Indian Pharmacopoeia Research Articles

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.

NOVEL ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR CEFOXITIN NEW β-LACTAM ANTIBIOTICS IN BULK AND DOSAGE FORM

The Objective of this work based on for development of a novel method and validation of method used for determination of amount in manner of assay present into Cefoxitin in bulk and Tablet Dosage form. The aspire and intention of the present study is to expand moreover authenticate a novel as well as rapid reverse phase chromatography separation technique for the estimating Cefoxitin in bulk and dosage form to justify the presence of drug in the developed dosage forms and give satisfaction towards presence of medicine and its assay estimation. As the drug Cefoxitin compendial monograph is not available in Indian Pharmacopoeia and British Pharmacopoeia, but a compendial monograph is available in United Sate Pharmacopoeia i.e. USP- 40 for injection dosage form only. The developed method is new, simple, economic, rapid, eco friendly, accurate, and precise HPLC method for qualitative and quantitative estimation of Cefoxitin in bulk and dosage form like tablet, capsule, injection also.

Knowledge and attitudinal survey of drug promotional literature among second year undergraduate students: a questionnaire based study

Background: Promotion of drugs has been increased enormously with the advancement of technology and use of internet and media etc. Pharmaceutical manufacturers spend vast amount of money on promotion usually through medical representatives by providing printed advertisements. But, 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. So, the present study has been conducted to assess the knowledge and attitude of second year undergraduate students about promotional literature and to train them accordingly for improving the prescribing behaviour.Methods: A questionnaire based study containing 9 questions was conducted in 110 second year undergraduate students after taking informed consent. Statistical analysis was done by using descriptive statistics by graph pad prism version 6.01.Results: Among respondents 60 (61.2%) were males and rest 38 (38.8%) were females. 50 (51%) of the respondents have chosen Indian pharmacopoeia as a trusted source of information followed by others. Most common factor affecting the prescribing attitude was reported as updates from clinical trials 49 (50%) followed by prescriber’s knowledge. Most important intervention taken to stop misleading drug promotional activities has been reported as formulation of strict regulation by the health care authorities against any misleading promotion.Conclusions: Promotional activities by manufacturers influence the attitude and prescribing pattern of doctors. So, it is important to teach the students about their rational use by critically analysing it.

CURRENT STATUS OF MATERIOVIGILANCE GLOBALLY-AN UTTER OVERVIEW WITH CLINICAL CASE PERUSAL

Today’s medical devices are the lifesaving tool and these tools are very frequently used globally since long ago. With the increase in the number of medical devices and their uses, there is an increase in the number of adverse events related to such devices. That is why Materiovigilance is an important tool for the identification, collection, reporting, and analysis of any aversive catastrophe related to the use of medical devices and protection of a patient’s life by fending its reiteration. Post marketing surveillance of medical devices has been initiated in many countries, like the United States of America has started a program under the name Medical Device Reporting (MDR), France, Australia and the United Kingdom have also come up with their own programs. Apart from this India has also initiated the Materiovigilance program by Drug Controller General of India (DCGI) at the Indian Pharmacopoeia Commission (IPC) in Ghaziabad in 2015. In this article we have discussed about the risks associated with the use of different classes of medical devices and the need of Materiovigilance program. This article also discusses the adverse events associated with the medical devices, the reporting criteria of those adverse events and the different clinical events of the medical devices.

Characterization of Thermal Fraction of Clarified Butter and its Applicability to Improve Bioavailability of Rosuvastatin

