Pharmaceutical facilities ought to maintain a robust safety culture
- Weak Enforcement: The primary failure lies with regulatory bodies like the Directorate of Factories and Pollution Control Boards. Inspections are often perfunctory, infrequent, and susceptible to corruption, allowing units to operate without adhering to Standard Operating Procedures (SOPs).
- Outdated Legal Framework: While acts like the Factories Act, 1948, and the Environment Protection Act, 1986, exist, their provisions and penalties are often not stringent enough to act as effective deterrents for large corporations.
- Lack of Manpower and Expertise: Regulatory bodies are chronically understaffed and lack officials with specialized training to audit complex chemical and pharmaceutical processes, leading to superficial compliance checks.
- Profit over Safety: The root cause is often a corporate culture that prioritizes production targets and cost-cutting over investment in safety infrastructure, regular maintenance of equipment like reactors and boilers, and worker training.
- Lack of Accountability: In many cases, accountability is limited to junior officials or contractors, while senior management escapes responsibility. The principle of “strict liability,” established post the Bhopal Gas Tragedy, is inconsistently applied.
- Weak Internal Safety Audits: Many companies treat safety audits as a mere box-ticking exercise rather than a genuine tool for risk assessment and mitigation.
- Human Cost: The most significant cost is the loss of life and grievous injury, predominantly affecting contractual and migrant labourers who are often poorly trained and lack social security. Compensation provided under the Employee’s Compensation Act is often inadequate and delayed.
- Damage to ‘Brand India’: Such incidents tarnish India’s reputation as a reliable pharmaceutical supplier. They can trigger stricter scrutiny from international regulators like the US FDA and the European Medicines Agency, impacting exports and the “Make in India” initiative.
- Public Health Crises: The release of toxic gases and chemical effluents poses a severe health risk to surrounding communities, leading to long-term respiratory illnesses and contamination of local water bodies and soil.
- Amend and Unify Laws: Enact a single, comprehensive Occupational Safety, Health, and Working Conditions Code with stringent penalties and provisions for mandatory imprisonment for top management in cases of criminal negligence.
- Technologically-Enabled Inspections: Empower inspectorates with technology like drones for surveillance, IoT sensors for real-time monitoring of critical parameters in factories, and a centralized digital database to track compliance history.
- Third-Party Audits: Mandate transparent and independent safety audits by accredited agencies, with reports made publicly available to ensure accountability.
- Invoke Strict Liability: Consistently apply the principle of “absolute and strict liability” to ensure corporations bear the full cost of accidents, including environmental remediation and community compensation.
- Promote a Culture of Safety: Companies must be incentivized to move from a compliance-based approach to a culture-based approach, where safety is an integral part of business ethics and operations.
- Strengthen Safety Committees: As mandated by the Factories Act, safety committees must be empowered with meaningful participation from workers, who are the first to notice safety deviations.
- Skill Development and Training: Regular, certified training on handling hazardous materials and emergency response must be made mandatory for all workers, including contractual staff.
