Latest news with #SigachiIndustriesLtd
Mint
19-07-2025
- Health
- Mint
Sigachi disaster: The blast must jolt pharma regulators out of their slumber
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.
Hans India
08-07-2025
- Hans India
Death toll in Telangana factory blast rises to 44
Hyderabad: The death toll in the blast in Sigachi Industries Ltd's manufacturing unit in Pashamylaram near Hyderabad rose to 44 with two injured succumbing on Tuesday. According to officials, the two workers who passed away were undergoing treatment at two different hospitals in the Sangareddy district. One of the workers Akhleshwar succumbed at Dhruva Hospital in Sangareddy while Arif breathed his last at Panacea Meridian Hospital near Beeramguda. Eight injured workers have so far succumbed at hospitals over the last week. Sixteen workers are still undergoing treatment at various hospitals. A major explosion occurred in the manufacturing plant of Sigachi Industries at Pashamylaram, Patancheru Mandal, Sangareddy district on June 30. The plant manufactures Microcrystalline Cellulose powder, which is used in tablets and capsules as a binding agent. Eight workers are still missing. Personnel from Fire Services, SDRF, HYDRAA and police continued combing through the debris for human remains. The anxious wait for the families of the missing workers continued at the help centre set up for the families of the victims. According to Sigachi Industries, of the 33 injured team members, 14 have recovered and been discharged from the hospital. Of the 143 members present on-site during the time of the accident, 61 are safe, the company statement added. Rescue teams found 44 pieces of human remains at the site, which were sent to the Forensic Science Laboratory (FSL), Hyderabad, for DNA analysis. Authorities have completed the identification process of 38 bodies at the mortuary at the Government Area Hospital, Sangareddy. Sigachi Industries has already announced Rs 1 crore compensation each to the families of the deceased. It also announced that it would bear all the expenditure towards the treatment of the injured and provide them all the support.
Hans India
06-07-2025
- Hans India
Two more die, death toll in Telangana pharma unit blast rises to 42
The death toll in the fire and explosion at Sigachi Industries Ltd's manufacturing unit in Pashamylaram near Hyderabad rose to 42 on Sunday. Two of the injured workers succumbed while undergoing treatment at a hospital in Patancheru on Sunday. Sigachi Industries, in a statement on Sunday night, said that it is saddened to share the loss of two more team members since July 4, taking the death toll to 42. Of the 33 injured team members, 14 have now recovered and been discharged from the hospital, while 18 continue to be under medical attention in various hospitals, it said. Eight team members are still missing. Of the 143 members present on-site during the time of the accident, 61 are safe, the company statement added. Setup in 1989, Sigachi Industries' Pashamylaram plant has been incident-free for 36 years. It is an ISO 45001:2018 certified facility and follows stringent safety and compliance measures. 'Since the time of the accident, we have been coordinating the emergency response, family support, and extending cooperation with the investigation and compliance efforts,' the company said. A major explosion occurred in the manufacturing plant of Sigachi Industries at Pashamylaram, Patancheru Mandal, Sangareddy district on June 30. The plant manufactures Microcrystalline Cellulose powder, which is used in tablets and capsules as a binding agent. Rescue teams found 30 pieces of human remains at the site, and they were sent to the Forensic Science Laboratory (FSL), Hyderabad, for DNA analysis. According to officials at Patancheru Government Hospital, of the 24 DNA samples collected so far, 22 bodies have been identified and handed over to their families. The deceased hailed from Bihar, Odisha, Uttar Pradesh and Andhra Pradesh. Authorities are sending the bodies in ambulances to their native places with police escort. Two police constables are accompanying each body. Personnel from Fire Services, SDRF, HYDRAA and police continued combing through the debris for human remains. Officials said they will continue the operation till they find all remains. Sigachi Industries has already announced Rs 1 crore compensation each to the families of the deceased. It also announced that it would bear all the expenditure towards the treatment of the injured and provide them all the support.
