The Jammu and Kashmir government has ordered all hospitals in the state to stop using Bupivacaine Hydrochloride, an anaesthetic drug supplied by J&K Medical Supplies Corporation Limited (JKMSCL). The decision was taken after severe complications were reported among patients who had been administered the drug, including kidney failure, bradycardia, and neurological disorders.

Key Points
Drug Linked to Severe Medical Complications:
Aishwariya Healthcare-manufactured Bupivacaine Hydrochloride in Dextrose Injection, Batch No: AA4022, has been issued a stop use notice following an incident that included complications such as:

• severe hypotension and bradycardia during spinal anaesthesia, acute renal failure in the post-operative period.

• severe headaches, palpitations, and dyspnea in patients who were recovering, and at least one serious neurological complication that necessitated a referral to a tertiary care hospital.

Stop use notice issued:

• Block Medical Officer Sopore, Dr. Zulfikar Nabi and the Chief Medical Officer Baramulla brought this to the notice of the higher authorities.

• Medical Officer (Quality Control) JKMSCL issued a notice to all Regional Drug Warehouses on 23 December that use of the affected batch of the drug be stopped forthwith.

Testing and Quality Concerns:

• Deputy General Manager, JKMSCL, Dr. Qazi Qamar confirmed that a batch of the drug had been sent for retesting.

• If retesting results classified the batch as not being of standard quality, this drug would be banned from ever being sold.

• The preliminary quality checks of the batch of the drug have already been tested in empanelled laboratories, but complications emerging from its usage have sent alarms.

Oversight by the government on drug procurement:

• A Drug Committee comprising senior officials like principals of medical colleges, directors of health services, and other important persons approves the drugs procured by JKMSCL.

• The various checks that take place in the process make it challenging to ensure the quality and safety of drugs procured in large numbers.

Impact and Implications:

• The health issues faced by the patients in J&K are a matter of great concern regarding the strictness of drug quality checks and lapse in monitoring post-market drug effects.

• Immediate halting of the drug's use reflects the administration's commitment to patient safety, but it also highlights the need for robust pharmacovigilance in government-supplied medications.

The swift action by JKMSCL and health authorities to address adverse reactions underscores the critical importance of vigilance in drug administration. As investigations continue, the incident serves as a reminder of the urgent need for rigorous oversight and quality assurance in public health systems.