Following the recent fires at Kerala Medical Services Corporation Limited (KMSCL) units in Kollam and Thiruvananthapuram, the Fire and Rescue Department has launched a state-wide inspection to check the safety features at various drug warehouses. With the pharmaceutical industry growing exponentially, India is expected to run an efficient end-to-end supply chain to meet the demand. However, such unfortunate incidents expose the gaps in the supply chain.
While the demand for outsourcing is driving the growth of the pharma industry, factors such as the lack of efficient logistics support in emerging economies are likely to impede market growth, says a report by Technavio. In Indian pharmaceutical warehouses and distribution centers, increasing warehouse capacity, adopting new automation technologies, enhancing staff safety, and complying with tight FDA and CGMP rules – all at the same time – is not a piece of cake.
What happened?
On Tuesday, 23rd May 2023, a 32-year-old fireman died while attempting to douse a massive fire that reportedly erupted on low quality cotton abandoned in the warehouse, before it reached the bleaching powder that was bought during the COVID crisis, at the state-run drug warehouse. The drug warehouse, owned by the Kerala Medical Services Corporation Limited (KMSCL) was located at the Kinfra Industrial Park near Thumba.
DGP B Sandhya, who visited the fire accident site, told reporters that the drug warehouse building did not have a No Objection Certificate (NOC) from the fire and rescue department and there was no mandatory equipment to douse the flames.
A similar incident took place last week when another warehouse of KMSCL was gutted in fire in Kollam district following which Health Minister Veena George ordered a probe into the incident.
Warehouse safety protocols:
Drug warehouses in India are required to comply with GMP, CGMP, and tight FDA rules and protocols to ensure the safe handling of dangerous goods.
GMP Rules:
As per the rules, manufacturers are required to
- Keep medications and raw materials for medicines safe during storage.
- Prevent all the final products from deterioration.
- Avoid cross-contamination with other materials.
- Prevent the shipment of faulty or expired products.
On the other hand, warehouse managers are required to manage three major items appearing on the packaging bill of the material that is usually supervised according to the GMP regulations.
They also have efficient inventory control. Under the GMP regulations, each commodity requires a label to feature a recognizable name and a Unique Identification Number (which should be documented in every system) distinct from the supplier’s lot number. As per the regulations, the labeling requires dates of expiration, barcodes for extra tracking possibilities, indications of status (generally in the form of a color code), products under quarantine, items being held for examination, rejection label if the object fails to satisfy specified requirement, and approval & release labels.
CGMP Rules:
FDA’s Current Good Manufacturing Process (CGMP) requires the careful tracking of commodities within the warehouse. As per the regulations, operators are required to maintain documented protocols that describe the storage conditions for each medicine they store. Also, each medicine must have a distinct, traceable code that specifies the lot’s condition (e.g., approved, quarantined, or rejected). Written protocols documenting each drug’s distribution process, including recalls, are also necessary.
