Recent incidents at pharmaceutical manufacturing plants point to glaring gaps in workplace safety standards. In the most recent one, four workers lost their lives on August 21, due to a gas leak at the Medley Pharmaceuticals plant located at Tarapur, Maharashtra. Two more workers were admitted to the ICU of a local hospital. all, much more is expected from the ‘pharmacy of the world.’
A few months back, on June 30, 46 people died at Sigachi Industries’ Pashamylaram plant in Sangareddy district, Telangana. RPG Life Sciences’ Navi Mumbai-based API manufacturing plant reported a fire in January this year. And these are just the incidents that made the headlines as they are listed companies or the plants are located relatively close to urban India. There would be many more such incidents at MSME pharma plants in industrial parks, as I argue in a recent editorial. (https://www.expresspharma.in/ walking-the-talk-on-esg-workplace-safety/)
The bigger companies have bounced back. RPG Life Sciences is reportedly on track to restore the plant with a completion target in Q2. Amit Raj Sinha, MD & CEO, Sigachi Industries commits to “bouncing back stronger”, with the incident on June 30 acting as “a catalyst for a decisive transformation in how we approach safety, process integrity, and operational resilience.” But the ripples of such incidents reach far beyond a manufacturing plant’s gates. After all, much more is expected from the ‘pharmacy of the world.’
As a company pioneering a virtual model with multiple cGMP-compliant partners, Hari Kiran Chereddi, MD & CEO, HRV Pharma and New Horizon Global Pharma perceives “workplace safety as not merely a legal and compliance obligation, but a shared responsibility that defines the credibility of our industry in the future. Such accidents have once again indicated how vulnerable safety systems are, though India is one of the world’s top producers of APIs and formulations.”
At the heart of the problem is the scarcely hidden secret that the troika of Environment, Health, and Safety, or EHS, is an afterthought. And this needs to change, because as Mehul Shah, Founder, Encube Ethicals and VP (Western Region), IDMA puts it, “Beyond compliance, a strong safety culture driven by leadership commitment and employee engagement is crucial.”
Without EHS at the centre, India Pharma Inc’s future is at stake because as Arpit Bhatia, Director, Laborate Pharmaceuticals warns, “Scaling high-volume pharma manufacturing safely requires embedding EHS as a hard production constraint, not a parallel function.”
Regulatory labyrinth
So, why do pharma companies find it difficult to comply with EHS norms? Perhaps part of the answer is the myriad laws. Pharma companies in India are governed by a mix of central and state government legislations, industry-specific regulations and international best practices. Shah puts them into four buckets:
- Factories Act, 1948 and respective state Factory Rules (covering health, safety, welfare, working hours, accident reporting, etc.)
- Environment Protection Act, 1986, Air & Water Acts, Hazardous and Other Wastes Rules, Biomedical Waste Management Rules – for environmental and waste management compliance
- Fire & Explosives Safety norms as per Petroleum & Explosives Safety Organization (PESO)
- International guidelines such as OSHA, ISO 45001, and WHO GMP to align with international best practices.
In addition, Chereddi points out that overseas guidelines including norms like US FDA, EMA, and WHO GMP also call for rigorous EHS systems.
Most norms are influenced by US Occupational Safety and Health Administration (OSHA) guidelines which include Risk assessment (especially for controlling solvents, inflammable chemicals, and biological agents) and even around hazard classification; stringent engineering controls like ventilation, fire-safety, and effluent treatment; training staff, SOPs, and PPE; and incident reports and documentation for accountability.
As Chereddi sums up, acquiring or renewing production licenses in India is often a time consuming process, with different timelines for each agency, and delays are common. For SMEs, this regulatory labyrinth will leave projects pending for months, eroding competitiveness.
Shah suggests that renewals are generally smoother if a company maintains compliance records, statutory submissions, and audit readiness. However, he agrees that first time approvals or expansions can take months due to sequential clearances.
