as per Indian Pharmacopeia. In vitro release studies indicated 60-91% release within 30 min in the formulated oral films. The best release was found to be 91.58% of formulation F7, having a minimum concentration of HPMC alone as a polymer along with other common ingredients and minimum release was found to be 60.01% of formulation F1. Surface pH was found to be near to neutral (pH 7) which was good for buccal mucosa.
 Conclusion: Increasing the concentration of polymer (PVA and HPMC) while keeping the plasticizer ratio constant showed enhanced folding endurance. The dissolution rates were also increased with the increase in the concentration of the polymers. The high concentration of polymers decreased the release rate of cetirizine while a low concentration of polymers causes an increment in the release rate of cetirizine.

A CLARION CALL TO ALL INDIANS TO FACILITATE INTENSE RESEARCH ON NATURAL PRODUCTS

More than 100 years before India was recognised as the “Generic Capital” or “Pharmacy of the World, India was acclaimed for the “Materia Medica” and the extensive research on natural products by Sir Col. Dr. Ram Nath Chopra, the father of Indian Pharmacology. In fact, Dr. M.L. Shroff got inspired from Sir R.N. Chopra and started the first Pharmacy course at Banaras Hindu University in 1932. Every student (even veterans) of Pharmacy should know that Drugs Act, 1940 (later renamed as Drugs and Cosmetics Act) as well as formal courses in Ayurveda, Siddha and Unani were started under his mentorship. DTAB (Drugs Technical Advisory Committee) was set up under his stewardship. The first edition of the Indian Pharmacopoeia (evolved from Indian pharmacopoeial list 1946) 1955 was published with his contributions. “We are reaping the fruits of the plant grown by their sown seeds. We should make the same available to our future generations” said the biographer, Roja Rani. Prof.Harkishan Singh in J.Young Pharm, 2009 (Vol.1/No.3) had profiled Dr.R.N. Chopra (which is reproduced herein). Later Dr. K.M. Nadkarni came out with “Indian Materia Medica” in two volumes in 1908 with Foreword by Dr. R.N. Chopra. These are extremely valuable reference books for further research in Indian Natural Products.

Formulation and Evaluation of Rapimelt Tablet of Anti-Vertigo Drug (Lorazepam)

A. Rapimelt tablet of Lorazepam was prepared by direct compression method using Indion 414, Cross Carmellose Sodium and sodium starch glycolate as superdisintegrants with aim to get rapid onset of action, improve bioavailability and to give pleasant taste and better mouth feel. The tablets prepared were evaluated for various parameters like various density parameters, thickness, hardness, friability, disintegration time, wetting time and invitro dissolution time and were found to be within limits as per Indian Pharmacopoeia. FT-IR spectra of physical mixture of Lorazepam with Indion 414showedretention of basic peaks of Lorazepam. The developed formulation of Lorazepam batch F5 (10% Indion 414) showed good palatability and dispersed within 30 seconds as compared to Crosscarmellose Sodium batches F1-F3 and Sodium starch glycolate batches F6-F9.

Quantitative analysis, cost comparison, physician, and patient perceptions on generic versus branded clopidogrel bisulfate tablets marketed in Kerala, India

Background: Clopidogrel bisulfate is sold in more than 60 advertised brand names (trade names) in the Indian market. Government health sector in India emphasizes on prescribing clopidogrel in its generic form, which refers to the chemical makeup of the drug, rather than to the advertised brand name, to reduce the economic burden. Preference for branded drugs and cost difference with generics are already well established, however physicians are apprehensive regarding the quality of generic drugs and have concerns about their reliability. Objective: We studied perspective of physicians and patients regarding generic versus branded medicines among hospitals in our locality. Cost difference incurred while prescribing various brands and generic clopidogrel tablets were calculated. Percentage purity of generic and branded clopidogrel tablets were analyzed to find if any difference really exists between them. Methodology: Perspective of 150 physicians and patients were studied using questionnaire method. Using ultraviolet spectrophotometer, generic and most commonly prescribed brands of clopidogrel were analyzed for percentage purity. Once analyzed, their costs were compared. Results: Eighty- six percent (n = 129) of physicians and 81% (n = 122) of patients surveyed, preferred branded medicines over generic ones. Among 10 branded clopidogrel tablets, only three complied with the Indian Pharmacopoeia standards of drug percentage purity. Pricing pattern of various brands of clopidogrel ranged from $1.4 to $3.13 per month. Generic clopidogrel tablets are available free of cost for patients from government-run hospitals but did not meet recommended percentage purity standards. Conclusion: Both branded and generic versions of clopidogrel have their merits and demerits. The general notion and doubt regarding difference in quality of generic versus branded version of medicines as evidenced by our perspective evaluation of physician and patients is appropriate in the present scenario. More large scale studies of different cardiovascular drugs are required to ensure their quality. Improved quality of generic medicines has to be ensured prior to marketing in India.

Intraocular devices associated adverse events reporting system in India.

Intraocular devices associated adverse events reporting system in India.

