Pharma companies looking at newer methods and approaches to minimise packaging costs and yet meet important goals such as enhancing patient compliance. By Usha Sharma
The Indian pharma market is expected to grow at a Compound Annual Growth Rate (CAGR) of 18 per cent by 2020, driven by an ageing and growing population, rising income levels, emerging medical conditions and new diseases, etc., as per Market Research Report. And, as packaging plays a crucial role in this industry and is a connector between the industry and the end consumer, it will have a bigger role to play in times to come. Global pharma packaging market is expected to reach $104,882 million by 2022 from $68,749 million in 2015, growing at a CAGR of 6.27 per cent from 2016 to 2022, according to the report. So, what are the major disruptors in this arena and what are their impact? Let’s examine
Growing therapeutic areas
Well, as per the information available in the public domain, oncology, central nervous system (CNS) disorders and infectious diseases are the top three therapeutic areas. According to GBI research, almost 7,000 new cancer products are in the pipeline, nearly double the respective totals of CNS and infectious disease products currently lined up.
Chandiprasad Ravipati, Head-Packaging, Aurobindo Pharma shares, “Highest number of anti-cancer drugs are in pipeline across the developed countries almost twice in recent years, both in innovator (branded) and in the generic sector, accounting about 30 per cent of total R&D on new molecules. Highest R&D expenditure is on this segment with assurance of high returns.”
Santanu Chowdhury, Sr GM-Packaging Development, Sun Pharmaceutical Industries too opines similar. He says, “Pharma companies are focussing on oncology and biosimilar products, probably they consider that these areas deserve focus owing to its formulation complexity and potent characteristics. Thus, we are also seeing a lot of progress in the packaging of the drugs in this segment.”
Similarly, many experts believe that biologics also get high R&D focus. As Shivaji Chakraborty, Asst GM, Packaging Development, Fresenius Kabi Oncology remarks, “Biologics are undoubtedly the future of medicine. These complex medicines cannot be mass produced as they are not chemically synthesised. Biologic medicines can only be produced in small batches. As biologics differ so much in structure, we won’t see mass production of generic biological packaging, instead tailored products will be the priority.”
However, biologics are temperature sensitive and vulnerable to contamination, thereby making packaging design more difficult. Materials like glass, plastics and rubber aren’t suitable, due to the ability of metals to be extracted, which could degrade the biologic protein structure. Hence, there is a lot of packaging innovation in this arena to protect the effectiveness of biologics.
Changing regulatory norms
Another aspect that impacts packaging in pharma market is the changing regulatory requirements across the globe. In the last five years, global regulators have tightened their grip on the industry and taken stringent measures to address issues of drug access and quality.
To cite an example from India, Tripti Nakhare, Sr General Manager, Regulatory Affairs & PDD, FDC, reminds us of a statement from Prime Minister Narendra Modi asking doctors to prescribe medicines using their generic or chemical names and not the brand name, which caused a flutter in the industry.
Likewise, across the globe, regulatory reforms are in fast forward mode and India has to catch up with the latest regulatory requirements such as Drug Supply Chain Security Act (DSCSA) for the US market and Serialisation and Tamper-Evidence requirements of EU-FMD. As the US and EU markets are very relevant to India Pharma Inc, these two regulations will have significant impact. But, being compliant with these norms would create a considerable cost-burden on the players.
As Ravipati points out, “These two are major projects for the entire pharma industry depending on these markets. The investment for serialisation and aggregation, serialisation and tamper-evident feature on packing lines and packaging materials is significant to the tune of Rs 5 to 10 crore based on the number of packing lines.”
He also informs, “Tamper-evident labels have to be affixed on both the sides of cartons for the European market and this is an additional cost. Font size regulation for labelling of Health Canada resulted in switching over multi-layer labels from conventional single-layer pressure-sensitive labels. This is an added cost by 2 to 2.5 times.”
Highlighting the impact of regulatory changes on pharma companies’ balance-sheet, Nakhare acknowledges, “In 2018, the following GSRs were released that led to changing all the packaging materials of all pharma companies. Fortunately, sufficient timeline was given to consume the existing stocks for most companies with conservative inventories. GSR 222 (Brand name/generic name proportion), GSR 408 (Schedule G, H, H1 to be placed in a red box), GSR 277 (some steroids included in Schedule H drug). However, the proofing, plate/cylinder costs and implementing the change levied heavy costs on the pharma companies. In-spite of all efforts, some write-off are bound to happen and when the entire domestic market is considered, the write-off also were in crores of rupees.”
Ajay Bapat, Packaging Head, Emcure Pharmaceuticals, expresses, “For the printed packaging material, regulatory changes is a curse. Every now and then, there are new requirements and the whole set of artwork, printed components need to be revised. Look at the recent requirements of Track and Trace, regulations for Schedule H warnings, removal of red line for prescription was the focus area when it comes to artwork changes. The printed packing material, affecting the environment and balance sheet, has to be thrown out (of course after trying to consume the maximum).”
However, he also believes, “All the changes are to be done together. Whatever time is required to study the process, it can be taken initially, but once the changes are done, it should continue for four to five years thereby reducing the burden of frequent changes in artwork, PM and internal QMS documents like BOM, batch records, etc. Every change is a cost to the organisation and has to be reduced.”
This is possible only if the pharma packaging industry becomes more innovative, flexible and affordable. Thus, regulatory challenges are a major factor driving change in the pharma packaging industry.
Improving patient adherence
Patient adherence is another challenge due to fast pace of life and patients being unaware of the consequences of non-adherence. And, packaging, if used effectively, is a great solution to tackle this problem.
As Chaudhury says, “Patient adherence to dosage regime, as prescribed by physician, is probably the single most important factor to intended cure other than various other aspects such as the nature of disease and specificity of individual state of health. Lack of awareness, indiscipline approach, forgetfulness, old-age syndrome are the biggest contributors to non-adherence in India. Certainly, packaging can play a big role through development of simple packaging, say calendared, pack or bringing out cost-efficient smart packaging.”
Ravipati also explains, “With very low per capita purchase of medicines in India and less affordability, patient adherence is a big challenge. In fact, lack of patient adherence in rural areas is very disturbing. While there will be improvement in these rates as a result of growing healthcare insurance by state and central governments in the last few years, packaging of selective therapeutics can be designed as per the prescribed dose and made affordable.”
Nakhare further informs, “We all know that the smart and intelligent packaging is fast catching up in India. And why is it happening? With the thrust of Indian FDA on boosting the generic sale, setting up Jan Aushadhi stores, etc., pharma companies have to innovate to convince the doctors and patients and hence they have to come up with solutions to improve the appeal of the packs by offering some additional benefits. Moreover, with the fast pace of life in metros, most people are not able to adhere to the dosage regime and hence companies are providing packs or associated technologies that reminds the patient to take their medicines on time and the dos and don’ts if they miss any doses.”
For instance, use of QR codes to give out product information as a sizeable population uses smart phones in India. Elaborating on this point, Nakhare suggests, “The rural population has to be educated about completing doses of antibiotics, going for follow up to doctors. Providing ways to communicate with the rural population vide smart packaging and communicating in their regional languages may help. Use of QR codes that link to the website that may communicate about the product in the language known to them may help.” Thus, most of the experts encourage growing adoption of smart packaging design and assert the need for packagi