Speaking from experience, Bhatia narrates that for a fivesite company like Laborate Pharmaceuticals, compliance and renewals typically hinge on coordination across CDSCO/ State FDA licensing, environmental consents, fire NOCs, PESO, boiler/electrical inspectorates, and occasional foreign inspections (e.g., EU-GMP). Pain points include asynchronous validity dates, interpretational differences between Schedule M and EU-GMP, and synchronising change control so one supplier or process change propagates consistently into each site’s license and validation file.
But it’s not impossible. As Bhatia reveals that what works is a central Regulatory Operations PMO with a master calendar, harmonised SOPs, and eCTD-ready QMS covering change, CAPA, training, and self-inspection mapped to ICH Q9/Q10 and WHO TRS. He also mentions having a “365day audit readiness”, evidenced through data integrity controls, validated cleaning hold times, and CAPA effectiveness checks.
In Bhatia’s opinion, one needs to start by designing flow, facilities, and staffing around hazard profiles. For instance, Laborate Pharmaceuticals had segregated beta-lactam/cephalosporin/highly potent areas with dedicated HVAC pressure cascades, airlocks, and validated cleaning.
In addition, the company maintains single-direction movement and red-yellow-green zoning. For potent APIs, Laborate implemented closed transfers, contained charging, split-butterfly valves, single use liners, and isolators. Laborate also reduced musculoskeletal risk with lift-assists, height-adjustable jigs, and tool balancers at repetitive stations.
Importantly, Bhatia specifies that Laborate treats contractors like employees – gate induction, task-specific permits, colour-coded access, and strict hot-work controls. The company also conducts quarterly drills for fire, chemical release, medical response, and HVAC loss. They close actions via after-action reviews.
Sigachi’s story so far: Bouncing back stronger
While the government-led investigation is still underway, Sinha of Sigachi Industries reveals that the company’s preliminary internal review, supported by independent experts, points to a dust explosion originating in the dry section of the facility, specifically near the spray dryer chamber.
Key learnings include:
◆Enhanced dust hazard analysis (aligned with NFPA 660 standards or Equivalent)
◆ Upgradation of Pressure Venting systems with installation of Rupture disc and interlock systems
◆Stricter environmental controls in powder-handling areas
◆Refined SOPs for preventive maintenance and inspection cycles
Sinha commits to “making our learnings publicly available, such that any powder manufacturing industry can benefit from them.” Such transparency will go a long way towards workplace safety across the sector. The final safety and design upgrades for the rebuilt Pashamylaram unit will be determined once the detailed government-led investigation report is received. This will ensure that every enhancement is rooted in evidence and addresses all identified risk factors. Sinha asserts that the rebuilt facility will incorporate global best practices in dust hazard management, process safety, benchmarked against leading international standards, with inputs from reputed equipment suppliers and safety experts.
While a final budget will be determined post design finalisation, Sinha anticipates safety system enhancements to require an additional Rs 1.5–2.0 crores over and above standard rebuild costs. These will be funded through a combination of insurance proceeds and internal accruals. Giving an update on the time to reopen the Pashamylaram site, Sinha explains that as it has not yet been formally handed back to the company, officials are awaiting access to conduct detailed structural assessments of the remaining building systems and critical equipment inside the premises. Timelines for reopening will only be firmed up once these evaluations are complete. Additionally, the design and rebuild plan will depend on the recommendations of the expert investigation committee to ensure that the upgraded facility fully incorporates all learnings and improvements.
Back to business
From a business continuity point of view, in parallel with strengthening safety systems across all existing facilities, Sinha states that they have fast-tracked a 12,000 MTPA capacity expansion at the Dahej SEZ. Civil works are already underway, and this project will elevate Sigachi’s total MCC capacity to 30,000 MTPA, reinforcing the company’s ability to serve customers without disruption.
Sinha stresses that the Dahej expansion will feature the most advanced spray dryer systems available, procured in consultation with reputed suppliers and process safety experts, underlining that the company is “not only rebuilding what was lost but also raising the safety and operational benchmark for the entire industry.”
