Indian pharma packaging market is in a transitional phase. On the one hand , its customers are facing an extended date for implementation of Trace and Track system for export of drug formulations, on the other hand it is facing the challenge of setting up state-of-the-art packaging plants to meet the stringent global regulatory norms.
The industry is shifting towards packaging which is lighter, safer and easier to use and discard. Nanotechnology is poised to be a game-changer by making way for innovative and futuristic packaging solutions involving new materials with better physical and technical and properties.
According to Vimal Kedia, managing director, Manjushree Technopak, pharma packaging has been facing competition from the unorganized sector, who manufacture bottles without proper clean room, inspection systems, certifications and many other crucial factors. Apart from this, tamper - proof and tamper evident packs are necessities of the day.
With the stricter norms imposed by the global regulatory authorities, there is a need for a holistic review of manufacturing process of packaging material as well as the eco system right from raw materials to quality system and continuous improvement. More and more domestic companies are adopting bulk packing of tablets in HDPE (High-density polyethylene) bottles instead of blister packing, he added.
As the government of India has extended the time to implement Trace and Track system for export of drug formulations in packaging to April 1, 2016 for non-SSI manufactured drugs and to April 1, 2017 for SSI manufactured drugs, the industry is relieved and is now gearing up to adhere to the norms.
This extension will make the companies accountable for quality of their products. Most of the organised players have welcomed this move and will implement robust tracking system in their manufacturing activities. However, this will affect many small and mid-size companies as they find it difficult to invest on such coding systems. To arrive at a logical conclusion, this needs to be addressed jointly by the Union government and the industry said Kedia.
Under the procedure for implementation of the Track and Trace system for export of drug formulations, companies have to print the barcode as per GS1 Global Standard at different packaging levels to facilitate tracking and tracing of their products. For primary level, the companies will need to incorporate 2D barcode encoding unique and universal global product identification code in the format of 14 digits Global Trade Item Number (GTIN) along with batch number, expiry date and a unique serial number of the primary pack. The bar code labelling at primary level is exempted till further notification.
For the secondary level packaging, the government insists one or two dimensional (1D or 2D) barcode encoding unique and universal global product identification code in the format of 14 digits GTIN along with batch number, expiry date and a unique serial number of the secondary pack. Bar code on mono carton containing one primary pack is optional till further notification.
“We are tying up with a couple of bar code companies to implement bar coding and tracking system of our semi finished goods and finished goods packaging materials,” said Kedia.
Tertiary level packaging requires one dimensional (1D) barcode encoding along with similar options of primary and secondary packs and a Serial Shipping Container Code (SSCC).
In addition, the pharma companies will need to maintain the data in the parent-child relationship for primary, secondary and tertiary packaging and their movement in the supply chain.
All SSI and non-SSI manufacturers are exempted from maintenance of parent-child relationship in packaging. However, the requirements of printing of barcodes on the different levels or packaging will be applicable. The pharma company is held responsible for the correctness, completeness and ensuring timely upload of data on the central portal.
The rules are not be applicable to those drug formulations manufactured for export purposes, where the government of the importing country has mandated a specific requirement and the exporter intends to avail the option to print barcodes in their format after seeking DCGI permission. However, the tertiary level of packaging will have additional printing of barcode.
Export of drugs manufactured by non-SSI units and having manufacturing date prior to March 31, 2016 and those by SSI units with manufacturing date prior to March 31, 2017 are exempted from requirement of data uploading on central portal.
But all drugs manufactured by non SSI units with manufacturing date of April 1, 2016 and for SSI units with that of April 1, 2017 can be exported only if both tertiary and secondary packaging carry barcodes as recommended by DGFT is uploaded on the central portal. Similarly the parent-child relationship in packaging is extended to April 1, 2016 for non SSI manufactured drugs and April 1, 2017 for SSI manufactured drugs.
Another issue which has impacted the industry is the Bureau of Indian Standards (BIS) draft on quality control of tin plates. In the pharma sector tin containers are opted to packs powders which covers nutraceuticals and dietary supplements. It has now mandated the use of cold reduced electrolytic tin-plate which is an imported component and is bound to escalate costs, said industry observers.
Dr NC Saha, director, Indian Institute of Packaging observes the critical need to educate transport and logistic players not just in the domestic but international market to handle medicine consignments and its storage requirements.
The Indian Institute of Packaging is working to device standard packaging specification as within a decade we would see a similar move, added Saha.
According to Kaushik Desai, general secretary, Indian Pharmaceutical Association and chairperson Industrial Pharmacy and Marketing Sector, FAPA, when Indian pharma is projected to grow from the current $32 billion to $55 billion by 2020, we see the need for packaging sector to increase its pace of modernization. Innovation is not just in convenient packaging formats but to identify counterfeit packs and preserve product identity till it reaches the end-customer.
Developments in packaging
Last year, Gerresheimer AG, one of the leading partners to the pharma and healthcare industry worldwide, extended its pharmaceutical packaging business with the acquisition of Centor, one of the world’s largest supplier of regulatory compliant prescription containers for medication dispensing.
Rexam Healthcare, one of the global leaders in healthcare rigid plastic packaging and medical devices, has now introduced Sof’Bag, the latest version of its industry reference in airless package. It ensures formulations are delivered with extreme accuracy with its two components : bag and bottle assembly, and secondly with its pump and cap assembly. The multilayer bag in the plastic bottle guarantees a maximum protection against contamination and oxidation.
The Sof’Bag is currently available in the US and European markets for hormonal treatments and anti-inflammatory gels for example. The container can be supplied in 100 ml and 50 ml.
In 2013, Aptar Pharma Prescription Division developed the Twister, its latest Dry Powder Inhaler (DPI) innovation. Twister has a simple and robust design with few components, making it cost-attractive for asthma and chronic obstructive pulmonary disorder (COPD) treatments in fast growing markets. With an increasing number of Indian pharma companies introducing products that are delivered through the nasal or pulmonary route, the company feels that there is a huge interest for such dispensing devices.
With new advancements in the parenteral segment, packaging is witnessing impressive growth.
Pharmaceutical companies manufacturing parenterals are giving utmost priority to preserve drugs in packaging that is not only safe and convenient but also helps retain the efficacy of the medicines.