Srinagar: Following adverse reactions to an anaesthetic drug in patients in the Kashmir Valley, the central government has started an “in-depth” investigation into it by deputing its team to the Valley and sought assistance from the Jammu and Kashmir government for a subject expert.
The use of the drug and its adverse reactions is being probed by the Assistant Drugs Controller (India), the Ministry of Health & Family Welfare, the Directorate General of Health Services (DGHS), and the Central Drugs Standard Control Organisation (CDSCO).
The Jammu and Kashmir government has deputed a senior pharmacologist with the ADC tram to assist them in the investigation of the anaesthetic drug, Bupivacaine Hydrochloride Dextrose Injection USP (0.5%) 5 mg/ml, after it created adverse reactions in patients in Sopore and Gandebal hospitals.
“In response to your communication received via email regarding the aforementioned subject, Dr. Sabreen Bashir, Assistant Professor, Department of Pharmacology, Government Medical College, Baramulla, is hereby deputed for the same. Principal Government Medical College, Baramulla," Dr Majid Jahangir, has written to ADC (India) on January 14. The ACD had sought the GMC Baramulla to depute the senior doctor to its team for assistance in the investigation.
Sources told ETV Bharat that the legal team of the Assistant Drug Controller carries out its investigation into such issues where drugs cause adverse reactions in patients.
The Jammu and Kashmir Medical Supplies Corporation Limited (JKMSCL), the government-owned company set up to procure drugs and medical equipment for hospitals, recalled the drug from all its hospitals and healthcentres in December last year after its adverse reaction caused kidney failure, heart-related problems, and neurological diseases among patients in the Valley.
Alarmed by the adverse reactions of the drug, the State Drugs Controller, Drugs and Food Control Organisations, J&K, alerted the Managing Director of Jammu and Kashmir Medical Supplies Corporation Limited (JKMSCL) to recall the anaesthetic drug from all public health centres.
ETV Bharat learnt from sources that two batches of Bupivacaine Hydrochloride in Dextrose Inj USP (0.5%), with manufacturing dates of April and May 2024 and an expiry date of 2026, manufactured by M/s Aishwarya Healthcare Limited, Samardung, Lower Kabrey Block, South Sikkim, were “put on hold, recalled, and lifted” by the State Drugs Controller on 24 December last year for test/analysis and were referred to a drug testing laboratory for framing of legal opinion.
The State Drug Controller, in a letter to MD, JKMSCL, on December 27 last year, stated, “As an abundant precaution, you are requested to recall all medicinal preparations (Category: Injectables) Mfd By & Mktd by: M/s Aishwarya Healthcare Limited, Samardung, Lower Kabrey Block, South Sikkim-737137 (JKMSCL Supply) till the investigations in the matter(s) are completed.” The letter was accessed by ETV Bharat.
The issue was flagged last year in December by doctors in Sopore and Ganderbal hospitals after the drug infusion in patients caused adverse reactions in them.
Officials in JKMSCL had told ETV Bharat that the drug was sent for retesting to different laboratories in the country. “The reports of the samples are yet to arrive from these labs,” an official of the JKMSCL told ETV Bharat.
Read More
