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Effective January 2018: New Pharmacovigilance Guidance Document in India is Expected to Significantly Change the Pharmaceutical Safety Landscape

The Indian Pharmacopeia Commission recently published a Pharmacovigilance Guidance Document for all Market Authorization Holders (MAHs) of Pharmaceutical Products in India, which will be effective January 2018. This is a welcome change to the Indian pharmacovigilance (PV) system both for patients and pharmaceutical industries. This will eventually help to provide the real picture of drug-related events, thereby having a positive influence on patients in India. The new guidance is heavily influenced by European PV regulations.

According to the document: “MAHs are required to collect and process comprehensive safety information related to pharmaceutical products and report to regulatory authority within the prescribed timelines. Every MAH shall have a system in place that ensures overall quality of AEs/ADRs.”

As I read through this new document, I noted the following changes that companies need to be particularly aware of:

  1. A pharmacovigilance master file (PvMF) (similar to the pharmacovigilance system master file [PSMF]) is now required. The PvMF must contain all the information related to the MAH’s PV system, including the PV Officer In-charge (PvOI), PV organization structure, sources of safety data, PV processes and PV systems performance.
  2. A PvOI, similar to the European Economic Area [EEA] Qualified Person for Pharmacovigilance [EU-QPPV]), is also now required. Each company must have at least one qualified and trained person that is a medical officer or a pharmacist trained in ADR report collection and analysis. This person should be authorized as a PvOI by the company and responsible for staff training, identification of PV activities, SOPs, establishment and maintenance of the PV quality management system (QMS) and respond to regulatory queries.
  3. System documentation about the PV hierarchy and related departments and organizations (including contract research organizations [CROs]) that help to fulfil the PV obligations should be provided.
  4. A QMS for PV activities should be established and include document and record control, training and audits.
  5. Periodic safety update reports (PSURs), a risk management plan (RMP) and signal management results should be submitted, at the required intervals, during the post-marketing phase, to monitor the safety and efficacy of the products.
  6. PV audits and inspections should be conducted both internally and externally to the PV systems. The audit report is to be documented within the quality system, with relevant information about the CAPA, identification date and anticipated resolution date.

Especially for the drug manufacturers who do not yet have PV systems in place, implementing these changes can seem to be an insurmountable task. However, Bioclinica already has a presence in India in addition to the services needed to address the new requirements: help to establish and maintain a PV system and QMS as well as draft the PvMF and submit the PSUR, RMP and signal management results. In addition, our services cover the PvOI and PV audits. We can help you transition to the new requirements and improve the safety of your products.

If you are interested in learning more about how Bioclinica’s pharmacovigilance services can help you navigate through these new regulations, please contact us. You can also read the entire Pharmacovigilance Guidance Document for all Market Authorization Holders (MAHs) of Pharmaceutical Products.


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