Abstract: Aim: The present investigation shows confirmatory evidence for the complex formation of Rosuvastatin with a fraction of Clarified Butter. Material and Methods: Fractions of Clarified Butter prepared according to thermal behavior at different temperatures (30°C, 40°C, 50°C). Rosuvastatin biform complex with Clarified Butter in the ratio (1:1) and (1:2) w/w was prepared. Physicochemical properties of all fractions of Clarified Butter had determined as per Indian Pharmacopoeia. The fractions were subject to Fouriertransform Infrared spectroscopy (FTIR), Differential Scanning Calorimeters (DSC) and in-vitro release studies (Simulated gastric fluid, pH 1.2 for 2 h and simulated intestinal fluid, pH 6.8 for 6 h). Results: Based on these investigations; the optimized ratio (1:1) w/w were further characterized for DSC and FTIR studies. Where Rosuvastatin showed a strong carbonyl band at 1543.05 cm−1 , all fractions showed the disappearance of strong carbonyl band at 1543.05 cm−1, spectra of biform complex shifted to higher frequency 1747.51 cm−1 (13.29 % increase), that show carboxylic and hydroxyl group of both saturated and unsaturated fatty acid present in Clarified Butter. From in vitro release study the highest percent release i.e. 99.23±0.08% of Rosuvastatin was obtained from 1:1 biform complex. DSC thermogram confirming the formation of eutectic mixture by lowering the peak of pure Clarified Butter (67.4°C) to 58.10°C by the formation of biform complex with the drug Rosuvastatin. Conclusion: Thus, Clarified Butter and its fraction are prominent in improving the bioavailability of Rosuvastatin. Key words: Rosuvastatin, Clarified Butter, Peroxide value, Thermal oxidation, Bioavailability.

Study of adverse drug reactions to antiretroviral therapy in a tertiary care hospital, Tirupati.

Purpose:Human immunodeficiency virus-infected patients do not adhere to their antiretroviral therapy (ART) due to adverse effects of drugs. The continuous monitoring of adverse drug reactions (ADRs) may ensure the safe use of drugs in patients. Hence, a retrospective analysis was carried out to assess the ADRs pattern, causality, and severity associated with various antiretroviral drug regimens in patients receiving ART.Materials and Methods:A retrospective, analytical study was carried out at ART nodal center in Sri Venkateswara Ramnarain Ruia Government General Hospital, Tirupati. Data were collected by spontaneous reporting of health-care professionals from ART centers using Suspected ADR Reporting Forms of Indian Pharmacopoeia Commission to record the ADRs occurred in the patients who underwent treatment from December 2015 to November 2016. A total of 299 ADR reports were collected during the study period. The causality and severity of the reported ADRs were assessed using suitable scales.Results:From a total of 299 ADR reports, females (63.81%) experienced higher ADRs than males (36.12%). The highest number of ADRs was reported to zidovudine/lamivudine/nevirapine (ZLN) regimen (76.92%) than tenofovir/lamivudine/efavirenz (TLE) regimen (23.07%). Cutaneous reactions were higher (34.34%) among patients receiving ZLN therapy, and drowsiness (53.62%) was the most common ADR in patients receiving TLE regimen. According to the World Health Organization causality assessment scale, most of the ADRs were possible (75.92%). On the assessment of Modified Hartwig and Siegel Severity Scale, 55.09% of ADRs were moderate.Conclusion:The study showed an increased incidence of ADRs to ART which calls for efficient pharmacovigilance systems to improve patient care and drug safety.

Method development, validation and comparative study of generic Vs. branded generic formulations of amoxicillin trihydrate in capsule dosage form

The present work relates to development and validation of simple, precise and sensitive UV spectrometric and high-performance thin layer chromatographic (HPTLC) method for the analysis of Amoxicillin Trihydrate in Capsule dosage form. Method were developed and applied for comparative study of generic vs branded generic formulations of Amoxicillin Trihydrate. Amoxicillin Trihydrate in methanol shows maximum absorbance at 229 nm and the data of linear regression analysis indicated a good linear relationship over the concentration range of 5-30 µg/ml with a correlation coefficient (R2) 0.998 by UV- Spectroscopy and the concentration range of 2000-12000 ng/band with a correlation coefficient (R2) 0.997 by HPTLC. The main objective was to compare and evaluate the price and quality of branded generic and generic formulations of Amoxicillin Trihydrate 250 mg Capsule. The evaluation parameters like content of active ingredients, content uniformity test, mass variation, disintegration test, and in vitro release studies were performed as described in Indian Pharmacopeia 2010. Keywords: Branded Generic, Generic, Quantitative and Qualitative Determination, Ultraviolet Spectroscopy, HPTLC, Comparative Studies.

The Regulatory Dilemma for Import of Radiopharmaceuticals in India

The inclusion of monographs of several radiopharmaceuticals in the Indian Pharmacopoeia has drawn the attention of drug control authorities in the country and other stakeholders. Therefore, in a move towards better regulation of radiopharmaceuticals, the Office of the Drug Controller General of India has issued some important notices concerning their import. However, these notices have resulted in several misgivings among the nuclear medicine community as appointment of patients for nuclear medicine scans had to be cancelled/rescheduled and clinical decisions delayed. An analysis of the sequence of events is presented in this study, highlighting the effects of decisions taken regarding import of radiopharmaceuticals, and suggestions to implement regulations with minimal repercussions.

