NEW DELHI: Now, consumers can call to directly report adverse reactions or their bad experiences from any medicine. The health ministry has launched a toll-free number where people can call and report the side-effects and problems faced by them along with details of the medicine, suspected to have caused the adverse reaction.
The information received would be then screened and assessed by the Adverse Drug Reaction Monitoring Centers by using international parameters set by the World Health Organisation (WHO), a senior official said. Thereafter, the analyzed information would be forwarded to the national coordinating centre, which maintains a database for adverse drug reactions (ADRs).
The health ministry has also set up a steering committee which will periodically review the data and suggest any intervention that may be required, the official said.
The government would also share this database with international agencies including WHO, which manages the Global Pharmacovigilance Database.
The ministry also plans to make it mandatory for pharmacists, hospitals and other independent clinics to display the toll free number - 18001803024 - in public interest.
The idea is to empower consumers to report adverse reactions on their own. The move would also enable an environment that will allow reportage of adverse reactions from every nook and corner of the country.
Surveillance of medicine, after it is approved for marketing, has been a major challenge for the government and the drug regulator. In the absence of enough field force and mechanism, the regulator often struggles to gather post marketing data on medicines.
Since 2011, around 1,10,000 adverse drug reactions have been reported from across the country. However, this was after the government made it mandatory for hospitals to have a pharmacovigilance cell. Still, officials say, there are only few hospitals across the country operating with a proper cell.
Currently, there are only 150 hospitals across the country which have pharmacovigilance cell, the official cell. However, the health ministry and the drug regulator are making efforts to ramp up such cells.
Experts say lack of awareness has also been a major roadblock because those facing problems with a particular medicine would not know where exactly to report.
"A toll free number would empower the consumer along with medical practitioners to directly report adverse reactions," the official said, adding the information provided by consumers or doctors would be handled in strict confidence.
The information received would be then screened and assessed by the Adverse Drug Reaction Monitoring Centers by using international parameters set by the World Health Organisation (WHO), a senior official said. Thereafter, the analyzed information would be forwarded to the national coordinating centre, which maintains a database for adverse drug reactions (ADRs).
The health ministry has also set up a steering committee which will periodically review the data and suggest any intervention that may be required, the official said.
The government would also share this database with international agencies including WHO, which manages the Global Pharmacovigilance Database.
The ministry also plans to make it mandatory for pharmacists, hospitals and other independent clinics to display the toll free number - 18001803024 - in public interest.
The idea is to empower consumers to report adverse reactions on their own. The move would also enable an environment that will allow reportage of adverse reactions from every nook and corner of the country.
Surveillance of medicine, after it is approved for marketing, has been a major challenge for the government and the drug regulator. In the absence of enough field force and mechanism, the regulator often struggles to gather post marketing data on medicines.
Since 2011, around 1,10,000 adverse drug reactions have been reported from across the country. However, this was after the government made it mandatory for hospitals to have a pharmacovigilance cell. Still, officials say, there are only few hospitals across the country operating with a proper cell.
Currently, there are only 150 hospitals across the country which have pharmacovigilance cell, the official cell. However, the health ministry and the drug regulator are making efforts to ramp up such cells.
Experts say lack of awareness has also been a major roadblock because those facing problems with a particular medicine would not know where exactly to report.
"A toll free number would empower the consumer along with medical practitioners to directly report adverse reactions," the official said, adding the information provided by consumers or doctors would be handled in strict confidence.
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