The India drug regulator has asked pharmaceutical firms to withdraw several medicines sold under the same brand name but used to treat different ailments as it leads to confusion and could harm consumers for taking a wrong medicine.
On Monday, the Drug Controller General of India (DCGI), Surinder Singh, asked all state drug regulators to immediately withdraw three separate medicines used as an anti-allergic, antibiotic and anti-parasitic all sold under the brand AZ by three local drugmakers-Sienna Formulations, Cure Quick Pharma and Eugenics . He also asked the state authorities to get pharma companies to recall all such medicines sold under the same brand before relaunching under different names.
Experts estimate there may be about 100 such medicines that may be affected from the decision but the authorities will not be able to effectively enforce the same in the absence of a centralised drug brands database. "How will a drug regulator in Kolkata know which brand his Tamil Nadu counterpart has approved and is marketed in that state?" CMD Gulati, drug regulatory expert and editor of the medical journal Monthly Index of Medical Specialties, said. State drug regulators should maintain a database of brands and aggregate it at the central level, he said. The problem arises from fact that drug marketing licences are given by the DCGI after efficacy and safety of a medicine is established. The manufacturing licences are then awarded by respective state drug regulators where the companies are based.
Companies submit details of the chemical and the drug brands only at the time of application at the state drug regulator for manufacturing license.
On Monday, the Drug Controller General of India (DCGI), Surinder Singh, asked all state drug regulators to immediately withdraw three separate medicines used as an anti-allergic, antibiotic and anti-parasitic all sold under the brand AZ by three local drugmakers-Sienna Formulations, Cure Quick Pharma and Eugenics . He also asked the state authorities to get pharma companies to recall all such medicines sold under the same brand before relaunching under different names.
Experts estimate there may be about 100 such medicines that may be affected from the decision but the authorities will not be able to effectively enforce the same in the absence of a centralised drug brands database. "How will a drug regulator in Kolkata know which brand his Tamil Nadu counterpart has approved and is marketed in that state?" CMD Gulati, drug regulatory expert and editor of the medical journal Monthly Index of Medical Specialties, said. State drug regulators should maintain a database of brands and aggregate it at the central level, he said. The problem arises from fact that drug marketing licences are given by the DCGI after efficacy and safety of a medicine is established. The manufacturing licences are then awarded by respective state drug regulators where the companies are based.
Companies submit details of the chemical and the drug brands only at the time of application at the state drug regulator for manufacturing license.
No comments:
Post a Comment