Quality control of marketed clove buds - reference to their quality and purity as per who guidelines

Two marketed clove buds were subjected to crude drug standardization by sampling from retail packages as per WHO recommended guidelines. The marketed clove products viz. brand-A and brand-B were standardized comparatively for various parameters like, powder fineness, foreign matter, ash values, volatile oil content, bitterness value, swelling index, foaming index, heavy metals, Mycological examinations, spectral analysis, qualification of Eugenol by TLC and quantification by HPLC. The results were compared with individual monograph limits specified in Indian Pharmacopoeia. The volatile oil content were estimated by Azeotropic distillation and were found to be 1.5ml and 1.2ml/10gms respectively for brand-A and brand-B against the limit 1.5 to 2.1ml. The UV spectra and ATR-IR spectra of both volatile oils were identical with the finger print of standard Eugenol oil. The foreign matter and ash value for brand-A and brand-B were 1.49%, 5.8% and 3.79%, 6%, respectively and brand-B doesn’t complies with the specified monograph limits (NMT 3%) for foreign matter. The Eugenol content in the volatile oil was quantitated by RP-HPLC method and was found to be 93.3.1% and 74.6% respectively for brand-A and brand-B against the standard monograph limit of 85-95%. It was noted that the brand-A was found to be superior quality and whilst brand-B disqualifies in standardization parameters such as Foreign matter, Volatile matter and Eugenol content. World Health Organization has emphasized the need to ensure quality control of medicinal plant products by applying suitable parameters and standards. In order to overcome certain inevitable shortcoming of the Pharmacopoeial monograph and other quality control measures, the present study explores the possible parameters of crude drug standardization for marketed clove buds with special reference to their quality and purity as per WHO guidelines.

Simultaneous Method for Quantification of Genotoxic Impurity in the Gemcitabine Hydrochloride by RP-HPLC

: Objective: In the pharmaceutical analytical field, effort to analyzing the degradation or related and impurity substances from the complex matrix in the ultra-trace levels is a really a challengeable task. Impurity is any component of the new drug substance that is not the chemical entity defined as the new drug substance. Gemcitabine hydrochloride is a new anticancer bio molecule. According to Indian Pharmacopoeia there is two impurities present in this drug. The literature review exploded that, there is no specific impurity profiling based analytical method developed to estimate the Cytosine. Methods: RP HPLC is developed to quantify and separate Gemcitabine hydrochloride and Cytosine. The Hibar® C18 (250 x 4.6 mm i.d., 5μ), Column choices as stationary phase, tri ethyl ether and Acetonitrile in ratio of 95:5 with 4.35 (with Orthophosphoric acid) as mobile phase, the flow rate fixed as 1ml/ min. at 279 nm. Results: A retention time found to be 3.44min and 8.28min for gemcitabine and cytosine respectively. The developed method was validated as per ICH guidelines and the method was proved as selective, specific and linear. The assay and recovery studies were carried out the assay limit was 99.19 and 99.32 for bulk drug and formulations respectively. The Cytosine were present 0.7821 μg/ml and 0.6531 μg/ml in the bulk drug and formulation respectively. Conclusion: It can be concluded that the developed RP-HPLC method was found to be suitable for the appraisal of cytosine impurities in Gemcitabine HCl. The developed RP-HPLC is economic and suitable for the use.Key words: Gemcitabine HCl (GCH), Cytosine (CYS), RP-HPLC, Genotoxin, Impurity, Anticancer.

Development and Characterization of Ofloxacin & Prednisolone Loaded Nanostructured Lipid Carriers (Nlc) for Topical Route

