In a relief to the drug importers, the Drug Controller General of India (DCGI) has given three more months for them to comply with the re-labelling norms for imported medicines.
The move followed after drug importers apprised the top regulator of their inability to immediately comply with its recent order imposing stringent labeling norms on the drugs imported by them.
"We had received representation from various stakeholders in the drug sector which had raised concern at the re-labelling issue and that the drug importers need to be given some time to implement the order," a senior official from the DCGI said.
He said after a recent meeting with the Union Health Ministry the importers of the drugs and drugs and devices have been given three months and six months time respectively. "It was also felt that immediate ban on the drugs would also hamper supplies to the patients," the official added.
The DCGI had asked the port offices to not allow the drugs consignments which fail to meet the labelling requirements.
However, now "it has been decided in the interest of patients safety and well being, that those drugs which are imported under universal packing and needs re-labelling post import, in order to comply with Drugs and Cosmetics rules, are given general permission under rule 104-A for three months in cases of drugs and six months for devices and cosmetics under Drugs and Cosmetics At and Rules," the recent DCGI circular says.