The Indian Pharmacopoeia Commission (IPC), Ghaziabad under the union health ministry, will collaborate with South East Asia Regulatory Network (SEARN) nations towards integrating their public health programmes with pharmacovigilance activities for drug safety. This will develop regulatory collaboration, convergence and reliance in the South-East Asia region over shared regulatory issues.
This initiative is very much relevant as many of the medicines used in public health programmes are new and have safety concerns associated with them. This includes collaboration with WHO and others on the establishment and training of a pharmacovigilance field force to actively assemble case information from the programme treatment centres.
Through this initiative, the Central Drugs Standard Control Authority (CDSCO) of India which is also a member of SEARN will help member countries like Bangladesh, Bhutan, Korea, Indonesia, Maldives, Myanmar, Nepal, Sri Lanka, Thailand and Timor to build capacity and enable National Regulatory Authorities of respective nations to fulfil their mandates and safeguard public health.
Informed Dr. V Kalaiselvan, principal scientific officer at the IPC, “A common questionnaire in pharmacovigilance (PV) and Public Health for the SEARN countries has been framed to better understand their programmes and how effectively India can provide necessary support for developing and integrating PV programmes in their public health systems.”
CDSCO under the Union health ministry had initiated a nation-wide Pharmacovigilance Programme of India (PvPI) in July 2010 with Ghaziabad based IPC as the national co-ordinating centre (NCC).
There are seven WHO collaborative centres globally in pharmacovigilance and WHO collaborative centre for PV in public health and regulatory services from India will serve as the eighth centre.
Uppsala Monitoring Centre (UMC) was the first WHO Collaborating Centre to be established for PV when, in 1978, the scientific and technical responsibility of the WHO programme for international drug monitoring was transferred to Sweden.
IPC has also been assigned to update information on adverse drug reactions (ADRs) that is being reported in India from across all its centres through Vigiflow software to the UMC in Sweden, which is WHO's collaborating centre for international drug monitoring.
IPC which has recently been designated as the WHO collaborative centre for Pharmacovigilance (PV) in public health, will be focusing on TB, neglected tropical diseases, vector-borne diseases, HIV-AIDS among other such challenges as part of integrating PV programmes in public health systems for SEARN member countries.
Adverse drug reactions reporting
Around 80 corporate hospitals have started reporting adverse drug reactions (ADRs) as part of their pharmacovigilance activities mandated by the government to promote monitoring of ADRs effectively by healthcare institutions to Pharmacovigilance Programme of India (PvPI).
IPC, Ghaziabad which is the national co-ordinating centre (NCC) for PvPI in the country has also signed a Memorandum of Understanding (MoU) with National Accreditation Board for Hospitals and Healthcare providers (NABH) to promote monitoring of ADRs through hospitals and nursing homes.
“The corporate hospitals have started co-ordinating with the respective adverse drug reaction monitoring centres (AMCs) to generate relevant clinical data based on effective ADR monitoring,” explains Dr Kalaiselvan.
Meanwhile, the CDSCO in collaboration with IPC has also started auditing healthcare institutions on aspects like SOPs and causality assessment in order to review the functioning of adverse drug reaction monitoring centres (AMCs) in the country.
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.
IPC has recently come out with draft guidelines focused on targeted drugs and events as a part of Intensive adverse drug reaction monitoring exercise under PvPI so that appropriate action can be taken on specific drugs involving adverse events or reactions. For this, Pharm D institutions have been identified and encouraged in the country to carry out Intensive ADR monitoring..
The exercise has been initiated keeping in view the fact that data from spontaneous reporting of ADRs have generally been misspelt.
This will also go hand-in-hand with IPC also having 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 Drug and Cosmetics Act, 1940.
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.
“Keeping in view the objective of bringing substantial improvement in the quality of pharmaceutical products, it has become imperative that all personnel employed in pharmaceutical manufacturing units shall undergo the certification programs developed by Life Science Skill Development Council (LSSSDC) and with effect from January 1, 2018, no person shall be employed in any pharmaceutical, bio-pharmaceutical manufacturing units unless he has obtained a formal degree in the relevant area, or has been certified by LSSSDC or equivalent organization in the area in which he has been deployed,” the DCGI circular then said.
Causality assessment through AMCs
The Union health ministry has also asked adverse drug reaction monitoring centres (AMCs) to set up causality assessment committee in each of the 250 AMCs functioning across the country.
This is urgently required as this will effectively help in establishing clinical evidence between the drug and the adverse drug reaction or serious adverse event associated with it in the patient. Each existing AMC has been mandated to follow the same in the interest of patient safety, informed a senior official associated with the development.
Causality or related assessment implies determination of whether there is a reasonable possibility that the product is causally related to the adverse event. Causality assessment includes evaluation of temporal relationships, association with or lack of association with underlying disease, presence or absence of a more likely cause, and biologic plausibility.
It should be emphasized that manufacturers should not separate out those spontaneous reports they receive into those that seem to themselves to be causally related to drug exposure and those they consider not causally related. A physician in making a spontaneous report to a manufacturer is indicating that the observed event may be due to the drug, i.e. the physician suspects that the event is a reaction.
As a practical matter, many companies do causality assessments on spontaneous reports as part of their signal analysis mechanisms.
IPC has recently come out with draft protocol and guidelines focused on targeted drugs and events as a part of Intensive adverse drug reaction monitoring exercise under PvPI so that appropriate action can be taken on specific drugs involving adverse events or reactions.
The intensive ADR monitoring protocol will be implemented in an ongoing manner based on the learnings of the projects undertaken with help from competent institutions. This will help in taking regulatory decisions in a timely manner.
Institutions have been identified and encouraged in the country to carry out intensive AD monitoring as per the guidelines for reporting specific events in a focused manner related to a specific drug.