The direction, made by the National Medical Commission (NMC) under the health ministry, comes after the Indian Pharmacopoeia Commission (IPC) made a request in this respect. The IPC collects and analyses data, monitors adverse drug reactions (ADRs) and make suitable recommendations, which are used by the Central Drugs Standard Control Organisation(CDCSO) to make regulatory interventions for the safety of medicines.
“All recognized medical colleges and standalone PG institutions are informed that IPC is functioning as the national co-ordination centre, pharmacovigilance programme of India (PvPI) to collect, analyze and monitor the adverse drug reactions (ADRs) from Indian population to promote patient safety and safeguard the health of patients by ensuring the benefits of use of medicines outweigh the risk associated with its use," said Dr Pulkesh Sharma, secretary, NMC.
The decision comes in the backdrop of controversy over the deaths of children in Gambia and Uzbekistan allegedly due to contaminated cough syrups. In December, Uzbekistan said 18 children died after consuming contaminated cough syrup manufactured by India’s Marion Biotech. Earlier in October, Gambia had said 69 children died due to kidney damage after consuming contaminated cough syrup made by India’s Maiden Pharmaceuticals Ltd.
The decision to sign up medical colleges was taken at IPC’s 22nd governing body meeting chaired by Union health secretary Rajesh Bhushan, where it was decided that all medical colleges and hospitals should enrol as AMCs with IPC, which sets the official standard for drugs produced in India.
“The safety of medicines is a concern for the patients. Each medical colleges and hospitals should have ADR monitoring centres irrespective of whether they are in private or public sector. This will help medical students to understand the subject in detail while they are posted in different wards so that they can collect evidence of adverse drug reaction and it will help in establishing the culture of reporting in our country," an official aware of the matter said on the condition of anonymity.
The official said that at present, there is no concrete data on ADRs as it varies from patient to patient; however, after the onset of the covid pandemic, the reporting of ADRs has increased.
“We have seen the tremendous response in the reporting culture of adverse drug reaction cases in the country particularly during the covid-19. Last year, around 1 lakh individuals case safety report were collected from Indian population across India," said the official.
Queries sent to the health ministry remained unanswered.
