Unfortunately, this is not an isolated incident. Over the last few years, such mishaps across different pharma plants have significantly added to the list of casualties. The irony is that these pharma companies claim to be in the business of delivering ‘lifesaving’ medicines to patients, but do not seem to value enough the lives of their plant operators and other staff at their manufacturing plants.
Feeling the heat
Despite an enormous improvement in the technology and techniques used to construct manufacturing plants, we continue to hear of incidences like gas leakages, boilers exploding, or an entire pharma /chemical plant razed to the ground by fire. So don’t we have foolproof technology or were the accidents man made errors?
| Dr Suresh R Saravdekar |
“Modern chemical and pharma industrial plants are by no means immune from catastrophes, as the events at Chernobyl and Bhopal in the past and more recently, in Japan have shown,” points out Dr Suresh R Saravdekar, Consultant-healthcare, pharmaceuticals, medical devices and diagnostics.
“It is safe to assume that no man-made system is foolproof, and in industries where a catastrophic failure in a safety system would have devastating effects on both the workforce and those living around it, plans must be made to deal with the worst-case event,” says Saravdekar.
He adds, “The main reasons for this type of mishaps in India, are non-observance/ compliance of standard norms of safety by the industry, laxi-ty on the part of regulators and legislators with regards to efficient and strict implementation of industrial safety rules. Total indifference about safety parameters, lack of training and awareness among management and employees also plays crucial role. No provision of appropriate safety devices and arrangements in the premises is yet another culprit.”
Not just manufacturing plants
Though recent mishaps were predominantly confined to manufacturing plants, the pharma industry does have many work areas that can follow the fate of plants that were gutted by fire or any such incident. In fact there were sporadic incidences of fire that took place at research laboratories as well.
| Archana Sohoni |
Archana Sohoni, Principal Architect, Arena Consultants, explains, “Research areas/ labs are no different from manufacturing plants, since the processes/ functions remain almost same only difference being the scale. Any company, SME or multinational, can choose to set up an R&D lab and the area occupied by these facilities can be as small as 1000 sq.ft. In fact, they are more prone to accidents since there are fewer regulations set for such kind of facilities.”
Salil Sansare, Director, Labguard, endorses Sohoni’s views. He says, “Labs are also susceptible to fire hazards or chemical spillage or a blast. In the last three years, there have been several cases reported. These range from a fire breaking out in a fume hood or reaction going wrong on lab table, spillage of chemicals on user’s body.”
Inferior infrastructure
| Salil Sansare |
According to Sohoni, worldwide research has proven that its ‘human error’ that is most responsible for mishaps. “To simply put it, the ‘attitude’ of a lab personnel is one of the most important factors in the safety of a lab. If the attitude/ approach is right and proactive then most accidents can be avoided,” asserts Sohoni.
During the recent fires that took place in manufacturing plants or in laboratories, the fire brigade took a long time to douse the blaze. One of the reasons put forward by the fire officials was that the materials that were used to build the lab/ plant were very quick in catching fire.
“In many cases there is little importance given to the use of the right type of materials while the laboratories are being set up. The stakeholders are often not aware of active and passive fire hazardous materials and these set ups are planned like any other commercial premises. Such under designed infrastructure leads to propagation of fire accidents. Infrastructure also includes safety devices, alarm systems and various sensors that give advance notifications. Facilities devoid of these are mainly responsible for catastrophes,” informs Sohoni.
Sansare adds to the points mentioned by Sohoni. He says, “A majority of lab accidents have happened due to the wrong selection of infrastructure. For example, if you use wood in lab furniture, it can catch fire. Also, if you do not store flammable chemicals in dedicated flammable chemical cabinets; it may not withstand fire.”
Fixing responsibility
| Kapil Bhargava |
Recent explosions at the manufacturing plant saw senior officials fleeing the spot to evade Government authorities. In all such cases the owner of the pharma / chemical company was not punished or put behind bars. Unless it is clear who will bear the responsibility and held guilty for such accidents, the culprit cannot be brought to book. Giving his views on this issues, Kapil Bhargava, Consultant – Pharma Compliance Alliance, asserts, “The management and the site head should be held responsible.” Saravdekar says, “Basically, management of industry and four main regulatory authorities are responsible for industrial safety of an unit, namely, Directorate of Industrial safety & Health, Maharashtra Pollution Control Board (MPCB), Directorate of Steam Boilers, Directorate of Explosives and Directorate of Maharashtra Fire Services.”
He adds, “Every unit likely to be engaged in manufacturing and synthesis of chemicals and pharmaceuticals has to obtain a license/ certificate from these regulatory authorities. In order to obtain a ‘Building Completion Certificate’ (BCC), it is mandatory to get these certificates/ licenses from the respective departments. A regular periodic renewal of all these licenses is also mandatory. In spite of these regulations in place, accidents are taking place repeatedly. This clearly points to the fact that regulatory authorities had either failed or were not strong enough to tackle this issue.”
|
Some recent accidents in pharma/ chemical industry
|
Rules are meant to be broken?
Repeated accidents only point to the fact that safety norms are not been followed as they are supposed to be. One accident can be excused as coincidence but repeated accidents fall under the category of mistakes and negligence. Since the Government has formulated safety rules, either the Government itself is not implementing them seriously or pharma companies are not paying heed to them.
Bhargava opines, “I have always been asking manufacturers for their practices of safety audits. To my surprise most of the site personnel have replied that there is no formal safety audit at their site and some report is made to ensure compliance of ‘Labour Laws’. Though Hazard and Operability Study (HAZOP) and Hazard Analysis and Critical Control Points (HACCP) has been an important aspect for such industries, this aspect was neglected at sites in India. Most MNCs have good Environmental Health & Safety (EHS) policies where good emphasis is given for safety audit. This may happen because their principles insist this. I hardly see a designated post of “safety officer” on the site.”
He adds, “I feel many companies flout safety rules quite often. Safety has not been considered an important aspect in the pharma industry and expenditure incurred on this is not considered worthwhile.”
Saravdekar narrates how on visits to industrial belts, he comes across instances where units have closed down but neglected to properly dispose off unused chemicals/remnants. Consequently, tanks of such hazardous material, either full or partly filled, still exist at the location of such closed units, waiting for accidents to occur.
He warns, “It is also seen that the proper segregation of different chemicals, as per their inflammable potential, toxic potential, is not done, which leaves a possible health-threat to the lives of the people handling these chemicals.” A number of pharma units and chemical plants are increasing and so are the dangers associated with them. Building a foolproof unit is important but employing staff that knows how to handle such units is even more important. Incidences of explosions, leakages at the pharma/chemical plants can be reduced, provided the Government ensures that rules are strictly being followed.
It is equally essential that managements of pharma/ chemical companies elevate plant safety as a top priority and take responsibility for ensuring that the right technologies and trained people are in place.