Pharmaceutical industry is the second most regulated industry in the world and pharmaceutical products require standard packaging which is superior to that of most other products in order to supply and comply with their main requirements. The technological advancement in the field of drug discovery, awareness and affordability for better health consciousness across globe is influencing the regulatory authorities of countries bringing more and more regulatory requirements for the patients’ safety and efficacy.
Pharma packaging should be patient convenient for clear communication of important information, ease of usage and disposal. There are two major regulations that impact the entire pharma industry globally . These are compliance to Drug Supply Chain Security Act (DSCSA) for products that are sold in the US and Falsified Medicines Directive (EU FMD) for products that are sold in countries of European Union. Compliance to these requirements need additional equipment on packing lines, a partner of reliable and robust cloud partner, changes in printed packaging materials.
An ecosystem comprising the pharma industry, experts from equipment manufacturers, serialisation, information technology etc aggregates around 70 per cent of the information flow, huge data management which would have helped the entire pharma industry in saving investments, project costs, time and considerable man-hours of expertise. To get best results, pharma companies can engage end-users for value addition.
Future trends of pharma industry shall be more filing of parenteral products, inhalation formulations, and semi-solids which are more complex than solid oral dosage forms (tablets, capsules, powders for oral suspensions and liquid orals). As the patents of solid oral dosage forms are shrinking considerably the focus is on new drug delivery systems. These formulations require robust packaging plus devices of administration. The regulatory requirements of medical devices are going to be very stringent. The trend can be filing New Drug Applications from India with the successful growth of revenues.
Building an ecosystem for innovation to face the present and future challenges would immensely benefit the entire industry by creating a win-win environment. The industry stalwarts have to come together in building this ecosystem which would not impact any proprietary rights. Industry should partner with academic and research institutions, experts from packaging industry and medical device manufacturers. A common stage with clean data base should be built for conducive and transparent interaction with information exchange. There should be clear guidelines of a working system.
Innovation strategy should be the core of the ecosystem with detailed goals to achieve, roles and responsibilities of each function. Growth platforms should be built which input demands. Ideas should be developed based on demands and objectives. Infrastructure should be provided to bring the innovation to realisation. A culture of innovation has to inculcated and sustained for the ecosystem to thrive and fruits should be shared equally.
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