Allahabad HC Flags Procedural Flaws, Quashes Drugs Case Summons Against Pharma Firm

New Delhi: The Allahabad High Court has quashed the summoning order issued against Associated Biotech and its directors in a drugs (Amoxycillin) quality case, holding that the trial court failed to comply with statutory safeguards and passed a “cryptic and unreasoned” order.

The judgment was delivered by Justice Vikas Budhwar, who examined whether the Special Judge (Drugs and Cosmetics), Aligarh, had adhered to the requirements of the Drugs and Cosmetics Act and the Bharatiya Nagarik Suraksha Sanhita (BNSS), 2023, while summoning the accused.

The case stemmed from an inspection carried out at Vimla Medical Store, Aligarh on August 23, 2023. A sample of Amoxycillin was drawn and later tested by the Government Analyst, Lucknow, who reported on October 13, 2023, that the drug did not conform to standards of the Indian Pharmacopoeia. Subsequent inquiry revealed that the medicines had been supplied through M/s Somkee India Pvt. Ltd., which had procured them from M/s Associated Biotech. A complaint was filed on September 23, 2024, and on November 15, 2024, the Special Judge summoned the company and its directors under Sections 18 and 27 of the Drugs and Cosmetics Act.

Challenging the summoning order, the applicants contended that:

  • The order was non-speaking, unreasoned, and failed to even record the complainant’s case.
  • Their statutory right under Section 25 of the Drugs and Cosmetics Act to seek retesting from a central laboratory was denied.
  • The Sessions Court lacked jurisdiction to summon them without a committal order from the Magistrate under Section 193 CrPC/213 BNSS.
  • Since the complaint was filed after BNSS-2023 came into force, they were entitled to be heard at the pre-cognizance stage under Section 223(1) BNSS.

The Additional Government Advocate, Sri Pankaj Srivastava, argued that prima facie offenses were indeed disclosed from the complaint. However, he conceded that the summoning order did not pass the test of legality as laid down by the Supreme Court and therefore should be set aside and the matter remitted back for fresh consideration.

The High Court found that the summoning order of November 15, 2024:

  • Did not mention whether the accused had been given a chance to be heard as required under Section 223(1) BNSS.
  • Was cryptic, lacking reasons, and failed to reflect even the basic case of the complainant.
  • Violated the standards set by the Supreme Court in JM Laboratories v. State of Andhra Pradesh (2025 INSC 127) and other rulings, which require speaking and reasoned orders while issuing summons.

Final Ruling:

Quashing the order, Justice Budhwar ruled;

“The order dated 15.11.2024 passed in Complaint Case No. 3654 of 2024 summoning the applicants under Section 18 and 27 of the Drugs and Cosmetics Act passed by learned Additional Sessions Judge, VIII, Aligarh is set aside; the matter stands remitted back to the court below to pass a fresh order.”

To view the official judgement, click the link below:

Powered by WPeMatico

Laser correction for short-sightedness is safe and effective for older teenagers: Study

Denmark: A major study of laser correction for short-sightedness shows that the procedure is as safe and effective in older teenagers as it is in adults, according to research presented today (Tuesday) at the 43rd Congress of the European Society of Cataract and Refractive Surgeons (ESCRS).

Short-sightedness, or myopia, affects around a third of children and teenagers and research suggests that it is becoming more common.

A laser treatment, called photorefractive keratectomy (PRK), is widely used to treat myopia in adults but questions remain over its use in teenagers.

The new study was presented by Dr Avinoam Shye, from the Department of Ophthalmology at Rambam Health Care Campus in Haifa, Israel. He said: “Some doctors worry that the eyes of teenagers may still be changing or that their eyes might respond differently to healing after laser treatment, increasing the risk of side effects. However, in certain situations teenagers do want permanent solutions to their myopia.

“We noticed that despite these concerns, many teenagers aged 17 or 18 were getting excellent results. That led us to study whether PRK is truly a safe and effective option for this age group.”

The study included a group of patients with myopia who were treated with PRK at Care-Vision Laser Centers, Tel Aviv, Israel, between January 2010 and June 2024, with 65,211 eyes treated in total.

