In next eight months or so, only drugs formulations with barcodes, will be allowed to be sold in the domestic market in the country.
Barcodes are a series of vertical bars and spaces that can be connected to computer databases containing information like product identity, manufacturer and brand owner identity, batch number, expiry dates etc. This helps in tracking the pharma products in the market.
The Union Health Ministry is preparing a guideline making barcoding of drug formulations mandatory for domestic manufacturers, a move that aims to check entry of counterfeit drugs in the market, said a senior official from the Ministry.
At present, only those pharma products meant for exports have barcodes on them. But with the new guidelines which will be out soon, the tertiary-level packaging (such as cartons), secondary packaging (like packets) and primary level packaging (on strips, bottles, vials or strips) being sold in the domestic market will have mandatory barcoding.
The small and medium industries (SMEs) had been opposing barcoding system stating it would lead to cost escalation.
However, the official said that they have finally agreed with the move which they now agree aims to safeguard the interest of the genuine drug manufacturers as well check the counterfeit drugs which is spoiling their image in the domestic market.
“We are in the midst of preparing guidelines after which six months’ time will be given to the manufacturers supplying pharma products in the local market to gear up for the new system that aims to ensure transparency,” the official said.
We do not need to bring any legislation in this regard and the guidelines will be implemented within six months after they are prepared, the official said.
He added that even a common man having barcode readers installed in their smart phones will be able to scan the details about the drugs.
Apart from curbing spurious drugs, the need for barcoding system has been constantly felt as presently due to thousands of manufacturers and sellers of drugs selling innumerable number of products in the market, the manual system of tracking by bills is cumbersome and extremely time consuming.
In 2011, the Director General of Foreign Trade (DGFT) had made it mandatory for drug-makers to print a barcode on every product exported out of the country in the wake of overseas allegations that some local firms ship out counterfeit medicines.