2021-11-30

As India’s pharmaceutical exports move from generics to biosimilars, new challenges arise. Following are six specific challenges of the pharmaceutical cold chain in India.

2. Paper work and administration

You can expect more paper work and administration compared to Western countries. Before leaving the manufacturing facilities, local authorities will inspect the shipment and approve documents, a procedure that will take up to one day. Similarly, when shipping to India, it will take one to three days to clear the shipment. The process includes pre-clearance and actual clearance.

3. Trucking and delays

There could be long distances of trucking to and from airports. Margins for trucking are generally low and the petrol price is high, which could be a challenge when shipping sensitive pharmaceuticals. Trucks can be stuck for hours in traffic and there have been scenarios where trucks have been stuck at airports for three to four days.

4. Special airline services needed to ensure an unbroken cold chain

Containers are opened at customs and go through X-ray before being loaded on the other side of the scanner. In some cases, there is a risk that goods will stay on the tarmac for one to two hours before being loaded onto the aircraft. The shipment will thus be exposed to a considerable amount of human intervention and manual handling.

5. High temperatures and limited availability of cold storage

There might be limited cold storage at airports and not all airports have cold storage facilities. Goods are often unloaded/loaded at night, but temperatures can still be very high.

6. Lack of quality orientation and training

India’s cost-conscious pharmaceutical industry is evolving towards a higher focus on quality, with the booming of the biologics industry. Consequently, there is a higher demand for trained personnel along the cold chain. It is advisable to check in advance that people along the cold chain have received proper training and education.