The plumes of smoke billowing out of Serum Institute of India’s Manjari, Pune facility on January 21 garnered more than its fair share of attention across India and the world. As one of the largest vaccine makers in the world, Covishield has made SII a household name in India and I daresay across a sizeable part of the world.
SII CEO Adar Poonawalla took to Twitter to allay concerns of a disruption in Covishield supplies, as the vaccine was being manufactured at multiple production sites to deal with such contingencies. The under-construction facility was reportedly being built for SII’s other vaccine products like rotavirus and BCG vaccines. Which is also bad news, as other vaccinations have taken a back seat to COVID-19 vaccinations and health agencies like the WHO and the UN have been warning that the pandemic is set to reverse years of hard work towards achieving the health goals under the SDGs, especially those related to maternal health and childhood vaccinations.
Five lives were lost in the fire, all labourers working on the insulation of the under-construction facility. There are reportedly top officials from the fire wings of three Maharashtra government agencies probing the cause of the initial fire as well as one that broke out later.
As nations manoeuvre to secure stockpiles of the COVID-19 vaccine and Pfizer/BioNTech lock horns with the EU and Canada over reduced vaccine deliveries, the fire at SII highlights how central the vaccine is perceived to be to human survival and economic revival.
Vaccine diplomacy is another huge initiative, with Covishield already being exported to friendly neighbouring countries. The pandemic is also rebuilding the reputations of Big Pharma, and now of the US as well. One of US President Biden’s first executive orders was to re-join the WHO, indicating his country will fulfil its financial commitments. This will hopefully go a long way towards bridging the funding gap for the COVAX facility.
The lesson for the future is that environment, health and safety (EHS) norms need to be monitored more closely, not just at operational facilities but also the ones under construction. Most often, these expansions are part of the same manufacturing campus and there is always the risk of the blaze spreading to existing facilities, endangering the lives of personnel as well as equipment and ready stocks.
As physical inspections by agencies like the US FDA are expected to re-start in CY21, pharma and vaccine companies had best prepare for more scrutiny on this front. US FDA inspections were limited in CY20 due to pandemic-travel restrictions. Even so, there were four warning letters in CY20-TD versus 15 in CY19, according to a recent report from ICICI Securities. CY21 is sure to see more physical inspections depending on how the pandemic pans out.
Corporate honchos and boardrooms will soon be abuzz with post-budget analysis and other matters, but if it took a pandemic to re-focus attention on research into infectious diseases, may this fire force more attention to EHS audits and employee safety. Not just the employees on the rolls but also the so-called temp staff. The five lives lost were from the bottom of the pyramid of India’s labour force. SII has announced a compensation of Rs 25 lakhs per deceased, in addition to the mandated norms, as per a tweet from SII CMD Cyrus Poonawala, but let us hope that it will not be back to ‘business as usual’.
The fact that the state’s chief minister travelled from Mumbai to visit the Pune facility gives an indication of what’s at stake not just for SII but also the state government, which could be held up for lax monitoring of regulations related to accidents and fires at construction worksites.
Fires and explosions at pharma facilities are unfortunately par for the course, as the input materials are most often inflammable and need to be stored under specific conditions. Let’s hope EHS regulations get a fresh look, and more efforts are made to follow them, in letter as well in spirit, without cutting corners.