PHARMACOVIGILANCE: THE PRESENT STATUS AND FUTURE PROSPECTS IN INDIA

 

About Authors:
Roohi Kesharwani1*, Devendra Singh2, Vishal Jacob1
1-Institute Of Foreign Trade And Management Lodhipur Rajput,
Delhi Road, Moradabad, India
2-Raj Kumar Goel Institute Of Technology, Delhi-Meerut Road, Ghaziabad, India
*roohi4mail@gmail.com, devendrasingh.pisces@gmail.com

ABSTRACT:
Pharmacovigilance is now accepted to be a continuous process of evaluation accompanied by steps to improve safe use of medicines which involves pharmaceutical companies, regulatory authorities, health professionals and patients. The methodologies have broadened to encompass many different types of study, with spontaneous reporting remaining the cornerstone. The concern for ADRs in highly vulnerable populations is of even greater concern.Pharmacovigilance is especially important since most of the adverse effects are reversible by modifying the dosage or omitting the offending medicine. All medicines (pharmaceuticals and vaccines) haveside effects.In a vast country like India with a population of over 1.2 Billion with vast ethnic variability, different disease prevalence patterns, practice of different systems of medicines, different socioeconomic status, it is important to have a standardized and robust pharmacovigilance and drug safety monitoring programme for the nation.  Collecting this information in a systematic manner and analyzing the data to reach a meaningful conclusion on the continued use of these medicines is the rationale to institute this program for India. In this review article various hospitals survey are done and the  survey questionnaire was analyzed question wise and their percentage value was calculated. Our study strongly suggests that there is greater need to create awareness and to promote the reporting of ADR among healthcare professionals of the country. Only such approach can greatly influence in bringing reporting culture among healthcare professionals and may improve the reporting rates of ADR in our country. Pharmacists, as doctors opined that their involvement may increase the reporting rate, have a greater role to play in the area of pharmacovigilance.

REFERENCE ID: PHARMATUTOR-ART-1676

INTRODUCTION:
Pharmacovigilance: The is defined by WHO as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug?related problems”. [1]

Drug toxicity is a relatively common phenomenon—despite a stringent drug safety and clinical trials process, several drugs have been removed from the market being approved by National Drug Regulatory Authorities, including US’ FDA, UK’s MHRA, and Europe’s EMEA [refer to annex of drug withdrawals]. In addition to the removal of potentially toxic drugs from the market, one out of every five drugs[1] are required to add additional warnings related to side?effects, contraindications, etc.  Globally, only about 500,000 to 700,000 adverse event occurrences are captured each year[2]—however, low?to middle?income countries, which represent more than two?thirds of the world’s population account for a tiny fraction of all the ADR data.

The concern for ADRs in highly vulnerable populations is of even greater concern. For example, in pediatrics, antiretroviral treatment (ART) intolerance and toxicity is a major cause of poor adherence, changing medications and eventually dropping out of a treatment program. “Adverse effects associated with antiretroviral medicines have been reported to occur in up to 30% of HIV?infected children on antiretroviral therapy.” Pharmacovigilance is especially important since “most of the adverse effects are reversible by modifying the dosage or omitting the offending medicine.”[1, 2, 3, 4]

The Pharmaceutical industry in India is valued at Rs. 90,000 Crore and is growing at the rate of 12 – 14 % per annum. Exports are growing at 25 % Compound Annual Growth Rate (CAGR) every year. The total export of Pharma products is to the extent of Rs. 40,000 Crore. India is now being recognized as the ‘Global pharmacy of Generic Drugs’ & has distinction of providinggeneric quality drugs at affordable cost. India is also emerging rapidly as a hub of Global Clinical trials & a destination for Drug Discovery & Development.

This is reflected in the fact that total number of applications received & processed has more than doubled from around 10,000 in the Year 2005 to 22,806 in Year 2009 at CDSCO, HQ, New Delhi. This includes increase in New Drug Applications, Global Clinical Trials , Market Authorization of Vaccine & Biotech products  from 1200 ,100 ,10 in Year 2005 to 1753, 262 & 137 in the Year 2009 respectively.

All medicines (pharmaceuticals and vaccines) haveside effects.In a vast country like India with a population of over 1.2 Billion with vast ethnic variability, different disease prevalence patterns, practice of different systems of medicines, different socioeconomic status, it is important to have a standardized and robust pharmacovigilance and drug safety monitoring programme for thenation.  Collecting this information in a systematic manner and analyzing the data to reach a meaningful conclusion on the continued use of these medicines is the rationale to institute this program for India.     Since, there are considerable social and economic consequences of ADRs there is a need to engage health-care professionals, in a well structured programme to build synergies for monitoring ADRs. The purpose of the Pharmacovigilance Program of India is to collect, collate and analyze data to arrive at an inference to recommend regulatory interventions, besides communicating risks to healthcare professionals and the public.[5]

FUTURE PROPECTS:
Pharmacovigilance has been expanding in recent years, as companies are required to monitor drug safety post launch. Drug safety issues, such as those raised by Vioxx earlier this decade, have led to increased risk-averseness by regulators, with greater post-marketing assessment of drugs. Many regulatory agencies require detailed pharmacovigilance, with companies bearing extra costs, our new report also observes. Healthcare payers, prescribers and patients have high expectations from pharmacovigilance. They want thorough information - on adverse reactions and overall drug safety - upon which to make informed judgements.

