Indian Pharmacopoeia Research Articles

Analysis of historical data to accelerate deletion of Abnormal Toxicity Test requirement for biologicals and vaccines

Abnormal Toxicity Test (ATT) is performed as quality control test by manufacturers and National Control Laboratory (NCL) to ensure safety of biologicals. However, stakeholders are in general consensus that extraneous toxic contaminations are extremely unlikely where Good Manufacturing Practices (GMPs) and consistent production have been established. This test requiring mice and guinea pigs is still a regulatory requirement for the batch release of biologicals in several countries although it has been deleted by some National Regulatory Authorities (NRAs) and Pharmacopoeias while some are still working on its elimination. Therefore, ten years historic data of ATT performed at National Institute of Biologicals (NIB), India on 4813 batches of biologicals including blood and related products, enzymes, hormones and vaccines by using 33637 animals was analyzed. As per Indian Pharmacopeia (IP), 4783 batches of these biologicals passed the test. The test had to be repeated in 30 batches, all of which were blood products and the repetition rate was 0.62 %. Further, after repeat testing, all these 30 batches also passed the test. This data will help the regulatory authorities of countries where ATT is still a requirement, take appropriate decision regarding its deletion. The elimination of ATT from specific monographs of these biologicals will help save many thousands of animals being used globally for this test.

Minimizing the risk of ethylene glycol and diethylene glycol poisoning in medications: A regulatory and pharmacopoeial response

Pharmaceutical and personal care products, including syrups and toothpastes, extensively use glycerin, sorbitol, and propylene glycol. However, past incidents of ethylene glycol (EG) and diethylene glycol (DEG) contamination in these products have raised serious health concerns. Recently, several child deaths linked to contaminated cough syrup consumption have heightened concerns regarding the safety of Indian pharmaceuticals. In response, Indian drug regulatory authorities and the Indian Pharmacopoeia have implemented several measures to enhance the quality, safety, and efficacy of pharmaceuticals manufactured in India. These measures encompass risk-based inspections of manufacturing facilities, rigorous quality control checks of medicinal products intended for export, and increased transparency in the supply chain of excipients prone to EG and DEG contamination. Further, the Indian Pharmacopoeia has updated monographs for five high-risk excipients: glycerin, propylene glycol, sorbitol solution (70%, both crystallizing and non-crystallizing), and liquid maltitol. These efforts are consistent with global regulatory standards and aim to ensure the overall quality and safety of pharmaceuticals produced in India.

Standardization of Katakadi Eye Drop: An Ophthalmic Preparation

Ayurveda is science in which we study about not only Atura Chikitsa but also Swasthasya Swasthya Rakshana. In this study an eye drop which comes under Arka Kalpana of Bhaishajya Kalpana. This eye drop not only treats allergic conjunctivitis but also prevent healthy eye from allergy. Main symptoms present in allergic conjunctivitis are redness, itching, burning sensation etc. In Ayurveda we correlate cataract with Vataja Abhishyanda. This eye drop is made up of Kataka, Karpura and Madhu mentioned in Sharangdhar Samhita Uttarkhand as Netraprasadana has a great potential to prevent and treat conjunctivitis. Also in this study light towards the pharmaceutical preparation of Katakadi Eye Drop. Standard operating procedures to quality assurance of ingredients, and also adhering to Indian Pharmacopeia's specifications for the final product's safety and quality for ophthalmic preparation. Pre-clinical ocular toxicity investigations have demonstrated this formulation's safety for topical use.

The Indian Pharmacopoeia Commission: Challenges, Compliance of Pharmaceutical Industries

The Indian Pharmacopoeia Commission: Challenges, Compliance of Pharmaceutical Industries

Ensuring Medication Safety in India: The Crucial Role of the Pharmacovigilance Programme of India (PvPI) in Adverse Drug Event Monitoring

