Roche receives USFDA clearance with CLIA waiver for cobas liat sexually transmitted infection multiplex assay panels

Basel: Roche has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance and Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver for its cobas liat sexually transmitted infection (STI) multiplex assay panels. These panels, including tests for chlamydia and gonorrhea (CT/NG) and chlamydia, gonorrhea and Mycoplasma genitalium (CT/NG/MG), enable clinicians to diagnose and differentiate between multiple STIs with a single sample. These tests will be exclusively available in the U.S. market in the coming months, with commercialisation under CE mark expected to follow shortly.

“Rapid molecular point-of-care testing can revolutionise the clinical management of STIs in decentralised and community-based healthcare settings, enabling informed treatment strategies, better health outcomes for patients, and contain further spread by providing timely diagnosis.” said Matt Sause, CEO Roche Diagnostics.

More than 1 million people worldwide acquire an STI every day. Common STIs often present overlapping symptoms and can frequently be asymptomatic, making diagnosis challenging, when relying solely on symptoms. Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are among the most prevalent STIs. If untreated, these infections can lead to serious health complications, including pelvic inflammatory disease (PID), urethritis, ectopic pregnancy, infertility, and an increased risk of HIV infection.1 Additionally, Mycoplasma genitalium (MG) is an emerging sexually transmitted pathogen affecting both males and females, with untreated infections resulting in severe health issues such as PID and infertility.

The cobas liat CT/NG and cobas liat CT/NG/MG STI assay tests further expand and complement Roche’s broad portfolio of lab-level solutions to help diagnose and address patients’ needs at the point of care. The test-to-treat approach can help combat potentially high loss to follow-up rates, making treatment more likely. Testing at the point of care can help reduce unnecessary antibiotic usage, facilitate targeted treatment strategies, improve healthcare efficiency and cost, and ultimately enhance the patients’ short and long-term health outcomes.

The cobas liat system utilises gold-standard PCR technology to provide results in 20 minutes or less. The cobas liat assays are CLIA waived*, enabling healthcare professionals to perform molecular testing in a variety of near-patient settings with speed, reliability and minimal training. The cobas liat system is a closed system, reducing contamination risks and enhancing the reliability of results. The cobas liat CT/NG and CT/NG/MG assays complement existing tests for the cobas liat system. These include singleplex and multiplex assays for a variety of pathogens such as SARS-CoV-2, influenza A, influenza B, Strep A., and C. diff. These assays are easily added to a testing programme by connecting the cobas liat system to cobas infinity edge to remotely schedule software and assay script updates, and to provide remote troubleshooting in all patient-care settings. Connected cobas liat instruments streamline testing workflow and reduce instrument maintenance time. Assays for other infectious diseases are currently in development. The cobas liat system is commercially available in select markets.

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Strides Pharma debuts with stellar ESG rating of 76/100 in S&P Global CSA 2024

Bangalore: Strides Pharma Science Limited has announced that the
Company has received an ESG score of 76/100 and CSA score of 75/100 in the Corporate Sustainability
Assessment (CSA) Annual Review (vide report dated 20th January, 2025) for its debut submission.

With this achievement, Strides has secured a
position in the 94th percentile among its peers in the DRG Global Pharmaceuticals industry. On Customer
Relations, the Company achieved 100th percentile. “The Company has demonstrated exceptional performance by achieving an ESG score of 76/100, driven by
the Social and Goverence Dimensions, which carry the highest weightage, securing the 97th percentile. In
Environment dimension, the Company attained a commendable 87th percentile,” Strides stated.

Arun Kumar, Founder & Executive Chairperson, and Mr. Badree Komandur, MD & Group CEO,
commented, “We are proud to announce that we have received an industry-leading ESG rating from S&P
Global on our debut submission. This accomplishment underscores our unwavering commitment to
sustainability. It validates our dedication to responsible business practices and reinforces our ongoing efforts
to integrate ESG principles across our business operations. As we continue to strengthen and expand our
ESG initiatives, we remain focused on creating a lasting, positive impact for all our stakeholders.”

“This outstanding performance is underpinned by key material drivers, including Contribution to Societal
Healthcare, Human Capital Management, and Corporate Governance, which continue to be pivotal in
shaping the company’s sustainability excellence. We remain committed to maintaining and further
enhancing our ESG performance, striving to set new benchmarks in sustainability and responsible business
practices in the years ahead,” the Company added.

Strides, a global pharmaceutical company headquartered in Bengaluru, India, is listed on the BSE Limited
(532531) and National Stock Exchange of India Limited (STAR). The Company mainly operates in the
regulated markets and has an “in Africa for Africa” strategy and an institutional business to service donorfunded markets. The Company’s global manufacturing sites are located in India (Chennai, Puducherry, and
two locations in Bengaluru), Italy (Milan), Kenya (Nairobi), and the United States (New York). The Company
focuses on “difficult to manufacture” products sold in over 100 countries.