PRK involves using a laser to remove tissue from the cornea, the clear, dome-shaped layer that covers the pupil and iris. The cornea acts as window for light to enter the eye, so reshaping the cornea can improve the way light enters the eye and treat vision problems including myopia.

Dr Shye and his colleagues grouped the patients according to their age, so they could compare the effects of laser treatment in those aged 17 to 18 with those aged 19 to 40.

They found that the outcomes for older teenagers were as good or even better than they were for adults. Around 64% of the teenagers’ eyes achieved 20/20 vision (normal visual acuity), compared with 59% of adult eyes.

The proportion of eyes that required a second treatment was very low (0.41%) in both groups. Complications such as hazy vision or weakening of the cornea (ectasia) were also very rare in both groups.

Dr Shye said: “This is by far the largest study of PRK in teenagers, and this large sample size means the findings are very reliable. A limitation is that it is a retrospective study, meaning we analysed data that were already collected, rather than setting up a new trial from the beginning.

“The research suggests that for well-screened teenagers with stable myopia, PRK could be a safe and effective option, especially when contact lenses or glasses are not ideal. These findings may support expanding the criteria for offering PRK to selected teenagers. Age alone should not disqualify a motivated and well-suited teenager from having this treatment.”

The researchers will continue to monitor the teenagers who received laser treatment to check for very late complications or changes in vision.

Professor Thomas Kohnen is Chair of the ESCRS Publication Committee, Director of the Department of Ophthalmology at Goethe University Frankfurt, Germany, and was not involved in the research. He said: “Short sightedness is increasing worldwide in children and teenagers, and it can worsen up to the age of 30. In children, short sightedness is treated with glasses or contact lenses, while adults can choose to have laser treatment to correct their vision.

“This large cohort study of photorefractive keratectomy for treating short sightedness shows that the procedure is safe and effective for older teenagers, suggesting that this could be an alternative option to glasses or contact lenses for some young people.”

Powered by WPeMatico

Negligence during surgery, missing notes: NCDRC slams hospital, orders Rs 5 lakh compensation

New Delhi: The National Consumer Disputes Redressal Commission (NCDRC) recently upheld the charges of medical negligence against a Karnataka-based hospital, which was told to pay Rs 5 lakh compensation to a patient.

Previously, while considering the matter, the District Commission had held the neurosurgeon negligent and directed him to pay Rs 15 lakh compensation to the patient, whereas the hospital had been slapped with Rs 5 lakh compensation.

While considering the hospital’s appeal against the district and state consumer court verdicts, the Apex Consumer Court opined that the District Commission order was fully justified in holding the hospital negligent. NCDRC observed that the discharge summary was incomplete, and operation notes were not provided despite an RTI appeal. 

The history of the case goes back to 2007, when a spinal surgery on the patient was performed at the treating hospital by a neurosurgeon. While performing the surgery, a metallic screw was utilised, and a minute fragment of the said screw seemed to have scraped during the performance of the surgery, which got lodged somewhere around the area of surgery.

Later, the patient discovered that such a metallic object was left behind when he faced some complications. After inquiring into the matter and obtaining some details, he filed a consumer complaint before the Dakshina Kannada District Consumer Disputes Redressal Commission, Mangalore, Karnataka.

The District Commission, through an elaborate order dated 29.10.2010, held the surgeon liable for negligence on a clear finding that the piece of metal that was left behind during the process of surgery was an act of gross negligence. Accordingly, the District Consumer Court allowed the complaint and directed the surgeon to pay Rs 15 lakh with interest @ 9% from the date of the complaint till the date of payment.

Further, the District Commission also held the petitioner hospital liable for not informing the patient/complainant about the said lapse in the procedure. Apart from this, the Commission held that the hospital had issued a discharge summary cryptically without mentioning the aforesaid lapse, which stood admitted in view of the evidence on record and the admissions made by the doctors themselves.

It was also held that the operation notes had not been provided and the complainant had to file applications under the Right to Information Act and it was much later when the complainant went to his work in Dubai, he experienced pain, whereafter he got himself examined and the radiological reports confirmed the lodging of the splinter metal in his body that was deliberately not informed by the hospital. Accordingly, the hospital was also held liable and was directed to pay a sum of Rs 5.00 Lakhs together with interest.

The hospital and the neurosurgeon challenged the District Commission’s order before the Karnataka State Consumer Court, which upheld the District Commission’s order and dismissed the appeals.

