AstraZeneca Faces NPPA Heat Over Symbicort Pricing, Slapped Rs 60 Crore Showcause Notice

New Delhi: AstraZeneca Pharma India Limited has received a show cause notice from the National Pharmaceutical Pricing Authority (NPPA), which has raised a demand of Rs 60.49 crore plus interest over alleged overcharging on its asthma drug, Symbicort Turbuhaler.

In a filing dated September 12, 2025, to BSE and NSE, the company stated, “Pursuant to Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, we would like to inform that AstraZeneca Pharma India Limited (‘the Company’) has received a Show Cause Notice from National Pharmaceutical Pricing Authority, Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India on September 11, 2025.”

According to the annexure submitted along with the disclosure, NPPA, in its notice, has alleged that the company “has overcharged for batches of ‘Symbicort Turbuhaler’ Inhalation Powder, 60 Doses each, by marketing or manufacturing them at prices above the notified ceiling price subsequent to the relevant price notifications issued for the period from April 2016 to July 2025.”

The company has been given 30 days to submit its response to these allegations.

Also Read:AstraZeneca Faces Setback as CDSCO Panel Rejects Seloken XL Prescribing Update

On the financial impact, AstraZeneca said, “The expected overall financial implication cannot be determined at this stage. The quantum of implication as per the notice is Rs. 60,49,79,385/- (Rupees Sixty Crore Forty Nine Lakh Seventy Nine Thousand Three Hundred and Eighty Five only) plus interest, which the Company disputes.”

The company clarified that no litigation has been filed in any court or tribunal yet, as this is at the show cause stage.

Also Read:AstraZeneca eyes year-end filing for BP drug Baxdrostat

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Telangana to expand organ transplant services at Govt Hospitals

Hyderabad: To strengthen organ transplant services across Telangana, Health Minister C. Damodar Raja Narasimha convened a meeting with senior Health Department officials on Wednesday and issued key directives aimed at expanding and improving transplantation facilities in government hospitals across the State.

During the review meeting, the Minister assessed the functioning of the State-run Jeevandan organ transplant programme. Currently, major transplants are conducted at Nizam’s Institute of Medical Sciences (NIMS), Gandhi Hospital, and Osmania General Hospital in Hyderabad. The Minister directed that organ transplantation surgeries also be conducted at MGM Hospital in Warangal and RIMS in Adilabad. 

Read: Karnataka Plans Organ Transplant Centres in 22 Medical Colleges

To further bolster the organ transplant infrastructure, the Minister directed health officials to prepare detailed proposals for setting up Organ Retrieval Centres in all district headquarters.

Officials also briefed the Minister on the recently adopted Central legislation on organ donation, which has widened the pool of eligible donors. The law now permits grandparents to both donate and receive organs.

The Minister highlighted the importance of operationalising organ swapping. In this process, if a donor in one family is medically incompatible with the intended recipient, and a donor in another family faces a similar situation, both families may exchange donors to ensure that each patient receives a compatible organ, reports the Hindu.  

Also Read:ESIC Hospital Hyderabad perform first in-house cadaver organ retrieval, Gives new life to three

Medical Dialogues had previously reported that over 18,900 organ transplants were performed in 2024 in India – the highest in a single year, said Union Health Minister JP Nadda. He was speaking at the 15th Indian Organ Donation Day organised by the National Organ and Tissue Transplant Organisation (NOTTO) under the aegis of the Directorate General of Health Services, Ministry of Health, at Dr Ambedkar International Centre. Nadda stated that the government is continuously streamlining organ donation and transplant so that more and more citizens can benefit from it.

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NEET PG 2025: Supreme Court postpones hearing by 2 weeks

The Supreme Court of India has postponed the hearing of the National Eligibility-Entrance Test Postgraduate (NEET-PG) 2025 examination-related case hearing.

The top court bench was supposed to take up all the pending matters related to NEET PG transparency today, but the Court has now adjourned the matter for two weeks.