Pharmacovigilance is now being called upon to produce clear results, expressed openly. What will those trends mean for pharmacovigilance, from the perspectives of major stakeholders, including the pharma and biotech industries? Where is pharmacovigilance heading? What regulatory measures will continue, and which new processes will emerge? This new report - Pharmacovigilance 2009: Present Challenges and Future Goals- explains how that field will develop from the present onwards.

Clearly, pharmacovigilance is increasingly important worldwide, especially to avoid reoccurrences of serious, costly problems damaging to the industry. Pharmacovigilance is designed to provide crucial data on how drugs work in medical practice, from the short-term to the long-term. This information can aid drug development and marketing if harnessed properly, being a boon rather than a hindrance. In particular, visiongain believes that live licensing will form a significant part of pharma regulations and drug development in coming years. Pharmacovigilance will underpin processes and developments such as these, as this report further explains.[6]

Medicines have helped to bring improved health and longer life to human beings. Medicines affect the lives of hundreds of millions of people every day. But they are not without risk, and have caused, do cause and will continue to cause harm to many people. There are also large numbers of people who experience no evident effect at all from the drugs they take.[5,6]To be eternally vigilant to ensure that medicines, which are developed for treatment of diseases, actually do not do more harm than good, is one of the important pre-requisites for the progress of medicine.

PLAN OF STUDY
·         Study of steps involved in ADR reporting.
·         Collection of data of pharmacovigilance andits status in India.
·    Pharmacovigilance  status in respect to Ayurvedic/ herbal medicine.
·         Survey on ADR reporting awareness of physicians at surrounding hospitals.
·         Importance of Pharmacy profession in ADR reporting.

LITERATURE REVIEW
Pharmacovigilance is characterized by the fact that it derives its knowledge about the safety of drugs from the clinical usage of drugs in daily practice. Pharmacovigilance is a two-way system, which is represented by the circle of knowledge and practice. [7, 8]

In the literature pharmacovigilance is frequently put on a par with Post Marketing Surveillance. This approach highlights pharmacovigilance’s most visible method, viz. the spontaneous reporting system (SRS).[9]

Flow chart of the flow of information/ different level of centre involved:


NATIONAL PHARMACOVIGILANCE CENTRE:
The Central Drugs Standard Control Organization (CDSCO) has initiated a country-wide Pharmacovigilance programme under the aegis of DGHS, Ministry of Health & Family Welfare Government of India.

 The programme is coordinated by the National Pharmacovigilance Centre at CDSCO. The National Centre is operating under the supervision of the National Pharmacovigilance Advisory Committee to recommend procedures and guidelines for regulatory interventions.

National pharmacovigilance’s programme:
The National Pharmacovigilance Programme was officially inaugurated by the Honorable Health Minister Dr.Anbumani Ramadoss on 23 November, 2004 at New Delhi. The National Pharmacovigilance Programme for India, sponsored by the World Health Organization (WHO) and funded by the World Bank, became fully operational in January 2005.

The Programme aims to foster the culture of ADR notification in its first year of operation and subsequently aims to generate broad based ADR data on the Indian population and share the information with global health-care community through WHO-UMC.The nationwide programme, sponsored and coordinated by the country’s central drug regulatory agency – Central Drugs Standard Control Organization (CDSCO) – to establish and manage a data base of Adverse Drug Reactions (ADR) for making informed regulatory decisions regarding marketing authorization of drugs in India for ensuring safety of drugs.[7]

Under the program 26 peripheral centers, 5 Regional Centers and 2 Zonal Centers were established. The Peripheral centers will record the Adverse Events (AE) and send to the Regional Centers.They in turn collate and scrutinize the data received from the Peripheral Centers and submit to the Zonal Centers. The Zonal Centers will analyze the data and submit consolidated information to the National Pharmacovigilance Centre. The Zonal Centre will also provide training, general support and coordinate the functioning of the Regional Center

Peripheral pharmacovigilance centers:
Primary pharmacovigilance’s centers. Relatively smaller medical institutions including individual medical practitioners’ clinics, private hospitals, nursing homes, pharmacies etc. First contact ADR data collection unit at a health care facility. They would be identified and coordinated by RPCs / ZPCs in consultation with CDSCO.

Regional Pharmacovigilance Centers (RPCs):
Secondary pharmacovigilance centers. Relatively larger healthcare facilities attached with medical colleges. They would act as second level centers in the administrative structure of the nppi. They will function as first contact adr data collection units also. They would be identified and coordinated by zpcs in consultation with the cdsco.

Zonal Pharmacovigilance:The Centre (ZPCs) :
Tertiary pharmacovigilance centers. Large healthcare facilities attached with medical colleges in metro cities identified by the CDSCO for the purpose. They would act as third level centers inthe administrative structure of the NPPI. They will function as First contact ADE data collection units also.[7]

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