With the establishment of 12 regional centers, India implemented a comprehensive system for monitoring drug reactions in 1986. In 1997, India became a member of the Uppsala Monitoring Centre in Sweden, which oversees the World Health Organization's Programme for International Drug Surveillance. Beginning at the outset, six regional centers were created in Chandigarh, New Delhi, Mumbai, Kolkata, Lucknow, and Pondicherry. ADR is being watched throughout the nation. Advocating for safe drug use may become a top focus for the Indian Pharmacopoeia Commission, which also functions as the National Coordination Centre for India's Pharmacovigilance Program. We currently have 179 adverse drug reactions under observation. At the moment, the National Coordination Centre receives adverse event reports from centers in India.Reporting Form; Phocomelia; Vigiflow; UMC; Death; Thalidomide

"Veterinary Vaccines- Harmonization of Veterinary Vaccines Monographs of Indian Pharmacopoeia (IP)"

"Veterinary Vaccines- Harmonization of Veterinary Vaccines Monographs of Indian Pharmacopoeia (IP)"

MORPHO-ANATOMICAL PROFILE OF ELAEOCARPUS TUBERCULATUS ROXB

Objective: The anatomical studies of Elaeocarpus tuberculatus Roxb. (Elaeocarpaceae), an indigenous medicinal plant in the Indian pharmacopoeia. Methods: Fresh leaf and stem samples of E. tuberculatus were scrutinized macroscopic and microscopically by standard procedures. Results: Macroscopically, the leaves are simple, long, coriaceous, and rusty below, base obtuse, margin serrate, apex obtuse and petiole 3 cm long. Microscopically, the leaf showed the presence of four prominent collateral bundles. Paracytic stomata were distributed in the abaxial epidermis whereas the adaxial epidermis was apostomatic. The petiole was four-angled including wing bundles. The stem exhibited fissured periderm, wide secondary phloem, secondary xylem with incipient growth ring and abundant calcium oxalate crystals. Powdered microscopic study of the leaf revealed the presence of long whip-like epidermal trichomes, crystals, vessel elements showing pits and fiber-like sclereids. The stem powder showed thick-walled fibers with wide lumen, narrow fibers and a sclerenchyma cell showing wide pits. Conclusion: The results of the study can serve as a valuable source of information and provide suitable standards for the identification of E. tuberculatus in future investigations and applications

Invitro evaluation of generic vs branded product of metformin tablet

The main aim and objective of present research work is to evaluate and compare the standards concerning quality of generic and branded anti hyperglycemic drug (Metformin Hcl). Metformin tablets are evaluated as per standard protocol and results shows that branded and generic meets the pharmacopoeial specifications. All tablets passed the test of weight variation, hardness, thickeness, friability, disintegration, dissolution and assay as per Indian pharmacopoeia. Both the generic and branded tablets of metformin shows similar results. So, health care professionals are suggested to prescribe generic drug so, that everyone can reach the cost of the drug and maintain good health.

Exploring gallic acid-rich leaf extract: Formulation and characterization of antioxidant blends

Antioxidant supplements derived from plants can aid in protecting cells from oxidative stress, which has been connected to various chronic illnesses. The formulation of antioxidant tablets faces challenges due to the unfavorable physicochemical and mechanical properties of dry plant extracts. The utilization of wet plant extracts and sugars in antioxidant tablet development can offer improved solubility, stability, and palatability, enhancing the overall efficacy and acceptability of the formulation. In this work, gallic acid-rich Ficus auriculata leaf extract was utilized as the active component in the development of antioxidant formulations. Formulations were prepared using starch, a biopolymer, and sugars as the major excipients and characterized. The formulations containing a higher concentration of hygroscopic components were sticky and unsuitable for tableting, while free-flowing formulations were formed into tablets. The disintegration times of all the tablets were less than 15 min, satisfying Indian Pharmacopoeia norms. The antioxidant activity of the formulations increased with an increase in the extract. The formulations demonstrated good stability in acidic and alkaline environments. Findings from the present study showed that antioxidant tablets with desirable properties can be prepared using plant extract and readily available excipients.