New Indian Express
04-07-2025
- New Indian Express
Sigachi blast debris sifted for DNA traces
10 persons still missing: Officials Officials have confirmed that 10 persons are still unaccounted for. 'Many bodies were mutilated beyond recognition. Some may have been reduced to ashes due to the blast's impact,' said an officer involved in the rescue effort. On Thursday, teams recovered half-burnt cellphones, footwear and other items scattered near the factory. Identity cards of some employees were also found in the debris. For reasons not disclosed by the authorities, mediapersons were barred from entering both the factory site and the open dumping area. It is believed this may be due to a scheduled visit by a four-member expert committee set up to ascertain the cause of the blast. Among the recovered items were the identity card of trainee chemist Syed Rizwana, a driving licence, an ID card and family photographs believed to belong to a machinist. Preliminary blast report in a week, says Sigachi In a statement issued on Thursday, Sigachi Industries Ltd said the investigation to ascertain the cause of the blast is ongoing, with preliminary findings expected within a week. 'We will refrain from commenting on the exact cause of the accident so as not to pre-empt the investigation. For now, we stand by our earlier statement that the blast was not caused by a reactor explosion,' the company said. It added that of the 33 workers injured in the blast, 12 have been discharged and each was given Rs 1 lakh as interim relief. The company said its teams are stationed around the clock at hospitals to offer emotional and logistical support to affected families. Expert panel visits site During a 3.5-hour inspection, the expert committee examined the blast's cause, safety valve function, machinery replacements over 30 years, inspection frequency by the Inspector of Factories and if any safety recommendations were issued.
Hans India
03-07-2025
- Hans India
Sigachi puts deaths at 40, but some still missing
Hyderabad: Two days after the deadly blast at its Pashamylaram plant, Sigachi Industries Ltd on Wednesday put deaths in the accident at 40, but some more employees were said to be still missing. Meanwhile, Telangana Fire Services Department said the factory did not obtain NOC (no objection certificate) from it. In a statement on Wednesday, the company which manufactures microcrystalline cellulose (MCC) powder used in pharmaceutical, food and other industries, announced an ex gratia payment of Rs 1 crore each to the kin of the deceased. Chief Minister A Revanth Reddy, who visited the accident site on Tuesday, announced that the state government would ensure Rs 1 crore compensation for the families of the deceased. The company, in its statement, denied the reports suggesting that the accident was caused by the reactor explosion. 'As we await the results of the investigation, we would like to clarify that the accident was not caused by a reactor explosion at the plant. We will continue to send updates as we receive information from the investigations. And the operations at the plant have been temporarily suspended for 90 days,' the company said. According to the company, the incident resulted in the death of 40 workers and left over 33 injured. 'It is with anguish that we share details of the accident that occurred at the Sigachi Industries facility in Pashamylaram, Telangana on June 30, resulting in the loss of 40 valued team members and one that left over 33 injured. Our thoughts are with those affected by this tragic accident,' it added. The company further said since the time of the accident, we have been coordinating the emergency response, family support, and extending cooperation with the investigation and compliance efforts. 'Sigachi Industries Ltd has committed to an ex gratia compensation of Rs 1 crore to the families of the deceased, while those injured will receive full medical and rehabilitation support,' the company stated. Meanwhile, a senior official of the Telangana Fire Department said the company has not obtained NoC from the department. There were no adequate safety measures, including fire alarms and heat sensors, in the plant. 'It is an online process for obtaining an NOC. Once any firm applies online, a committee will decide and then issue the certificate. This unit has not applied for any NOC and hence we have not issued,' said the official. The Sangareddy police, based on a complaint by a family member of one of the victims, have registered an FIR against the factory management in connection with the explosion under Sections 105, 110 and 117 of BNS. So far, authorities have handed over Rs 1 lakh cash as immediate assistance to the families of 11 victims.
