Drugs Controller General of India (DCGI) has directed the state drug controllers (DCs) to instruct manufacturers of proton pump inhibitors like pantoprazole, omeprazole, tansoprezole, esomeprazole and rabeprazole to incorporate acute kidney injury as the adverse drug reaction (ADR) in the package insert leaflet (PIL) of these drugs.
This is based on the recommendation of the Signal Review Panel -Pharmacovigilance Programme of India (SRP-PvPI) recommendations at its meeting held in Delhi at Central Drugs Standard Control Organisation (CDSCO) headquarters.
Accordingly, State DCs have directed manufacturers of formulations of proton pump inhibitors under their respective jurisdictions to mention acute kidney injury as an ADR in the PIL or promotional literature.
The National Co-ordination Centre for Pharmacovigilance Programme of India (PvPI) functioning at Indian Pharmacopoeia Commission (IPC), Ghaziabad forwarded their recommendation based on ADR reports of proton pump inhibitors deliberated in the 15th SRP meet held on August 21, 2019 at IPC with an objective to detect signal or prescribing information leaflet change from Indian data and promote patient safety.
In the meet, the SRP evaluated the drug proton pump inhibitor ADR on the basis of individual case study reports (ICSRs) and recommended to PvPI that CDSCO be informed to take necessary steps to incorporate acute kidney injury into PIL of proton pump inhibitors.
DCGI directs cos of proton pump inhibitors to list kidney injury as ADR in package insert
Indian Pharmacopoeia Commission is an Autonomous Institution of the Union health ministry. It was created to set standards of drugs in the country. Its basic function is to update regularly the standards of drugs commonly required for treatment of diseases prevailing in this region.
It publishes official documents for improving quality of medicines by way of adding new and updating existing monographs in the form of Indian Pharmacopoeia (IP).
It further promotes rational use of generic medicines by publishing National Formulary of India. IP prescribes standards for identity, purity and strength of drugs essentially required from health care perspective of human beings and animals.
IPC also provides IP Reference Substances (IPRS) which act as a finger print for identification of an article under test and its purity as prescribed in IP