Formulation Development and Evaluation of Montelukast Sodium Paper Tablets for Enhanced Drug Release

In this study, the technique of paper-based tablets was evaluated for solubility enhancement of montelukast sodium (MS), an anti-asthmatic, Biopharmaceutical Classification System (BCS) class II medication. Initially, the potential for compressing regular paper into tablets was rigorously examined. Results demonstrated that paper may be utilised to make tablets, regardless of type of the paper utilized. The medicinal quality was satisfactory; and entire tablets of the batch met the Indian Pharmacopeia’s criteria. Compressing drug-loaded paper resulted in the formation of drug-loaded tablets. The MS loaded tablets prepared using kitchen roll paper delivered the best results. The tablet was disintegrated in 27 seconds, and drug release of MS was enhanced by 1.88 folds. The tablets were sufficiently hard, and they did not get broken during friability studies. Also, the tablets passed the other evaluation parameters. These paper tablets were also stable under accelerated storage conditions.

Less is more: Validating a single method for comprehensive rh-insulin analysis

The objective of this current study is to establish a single method for potency and related proteins analysis of human insulin formulations using reverse-phase high performance liquid (RP-HPLC) chromatography technique which was validated and verified for the potency analysis in insulin formulations. Chromatographic separation was achieved using an octadecylsilane (C-18) stationary phase and a mobile phase composed of 55% (v/v) buffer (0.2 M sodium sulfate in water, {pH 2.3}) and 45% (v/v) acetonitrile. Detection was performed by UV detector at 214 nm with a flow rate of 1 ml/min and an injection volume of 20 µL, at 40°C. Currently there are separate methods available in Indian Pharmacopoeia for analysis of Potency and Related proteins in human insulin. We have validated a single method where quantitation of potency and related proteins can be performed in the same run. The method validation exhibited linearity over the concentration range of 0.08–4.5 mg/ml (r2=0.999) with limit of detection of 0.094 mg/ml The accuracy of the method was 99–102.8%. Thus, it is proposed that both potency and related proteins in insulin formulations can be precisely evaluated using a single run thus saving the time and cost for quality analysis of insulin preparations both at manufacturing and regulatory laboratories which in turn will increase the market availability of such standard quality insulin preparations for public health use.

Materiovigilance as a Health Care Safety in India: A Regulatory Prospective

Abstract: Over the past few centuries, life-saving tools have been extensively used across the globe. The use of medical devices has increased adverse events associated with them. Materiovigilance is the process of identifying, collecting, reporting, and examining unfavorable events connected to medical devices in order to prevent the recurrence of such occurrences. Several countries keep an eye on medical products once they are commercialized. Other nations with similar programs include France, Australia, and the United Kingdom, in addition to the Medical Device Reporting (MDR) programme in the United States. This article addressed how some types of medical equipment might be dangerous and how a Materiovigilance programme is essential. : This page provides information about how to report adverse reactions to these medical devices, as well as what they are. : In many countries, post-marketing surveillance for medications has been initiated but is not as reliable and advanced as it is today. By monitoring adverse events related to medical devices, generating safety data, educating stakeholders, and recommending appropriate procedures and interventions, the Indian Pharmacopeia Commission established the committee on July 6, 2015. : Monitoring adverse events related to medical device usage can increase patient safety. On the basis of safety data gathered and generated, the Central Drugs Standard Control Organization (CDSCO) will make recommendations about the safe use of medical devices in the Indian population.

The exploring role and responsibility of Indian pharmacopoeia commission: An introduction

: This article emphasise on the Journey of Indian Pharmacopoeia and its parent organisation, the Indian Pharmacopoeia Commission (IPC) as setting up standards for maintaining the efficacy and quality of drugs used for the treatment of diseases prevailing in India. This study attempts to explore Indian Pharmacopoeial growth and general awareness among the scientists, research scholars, drug manufacturers, testing laboratories, healthcare professionals and other stakeholders for their compliance and usage. This article describe the functions of IP Commission such as revision and publication of the Indian Pharmacopoeia, addendum, National formulary of India on a regular basis also providing IP Reference Substances and professional training to the stakeholders on pertaining the Pharmacopoeial work. The objectives of the study are as follows:i. To increase awareness about the Indian Pharmacopoeia (IP) and National Formulary of India (NFI) among the stakeholders; ii. To highlight the Pharmacopoeial importance in India; iii. To discuss landscape for safety and efficacy of the medicines; iv. To explore the journey of the Indian Pharmacopoeia (IP) and National Formulary of India (NFI).This article has been brought out on the basis of evaluation of pharmacopoeial publications and recent literature published online relevant to the drug and pharmaceuticals and it is a kind of descriptive study. There is a shortage of previous similar studies observed on Pharmacopoeial importance and its compliance. It is an attempt being made to understand the drug standardization for rational use of medicine in India.