As per the Supreme Court’s official website, the case has been listed for further hearing on 23.09.2025.

Medical Dialogues had earlier reported that a group of NEET-PG 2025 aspirants filed a plea before the Supreme Court challenging the “corrective notice” issued by the National Board of Examinations in Medical Sciences (NBEMS) on August 21.

For more details, check out the full story on the link below:

Supreme Court Delays NEET PG Transparency Case Hearing by Two Weeks

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Delhi High Court seeks UPSC reply on reservation for blind, low vision candidates in Combined Medical Services exam

The Delhi High Court recently sought to know the Union Public Service Commission’s (UPSC) stance on a plea seeking one percent reservation for candidates with blindness and low vision in the Combined Medical Services Examination (CMSE).

While considering the matter, the HC bench comprising Chief Justice Devendra Kumar Upadhyaya and Justice Tushar Rao Degela issued notices to the UPSC, the Department of Personnel and Training (DoPT), the Union Ministry of Health and Family Welfare, and the Department of Empowerment of Persons with Disabilities (DEPwD).

For more details, check out the full story on the link below:

Delhi High Court Seeks UPSC Reply on 1% Blind, low vision Reservation in Combined Medical Services exam

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Fixed Dose Combination of Metformin-Voglibose Now CDSCO Approved

New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has clarified that the fixed-dose combination (FDC) of Voglibose 0.2 mg and Metformin Hydrochloride (SR) 500 mg is an approved formulation, removing it from the earlier list of unapproved FDCs.

In a communication to all State and UT Drugs Controllers, CDSCO referred to its earlier letter dated April 11, 2025, which listed certain FDCs as unapproved.

However, following a review, the regulator confirmed that the Voglibose-Metformin sustained release (SR) combination (listed at S. No. 31 in that letter) had already received CDSCO approval. The matter was also taken note of by the Hon’ble Delhi High Court during a hearing on July 14, 2025.

Consequently, the regulator has now formally excluded this FDC from the unapproved list circulated earlier.

A Voglibose-Metformin SR combination is a medication for type 2 diabetes that helps control high blood sugar levels by combining two drugs with different mechanisms of action: Voglibose, an alpha-glucosidase inhibitor, and Metformin, a biguanide.

Voglibose is an alpha-glucosidase inhibitor indicated in the management of postprandial blood glucose in patients with type II diabetes. Metformin is a biguanide antihyperglycemic used in conjunction with diet and exercise for glycemic control in type 2 diabetes mellitus.

Earlier, the Medical Dialogues Team had reported that the Central Drugs Standard Control Organisation (CDSCO) had issued a stern directive to all State and Union Territory Drug Controllers, instructing them to immediately stop the manufacture and sale of 35 unapproved Fixed Dose Combinations (FDCs), including Metformin Hydrochloride IP (as Prolonged-Release) 500mg and Voglibose IP 0.2mg Tablet.

Also Read:Govt Bans 35 Combination Drugs, See Full List

In its latest communication, the drug regulator noted,

“In this regard, it may be mentioned that one of the FDCs, namely Voglibose 0.2 mg and Metformin HCL (as SR form) 500 mg (at S.No. 31), has been found to be approved by CDSCO and the same was also recorded by the Hon’ble High Court, Delhi, during the hearing on 14.07.2025.
Accordingly, the FDC, i.e., Voglibose 0.2 mg and Metformin Hcl (as SR form) 500 mg (at S.No. 31), stands excluded from the list of unapproved FDCs in the letter dated 11.04.2025.”
Also Read:Glipizide and Metformin FDC – Effective, Safe and Cost-Effective in T2D: Latest Indian Real-World Study
To view the official notice, click the link below:
https://medicaldialogues.in/pdf_upload/corrigendum-to-the-letter-dated-11042025fdc-300737.pdf

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Insufficient Efficacy, Safety Data: CDSCO Panel Rejects Zydus’ Phase III CT Waiver Request for Voclosporin

New Delhi: Citing lack of sufficient efficacy and safety data to prove that the dose requirement in the Indian population is adequate, the Subject Expert Committee (SEC), functioning under the Central Drug Standard Control Organisation (CDSCO), has rejected Zydus Lifesciences’ proposal to conduct a phase III clinical trial of Voclosporin capsule 7.9 mg.