Healing employee morale
But merely rebuilding and expanding infrastructure will not get Sigachi Industries or any other company back on track. Acknowledging this, Sinha says, “Our stakeholders — from customers and employees to investors and suppliers — have stood by us during this period. Their trust fuels our determination to emerge from this stronger, safer, and more competitive than ever.”
Sinha reveals that since the incident on June 30, Sigachi has rolled out a multi-layered safety reinforcement programme across all operating sites to protect the workforce. Key measures include:
◆ Comprehensive third party safety audits: Engaged independent safety experts to conduct detailed dust hazard analyses, fire safety assessments, and equipment integrity inspections at all MCC units.
◆Immediate hazard mitigation: Addressed identified dust accumulation risks, upgraded grounding and bonding systems, and recalibrated interlocks and emergency shutdown systems across facilities.
◆Refresher safety training for all staff: Conducted 100 per cent retraining of operational and maintenance teams on dust handling protocols, hot work permit compliance, Lockout-Tagout (LOTO) procedures, and emergency evacuation drills.
◆Daily EHS checklists: Instituted mandatory daily safety inspections signed off by plant heads, covering dryer systems, powder transfer lines, rotary valves, and dust collection equipment.
◆ Safety committee formation: Established an Expert Safety Committee combining internal leaders and external specialists to monitor and guide safety improvements across all MCC units.
◆ Enhanced preventive maintenance: Shortened maintenance cycles for critical equipment such as spray dryers, flash dryers, FBDs, and dust collectors; introduced predictive maintenance tools for early fault detection.
◆Employee engagement and whistleblower protection: Launched open forums and a confidential reporting line for safety concerns, with strict non-retaliation assurance.
◆ Job and income security commitment: Ensured there are no layoffs, wage cuts, or benefit reductions — even at the Pashamylaram facility during its 90-day shutdown — with redeployment to training or administrative functions where required.
◆Psychological support: Provided trauma counselling, wellness sessions, and ongoing check-ins for employees directly or indirectly affected by the incident.
Through these steps, Sinha reiterates that the company is “not only reinforcing safety systems but also building a culture where every employee feels responsible for, and confident in, the safety of their workplace.”
One hopes that publicised cases like Sigachi Industries are a wake up call for the entire sector. The bad news is that this can’t happen overnight, as it needs concerted action from industry as well as policymakers.
An insidious erosion
Chereddi cautions that while in comparison to sectors like mining or heavy engineering, pharma experienced fewer accidents, the risks are typically sneaky. “A chemical spill or exposure to high-concentration APIs may cause no immediate trauma but poses long-term occupational hazards. The challenge is cultural: pharma is a process-oriented sector, and hence safety often becomes a “checkbox” and not a holistic approach.”
He also points out that globally, regulators have always held pharma plants to higher standards than, say, FMCG or textiles. But within India, enforcement varies —Tier-1 exporters follow stricter rules, while smaller facilities loosen under cost and other pressures.
Handling of inflammables and solvents tops Chereddi’s list of the most common areas of non-conformities. He believes that employees far too often rely on “experience” at the cost of SOP rigor. Awareness classes supplemented by electronic checklists and real-time monitoring can cut risks considerably.
Secondly, insufficient training budgets lead small businesses to treat safety drills as one-off activities. Regular spending on refresher training is required. Bureaucratic documentation errors is third on the common non-conformities list, as a majority of SMEs consider EHS records as inspector’s forms instead of an active safety dashboard.
Lastly, structural shortcomings – fire alarms, PPE warehouses, and effluent systems are occasionally neglected due to a lack of funds. Chereddi emphasises that these areas must have management commitment: safety must be part of boardroom KPIs, and not just floor level audits.
A time for reform?
With Prime Minister Modi’s Independence Day address signalling reforms to nullify the coming tariffs regime, it is perhaps the best time for India Pharma Inc to ask for sweeping changes.