Consequently, the treating hospital filed a revision petition before the NCDRC bench. The counsel for the hospital argued that the hospital was a charitable institution and, therefore, was not liable for any deficiency. It was also submitted that the District Commission had already recorded a finding that even the surgical instruments that were utilised by the doctor during the surgery were not supplied by the hospital and belonged to the doctor alone. Therefore, any negligence by the doctor while performing the surgery could not be saddled as a deficiency against the hospital, argued the top consumer court.

Further, the counsel submitted that all documents had been provided to the complainant, and in fact, there was no evidence to draw any inference of deficiency against the hospital. 

However, the counsel for the complainant urged that the deficiency regarding non-supply of the documents, providing a deficit discharge summary without mentioning the negligence of the doctors, was a deficiency in service.

After going through the District Commission’s orders, as well as the findings recorded by it, the Commission observed that the information regarding the presence of a metallic object that was left behind during surgery was not mentioned in the discharge summary that was admittedly issued by the petitioner hospital.

At this outset, the Commission observed,

“The discharge summary is cryptic and without any indication of the fact of the presence of the metallic object which stood admitted and was left inside the body of the patient. The hospital had the custody of the operation notes and there can be no two opinion that the said notes did indicate the presence of a cut-piece surgical instrument inside the body. Not only this, the patient had been taken inside the operation theatre for the second time and it was the evidence of the doctor before the District Commission that he had informed the complainant/respondent no.1 (patient) about the presence of the metal inside the body immediately after the operation with an assurance that it will not have any side effect. It is therefore evident that the fact of the presence of the metallic object stood admitted by the surgeon being present in the body of the complainant/respondent no.1 and its mention in the operation notes which were in the custody of the petitioner/hospital. The petitioner hospital has been unable to give any explanation as to why the said fact was omitted from being mentioned in the discharge summary of the hospital.”

Opining that the District Commission’s order was justified, the Apex Consumer Court held,

“In our opinion, the District Commission was fully justified in drawing an adverse inference against the petitioner hospital on that count. The negligence of the petitioner hospital in providing a discharge summary which was clearly incomplete and which withheld a material fact affecting the health of the complainant/respondent no.1 was therefore a gross negligence. Not only this, the operation notes were also provided after an attempt was made under the Right to Information Act. This also, in our opinion, was a deficiency on which the District Commission has rightly arrived at a correct conclusion. The findings of the District Commission have been therefore appropriately confirmed in appeals and these findings of fact do not suffer from any perversity or non-consideration of relevant material.”

With this observation, the NCDRC dismissed the review petition.

To view the order, click on the link below:

https://medicaldialogues.in/pdf_upload/ncdrc-upholds-compensation-301953.pdf

Also Read: Nerve injury due to negligence in spinal anaesthesia: Consumer court slaps Rs 3.2 lakh compensation on hospital, doctors

Powered by WPeMatico

Lactate IV infusion found to trick the body into releasing a hormone behind that post-workout brain boost

Science has confirmed what sports lovers have always known from experience: exercise is good for the brain. It increases blood flow, inhibits stress hormones, and stimulates the release of ‘feel good’ endorphins. One way by which exercise is thought to yield these benefits on the brain is through a chain of processes that ultimately results in the release of the hormone BDNF. Produced by the liver, brain, skeletal muscle, and fat tissue, BDNF is known to promote the growth, survival, and maintenance of nerve cells.

Powered by WPeMatico

Lactate IV infusion found to trick the body into releasing a hormone behind that post-workout brain boost

Science has confirmed what sports lovers have always known from experience: exercise is good for the brain. It increases blood flow, inhibits stress hormones, and stimulates the release of ‘feel good’ endorphins. One way by which exercise is thought to yield these benefits on the brain is through a chain of processes that ultimately results in the release of the hormone BDNF. Produced by the liver, brain, skeletal muscle, and fat tissue, BDNF is known to promote the growth, survival, and maintenance of nerve cells.

Powered by WPeMatico

Global study shows drug shortages can become a systemic issue for millions

In the largest study of its kind, new global research has revealed that drug shortages can become a systemic issue affecting the health of millions of patients and impacting health care systems in Europe and North America.

