Nisha Pandey

Why Has ISA Asked Doctors & Hospitals To Stop Prescribing Themis Spinal Anaesthesia?

ISA Issues Advisory To Stop Prescribing Themis Spinal Anaesthesia

The <span>Indian Society of Anaesthesiologists</span> (ISA) has issued an urgent advisory asking anaesthesiologists and hospitals across the country to immediately stop administering <span>Hyperbaric Bupivacaine</span> manufactured by Themis for <span>spinal anaesthesia</span> until further notice. 

<h2>Why Has ISA Issued This Advisory? </h2>

<span>Themis Hyperbaric Bupivacaine</span> is commonly administered as a <a href="https://www.healthandme.com/health-wellness/how-reconstructive-plastic-surgery-transforms-lives-after-trauma-and-cancer-article-154778685" data-type="tilCustomLink">spinal anaesthesia</a>. According to the ISA and the Anaesthesia Patient Safety Association (APSA), the anaesthesia resulted in several suspected adverse events.

These reports were significant enough to warrant an immediate nationwide safety alert, even though the exact cause and frequency of the adverse events have not been revealed yet. 

However, according to Medical Dialogues, the Indian Society of Anaesthesiologists has suspected that the adverse incidents linked to Themis Hyperbaric Bupivacaine were reported at Apollo Hospitals and Yashoda Hospitals. They also said that Adverse Drug Reactions (ADRs) related to the drug have been reported, and an investigation is underway. 

The associations also stressed that the advisory is strictly precautionary and does not imply that the drug is defective or that Themis is responsible for any negligence or unethical practices. 

Also read: <a href="https://www.healthandme.com/health-wellness/national-doctors-day-2026-stronger-protection-against-violence-in-healthcare-need-of-the-hour-say-doctors-article-154816167" data-type="tilCustomLink">National Doctors' Day 2026: Stronger Protection Against Violence In Healthcare Need Of The Hour, Say Doctors </a> 

Apart from stopping the administration of <a href="https://www.healthandme.com/health-news/medical-miracle-uks-first-baby-born-after-womb-transplant-article-151423539" data-type="tilCustomLink">Themis Hyperbaric Bupivacaine</a>, the advisory has also asked hospitals and healthcare facilities to: 

<ul><li>Identify, segregate, and isolate existing stock of Themis Hyperbaric Bupivacaine from clinical use. </li></ul>

<ul><li>Switch to alternative approved brands of hyperbaric bupivacaine.  </li></ul>

<ul><li>Preserve details like batch number, manufacturing date, expiry date, and storage conditions. </li></ul>

<ul><li>Report any suspected adverse events related to the drug to APSA and the relevant regulatory bodies.  </li></ul>

Dr Sherry Mathews, President of the Hyderabad Metro City Branch of the Indian Society of Anaesthesiologists, said, “This is a precautionary advisory issued in the interest of patient safety. Reports of serious adverse events have been received from multiple hospitals, and until the investigation is completed, we have advised doctors to stop using the product.” 

Also read: <a href="https://www.healthandme.com/health-news/are-sea-squirts-the-future-of-skin-cancer-treatment-new-study-says-they-can-kill-melanoma-cells-article-154811663" data-type="tilCustomLink">Are Sea Squirts The Future Of Skin Cancer Treatment? New Study Says They Can Kill Melanoma Cells </a> 

A separate notice issued by the ISA's Hyderabad Metro City Branch directed consultants, resident doctors, anaesthesia technicians and operation theatre staff to immediately stop the use of Themis Bupivacaine for spinal anaesthesia. 

It also said that no ampoules of the product should be used for neuraxial administration until an official clearance is issued. It added that any inadvertent use must be reported to the head of the department without fail. 

The authorities are currently investigating these suspected adverse reactions, particularly their nature and association with the drug.  

<h2>About Themis Hyperbaric Bupivacaine </h2>

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Themis Hyperbaric Bupivacaine, marketed under brand names like Bupicain Heavy, is manufactured by Themis Medicare Limited, a 53-year-old Indian pharmaceutical company.  

It contains Bupivacaine hydrochloride 0.5% (5 mg/mL), a local anaesthetic. It also contains Dextrose, which makes the solution hyperbaric (heavier than cerebrospinal fluid), which helps anaesthesiologists control how the anaesthetic spreads through the spinal canal.  

