India’s health ministry has recently released a set of draft rules aiming to implement quick response (QR) code on the labels of all active pharmaceutical ingredient (API) packs manufactured in and imported to the country. At each level of packaging, the coding that stores all essential information—manufacturer location, batch number, date of expiry, etc.—is readable with software applications that can facilitate the tracking and tracing of the product. Such a system will help regulators and companies determine the authenticity and identity of a particular drug product.

The so-called track and trace system, which ensures the authenticity of drug packs has become the new global standard for pharmaceutical drug distribution.

Utilizing the 2D barcode technology, the system makes it harder for counterfeit drugs to enter the pharmaceutical supply chain. The authenticity of each pack is checked by entering its unique identifier number into a repository system at the time of manufacture. The unique identifier can be verified against its entry in the storage system at one or more points in the supply chain. As this simple technology makes the distribution system more transparent, it becomes easier for authorities to locate at exactly which point fake drugs infiltrated the distribution system.

QR code will become mandatory for API manufacturers and importers to track-and-trace the ingredients used to make medicines in India, the health ministry announced through a notification issued in the official gazette in August.

The government is proposing to make necessary amendments in the currently governing Drugs and Cosmetics Rules, 1945 to incorporate the new rules as a subset. The revised rules will come into force on the date of their final publication in the gazette, according to the notification.

Meanwhile, India’s ministry of commerce is planning to implement an online system that traces and authenticates pharmaceutical export packages from April 1, 2020, reports said.

The online system is envisaged to help manufacturers and merchant traders to generate and utilize tertiary and secondary level coded data in a user-friendly manner. It will act as a single-window integrated system that enables the tracing of an exported pharmaceutical product.

Exporting companies have welcomed the decision hoping that the initiative will solve a myriad of problems currently hampering track and trace.

Low-cost production hub
The global pharmaceutical packaging market is booming. Reports forecast that the medicine packs market will double in size to $149 billion in the next ten years’ time.

India’s pharma packaging market, which relies heavily on plastic packaging, is passing through a transformational phase.

The demand for glass tubing is growing to unprecedented levels as Indian drug makers are increasingly launching injectable drugs both for domestic and overseas markets. They are looking at low competition-high margin generic injectable drugs. In addition to FDA approvals, the growth is accelerated by innovative drugs and formulations such as biosimilars, cancer drugs and vaccines.

Several multinationals have already identified India as hub of low-cost production of packaging materials. 

Schott, a leading specialty glass manufacturer, announced an additional “multimillion-euro figure” investment to build a new glass tank at its tubing manufacturing plant in Jambusar, Gujarat in June.
Last year, the German glass major made significant investments at the site including the construction of an additional tank.

The new facility will be built and equipped with the latest state-of-the-art machinery featuring the big data approach, perfeXion. The process, which has been rolled-out globally by Schott since 2017, ensures 100% quality control of each tube on the line by using cameras, laser and IR inspection systems.

The capacity expansion has been done keeping in view of the very high demand for premium pharmaceutical packaging and tubing. The increased production capacity at Jambusar will be utilized to supply the rapidly growing domestic and Asian market, Schott said.

The company expects to start production of pharmaceutical Fiolax tubing from the new tank in the second half of 2020.

The high hydrolytic resistance of Fiolax borosilicate glass tubing makes it an ideal material for primary packaging of medicines. It has been established as the gold-standard material for pharmaceutical containers. In India, Flolax is primarily used to manufacture glass vials and ampoules. The Jambusar facility will combine Indian and European technologies and local skills, according to Schott.