Aim: The present study was designed to develop and characterize nanostructured lipid carriers (NLC) of Ofloxacin and Prednisolone for topical use in case of infections associated with inflammation. Materials and Methods: Ofloxacin was obtained as gift sample from Mankind Pharma Ltd, VillKyarta, P.O. Misserwal, Poonta Sahib, Sir Mour. H.P. Whereas Prednisolone was purchased from Yarrow chem., Mumbai. It was evaluated for its pre-formulation studies (organoleptic properties, melting point, solubility, compatibility, max. wavelength of absorption). NLCs were prepared through melt-emulsification followed by ultra-sonication technique. Further optimized batch of NLCs was incorporated into Gel. Formulated NLCs were evaluated in terms of morphological characteristics, particle size (Polydispersity Index), drug content, In-vitro drug release (using egg membrane), drug release kinetics (Ritger-Peppas diffusion method). Finally, gel containing NLCs was studied by physical characteristics, pH, viscosity, spreadability, drug content, In-vitro drug release and its kinetics. Results and Discussion: In pre-formulation study, drugs were found having the similar properties as described in Indian Pharmacopoeia (IP) and United States Pharmacopoeia (USP). SEM photomicrograph revealed that NLCs were spherical with more or less smooth surface; particle size 512.3-1703 nm and PDI- 0.399-0.742 (ofloxacin) and particle size 539.3-1736.7 nm and PDI- 0.335 - 0.711 (prednisolone);drug content was found in range of 56.7 - 75.6% for ofloxacin and 65.9 – 81.8% for prednisolone. NLC1 demonstrated maximum release rate with 83.37±1.70% and NLC8 73.96±0.53%.NLC6 was best fitted in Korsmeyer - peppas model as the regression coefficients were 0.960, 0.964, 0.977, 0.950, 0.980 & 0.987 respectively and prednisolone NLC 9 (0.953) and they were close to 1. Conclusion: In conclusion, the prepared NLCs had prolonged release effects with good potential for topical delivery of NLC based gel formulation of ofloxacin& prednisolone.

Establishment of the First National Reference Standard for Insulin Lispro: Report of a collaborative study

The present study was aimed to establish the First National Reference Standard (NRS) for Insulin lispro to allow stakeholders including manufacturer's laboratories, drug testing laboratories, drug regulatory authorities and academic institutions to demonstrate accuracy of the test results and to enable comparison and validation of analytical methods. The candidate standard for Insulin lispro was evaluated in a collaborative study to assign the vial content in order to serve it as NRS to support the Indian Pharmacopoeia (IP) monograph. The candidate standard was calibrated against the Ph. Eur. Insulin lispro reference standard by each of six participant laboratories in India using HPLC assay method as per the requirements of IP monograph. The results indicate that the candidate standard has an average content of 5.79 mg per vial with purity of 99.87%. Based on the study results the candidate standard was judged suitable to serve as the first NRS for Insulin lispro.

An intensive monitoring of adverse drug reaction in indoor patients of medicine department at tertiary care teaching hospital: A single center, prospective, and multisource observational study

Background: Adverse drug reactions (ADRs) have been evolved as a serious and major health-care problem affecting the quality of life of patients and increasing burden over the health-care system. Studying the pattern and spectrum of ADRs can help to find measures to address the problem and possibly prevent it effectively. Aims and Objectives: The study aimed to intensively monitor ADRs in indoor patients of medicine wards and estimate the incidence rate with documentation of the spectrum of ADRs in studied patients in terms of causality, severity, and preventability. Materials and Methods: This was prospective, observational, and single-center study, conducted at internal medicine wards of Sir Sayajirao General Hospital, Vadodara, over a duration of 8 months, after taking prior permission from the Institutional Ethics Committee. The necessary data were obtained and recorded on a pre-designed “case record form” and “Indian Pharmacopoeia Commission-ADR reporting form” after taking written informed consent and analyzed with Microsoft Excel-2016. Results: A total 11,400 admissions recorded during the study period in all nine wards of medicine department, of which 66 patients developed 88 ADRs with the incidence of 0.5789%. They were classified into Group A (38, 57.58%), ADR developed after hospitalization and Group B (28, 42.42%), ADR is the reason for hospitalization. The most common category of causality assessment was “probable” according to both WHO-UMC criteria (53, 54.65%) and Naranjo scale (54, 55.68%). According to modified Hartwig-Siegel scale majority, ADRs (43, 48.32%) fall into “moderate” category, and according to modified Thornton and Schumock criteria, the “preventable” ADRs were (29, 30.85%). Conclusion: The drug safety seems to be well considered in this setup with lower incidence rate found in our study, but there is still a need for improvement to reduce the huge portion of preventable ADRs.

