Logistics compliance strategies for the new pharma

Pharma shippers are pointing towards a very different and new pharmaceutical industry that will emerge soon. Such a change will demand a complete transformation both in logistics as well as in regulatory compliance. Is the logistics industry ready?

“The pharmaceutical industry, as we see it today, is going to transform with the introduction of personalised medicines, highly complex injectables, biologics and biosimilars which need a different degree of attention as we manufacture and move goods till they reach the patient.”

This is how Vickram Srivastava, head of planning - global supply chain, Sun Pharma, summarised the pharma supply chain of the future. It also encapsulates the discussions at the recently concluded annual one-day conference Global Pharma Logistics Summit 2023, where he spoke.

The sixth edition of the pharmaceutical shipper-focused conference and networking event was held in Mumbai on September 12, 2023, and was supported by Etihad Cargo, Mumbai International Airport (Adani Airports), Cargo Service Center, TPC Packaging, Frankfurt Airport, Hong Kong Air Cargo Terminals (Hactl) and Association of Healthcare Providers - AHPI (India).

Srivastava also spoke about the learnings that he had during Covid-19 pandemic and the disruptions that followed. This includes the importance of visibility, conscious collaboration and scenario planning.

“Number one is building visibility which is where many tools, technologies and Industry 4.0 will play a major role. As we talk about Industry 4.0, Industry 5.0 is going to take over very quickly. Number two is collaboration with vendors and logistics service providers. There should be conscious collaboration for making them business partners and stakeholders in business. Number three is scenario planning with how we can have plan A, plan B and plan C which ensures integrated collaboration and not just attempts in silos. This should include working with service providers, freight forwarders, airport and customs to make sure if something can go wrong, it can’t,” he said.

Meanwhile, talking about the challenges of the pharma supply chain, Dimple Parikh, head inbound logistics, Lupin, noted that the transportation of pharmaceuticals right after the manufacturing site to warehouses and even for exports is still very fragile in India.

“India produces pharmaceutical products like APIs, intermediates, formulations, biosimilars and surgicals. All these different products have different compliances and distribution requirements.

"The United States, Europe and Japan are the most important export markets from Indian pharmaceuticals and these are some of the most regulated markets in the world where compliances are necessary even for transporting simple packages,” he said.

According to him, still transportation and warehouse partners have not upgraded themselves to the level which is required as per these compliances. Meanwhile, he also pointed out the increase in demand for pharma products that have frozen and cold chain requirements.

He added, “Regarding compliances, fortunately, airlines have done it, airports have done it worldwide. But unfortunately, our transport and warehouse partners in India are still not acute with the knowledge nor with the equipment requirements.”

He pointed out how the International Air Transport Association’s (IATA) The Center of Excellence for Independent Validators (CEIV) for Pharma helped airports and airlines activate these compliances and opined that it is high time for other partners to also embrace the same.

Logistics regulatory compliance became an important topic of discussion across the business sessions during the event and particularly after the presentation by Rishi Agrawal, co-founder and CEO of TeamLease Regtech. “Avoid drifting away to the wrong side of the law,” he cautioned the attendees.

“A single entity, single corporate office and single factory Indian pharmaceutical company deals with 998 compliances in a year. If it has five plants, it will deal with 5,500 compliances depending on the specific nature of operations. And if it's a large pharma company with 10 or more plants, the number of compliances and obligations range between 10 and 20 thousand depending on the specifics. Such a company deals with 85 unique acts and rules with 58 central and 27 state-based rules and 70 unique licences,” he said.

Pratyush Kumar, senior general manager, demand planning & logistics excellence, Glenmark Pharmaceuticals, took an example of his conversation with the quality control regulators in Europe and noted that wherever European regulatory authorities are doing an audit the focus on Good Distribution Practices (GDP) has become equally important if not more, than the Good Manufacturing Practices (GMP).

“Transporters are not taking the movement of pharmaceuticals as seriously as we take it while manufacturing. We need more support. I must congratulate the airports and airlines for the improvements they have made in the last four years but there is scope for improvement there as well,” he said.

While there are challenges, he also pointed out that there are also very good solutions like in the area of packaging pharma goods.

“For example,” he added, “The gel pack is a great solution to move goods in strict temperature ranges. Once the goods are packed in a gel pack which has got the validity of 15 days or one month or even 2 months, irrespective of the temperature outside, it reaches with no harm. But it is very costly and doubles the weight, which is not efficient and airlines charge for that. It is also an environmental hazard. In our United States warehouse, we got 50 to 60 containers of gel packs. We can't destroy it in the US or in Europe. The solution is very effective with no temperature excursions but it led to other problems. Other innovative solutions are also coming up like the good quality thermal covers. Also, there should be biodegradable packaging solutions.”

Putting this into a larger context and drawing upon his experience as the French army officer 25 years ago, Fabrice Panza, Manager, Global Cool Chain Solutions, Etihad, said, “It is not the vaccines in itself that save lives but vaccination,” emphasising the need for strong distribution channels.

“There are key parallels, when it comes to the army, specifically when you are in charge of many people who are using some of the difficult and risky equipment, and air transportation. It is about measuring the risk, how we can get this risk mitigated and bringing the right level of cohesion within the ecosystem,” he said.

Agreeing with the pharma manufacturers on the new kind of personalised products getting introduced, Roland Weil, Vice President Sales - Cargo, Frankfurt Airport, emphasised the importance of investing for both the aircraft capacity as well as landside capacity in terms of new facilities at airports.

He said, “It's never the right time to invest. Because if we are going down in terms of demand, we would say it is a downward trend so we don't want to invest. If it is already down, we don't want to invest because it is down. If it is going up, we don't want to invest because we don't know how long it is going to go up, then if we are up, we still say we don't know how long it is going to stay up so we don't want to invest.”