This came after the firm presented a bioequivalence (BE) study report and justification of the Phase III local clinical trial waiver before the committee.

The Committee considered the BE study results. However, the expert panel noted that the data presented with respect to orphan drug status is anecdotal.

Accordingly, the expert panel requested the firm to submit adequate data to substantiate the orphan drug status in the Indian context.

Voclosporin is a calcineurin inhibitor for the treatment of lupus nephritis (LN) in patients diagnosed with systemic lupus erythematosus (SLE).Through the inhibition of calcineurin, voclosporin blocks IL-2 expression and T-cell mediated immune responses, stabilizing podocytes in the kidneys

Lupus nephritis (LN) is a type of glomerulonephritis occurring in patients with systemic lupus erythematosus (SLE). LN is a significant cause of renal failure, morbidity, and death in patients with SLE. Within 10 years of being diagnosed with SLE, 5-20% of those suffering from LN develop end-stage kidney disease, a fatal condition. Early and accurate intervention for LN is important in improving clinical outcomes.

At the recent SEC meeting the expert panel reviewed the bioequivalence (BE) study report and justification of the Phase III local clinical trial waiverher

Furthermore, there are concerns over the safety profile of the drug in the Indian population, as the published study data included Asian patients but not patients from India specifically, the committee noted.

The committee also noted that dose titration of the drug in the Indian population is required.

In view of the above, the committee is of the opinion that there is a lack of sufficient efficacy and safety data to prove that the dose requirement in Indian population is adequate.

In addition, the data on the course of dose titration is also inadequate considering the safety profile of the drug. Therefore, the expert panel stated that the firm is required to submit data proving that there is no substantial ethnic variability.

After detailed deliberation, the committee didn’t agree to Phase-III CT waiver at this stage.

Also Read: Sun Pharma Fails to Secure CDSCO Nod for BE, Phase III Waiver on Sitagliptin, Glimepiride, Metformin FDC

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Torrent Pharma Brand Misused in Online Investment Scam, Fake Portals Promising High Returns Busted

Ahmedabad: A major cyber fraud has come to light after criminals set up fake websites using the name of Torrent Pharmaceuticals to lure investors with promises of unusually high returns.

The scam was exposed when a resident of Surendranagar contacted Torrent Pharma’s official helpline to inquire about “profits” he was promised from one such investment plan. The company’s legal manager, Siddharth Kale, then filed a complaint with Navrangpura police on Thursday.

According to the FIR, the fraudsters created websites such as torrenthealthier.com, torrentbiotech.com, and torrentbiology.com. These portals used the company’s branding and logo to appear legitimate while promoting investment schemes. One advertisement read: “Invest Rs 670 and earn Rs 275 daily for a total of Rs 14,025 in 51 days.”

Also Read: Hyderabad doctor defrauded of over Rs 30 lakh on pretext of marriage

The fake websites were circulated aggressively on social media platforms, including Instagram, YouTube, and Telegram, tricking multiple people into believing they were official Torrent Pharma initiatives. Kale noted in his complaint, “We discovered that many others were being targeted through different numbers, all connected to these fake websites.”

Police stated the accused exploited Torrent’s brand credibility to build trust with victims. A Navrangpura police officer commented, “This is a serious case of identity theft where criminals exploited a trusted brand to trap people.”

A case has been registered under provisions of the Information Technology Act for identity theft, and investigators are working to trace those behind the scam.

Times of India reports that the authorities have issued an alert urging people not to fall prey to fraudulent investment plans that misuse the names of reputed pharmaceutical companies.