Chereddi’s ask to essentially improve Ease of Doing Business lists three actions that are critical now:
- Unified, single-window digital clearing system – Licensing, renewals, and safety clearances must be harmonised across agencies.
- Proactive checks – Regulators need to shift from a “fault-finding” approach to a partnership approach, cautioning SMEs in advance.
- Faster clearances for compliant units ISO/GMP/EHS-certified units should have risk-based rapid clearances, freeing bandwidth to subject substandard units to stricter vigilance.
He believes that some of these changes would not only reduce accidents but bolster India’s reputation as a safe, dependable global supplier.
Bhatia’s recommendations on policy improvements to ease doing business include timebound, risk-based pathways for post-approval changes, reliance on Stringent Regulatory Authority and WHO Prequalification decisions, and a single national portal consolidating permits with reusable master data and machine-readable submissions. He also asks for predictable inspection calendars with standardised checklists and issue grading, digital acceptance of e-records/e-signatures and hybrid inspections, and coordinated joint visits for safety and environmental clearances.
On international harmonisation, Bhatia recommends aligning to ICH Q8–Q12 and adopting PIC/S inspection methodology to reduce duplicative expectations. Likewise, he suggests pursuing mutual recognition for GMP inspections and pharmacopoeial convergence, and accepting CEPs where suitable. He concludes that the outcome of these actions would be “safer plants, fewer administrative cycles, faster scale-up, and improved global market access.”
And a cultural reset
In Shah’s words, “Linking environmental sustainability with workplace safety is a must in the future pharma industry. Beyond compliance, a strong safety culture driven by leadership commitment and employee engagement is crucial.” While policy reforms would improve compliance culture and reduce delays, managements of pharma companies need to introspect and put in place additional workplace safety measures that go beyond mere laws. Shah mentions periodic health surveillance, ergonomics, and mental health support as essential for employees in pharma plants.
Zooming out to the bigger picture of ESG and cultural change, Chereddi emphasises the long term and often hidden impact. “Accidents do not just cause physical damages but also impact the morale of employees, confidence of investors, and faith of the local communities as well. Overseas customers now factor in ESG ratings when taking buying decisions. In order to have India continue as being the “pharmacy of the world”, we must instill a safety culture—beginning from leadership commitment to shop-floor awareness.
He suggests that virtual manufacturing ecosystems like HRV’s business model, can reduce this burden by working through existing licensed infrastructure. “By pooling resources, standardising SOPs, and sharing best practices across several partners, they can help with raising the safety baseline even for the smaller players,” suggests Chereddi.
He also points out that startups which lack such networks, face a lot of friction, discouraging innovation. For instance, HRV Global partners up only with cGMP-compliant & also cGMP capable units. Audits are conducted by HRV teams as well as third party safety firms from time to time. Co-sponsoring training modules for smaller partners and evaluating AI tools to predict compliance gaps before they turn into incidents also reduce risks of non-compliance.
As Chereddi highlights, workplace safety in the pharma and biopharma industry is no longer a compliance only discussion—it is a discussion of business continuity, ESG assurances, and public trust.
Comply or die
India Pharma Inc will have no choice but to comply with ESG norms and better workplace safety practices, if it wants to achieve its global aspirations. As Chereddi reminds us, “Safety in the workplace for pharma is not a choice—it is a matter of existence. Some recent tragedies at other industries are reminders that one failure can negate years of achievement. Indian pharma has been built on quality and trust; to keep the leadership in this area, we have to shift from ‘mere’ compliance to ‘strong’ commitment.”
Pharma managements cannot blame regulatory hurdles and wait for policy reform. Prevention is always better than damage control. Thus nurturing a safety culture should become the foundation stone for India Pharma Inc to be known as a safe, sustainable pharma manufacturing leader.
viveka.r@expressindia.com
viveka.roy3@gmail.com