A questionnaire-based survey on knowledge and attitude toward drug promotional literature among second year undergraduate students at tertiary care hospital

Background: With the advancement of the use of technology, media, and use of internet promotion of drugs has been increased. Pharmaceutical manufacturers spend vast amount of money on promotion usually through medical representatives by providing printed advertisements. However, it has been seen that these printed advertisements are not up to the mark; usually, they either overemphasize the efficacy or hide the safety profile for the sake of company’s profit. All these promotional activities influence the prescribing pattern of doctors. Aim and Objective: The objective of this study was to assess the knowledge and awareness about the drug promotion literature concept among the 2nd year undergraduate students at a tertiary care teaching hospital Vijayanagar Institute of Medical Sciences Ballary. Materials and Methods: The study was a prospective cross-sectional pre-validated questionnaire-based study conducted in the Vijayanagar Institute of Medical Sciences, Ballary. A total of 150 2nd year undergraduate students were enrolled and instructed to fill the questionnaire forms. These filled forms were collected and data were analyzed. Results: Among respondents, 69 (71.81%) of the respondents have chosen Indian Pharmacopoeia as a trusted source of information followed by others. The most common factor affecting the prescribing attitude was reported as updates from clinical trials 69 (70.40%) followed by the prescriber’s knowledge. Conclusion: The most important intervention taken to stop misleading drug promotional activities has been reported as the formulation of strict regulation by the health-care authorities against any misleading promotion. Promotional activities by manufacturers influence the attitude and prescribing pattern of doctors. Hence, it is important to teach the students about their rational use and critically analyze them.

Advances in pharmacovigilance in India: Role of mobile application

India is the fourth largest manufacturer and the second largest consumer of pharmaceuticals in the world. Hospitalizations due to adverse drug reactions (ADRs) lead to a considerable burden on the health-care system and economy of the country. Pharmacovigilance in India faces considerable hurdles due to overburdened hospitals, underreporting of ADRs, variations in reporting formats, etc. To augment ADR reporting, many countries are exploring the option of mobile- and web-based solutions. The National Coordination Centre for Pharmacovigilance Program of India, Indian Pharmacopoeia Commission has released a mobile application (app) called “ADR PvPI” to mitigate some of these issues and both standardize and enhance the reporting of ADRs. This is in line with global focus on patient-reported outcomes and real-world data in pharmacovigilance. However, this approach has many implementation challenges including lack of awareness about mobile app, the use of English language in app, low smartphone adoption among the elderly, and in rural areas.

Inclusion of Radiopharmaceuticals in the Indian Pharmacopeia: A Step Forward.

Pharmacopeia is the national collection of quality standards of pharmaceutical products. It is an important instrument for drug safety. The inclusion of radiopharmaceuticals (RPs) in the Indian Pharmacopeia is a step-in right direction as the adaptation of provision of pharmacopeia will reduce the unwanted adverse effects and ensure the effectiveness of RPs.

Haemovigilance: New approach for safe Blood transfusion

Haemovigilance is an urgent need of the country to identify and prevent occurrence or recurrence of transfusion related adverse reactions, thereby to increase the safety and quality of blood transfusion and blood products administration. Haemovigilance is an organised scheme of monitoring, identifying, reporting, investigating and analysing adverse events and reactions pertinent to transfusion and manufacturing blood products. Thus the information collected will facilitate corrective and preventive actions to minimise the potential risks associated with blood collection, processing and transfusion to patients. Indian Pharmacopoeia Commission has started a Haemovigilance Program of India (HvPI) in 2012 under its Pharmacovigilance Program of India (PvPI) in collaboration with National Institute of Biologicals (NIB), Noida, Uttar Pradesh, under Ministry of Health and Family welfare, Government of India with a primary objective to track adverse reactions/events and incidences associated with blood transfusion and blood product administration. The main objective of this article is to brief (s) about the system which monitors each and every step of transfusion reaction.

Clinical Efficacy of Sodium [99mTc] Pertechnetate from Low Specific Activity 99Mo/99mTc Autosolex Generator in Hospital Radiopharmacy Centre.