Polyherbal Syrup for Coronavirus Infection: Formulation and Evaluation

Background: SARS-CoV-2 emerged in Wuhan in December 2019, and after that, it spread quickly around the world. The virus could spread to millions of individuals since there were no particular treatments or preventative measures. The COVID-19 infection is often treated with current drugs such as Remdesivir, steroids, tocilizumab, favipiravir, and ivermectin. However, the immunosuppressive effects of these medicines might worsen COVID-19 symptoms and put the lives of immunocompromised individuals in peril. Thus, it is important to sustain a robust immune system when undergoing therapy for COVID-19. Herbal treatment has the potential to accomplish this objective. Objective: The current investigation involves the preparation of polyherbal syrup containing various medicinal plants such as ephedra, diascorea, ginger, echinacea, garlic, rhubarb, and glycyrrhiza for the effective control of the COVID-19 infection. Methods: All varieties of the individual plant powders (200 g) were treated to a 7 day maceration in aqueous ethanol (70:30) in a percolator at room temperature with intermittent vigorous shaking at room temperature and storage of the extract in a dark room. The mixture was run through a muslin cloth and then a Whatman qualitative grade 1 filter paper to produce the filtrate. The filtrate was evaporated to a thick paste-like consistency at 370 °C under decreased pressure in a rota evaporator connected to a vacuum pump. After that, each individual extract was collected and kept in airtight jars at 4°C. According to the Indian Pharmacopoeia, simple syrup (66.67% w/v) of polyherbal extract was prepared. The oral administration of polyherbal syrup was carried out at varied doses of 0.5 ml, 1 ml, and 1.5 ml to infected golden Syrian hamsters from the 7th day for one week after infection reached its peak. Results: When compared to the infection control group, the results revealed that the viral load was significantly reduced by 79.1% when treated with polyherbal syrup. A histological examination of the infected hamster lung on days 7, 10, and 13 demonstrated that polyherbal syrup significantly decreased viral load in a dose-dependent manner. Conclusion: It is inferred that the polyherbal syrup formulation demonstrates efficacy in the prevention of COVID-19 infection during its first stages and may serve as a potential contender for SARSCoV- 2 due to its immunomodulatory properties.

Pattern of central nervous system related adverse drug reactions (ADRs) due to anti-retroviral therapy in HIV infected patients in tertiary care hospitals in North India

Background: Anti-retroviral therapy is associated with myriads of side-effects. Central nervous system related side effects are troublesome and mostly self limiting. Working knowledge of these side effects can improve the prescription habits of physicians. The study aimed pattern of central system related adverse drug reactions (ADRs) due to anti-retroviral therapy in HIV infected patients in tertiary care hospitals in North India. Materials and methods: A prospective observational study was conducted and all HIV positive patients, previously registered and new; attending OPD who encountered ADRs were enrolled in our study irrespective of their age and sex. Data was collected using ADR reporting form issued by Indian Pharmacopoeia Commission. Causality assessment was done by using Naranjo’s Probability Scale. Modified Hartwig severity scale was used to evaluate severity, WHO criteria for seriousness and guidelines of council for international organizations of medical sciences to decide the predictability of ADRs. Results: A total of 250 patients encountered various types of ADRs during the study period. Total number of ADRs recorded was 452. Out of total ADRs (n=452) recorded, 20.35% (n=92) were central system related ADRs. Most common central nervous system related ADR was dizziness. Most central nervous system related ADRs were of moderate type and possible in nature on causality assessment. Conclusion: Relatively overweight, older age and baseline CD4 absolute count below 250 cells/mm3, were predictors for central nervous system related side effects due to anti-retroviral therapy in HIV patients. We suggest that more stringent evaluation and monitoring should be carefully done in all HIV/AIDS patients who will receive and on efavirenz based anti-retroviral therapy, especially if they have the above predictors.

