26 March 2014

Current trends of Pharmacovigilance in India – approach towards a more structured workflow

Pharmacovigilance (PV) system in India has been developed at a much later point of time compared to countries like USA, EU and Japan.  Adverse drug reaction (ADR) monitoring system for India was first proposed in 1986 and consequently 12 regional centres were established for this. During this initial establishment stages the ADR system was not organized properly and awareness was lacking among the healthcare professionals as well as patients about the utility of spontaneous ADR reporting. India being a large country with huge population, it needed proper adverse drug reaction monitoring and reporting system to ensure patient’s safety as well as rational and safe use of the medicines/medical devices/other interventions in patients. Thus, in 1997 India joined the World Health Organization (WHO)-Adverse Drug Reaction monitoring programme which was a milestone towards development of proper drug monitoring system throughout India. As an initiative of that program 3 centres were developed as ADR monitoring centres, in AIIMS in New Delhi, King Edward Memorial Hospital (KEM) in Mumbai and Jawaharlal Nehru Medical College, Ajmer (JLN). Currently around 94 countries worldwide has joined WHO Pharmacovigilance program.

The Pharmacovigilance program in India (PvPI) (the current PV program in India), started in July 2010 and ALL India Institute of medical Science (AIIMS), New Delhi was established as the National Coordinating Centre (NCC). The main aim of this program was to monitor adverse drug reactions (ADR) in the whole country to ensure safety and protection of public health which in turn would ensure systematic and rational use of medicines.  The NCC has been shifted from AIIMS, New Delhi to Indian pharmacopeia commission (IPC), Ghaziabad on 15th April 2011. The Pharmacovigilance program in India (PvPI) is currently under developmental stages from 2010 to 2015, and these 5 years have been targeted to develop this program according to the international standards.

Currently within the National Coordinating Centre (NCC), a panel of three committees have been formed; Signal review committee, Core training committee, and Quality review panel. They would collect information from the various Adverse drug monitoring centres (AMC) located in different parts of India. As India is a huge country, to ensure proper collection and transmission of different adverse events or drug side effect reports to the IPC (Indian Pharmacopeia Commission), many adverse drug monitoring centre (AMC) have been established across the country. Currently about 19 AMC has been established all over India. Some of them are: (i) Government Medical Colleges, Bakshi Nagar, Jammu (ii) PGIMER, Chandigarh (iii) R.G. Kar Medical College, Kolkata (iv) Lady Hardinge Medical College, New Delhi (v) Seth GS Medical College & KEM Hospital, Mumbai (vi) JIPMER, Pondicherry (vii) Madras Medical College, Chennai (viii) Santosh Medical University, Santosh Nagar, Ghaziabad etc. Adverse drug monitoring centres have been established within the pharmacology department of these colleges. The main function of these centres is to collect ADR informations from the patients and healthcare professionals from their neighbouring regions and transfer the information to the National Coordinating   Centre (NCC). All the data collected by the NCC would be finally saved in the central worldwide database at Uppsala Monitoring Centre, Sweden, which is the worldwide adverse drug reaction reporting centre (developed by WHO at Uppsala, Sweden).

As the Pharmacovigilance program of India is approaching towards a more developed and organized structure, one may raise the question about the significance of PV in India. Before receiving marketing authorization and marketing of a particular medicinal product/device, clinical trials are conducted to know about the safety and tolerability of the drug in human participants. As clinical trials would be conducted for a short period of time, with limited number of participants and in a controlled environment, the long term side effects and safety related issues as well as how the drug works in a real time scenario would be often missed in a clinical trial. Thus even after the drug receives marketing authorization, there is still the need for collecting the safety and efficacy information of a drug and this is usually done under the post marketing surveillance (PMS) program. PMS is also a major focus of current worldwide Pharmacovigilance programs, as it would give valuable information about any unknown side effects/reactions of a medicinal product that was not detected during the clinical trials.

Thus, the Indian PV system is currently under developmental stages and more adverse drug monitoring centres are being established with the aim of building the Indian PV system on par with International standards. Because of this new establishment, there has been a boom in the career opportunities for aspirants who would like to build their career in PV domain in India. Aspirants who would like to pursue a career in Pharmacovigilance under PvPI (Pharmacovigilance program in India) have to be qualified and must pass the exam conducted by IPC, Ghaziabad, India. The eligibility criteria for attending those examinations would be: B.Pharmacy, Pharm D, B.Pharmacy, MBBS etc. The aspirants should apply to IPC within the notification period. Once they have been shortlisted, the selected candidates will be invited for an interview. Selected candidates would be trained for two to three weeks and upon the successful completion of training, they would be placed in different states in different affiliated hospitals as Drug safety associate, Drug safety analyst, Pharmacovigilance technical associate etc. Based on their performances, extensions would be approved and finally they would be selected as permanent employees.

Clinnovo is a clinical innovation company. It is pioneer CRO industry in India. Clinnovo offers professional Clinical Research Course, clinical data management course , SAS and imaging training. Clinnovo has been serving different bio-pharma industries across the world with excellence and high quality. For more information contact at +91 9912868928, 040 64635501

No comments:

Post a Comment