Powered by WPeMatico

Experts outline health care, policy and social changes needed to make the most of Alzheimer’s treatment breakthroughs

The approval of new antibody medications for Alzheimer’s disease—lecanemab and donanemab—and diagnostic tests in the blood mark the beginning of a new era in Alzheimer’s disease diagnosis and treatment. However, without rapid reform in health care systems, public policy, and societal attitudes, their potential will not be fully realized, argue 40 leading Alzheimer’s disease experts in The Lancet Series on Alzheimer’s disease.

Powered by WPeMatico

Patient outcomes worsen in hospitals acquired by private equity firms

A difference-in-differences analysis examined hospital staffing and patient outcomes after private equity acquisition, focusing on emergency departments (EDs) and intensive care units (ICUs).

Powered by WPeMatico

New PET tracer enables same-day imaging of triple-negative breast and urothelial cancers

A promising new PET tracer can visualize a protein that is commonly overexpressed in triple-negative breast and urothelial bladder cancers within four hours, according to research published in the Journal of Nuclear Medicine. This same-day imaging approach has the potential to save valuable time in guiding treatment decisions and reduce unnecessary exposure to ineffective therapies.

Powered by WPeMatico

Simple Airway Device Slashes Hypoxemia Risk During Endoscopy: Study Shows

China: Using a simple nasopharyngeal airway before painless gastrointestinal endoscopy can dramatically cut the risk of dangerous oxygen drops in obese outpatients, new research in Respiratory Medicine has reported. 

The prospective randomized trial found that inserting the soft airway tube ahead of the procedure nearly eliminated hypoxemia—episodes of low blood oxygen—without causing extra discomfort or complications.
The study compared standard practice with the use of a prophylactic nasopharyngeal airway in adults with obesity scheduled for outpatient endoscopy under intravenous sedation. Hypoxemia is a common concern during these procedures because sedative medications can relax upper airway muscles and narrow breathing passages, a problem made worse by excess weight. Researchers set out to see whether inserting a small, flexible airway through the nose before starting the endoscopy could prevent those episodes.
The trial enrolled 174 participants who were randomly assigned to either receive a nasopharyngeal airway before painless gastrointestinal endoscopy or undergo the procedure without it.
The study revealed the following notable findings:
  • Only 2.3% of the 88 patients fitted with the device experienced hypoxemia, compared with 37.2% of the 86 patients in the control group, a difference described as striking by the authors.
  • Oxygen saturation after the procedure remained higher in the airway group, with no differences noted in vital signs during insertion or removal.
  • Airway placement was quick and straightforward: of 87 successful insertions, 69 were completed in under five seconds and 18 within ten seconds, with only one patient needing a second attempt.
  • Discomfort was minimal, as every participant reported a visual analog pain score of 3 or less.
  • Both endoscopists and anesthesiologists reported higher satisfaction when the airway was used, citing fewer interruptions and smoother procedures.
  • The additional step did not increase the risk of gastrointestinal complications or other adverse events, and no serious side effects were reported, confirming the device’s safety profile.
  • Although arterial blood gas analysis was not performed and standard non-invasive monitoring was used instead, the randomized design and consistent results strengthen confidence in the findings.
Given its low cost, speed of placement, and strong protective effect, the nasopharyngeal airway may represent an easy upgrade to current sedation protocols for obese patients. Keeping the upper airway open and maintaining oxygen flow reduces the likelihood of sudden desaturation and the need to pause or abort procedures.
The investigators conclude that routine use of a prophylactic nasopharyngeal airway offers a practical, well-tolerated method to enhance safety in outpatient gastrointestinal endoscopy for individuals with obesity. Broader adoption, they suggest, could lower complication rates and improve overall patient and clinician satisfaction without adding significant time or expense to the procedure.
Reference:
Peng, Y., Deng, L., Dai, S., Xiang, D., Zhou, R., Zhang, X., Tian, L., Zhou, Y., Chen, W., & Zhou, J. (2025). Nasopharyngeal airway relieves upper airway obstruction to alleviate hypoxemia during painless gastrointestinal endoscopy for obese outpatients: A prospective randomized controlled trial. Respiratory Medicine, 108359. https://doi.org/10.1016/j.rmed.2025.108359

Powered by WPeMatico