India's move to kill Sub-standard Medicine

The Union ministries of commerce and health in India have set themselves an identical goal of putting in place a system whereby every package of medicine can be monitored under a system of tracing and tracking, preferably using two dimensional bar-coding technology. The commerce ministry wants to safeguard India’s pharmaceutical exports from the bad name they were given when some spurious medicines in Africa, labelled “Made in India”, were eventually traced to China. It has issued a notification to make this system compulsory by July.

While surveys have shown that spurious medicines are rare, being substandard is another matter. Medicines available through the public healthcare system are routinely found to be substandard. If such bar-coding covers government procurement, pinpointing the culprits will become easier, this will open a new chapter in public health care. Most major drug regulators around the world are making such bar-coding mandatory and exporters to regulated markets have to fall in line.

Under the proposed system, a package going out of a factory will have an identifying bar code and unique number that can be read at any point in the supply chain. These can then be matched with the batch number and other manufacturing details stored in a central database to find out if the package is genuine or not. Any cell phone will be able to snap up and transmit a picture of the bar code and the number, and the verification will come from the database in seconds.

Small and medium drug makers are up in arms since many of them do not follow GMPs and survive on the patronage of state procurement. Equally predictably, the Indian Pharmaceutical Alliance, representing large Indian-owned pharma companies, is willing to go along with the new requirement but has sought more time and phased introduction.

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