Sigachi disaster: The blast must jolt pharma regulators out of their slumber

Mint

19-07-2025

The 30 June explosion, which ripped through Sigachi Industries Ltd's pharmaceutical plant in Hyderabad, has left the already bruised reputation of India's pharmaceutical manufacturing industry in tatters.
The blast—which claimed the lives of 44 workers and critically injured 33 more, with eight officially listed as 'missing"—has once again put the spotlight on shortcomings in occupational safety and GMP (good manufacturing practice) compliance in India's pharmaceutical sector.
The industrial accident also exposes the huge gaps in regulatory oversight and enforcement.
That can have disastrous consequences because this not only endangers the lives of the workers, but also the lives of residents living near such plants. Besides, poor-quality medicines and formulations pose a serious threat to patient safety and could damage the reputation of India's $65 billion pharmaceutical market.
The Sigachi disaster
The Sigachi blast is the worst industrial accident in Indian pharma manufacturing in terms of the number of casualties.
The unit had not put up the mandatory 'green board", which is supposed to list potentially hazardous material and processes used in the plant, so that emergency services know what they have to deal with, The Hindu reported on 6 July.
These details are also supposed to be filed with the fire department, which also wasn't done. And clearly no one bothered to even check.
Further, an FIR filed by the family member of a deceased worker claimed that workers had raised concerns about the safety of the equipment—which was allegedly old. Periodic safety inspections of the unit—if they were carried out—should have noted this, if this was indeed the case.
A commission of inquiry has been appointed to investigate the accident. But the point is that poor attention to safety and quality is putting at risk India's claim to be the pharmaceutical capital of the world—it's the world's third-largest pharmaceuticals exporter.
More importantly, the sector—the fifth-largest contributor to the country's manufacturing gross value added—accounts for a fifth of the world's generic formulations output and three-fifths of global vaccine production. This thriving market is now at risk due to repeated cases of India-made drugs failing to pass regulatory quality control.
Chequered track record
In May 2024, India's apex drug control authority, Central Drugs Standard Control Organization (CDSCO), put out a list of 50 formulations, used to treat widely prevalent issues ranging from fever to diabetes, which were found to be substandard. That's a pretty routine occurrence.
In May 2025, the CDSCO's alert listed 128 formulations as being not of standard quality, while two more were found to be fake. Mind you, only around 3 % of samples are tested, because the state drug control laboratories are severely underfunded, understaffed, and underequipped.
In fact, overseas regulators, particularly the US Food and Drugs Administration (FDA) have been far more diligent in inspections and evaluations, although the FDA's actions are confined only to those units that manufacture drugs exported to the US. But that is not an inconsiderable number. India has the largest number of USFDA-approved plants worldwide, excluding the US, at 499. The US has 530 such plants, while Europe has 416.
A June 2025 analysis by CARE Ratings found the same troubling issues, which have dogged Indian pharma manufacturing over the years. According to the report, between 2022 and 2025, 33 warning letters were issued to Indian pharma companies.
The main reasons included failure to maintain quality and purity (24%), lack of data documentation and rigour (21%),, and unsanitary/unhygienic conditions at the facilities. There were also multiple incidents of regulatory non-compliance, including failure to properly test raw material and failure to use globally validated analytical methods.
Perhaps, the most sensational case was of Ranbaxy Laboratories Ltd, which admitted to seven felony counts, including selling adulterated drugs, not reporting that its drugs failed to meet standards, and intentionally lying to the authorities. Ranbaxy, then India's largest generics manufacturer, was forced to pay $500 million in fines and eventually was forced to sell out to a Japanese pharma company.
A national priority
Nearly two decades on, similar incidents are cropping up with alarming regularity, pointing to systemic failures that need to be addressed with urgency. These include a chronically under-resourced regulatory system, lack of adequate infrastructure and technical knowledge among regulators, endemic corruption, and weak enforcement of existing rules and laws.
Part of the problem stems from the industry's fragmented nature. Due to policy and licensing issues, most of India's 10,000-odd pharma manufacturing plants fall in the MSME space. They lack the capital to adequately invest in technology, GMP compliance, and worker training. Most of the workers killed in the Sigachi incident, for instance, were poor migrant workers from Bihar.
India needs to urgently address these systemic issues—particularly in view of China's strides in this sector—if it is not to lose its preeminent place in the global pharma sector. It must be a national priority where both states and the Centre work in tandem to adequately support the regulatory structure—in terms of money, human, and technical resources.