Also Read: Fake NRI Quota Scam: ED busts 18,000 fraudulent MBBS Admissions

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MUHS to close application window for fellowship in integrated family medicine programme 2025

Nashik: The Maharashtra University of Health Sciences (MUHS) is going to close the application process for its Fellowship in Integrated Family Medicine course for the academic year 2025-26 tomorrow.

The last date for submitting applications online is September 14.

According to University Registrar Dr Rajendra Bangal, the new fellowship was launched on the concept of Vice Chancellor Lt. Gen. Madhuri Kanitkar (Retd.) to empower primary healthcare and provide skilled services in urban and rural areas.

The course, which prioritises multi-disciplinary education and the Indian knowledge system in line with the National Education Policy, is open to graduates of medicine and Ayurveda.

Also Read:MUHS invites applications for PG health courses 2025, details

Dr Bangal said the students will be given basic skills in primary examination, screening, and treatment for common diseases, gynaecology, paediatrics, primary emergency management, and mental health. The core of the fellowship is to provide proper advice and treatment of both Ayurveda and modern medicine, which will help reduce pressure on major hospitals, quotes UNI

MPGI Dean Dr Mrinal Patil said that training for modern medicine subjects would be imparted to students at Maharashtra Postgraduate Medical Education and Research Institute in Nashik. For Ayurveda subjects, students will be trained at two affiliated Ayurveda colleges, including Ayurved Seva Sangh Ayurveda College and Shri Saptashrungi Ayurveda College. Dr Patil said the one-year fellowship, consisting of 15 modules, will offer experiential education in various hospital departments.

In May, Medical Dialogues had earlier reported that Highlighting major concerns regarding the quality of medical education in Maharashtra, a recent inspection report by the Maharashtra University of Health Sciences (MUHS), Nashik, revealed an acute shortage of teaching faculty in the government medical colleges across the State.

As per the MUHS inspection report, not a single government medical college and hospital in Maharashtra has 100% of its teaching posts filled. In fact, ten GMCs in the State are reportedly functioning with less than half the sanctioned teaching staff,

Also Read:Medical Education Dept Upholds Suspension in BJ Medical College Ragging Case, But students Allege Evidence Suppression

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Alembic Pharma gets USFDA EIR for 2 API facilities in Panelav

Vadodara: Alembic Pharma has announced that the Company has received Establishment Inspection Report (EIR) for the inspection carried out by the US Food and Drug Administration (USFDA) at its API – I & API – II Facility located at Panelav.

The EIR follows the inspection conducted from 26th May, 2025 to 31st May, 2025.

During the inspection, the facilities initially received four observations. Now EIR has been issued.

Read also: Alembic Pharma gets four USFDA observations for Panelav facility

Headquartered in India, Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company. It is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic’s state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA.

Read also: Alembic Pharma gets USFDA nod for Phytonadione Injectable Emulsion for hypoprothrombinemia due to vitamin K deficiency

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India witnessed rise in chronic disease deaths between 2010-2019 amid global decline: The Lancet

A recent study published in The Lancet reveals a worrying trend: the risk of dying from non-communicable diseases (NCDs) has increased in India, unlike the global decline observed in most countries. NCDs such as heart disease, chronic respiratory illnesses, and cancers pose growing challenges, particularly affecting Indian women over 40 and men over 55. Between 2010 and 2019, the probability of dying from NCDs rose to 48.7% for women and 57.9% for men in India, with heart disease and diabetes being the top causes.

This contrasts sharply with declines seen in 152 countries for women and 147 for men worldwide during the same period. Experts point to lifestyle factors, pollution, urbanization, and insufficient healthcare access as key drivers. The study also highlights data quality issues in India, making accurate assessments difficult. The findings underscore urgent need for stronger public health policies, improved healthcare infrastructure, and better data collection to combat rising NCD deaths and protect vulnerable populations in India.

REFERENCE: Bennett, James E et al.; Benchmarking progress in non-communicable diseases: a global analysis of cause-specific mortality from 2001 to 2019; The Lancet, Volume 0, Issue 0; doi: 10.1016/S0140-6736(25)01388-1

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