The Indian Pharmacopoeia Commission (IPC), nodal agency for the Pharmacovigilance Programme of India (PvPI) is in the process of submitting a high profile adverse drug reaction (ADR) report on existing drugs running in the market to the DCGI office soon. The report which points out new adverse reactions on the patients were detected after detailed analysis and study of adverse drug reactions received from different ADR centres across the country.
Sources inform that the newly detected cases of the adverse drug reactions are from the already existing drugs that have been long running in the market. It has been observed that the patients from across the country have been showing cases of side effects long after they have been under the medication of these drugs. The senior officials from the PvPI programme refrained from stating the therapeutic area in which the drugs belong, stating that the information is strictly embargoed owing to impending investigation.
However, it is understood that the drugs that are currently under the scanner of the pharmacological programme cater to addressing the major diseases and disorders like BP, heart ailments, diabetes, neurological disorders, cancer, etc.
Based on the current data and other reports collected from 90 ADR centres spread across different location throughout the country, the IPC has already begun the process of reporting the same to the Drug Controller General of India's (DCGI) office. Dr S K Gupta, advisor to PvPI programme of India, informed that immediate steps will be taken to address this issue at the earliest as the safety of the patients is at stake.
“At present we have data from across 90 ADR centres to support our observation which disturbingly point out to the fact that some of the drugs that we have perceived to be safe, have been showing signs of adverse reactions on the patients over the years. Once the report is submitted and reviewed by the drug regulatory authority they will be taking requisite steps as deemed necessary to address this matter,” he added.
Informing about the current status of the PvPI programme of India, he said that at present, IPC is taking all the measures to strengthen the programme to make it most effective and best adverse reporting system in the world. In fact, Dr Gupta pointed out that, today India has one of the largest pharmacovigilance programmes present anywhere in the world proving the dedication of the government in preserving and ensuring the well-being of the patients in the country.