NEW DELHI: 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-parasatic
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
journalMonthly Index of Medical Specialities,
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 licence.