Pattern of adverse drug reactions to commonly prescribed antibiotics in a tertiary care hospital

Background: Antibiotics have been one of the most significant discoveries in the history of medicine, as they saved countless lives and prevented many serious complications from bacterial infections. Antibiotics are usually safe and effective in treating bacterial infections but can result in adverse drug reactions (ADRs) in some patients. Antibiotics are the most common class of drugs which implicate a greater number of ADRs, because of overuse and misuse of antibiotics, antibiotic resistance, and decreased efficacy. Aims and Objectives: The aims and objectives of the study are to determine clinical symptoms, causality, and severity of antibiotic-associated ADRs. Materials and Methods: A retrospective study was carried out from January 2021 to June 2022; data were collected from Adverse Drug Monitoring Center, GMC/Government General Hospital, Guntur. Prior Institutional Ethics Committee Approval and Permission from Indian Pharmacopoeia Commission, Ghaziabad, were taken. The collected reports were analyzed for ADR pattern, drug groups, causality, and severity. Descriptive statistics were used. Results: Out of 847 ADRs reported, 119 (14%) ADRs were related to antibiotics. The majority of ADRs (65%) were reported in males. A greater number of ADRs were reported in mean age group 31–40 years. Anti-tubercular drugs (27%) were the most commonly implicated antibiotics followed by cephalosporins (22%). Most commonly affected system was cutaneous system (45%) followed by gastrointestinal system (21%). Most common ADRs reported were pruritus (20%), followed by rash (14%). 93% of ADRs were possible and 7% were probable. 87% of ADRs were mild, 12% were moderate, and 2% were severe ADRs. Conclusion: ADRs can be prevented by taking proper action at an early stage. Implementation of antibiotic guideline policy for the hospital and strict adherence to it should be ensured to promote their rational and safe use.

Preparation and Evaluation of Classical Ayurvedic Formulation Triphala gritha

Objective The objective of this study was to prepare and evaluate Triphala gritha.Methods The selected formulation Triphala ghrita was prepared as per the methodology described in Ayurvedic texts. The prepared and marketed formulations were analyzed for their physico-chemical constants using established methods in accordance with WHO guidelines the Indian Pharmacopoeia and standard protocols from the Ayurvedic Pharmacopoeia of India Herbal Pharmacopoeia and other relevant sources.Results A profile consisting of distinguishing parameters was developed to provide means of correct identification. Some important organoleptic features of Triphala ghrita laboratory and market formulations like color odour taste appearance touch etc. were documented. Physico-chemical constants were determined and documented. The formulations were tested for the presence of heavy metals microbial content pesticide residues and aflatoxin which were also found within the limits of WHO specifications. Preliminary phytochemical studies of Triphala ghrita revealed the presence of terpenoids and phenolics as chief constituents. High performance thin-layer chromatography HPTLC method was developed and reported for the quantification of ascorbic acid and gallic acid as marker constituents to ensure identity and quality of Triphala ghrita.Conclusion The studies carried out on Triphala ghrita can serve as a valuable tool and provide suitable standards for its identification. Phytochemical screening and the quantitative HPTLC assay method developed for quantification of ascorbic acid and gallic acid in Triphala ghrita can serve for the routine quality control of commercial samples and help in justifying the traditional claims endowed upon this formulation in a scientifically accepted manner.

Insights into Mefenamic Acid-Induced Allergic Reactions: A Comprehensive Clinical and Research Review

This study investigates the incidence of Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) syndrome associated with the over-the-counter non-steroidal anti-inflammatory drug (NSAID) mefenamic acid. Approximately 10% of individuals exposed to mefenamic acid experience DRESS syndrome, a severe and potentially fatal allergic reaction characterized by fever, skin rash, lymphadenopathy, hematological abnormalities, and internal organ involvement. Leukocytosis with eosinophilia (90%) and mononucleosis (40%) has been linked to certain cases, emphasizing the diversity of clinical presentations. The causative medication must be promptly discontinued upon identification of DRESS syndrome, with documented evidence indicating improved prognosis with early drug removal. Despite the severity of these reactions, the study sheds light on the alarming accessibility of mefenamic acid and other banned medications in developing nations, particularly exemplified by the Indian Pharmacopoeia Commission’s alert on mefenamic acid issued on December 7, 2023. The lack of effective law enforcement and medical awareness poses significant challenges, allowing banned drugs, including Nimesulide and Rofecoxib, to persist in the market despite being banned by the USFDA. This research underscores the critical need for global collaboration to address regulatory gaps, enhance medical awareness, and enforce stringent measures to restrict the availability of harmful medications in developing nations. Urgent attention to these issues is imperative to safeguard public health and ensure the effective implementation of drug regulations on a global scale.

