Costly lapses (Pharma plants should have a high level of safety culture), Pg8

Context: 

• A devastating industrial accident at Sigachi Industries’ pharma plant in Hyderabad has resulted in 36 fatalities, prompting renewed scrutiny of safety standards in India’s pharmaceutical manufacturing sector. 

Key Highlights:

• Microcrystalline Cellulose (MCC) is non-toxic and chemically inert, widely used in pharmaceuticals, food, and cosmetics.
• The accident in Hyderabad involved an explosion in a unit producing MCC, likely due to equipment malfunction and poor maintenance.
• Most victims were young migrant workers from North and East India, lacking social security and support.
• The Telangana government has announced ₹1 crore ex gratia to the victims’ families.
• Industrial accidents in pharma units have been frequent, with similar incidents in Anakapalli (2024) and Hyderabad (April 2024).
• The editorial stresses the lack of a strong safety culture in Indian pharma manufacturing units.

Detailed Insights:

1. While MCC itself is safe, the production process involves hazardous steps that demand strict process control and maintenance.

2. HAZOP (Hazard and Operability Study) and other process hazard analysis methods are essential but often ignored or inadequately implemented.

3. Effective safety depends on:

• Skilled manpower operating and monitoring equipment.
• Data integration to detect operational anomalies.
• Continuous training of staff on safety protocols.

4. In the context of India’s growing pharmaceutical exports, such accidents tarnish India’s image globally and threaten its role as a reliable pharma hub.

Way Forward

• Enforce stringent safety audits and ensure third-party process hazard assessments in pharma units.
• Create centralised industrial safety databases and ensure proactive inspections by regulatory bodies.
• Provide social security, insurance, and training programs for migrant industrial workers.
• Foster a culture of safety through leadership training, periodic drills, and zero-tolerance policies on safety lapses.

Key Concepts Involved:

• Microcrystalline Cellulose (MCC): Chemically inert excipient used in pharma; non-reactive but produced via risky processes.
• HAZOP (Hazard and Operability Study): A systematic technique to identify process hazards and operability problems.
• Process Hazard Analysis (PHA): Evaluates the potential hazards of industrial operations using methods like HAZOP, FMEA, etc.
• Safety Culture: The commitment of an organization to prioritize safety in all operations and decision-making.