DTAB approves DCGI's proposal for introducing unique code to drug packs to curtail spurious drugs in domestic market
The Drugs Technical Advisory Board (DTAB), the highest decision making body under the Union health ministry on technical matters, has approved Drug Controller General India (DCGI)'s proposal for introducing a unique code on drug packs whether it is bottle, strip or vial to ensure authenticity of the medicine. It will help curb menace of spurious drugs in the domestic market.
The proposal was approved by DTAB at its meeting last week. About 300 best selling brands accounting for 90 per cent of counterfeit activity will be covered in the first phase.
As per the proposal, manufacturers of these 300 brands are required to print a 14 digit alphanumeric code on the medicine packs along with a contact number.
Consumers can message this code to the designated contact number and they get a prompt response giving details about drug manufacturers' name, batch number, manufacturing date, expiry date of the medicine.
Talking about the initiative, DCGI Dr S Eswara Reddy said “Over the last three months, we had been looking into the mechanism to deal with counterfeit drugs in the domestic market. Counterfeiting happens in both products having high value and products with high volume. Counterfeiting happens in big brands rather than small brands of SMEs. Hence it is not required to introduce track and trace system for all drug manufacturers.”
“We are initially introducing unique code to 300 top selling brands where there is a probability of counterfeiting. We have appealed to owners of these brands to put in place 14 digit alphanumeric number on packs of drugs instead of going for barcoding on packaging of medicines which is a costly affair,” he said.
The 14 digit alphanumeric number printed on each bottle, vial or strip of the drug will be unique to the particular pack.
At times patients find it difficult to reach manufacturers to conclude the authenticity of drugs. This unique code will help them avoid buying spurious drugs.
As per the CDSCO survey from 2014-2016, 3.16% of the total samples were found to be sub-standard drugs and 0.02% were spurious.