Read also: Strides Pharma Science arm gets USFDA nod for Acetaminophen and Ibuprofen Tablets

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Doctors’ Association urges CM to grant Govt Job to wife of doctor who died during COVID-19

Chennai: The Legal Coordination Committee for Government Doctors (LCC) has urged Chief Minister M.K. Stalin to fulfil a longstanding promise and announce a government job for the widow of Dr Vivekanandan, a government doctor who tragically passed away while serving during the COVID-19 pandemic. The appeal comes after a prolonged delay in providing justice and relief to the grieving family, despite previous assurances from the state government.

Medical Dialogues had earlier reported that The Indian Medical Association (IMA) has written to Prime Minister Narendra Modi asking that all doctors who have died of COVID-19 be treated at par with martyrs of the armed forces, and their dependents be provided government jobs in accordance with their qualifications.

Also Read: IMA asks Govt job for surviving spouse, dependents of doctors losing lives in COVID fight, writes to PM Modi

Dr. Vivekanandan, who died on January 26, was one of the many healthcare workers who lost their lives while serving on the frontlines of the pandemic. As the leader of the opposition in the previous government, current Chief Minister M.K. Stalin had called on the then administration to provide Rs. 1 crore in relief to the families of government doctors who died while serving during the pandemic. However, LCC president S. Perumal Pillai pointed out that under Stalin’s government, no financial relief had been given to the families of deceased doctors.

Dr. Vivekanandan’s widow, along with her children, has repeatedly sought a government job as promised by the Health Minister Ma. Subramanian. Pillai also highlighted an ironic situation where the government has announced jobs for individuals recovering from alcohol addiction, yet no relief or support has been provided to the family of a deceased doctor who sacrificed his life during the pandemic.

Despite the High Court’s order to provide a job to the widow, the family has yet to receive justice. During the recent Assembly session, BJP MLA Vanathi Srinivasan urged the government to provide a job for her.

In response, Health Minister Subramanian claimed that Dr Vivekanandan had two wives and that family disputes were complicating the matter.

Also Read: Covid-19 Death: Delhi CM provides Rs 1 crore assistance to kin of doctor, assures Govt job for spouse

Speaking to The Hindu, Pillai said, “Such a dishonoring baseless statement, along with failure to honor the promise made, has deeply hurt the already grieving family.”

The LCC has now called on the Chief Minister to take immediate action. Additionally, the LCC is also seeking the implementation of pay band 4 at 12 years of service for government doctors, as part of broader efforts to ensure fairness and respect for those working on the front lines.

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HC relief to gynaecologist, says Investigating Officers Should Be Extra Cautious Before Implicating Doctors under POCSO Act

Ernakulam: Highlighting the mental trauma that the doctors have to face for falsely being implicated as accused under the POCSO Act for failing to report the commission of a crime against a minor, the Kerala High Court has asked the investigating officers to be extra cautious. With this, the bench granted relief to the gyanceologist.

The Court issued this direction after noting that doctors got arrayed as accused with Section 19 of the POCSO Act mechanically, without applying the mind of the investigating officer.

Terming it to be “absolute injustice”, the HC bench highlighted how it puts the doctors under mental trauma of criminal prosecution, ultimately preventing them from discharging their duties promptly.

“…it is inevitable to observe that I had occasion to come across many cases where doctors being inveigled into criminal cases under the POCSO Act within the sweep of Section 21 r/w Section 19, urging that there was failure to report the crime as stipulated in Section 19. In this regard, it is high time to address on this issue. Doctors are bestowed with the duty to save the life of the patients and have been busily engaged in their vow. Therefore, while implicating doctors in criminal cases with the aid of Section 19 of the POCSO Act, the investigating officer must apply his mind from the materials collected and form an unbiased opinion to see, prima facie, that there is deliberate intention or omission to report the crime. Unless the said deliberate intention not divulged from the records, unwanted implication of doctors in crime shall be avoided,” observed the HC bench comprising Justice A. Badharudeen.

“It is noticed that doctors got arrayed as accused with the aid of Section 19 of the POCSO Act mechanically, without applying the mind of the investigating officer. This is nothing but absolute injustice and putting the doctors under mental trauma of criminal prosecution and the same would stand as a rider for the doctors in doing their duties promptly,” the bench further noted.

Also Read: HC grants relief to doctor accused under POSCO Act for not informing police about offence within time-limit, says Doctors should get reasonable time

“Therefore, the investigating officers are specifically directed to be more cautious when doctors’ involvement is doubted in POCSO offences and implication of doctors in criminal cases under the POCSO Act shall be avoided unless relevant materials do not justify the same,” the Court ordered.