Hyperbaric bupivacaine is commonly used for: 

<ul><li>Orthopaedic surgeries involving limbs in the lower half </li></ul>

<ul><li>Hip and knee surgeries </li></ul>

<ul><li>Gynaecological surgeries </li></ul>

<ul><li>Other surgeries below the umbilicus  </li></ul>

Hyperbaric bupivacaine is widely trusted for spinal anaesthesia globally. Many pharmaceutical companies manufacture it. The concern raised by the <a href="https://www.healthandme.com/health-wellness/explained-the-critical-role-of-anaesthesia-in-liver-transplant-surgery-article-153992424" data-type="tilCustomLink">Indian Society of Anaesthesiologists</a> is not against the drug, but about one manufacturer's production.

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The Indian Society of Anaesthesiologists (ISA) has issued an urgent advisory asking anaesthesiologists and hospitals across the country to immediately stop administering Hyperbaric Bupivacaine manufactured by Themis for spinal anaesthesia until further notice. Why Has ISA Issued This Advisory? Themis Hyperbaric Bupivacaine is commonly administered as a spinal anaesthesia. According to the ISA and the Anaesthesia Patient Safety Association (APSA), the anaesthesia resulted in several suspected adverse events.  These reports were significant enough to warrant an immediate nationwide safety alert, even though the exact cause and frequency of the adverse events have not been revealed yet. However, according to Medical Dialogues, the Indian Society of Anaesthesiologists has suspected that the adverse incidents linked to Themis Hyperbaric Bupivacaine were reported at Apollo Hospitals and Yashoda Hospitals. They also said that Adverse Drug Reactions (ADRs) related to the drug have been reported, and an investigation is underway. The associations also stressed that the advisory is strictly precautionary and does not imply that the drug is defective or that Themis is responsible for any negligence or unethical practices. Also read: National Doctors' Day 2026: Stronger Protection Against Violence In Healthcare Need Of The Hour, Say Doctors  What Does The Advisory Say?  Apart from stopping the administration of Themis Hyperbaric Bupivacaine, the advisory has also asked hospitals and healthcare facilities to: Identify, segregate, and isolate existing stock of Themis Hyperbaric Bupivacaine from clinical use. Switch to alternative approved brands of hyperbaric bupivacaine.  Preserve details like batch number, manufacturing date, expiry date, and storage conditions. Report any suspected adverse events related to the drug to APSA and the relevant regulatory bodies.  Dr Sherry Mathews, President of the Hyderabad Metro City Branch of the Indian Society of Anaesthesiologists, said, “This is a precautionary advisory issued in the interest of patient safety. Reports of serious adverse events have been received from multiple hospitals, and until the investigation is completed, we have advised doctors to stop using the product.” Also read: Are Sea Squirts The Future Of Skin Cancer Treatment? New Study Says They Can Kill Melanoma Cells  A separate notice issued by the ISA's Hyderabad Metro City Branch directed consultants, resident doctors, anaesthesia technicians and operation theatre staff to immediately stop the use of Themis Bupivacaine for spinal anaesthesia. It also said that no ampoules of the product should be used for neuraxial administration until an official clearance is issued. It added that any inadvertent use must be reported to the head of the department without fail. The authorities are currently investigating these suspected adverse reactions, particularly their nature and association with the drug.  About Themis Hyperbaric Bupivacaine                      Themis Hyperbaric Bupivacaine, marketed under brand names like Bupicain Heavy, is manufactured by Themis Medicare Limited, a 53-year-old Indian pharmaceutical company.  It contains Bupivacaine hydrochloride 0.5% (5 mg/mL), a local anaesthetic. It also contains Dextrose, which makes the solution hyperbaric (heavier than cerebrospinal fluid), which helps anaesthesiologists control how the anaesthetic spreads through the spinal canal.  Hyperbaric bupivacaine is commonly used for: Caesarean sections Orthopaedic surgeries involving limbs in the lower half Hip and knee surgeries Urological procedures Gynaecological surgeries Hernia surgeries Other surgeries below the umbilicus  Hyperbaric bupivacaine is widely trusted for spinal anaesthesia globally. Many pharmaceutical companies manufacture it. The concern raised by the Indian Society of Anaesthesiologists is not against the drug, but about one manufacturer's production.