In the Indian freight forwarding industry, to a large extent, doing Pharmaceutical Freight Forwarding is still considered to be a similar job as the logistics of any other commodity.
This is because maintaining top line budgets and reducing the logistics cost is always the foremost requirement; although the accusations cannot be level on both the stakeholder i.e. logistics service provider and the clients since it is a highly competitive industry, inexplicably for the service provider as well as for the manufacturer.
As per a CII Logistics Survey, the cost and packaging comprise approximately 3.55% to 4.60% cost of the pharmaceutical value chain for any pharma company.
For all we know, the pharma industry is a highly regulated market both globally as well as on a national and local level. Since it is directly attached to the masses of the country and any minuscule changes or non-uniformity can cost the lives of the many patients.
So the storage and distribution of such products in some cases is a serious business. However, a person or entity involved in the distribution of pharmaceutical products is only involved in and is responsible for certain elements of the distribution process like freight forwarding.
The storage, trade and distribution of pharmaceutical products are activities that are carried out by various companies, institutions and individuals. The nature of the risks involved may generally, however, be the same as those in the manufacturing environment, e.g. mix-ups, contamination and cross-contamination.
There are thus aspects in distribution to which the principles of Good Manufacturing Practice (GMP) should be applied. These are not limited to, storage, distribution, transportation, packaging, labelling, documentation and recordkeeping practices etc.
The quality of pharmaceutical products can be affected by a lack of adequate control over numerous activities which occur during the Freight Forwarding process.
Furthermore, the Freight Forwarding process has generally not been well-emphasized with regard to the need for GDP Training and Implementation, pharma knowledge, maintenance and control over the activities involved.
The objective of such guidelines is to assist in ensuring the quality and integrity of pharmaceutical products during all aspects of the distribution process internationally or domestically.
The manufacturer should communicate all relevant conditions for storage and transportation to the entities responsible for the transportation of pharmaceutical products and ensure they have thorough relevant certification and pharma handling knowledge.
Such an entity, i.e. the Freight Forwarder should ensure adherence to these requirements throughout transportation and at any intermediate storage stages.
Pharmaceutical products should be stored and transported in accordance with procedures in such a way that:
- The identity of the product is not lost
- The product does not contaminate and is not contaminated by other products
- Adequate precautions are taken against spillage, breakage, misappropriation and theft
- Appropriate temperature and relative humidity conditions are maintained.
The required storage conditions for pharmaceutical products should be maintained within acceptable limits during transportation. The specific storage conditions of the product should thus not be grossly exceeded or exceeded for an unacceptable period of time during the transit period.
Any deviations from storage conditions which are considered to be acceptable should be determined in consultation with the marketing authorization holder and/or the manufacturer.
Where special conditions are required during transportation which are different from or limit the given environmental conditions (e.g. temperature, humidity) these should be provided, monitored and recorded.
The transportation process should not have a negative effect on the integrity and quality of pharmaceutical products.
Written procedures should be in place to investigate and deal with any violations of storage requirements, e.g. temperature violations.
Products comprising highly active and radioactive materials, other dangerous drugs and substances presenting special risks of abuse, fire or explosion (e.g. combustible liquids, solids and pressurized gases) should be stored and transported in safe, dedicated and secure areas, containers and vehicles. In addition, applicable international agreements and national legislation should be followed.
The pharmaceutical logistics sector is poised for growth in India. But inefficiency in logistics of life sciences products could be an impediment to this growth. Hence, we should focus on building the knowledge base and enhancing the right skill-set for winning the manufacturers’ confidence and scale-up the bottom line too for longer benefits for all the stakeholders.
This article has been authored by Vijay Chouhan, a Pharma & Healthcare supply chain professional having 14 years of experience. All views expressed are of the author’s own.