Few nuclear reactors in the world producing high specific activity (HSA) 99Mo using enriched 235U (HEU), are aging and are planned for shut down in the near future. Further, HEU will not be freely available, due to safeguards, and the technology for 99Mo from low-enriched 235U (LEU) is not yet widely accepted since 239Pu contamination in the product is an issue. Production of 99mTc from low specific activity (LSA) 99Mo obtained from 98Mo(n,)99Mo reaction in research reactor and 100Mo(,n)99Mo reaction in accelerator or directly from 100Mo(p,2n)99mTc nuclear reaction in cyclotron, has been explored [1]. The methyl ethyl ketone (MEK) based solvent extraction technique is n well known method for the separation of 99mTc from low specific activity 99Mo. The 99Mo/99mTc autosolex generator [2], a computer controlled automated module, utilizes the conventional MEK solvent extraction method for extraction of 99mTc. Herein, we have validated the usage of autosolex for preparation of pharmacopoeia grade 99mTcO4- from 7.40-27.5 GBq of LSA 99Mo-SodiumMolybdate (99MoO42-) solution and validated the quality of the 99mTcO4- by preparing wide range of 99mTc-radiopharmaceuticals (99mTc-RP). The 99mTcO4- was extracted from the autosolex as described in [2] starting from 7.40-27.5 GBq of LSA 99MoO42- and subjected to the required physico-chemical and biological quality control (QC) tests. The eluted 99mTcO4- labeled various fourth generation 99mTc radiopharmaceuticals cold kits (99mTc-cold kits) apart from regular 99mTc-cold kits in our centre. Various 99mTc-RP extracted 99mTcO4- using standard procedures [3] were prepared and subjected to required QC as Indian Pharmacopeia monograph [4] and used in scintigraphic imaging in patients. The radiation exposure dose to the operator were compared between autosolex and manual MEK based solvent extraction generator. The extracted 99mTcO4- from autosolex is a clear and colorless solution with pH between 5.0-6.5. The elemental molybdenum (Mo) and aluminum (Al) content <10µg/mL, MEK levels <0.1%, 99Mo breakthrough <0.030% and radiochemical purity (RCP) >98%. All the extracted 99mTcO4- batches complies sterility test, endotoxin limit (EL) <5EU/mL. The RCP of all the labeled 99mTc-RP >95%. The autosolex delivers much less radiation dose to the operator than the convention manually handled MEK based solvent extraction generator. Autosolex Generator was successfully used to obtain pharmaceutical grade 99mTcO4- from LSA 99MoO42- and generator is safe in radiological and pharmacological point of view. The suitability of the autosolex for use in hospital radiopharmacy was shown by using the 99mTcO4- to prepare various 99mTc-RP and using these 99mTc-RP for scintigraphic imaging in patients.

ASSESSING THE RATIONALE OF FDC CONTAINING OFLOXACIN AND AZOLES: DISSOLUTION, PERMEATION AND ANTIMICROBIAL STUDIES

Objective: To study fixed-dose combinations (FDC) of antibacterial and antiprotozoal products (ofloxacin and azoles), prescribed for the treatment of diarrhea.&#x0D; Methods: Rationality of these FDC products was verified by assessing parameters such as drug content and release by assay and dissolution tests, respectively mentioned in the Indian Pharmacopoeia (IP). Amount of drug solubilized and permeated as per the Biopharmaceutics Classification System (BCS) was determined. Ex vivo permeation study was performed on the gut of goat using the everted gut sac technique. Antimicrobial efficacy in terms of minimum inhibitory concentration (MIC) was assessed using agar well diffusion method against Shigella boydii, the causative agent for diarrhea. Comparative studies were performed on an individual as well as combination doses of antibacterial and antiprotozoal products for the synergistic effects to assess the rationale of these FDC.&#x0D; Results: The BCS solubility of ciprofloxacin (CPX), norfloxacin (NFX) and tinidazole (TNZ) was high in acidic medium (pH 1-5) and decreased at pH above 5. The assay studies showed that the individual drug contents of FDC were within the IP limits. In vitro dissolution results for both, individual drugs and their combination illustrated 99 % drug release within 30 min in 0.01N HCl. Ex vivo permeation of TNZ was higher than CPX and NFX in individual drugs. No significant change in the permeation rate was observed for individual drugs and their FDC. CPX and NFX exhibited more antimicrobial activity in terms of inhibitory zones than their FDC with antiprotozoal TNZ, above 2.5 µg/ml MIC. The pharmaceutical, biopharmaceutical and antimicrobial evaluation study showed the similarity of FDC with the individual drugs.&#x0D; Conclusion: The study showed no significant data to justify the therapeutic advantage of FDC over individual drugs.

Implementation of adverse event reporting for medical devices, India.

ProblemRapid growth in the use of medical devices has drawn attention to gaps in the systematic monitoring of medical device-associated adverse events in India.ApproachImplementation of national regulations on medical devices started in January 2018. Supported by a nationwide network of monitoring centres, the Indian Pharmacopoeia Commission coordinates adverse event reports from manufacturers, legal representatives and patients or users. The commission follows-up and reviews reports with subject expert groups and sends recommendations on necessary action to the national regulatory authority.Local settingBefore 2015, no systematic structure was in place to collate adverse events associated with medical devices. Several reports of deaths and hospitalization due to faulty hip implants, cardiac stents and poor-quality devices prompted the health ministry to launch the materiovigilance programme.Relevant changesFrom July 2015 to October 2019, the commission received 1931 adverse event reports, mostly from marketing authorization holders; 1277 were serious events. Reporting increased markedly after 2017. Cardiac stents were the most reported device (926 events; 47.95%). To encourage a culture of reporting, the commission has raised awareness about the programme among stakeholders, developed user-friendly reporting tools and guidelines, and conducted training for hospital personnel on medical device adverse event reporting.Lessons learntRegular training to stakeholders develops a sense of responsibility towards reporting medical device adverse events and ensures quality data reporting. Reporters must be assured that reporting adverse events does not have any legal implications for them and given acknowledgement of their role in high-quality device associated adverse event reporting.