Express Pharma

Pharma packaging: An evolving sphere

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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

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.”

Santanu Chowdhury

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.

Shivaji Chakraborty

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.”

Tripti Nakhare

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).”

Ajay Bapat

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 packaging solutions that can communicate effectively with patients and prevent counterfeits.

Can pharma go the FMCG way?
Nevertheless, there is a lot more that can be done to optimise the potential of packaging but it would also require significant investments. Therefore, can the FMCG sector, which has come up with some good solutions in packaging give some new ideas to improve pharma packaging as it strives to strike a balance between cost and innovation? What do the pharma packaging experts feel about it?

Chowdhury feels that it’s unlikely that pharma industry would follow, at least in coming years, on packaging-free products primarily due to basic difference between consumption within human body versus use over human body. However, the pharma industry is now patronising ‘less is more’ concept and sustainable packaging through various initiative programmes.

“I don’t think pharma industry can do away with product packaging,” says Ravipati. But he also suggests, “Wherever over packaging is there, it can be reduced. Bulk packages are common in pharma industry for hospital supply. Also, due to the advent of information technology, some packaging, especially prescribing information to medical practitioners and medication guides/patient information sheets, can be made electronic and available to pharmacists to dispense. This will result in saving packaging material, especially paper, which will also have an environmental impact. With increase of e-pharmacies, there can be less packaging by manufacturers supplying medicines in high bulk packs.

Becoming future-ready
However, everyone is in accordance that pharma packaging has to evolve and enhance to meet the future demands of the industry. And, the experts opine that investing in technology and eco-friendly initiatives will also prove crucial. Ravipati explains, “The cost of pharma packaging is expected to reduce with the advancement in technology and eco-friendly packaging. Growth in demand for reusable and eco-friendly packaging is expected to drive the market. Additional feature which is becoming more significant is patient and administrator convenience.”

He also informs, “Technological advancements in pharma packaging result in immense innovative and advanced applications to pharma and biopharma industries to improve their packaging standards. In the ever-growing technological environment, more types of packaging materials are available which offer more. Package designing is focussed on this aspect to create and sustain brand loyalty in the market.”

Citing another example, Chakraborty adds, “Digital watermarks will also become more widely used, offering an extra layer of protection by providing invisible, encoded data on packaging that can only be verified by specialised software. It can be captured using webcam, mobile phones and other scanning device but is invisible to the naked eye.”

Expectations from the government
At the same time, the industry also feels that government support can be of aid in ushering progress and enabling regulatory compliance.Chowdhury feels, “The government should be cognizant of the effort, resources and investment that requires to be compliant to global quality norms besides promoting innovation for the overall benefit of healthcare system. Moreover, it must come forward for funding and special concession in-terms of pricing cap, commonly known as NPPA.”

Nakhare adds, “Talks are on to implement track and trace for the domestic market as well. If the government wishes to implement the same, some monetary help should be extended to SMEs as implementation of these projects runs in crores of rupees. Since most companies have implemented the DSCSA requirements for the US markets and FMD for Europe, they are aware of the challenges in implementing the system.”

Seeking government support might be an alternate but not the long-lasting solution to the industry. So, the industry needs to evaluate all the possible solutions which can minimise the usage of pharma packaging material following the patient adherence and eco-friendly way. As we know protection and trend in the industry is more in adapting newer technology, pharma companies will continue with it.

Ravipati also shares his views and states, “Overall packaging for a drug product cannot be compromised and cannot be reduced. In fact, better packaging is required for new drug delivery systems. The government can help the packaging industry by reducing import costs and taxes on raw materials such as glass, plastics, paper and board. It can play a major role in encouraging packaging research and development at academic, institutional and industry levels.”

The pharma packaging industry in India has become more innovative, flexible and affordable and the country needs to catch up with the latest regulatory requirements. Regulatory challenges can play a major role in driving the change in pharma packaging industry. Though adoption of smart packaging design and the need for packaging solutions is the need of the hour, there is a lot more that can be done to optimise the potential of packaging, which will require significant investments. The packaging industry needs to evaluate possible solutions which can minimise the usage of pharma packaging material following the patient adherence and eco-friendly way.

Thus, the pharma packaging industry is transforming rapidly and while the government can definitely speeden its growth journey, the players themselves should restrategise to become more innovative and responsive to the demands of the life sciences industry.  Fortunately, the stakeholders of this industry have already taken note of this fact and they are devising various approaches and investing significantly to become more patient-centric even as they leverage the growth potential in this segment. Thus, it is to be hoped that the pharma packaging industry will become much more value-driven and grow from strength to strength in the days to come

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