The West Bengal authorities have halted the operations of Paschim Banga Pharmaceuticals Limited, the producer of the Ringer lactate IV solution. This product is under scrutiny as it is linked to the demise of four expectant mothers at a Ballari district hospital in Karnataka, which occurred during the second week of last month.
In response to these events, West Bengal enforced a cessation of all IV fluid production and other activities at the company, pending further examination. According to Pharmabiz, governmental sources indicated that the company discontinued its operations starting December 10. Rigorous checks are being implemented following joint inspections conducted last week.
A collaborative inspection was performed with officials from the Central Drugs Standard Control Organisation (CDSCO). The findings prompted the government to issue a cessation notice, with investigations actively continuing. While specific details of these ongoing investigations weren’t disclosed, a thorough examination across all aspects is promised.
When queried about the distribution of products produced before the incident, a senior government source confirmed that the supply has been temporarily halted, including the implicated batch of the IV fluid. Diverse inspections by the drug control department are currently underway.
Replying to enquiries about the company’s World Health Organisation certification or adherence to good laboratory practices (GLP), a government source affirmed that Paschim Banga Pharmaceuticals, being an established and reputable entity, meets all necessary certifications and standards. Nevertheless, governmental inspections are ongoing.
The tragic incident took place at Ballari district hospital between November 9 and 11 following the administration of Ringer lactate solution made by Paschim Banga Pharmaceuticals. In response, Karnataka’s government established a four-person committee to investigate the maternal fatalities and called for legal action against the West Bengal company for providing substandard IV solutions. The state also suspended the drug controller, Dr. S Umesh, due to alleged lapses in duty. Karnataka’s health department has contacted the Drug Controller General of India (DCGI) to explore the issue and hold the manufacturer accountable. The IV fluids were procured from Paschim Banga by the Karnataka State Medical Supplies Corporation Limited (KSMSCL).
The Drug Control Officers Association of India (DCO India) criticized the action taken against the drug controller, urging Chief Minister Siddaramaiah for his reinstatement, highlighting that it was done without a thorough investigation. G Koteeswara Rao, DCO India’s president, announced his intent to discuss the matter officially with the Karnataka chief minister as soon as he returns from the USA.