Comparison of Physicochemical Evaluation of Different Brands of Honey

Marketed brands of honey in our country do not have much more standardization. Even pharmacopeia standards of honey far from complete. The present study assessed parameters to determine appropriate identification and quality of three brands honey sold in India market. For this purpose, honey of three popular brands of Indian market was selected for evaluation purpose and investigated for following parameters such as macroscopic evaluation, ash value, loss on drying, chemical tests and viscosity. In result study based on macroscopic parameters all three brands were found complies with Indian Pharmacopeia 1996. But in physical evaluation sample of brand D1 was found complies pharmacopeia standards and other two brands S1 and B1 fail in this evaluation even not about near to official minimum standards. On the basis of chemical tests evaluations, we found all three brands complies the official standards as shown in results. As per our overall observations brand D1 found good and most effective of different types of parameters of evaluations.

Biovigilance: A Global Perspective.

A biological is a substance which either comprises, contains, or is derived from human cells or human tissues. The use of biological products is associated with the risk of infection transmission, allergic reactions, and other adverse events (AEs). The science and activities relating to the detection, assessment, understanding, and prevention of AEs or any other problems related to biological products (blood, cells, tissues, organs, and vaccine in international perspective) are termed as biovigilance. With more and more biologicals being marketed and the rapid revolutionary changes in transplant-related services, the importance of biovigilance is increasing day by day. Although specific types of vigilance systems (pharmacovigilance and materiovigilance) exist, activities related to “biovigilance” are still in an infancy stage. Many developed countries such as the USA, Europe, and Australia have implemented nationwide biovigilance programs. In India, the National Institute of Biologicals, in collaboration with the Indian Pharmacopoeia Commission, has launched the Biovigilance Programme of India. In this article, the biovigilance systems of different countries across the globe have been reviewed along with highlights of the current biovigilance needs.

Physico-chemical standardization of Hansraj (Adiantum capillus-Veneris)

Ethno-botanical use and traditional knowledge of plants have been usually recognized all over the world. The outstanding characteristics of extracts obtained from this drug have been technically studied, attributing the main biological activity to its tannin and flavonoid content. Recent study about this drug Adiantum capillus-veneris Linn requires pharmacognostical evidences to develop quality-control methods for raw materials and extracts produced with this plant drug. In this research article macro and micro-scopic studies were proven the authentication of the real drug in which adulteration is allowed in commercial samples of this plant material. The parameters which were mention in this study all are according to WHO guidelines and Indian Pharmacopoeia (IP). The morphological characteristics present in this article can be useful for quick identification of the drug, particularly useful in the case of powdered drug. Physicochemical parameters such as total ash, water soluble ash, acid insoluble ash, loss on drying, percentage of foreign matter and extractive values were determined. Preliminary phytochemical screening in different solvents showed the presence of flavonoids, terpenoids, fats, tannins and phenolic compounds. The various phytochemicals presence in the drug are confirmed by thin layer chromatography (TLC) profile. The study can serve as a valuable source of information and provide suitable standards for the presence of various phytochemicals. The results extracted from this study such as identification, phytochemical investigation etc. could be helpful in future research and uses

Analysis and reporting of adverse drug reactions at a tertiary care teaching hospital

ObjectivesTo analyze and report adverse drug reactions (ADRs) in a tertiary care teaching hospital. MethodsThis was an observational study, conducted to analyze and communicate the ADRs reported from July 2016 to June 2017 in a south Indian tertiary care teaching hospital. On daily basis, ADRs reported by healthcare professionals (HCPs) were analyzed and the reports that meet pharmacovigilance programme of India (PvPI) reporting criteria were communicated to PvPI through a specified updated Indian Pharmacopoeia Commission (IPC) suspected ADR reporting form. In this study, ADRs were summarised based on demographics, drug, incidence, type of reaction and its outcome. Causality, severity, seriousness, and predictability were assessed through WHO causality assessment scale, Hartwig and Siegel Severity Assessment Scale and PvPI criteria. ResultsA total of 254 ADRs communicated to PvPI through specified, updated IPC suspected ADR reporting form. The incidence of ADRs in both males and females was identical. The occurrence of ADRs in adult patients (71.26%) was significantly higher than other age groups. Of total ADRs, most of them were with Antibiotics (24.01%) followed by antipsychotics (11.42%). In causality assessment, a majority of ADRs (48.82%) were considered possibly related to the drug or treatment and 55.12% were mild in severity. Overall, 36.22% patients were recovered from ADRs. Most of the reported ADRs (54.33%) were probably preventable. ConclusionsThe results provided an insight to the HCPs on the importance of monitoring and reporting of ADRs. High-quality data gathered through a reporting system, most of the reported ADRs were probably preventable; the proper review of patient history and monitoring by HCPs can reduce the incidence of ADR. Our study results emphasize a need for establishing a pharmacovigilance centre to ensure the safe use of drugs.

