This according to a senior health ministry official is due to its integration and alignment with market authorisation holders (MHA) which has gone well with government mandating MHA to set up pharmacovigilance (PV) cell in their companies in accordance to the Drugs and Cosmetics Rules, 1945.
This mandates MHAs to collect, process and forward the report to the licensing authority for information on adverse drug reactions (ADRs) emerging from the use of the drug manufactured or marketed by the respective MHA in the country through a gazette notification March 8, 2016.
Adverse drug Reactions (ADRs) are reported from all over the country to National Co-ordination Centre (NCC-PvPI), which also work in collaboration with the global ADR monitoring centre (WHO-UMC), Sweden to contribute in the global ADRs data base.
NCC-PvPI monitors the ADRs among Indian population and helps the regulatory authority of India (CDSCO) in taking decision for safe use of medicines. The National Coordinating Centre had been shifted from the All India Institute of Medical Sciences (AIIMS), New Delhi to the Indian Pharmacopoeia Commission (IPC), Ghaziabad, (UP) in April, 2011.
The drug exporting pharmaceutical companies can set up a PV system to fulfill its legal tasks in relation to pharmacovigilance, design to monitor the safety of authorised medicinal products and detect any change to their risk-benefit balance.
A pharmaceutical company can meet their pharmacovigilance obligations either by setting up in-house systems for pharmacovigilance or can enter into contractual arrangements with Contract Research Organizations (CROs) specializing in pharmacovigilance function.
List of SOPs for PV Dept involves procedures for collecting the adverse event reports, validating the adverse reaction reports, evaluating the cases for their seriousness, follow up of cases for missing information, expedited reporting, electronic reporting, periodic reports, signal management and risk benefit assessment and response to request for information from regulatory authorities, Interaction between safety issues and product defects, handling of urgent safety restrictions and safety variations, management and use of databases, training, internal audit of the pharmacovigilance system and archiving.
Around 100 pharma companies have also joined hands with CDSCO and Pharmacovigilance Programme of India to come up a set of exhaustive guidelines on par with the existing global guidelines towards good pharmacovigilance practices in the country for drug safety.
The guidelines will feature pertinent areas like signal detection for risk-benefit evaluation and risk management programmes. Signal management is not compulsory in the present set of guidelines. Risk benefit of the product can be measured properly through signal detection.
Pharm.D @ SRIPMS-CBE-TN