The Union ministries of commerce and health have set themselves an identical goal of putting in place a system whereby every package of medicine (bottle, blister, vial) can be monitored under a system of tracing and tracking, preferably using two dimensional bar-coding technology.The commerce ministry wants to safeguard Indian 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. The health ministry wants to replicate that for medicines sold within India to strike a decisive blow against the menace of substandard and spurious medicines.
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.
Predictably, small and medium drug makers are up in arms since many of them do not follow good manufacturing practices and survive on the patronage of state procurement and through heavily discounted sale by chemists.
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.
Most major drug regulators around the world are making such bar-coding mandatory and exporters to regulated markets have to fall in line.
Small manufacturers say the bar-coding
will impose an unbearable financial burden on them, make the use of automatic packaging mandatory, and remove their current cost advantage.
In any case, the exporters have to fall in line. So the real issue is whether what is safe and mandated for the rest of the world also holds good for India.
Unfortunately, even regulation sometimes follows two different standards in India, recently reiterated for export of ayurvedic products, whereby the Indian consumer is denied the health safeguards mandated for foreign consumers.
While the common linear bar codes - they can become unwieldy on a small pack - cost no more than a paisa or two an item, the 2D ones, incorporating a lot more data in much less space, will cost almost 10 paise.
More importantly, the manufacturer will have to install a few PCs, coders/printers, cameras and, preferably, automatic packaging lines.
These cost around Rs. 20 lakh each, though the small and medium enterprises manufacturers' body claims it is nearly Rs. 1 crore (Rs. 10 million).
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 right up to the retail shop.
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.
There is a need to break the back of the substandard drug economy and this is a good chance to do that. A cheap half-good medicine is no medicine.