In vitro quantitative and qualitative analysis of anti-hypertensive tablets and comparison between their generic versus branded formulations

Background: While generic drugs and branded drugs are supposed to be bioequivalent, generic drugs have the additional benefit of being available at a lower cost which can be important in patients with chronic diseases such as hypertension. However, there are some concerns among clinicians that generic drugs may not be as effective as the branded counterparts. Hence, there is a need to generate comparative data between the branded and the generic drugs. Aims and Objectives: The objective of the study was to compare the pharmaceutical parameters and costs of four generic antihypertensive drugs with their branded counterparts. Materials and Methods: Four antihypertensive drugs, namely, Ramipril, atenolol, enalapril, and amlodipine were considered for evaluation for which their generic and branded samples were taken. All the drugs were in tablet form. The costs of these drugs were recorded, and various in vitro tests were conducted to assess and compare their characteristics, including disintegration, dissolution, hardness, weight variation, friability, thickness, diameter, and quantitative analysis using high-performance liquid chromatography and ultraviolet spectrophotometry. These tests were done in accordance with the specifications outlined in the Indian pharmacopoeia 2018. Results: All the branded drugs were more expensive than the generic counterparts. Quantitative assay of the generic sample of ramipril tablets showed a lower amount of the active ingredient than the stated value. Apart from the hardness values of the tablets, all the generic and branded samples fell within the specified normal range for most of the other important parameters. Conclusion: Generic antihypertensive tablets, were less costly than their branded counterparts and generally met the specified standards in in vitro testing. However, there were instances of subpar hardness results and a deficiency in the stated drug amount in the generic (less ramipril content in sample). These findings suggest the importance of rigorous quality control measures for generic medications particularly for those formulations liable for degradation.

Quality Parameters of Polyherbal Formulation of Three Different Marketed Brands of Vilwadi Gutika: A Comparative Evaluation Study

Background: Ayurveda is a highly beneficial medical system due to its natural components that effectively eliminate disease causes, restore balance, and prevent further recurrence. Polyherbal formulations are highly popular due to their wide therapeutic range, making them safe at high doses and producing minimal negative effects when taken improperly. The goal of this study was to standardize the efficacy and quality of commercial herbal tablet formulations. Methods: Three marketed samples of vilwadi Gutika ware used for the study. After authentication of the samples, the phytochemical stander like determination of pH, ash value, acid insoluble ash, water soluble ash, water soluble extractive, alcohol and soluble extractive were determined. In vitro anti-microbial activity was determined using Agar well diffusion method and the anti – inflammatory activity of Vilwadi tablet of different ayurvedic agency was assessed by in- vitro HRBC (Human Red Blood Cells) membrane stabilization method. Results: The physicochemical properties of polyherbal pills met Pharmacopeial criteria, including pH, ash value, hardness, and friability. Sample 1 was the most acceptable, with a noticeable hardness (0.93) for rapid disintegration. The sample 3 (Vilwadi gutika – Arya Vaidya Pharmacy, Coimbatore) exhibited the highest antimicrobial activity against E. coli, Staphylococcus sp, and Candida sp, while sample 1 showed the highest activity against E. coli and Staphylococcus sp, and less activity against Candida sp. The in vitro anti-inflammatory activity shown that at concentration of 100µg / ml, the test compound inhibited 66.6 % of RBC haemolysis as compared with 54.16 % produced by Indomethacin (positive control) at 100µg / ml. Conclusion: The investigation reveals that the Viladi gutika herbal formulation can be standardized using a scientific quality control technique, meeting Indian pharmacopoeia requirements for tablet dosage form, with further research needed to analyze other characteristics. Keywords: Viladi gutika, anti-microbial activity, anti-inflammatory activity.