Pharmacovigilance programme of India: revival of the renaissance

Adverse drug reactions (ADRs) are the fourth leading cause of morbidity in the world. In order to safeguard the health of the community, Pharmacovigilance Programme of India (PvPI) is implemented as the monitoring body by Indian Pharmacopoeia Commission (IPC). It is leading national authority. National Coordinating Centre (NCC) PvPI works as the World Health Organization (WHO) collaborating centre for pharmacovigilance. Adverse drug reactions are reported to NCC PvPI which are then directed towards WHO Uppsala Monitoring Centre (UMC) Sweden which is the global monitoring centre for worldwide data. Central Drugs Standard Control Organization (CDSCO) is the regulatory authority of India under the Ministry of Health and Family Welfare (MOHFW), Government of India. This article focusses on the various strands of pharmacovigilance at the healthcare professional and consumer level. It also discusses the pitfalls in the journey of pharmacovigilance thus helping in enhancing the quality of health safety. Even a minuscule contribution by a health care professional or a consumer can voluminously help in promotion of drug safety. Therefore, there is a need of inculcating the culture of adverse drug reaction reporting for the welfare of the vulnerable masses.

Pharmacovigilance Program of India: history, evolution and current status

Summary Unlike developed nations most of whom put into place systems of pharmacovigilance in the early 1960s following the thalidomide disaster, India's Pharmacovigilance Program formally began only in the mid-1980s. After several unsuccessful attempts, a robust program was put in place by the Central Drugs Standard Control Organization in 2010 called the Pharmacovigilance Program of India. Today, this is a stable system with the Indian regulator at the helm, a formal legislation in place to support the program and a National Coordinating Center located at the Indian Pharmacopoeia Commission. In the 8 years since its resurrection, the activities have expanded by leaps and bounds. There are 250 adverse reactions monitoring centers throughout the country and India contributes 1.7% of Individual Case Safety Reports to the Uppsala Monitoring Center's database. The WHO, recognizing India's concerted efforts in the area of pharmacovigilance, established its first WHO Collaborating Centre for Pharmacovigilance in Public Health Programs and Regulatory Services at the National Coordinating Center. The proposed expansion of the program in the coming years will further strengthen the cause of medicines safety in the country in line with the WHO's Third Global Patient Safety Challenge of Medication without Harm.

Pharmacovigilance in India: Present Scenario and Future Challenges.

Pharmacovigilance in India was initiated way back in 1986 with a formal adverse drug reaction (ADR) monitoring system, under supervision of the drug controller of India. India joined the World Health Organization (WHO) Programme for International Drug Monitoring in 1998, but was not successful. Later, the National Programme of Pharmacovigilance was launched in 2005, and was renamed as the Pharmacovigilance Programme of India (PvPI) in 2010. In consideration of having a robust pharmacovigilance system in India, steps were taken. The National Coordination Centre was shifted from New Delhi to the Indian Pharmacopoeia Commission (IPC) in Ghaziabad. The PvPI works to safeguard the health of the Indian population by ensuring that the benefit of medicines outweighs the risks associated with their use. The culture of reporting of ADRs has achieved remarkable success, with 250 PvPI-established adverse drug monitoring centres all over India and provision of training to healthcare professionals. The programme is striving hard to build trust between the physician and the patient, thereby increasing patient safety and the confidence of people in the country's health system, in addition to the detection of substandard medicines and prescribing, dispensing and administration errors. The IPC-PvPI has now become a WHO Collaborating Centre for Pharmacovigilance in Public Health Programmes and Regulatory Services. In spite of these achievements, several challenges are faced by the PvPI, like the monitoring of generic drugs, biosimilars, and disease-specific ADRs of antidiabetic, cardiovascular and antipsychotic drugs and, above all, creating awareness, which is a continual process. At the same time, the PvPI is trying to address other challenges like counterfeit drugs, antimicrobial resistance, and surveillance during mass vaccinations and other national programmes.