In order to review the functioning of Adverse Drug Monitoring Centres (AMCs) in Gujarat, Central Drugs Standard Control Organisaion (CDSCO), Western Zone in collaboration with Indian Pharmacopoeia Commission (IPC) have audited 5 medical institutions in Gujarat with assessment on aspects like SOPs and causality assessment.
The exercise is an initiative taken by IPC to generate awareness in medical institutions to put in place effective surveillance system for detection of Adverse Drug Reactions (ADRs). IPC is the National Coordination Centre (NCC) for Pharmacovigilance Programme of India (PvPI).
CDSCO under the Union health ministry had initiated a nation-wide PvPI in July 2010. Dr Y K Gupta is credited to have started PvPI in 2010 at AIIMS with support from CDSCO and government of India. This got further expanded and for administrative reasons was shifted to Ghaziabad based IPC.
PvPI leads with 0.82 points as per quality completeness score of Individual Case Safety Reports (ICSR) as against the global average of 0.55 accounted on a quarterly basis for a total of 150 countries including India which contribute to the global PvP database.
ICSR as part of ADRs are reported from all over the country to NCC-PvPI, which also work in collaboration with the global ADR monitoring centre (WHO-UMC), Sweden to contribute in the global ADRs data base.
Uppsala Monitoring Centre was the first WHO Collaborating Centre to be established for pharmacovigilance when, in 1978, the scientific and technical responsibility of the WHO Programme for International Drug Monitoring was transferred to Sweden.
The WHO Programme for International Drug Monitoring is a group of more than 150 countries that share the vision of safer and more effective use of medicines. UMC has been responsible for the technical and operational aspects of the programme since 1978.
IPC has also signed an Memorandum of Understanding (MoU) with NABH following which around 600 National Accreditation Board for Hospitals and Healthcare providers (NABH) accredited hospitals have also started reporting ADRs as part of their pharmacovigilance activities mandated by the government.
Pharmacovigilance (PV) is a science that relates to detection, assessment, understanding and prevention of adverse affects or any other drug related problem. To track adverse drug reactions (ADRs) in Indian population, Union health ministry launched PvPI which has outreach all over the country but only a small portion of healthcare professionals have formal training in PV.
Keeping this in view, IPC has also started “Skill Development Programme on Basics and Regulatory Aspects of Pharmacovigilance” from January 2017 onwards. The programme aims to enhance the knowledge and skill of qualified pharmacovigilance professionals working for ensuring better patient safety as per the requirement of Schedule Y of Drugs and Cosmetics Act, 1940.
The skill development initiative will encourage process of creating a registry of skills, enable and mobilize a large number of healthcare professionals to take up training and acquire requisite skills for employment apart from capacity building and strengthening of Qualified Person for Pharmacovigilance (QPPv) as per the requirement of the schedule Y of D&C Act.
In August 2016, Drug Controller General of India (DCGI) had issued a circular stipulating the deadline at January 1, 2018 for upgrading skill sets of persons employed in their units.