While Section 19 of the POCSO Act puts a legal obligation on a person to inform the relevant authorities when there is knowledge that an offence under the POCSO Act has been committed, Section 21 deals with the punishment for failing to report or record a sexual offence.

The High Court made these observations while considering a case alleging that a minor was subjected to repeated sexual intercourse by the first accused. In this case, the petitioner, who is a 68-year-old gynaecologist was arrayed as another accused for allegedly failing to report about the pregnancy of the minor to the police.

It was further alleged that after examining the minor, when the doctor came to know about the pregnancy, she conducted an abortion without the minor’s consent. Accordingly, the doctor was booked for committing offences under Section 19 (reporting of offences), 21 (punishment for failure to report or record a case) of the POCSO Act and Sections 312 (causing miscarriage), 313 (causing miscarriage without woman’s consent) of the IPC.

Challenging this, the doctor approached the High Court and submitted that it was the victim’s parents who brought her to the doctor in an advanced stage of pregnancy. Further, the doctor claimed that she was also informed that the girl was 18 years old and married. Further, the doctor clarified that she had no reason to suspect that it was a POCSO case. 

Apart from this, the doctor also submitted that the victim was brought with severe bleeding with symptoms of a possible miscarriage and as a doctor, her primary aim was to save the minor’s life, without intentionally causing an abortion. Further, the doctor claimed that the minor’s parents as well as the minor herself, who posed as a major, consented to the treatment.

While adjudicating the issue, the Court referred to the Supreme Court‘s order in the case of Tessy Jose & Ors. v. State of Kerala, where the Court had held that mere likelihood of suspicion was not sufficient but there must be grave suspicion that the doctors knowingly failed to report the POCSO offence. In that particular case, the Apex Court had exonerated the accused doctors, who were booked for committing an offence under Section 19 of the POCSO Act, by stating that it was not their obligation to investigate and gather knowledge regarding the victim’s age.

Relying on this, the HC bench, after perusing the consultation and hospital records, noted that the victim’s age was mentioned as 18 years. Therefore, the Court stated that the doctor did not deliberately fail to inform the police as she had no occasion to find that the victim was a minor.

“As a natural phenomenon when a patient meets a doctor, the doctor would act upon the age disclosed by her and no rowing enquiry in this regard is mandated by law…. Fastening criminal liability under Section 21 of the POCSO Act r/w Section 19(1) cannot be based on irrelevant materials and subsequent facts brought into, for which the accused has no nexus…There is no need to scrabble about the age rather than believing it for the purpose of proceeding further,” noted the Court.

“Regarding the offences under Sections 312 and 313 of IPC, it is discernible from the statement of the victim and the witnesses that the victim reached the hospital with profused bleeding and on the verge of miscarriage. Then the doctor had given treatment to complete the process of miscarriage with a bona fide attempt to save the victim. Thus, prima facie, offences under Sections 312 and 313 of IPC also would not attract, against the petitioner. In such view of the matter, prosecution against the petitioner is liable to be quashed,” the Court observed.

To view the order, click on the link below:

https://medicaldialogues.in/pdf_upload/kerala-hc-pocso-270840.pdf

Also Read: HC quashes FIR against Gynaecologist for not reporting POCSO Case: Doctors Not Liable for Verifying Victim’s Age

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NEET PG- Hind Institute of Medical Sciences lowers fee for Non-Clinical Depts, check details

Uttar Pradesh- Through a letter, the Hind Institute of Medical Sciences (HIMS) has notified regarding charging less tuition fees for non-clinical departments. The HIMS informed about the decision through a letter to the Uttar Pradesh Director General Medical Education and Training (UPDGME).

UPDGME published the said notice regarding the fee to be charged from the candidates under UP National Eligibility and Entrance Test-Postgraduate (NEET PG) for the academic year 2024 seeking admissions at HIMS

According to the letter, HIMS has informed UPDGME that the institute had earlier agreed to charge lower tuition fees than the government-prescribed tuition fees for clinical departments. Additionally, tuition fees for the non-clinical department courses can also be charged less.

Also Read: UP DGME Releases Revised Schedule for Round 3 NEET PG Counselling, details

HIMS mentioned the list of courses in which the institute is going to charge less tuition fees. According to the list, there are a total of 8 subjects, including Pathology, Community Medicine and Microbiology which have tuition fees of Rs 6,00,000 and Anatomy, Physiology, Biochemistry, Forensic Medicine and Pharmacology have no tuition fees.

The details are as follows-

S.NO

BRANCH

TUITION FEES

1

PATHOLOGY

6,00,000

2

ANATOMY.

00

3

PHYSIOLOGY.

00

4

BIOCHEMISTRY.

00

5

COMMUNITY MEDICINE.

6,00,000

6

FORENSIC MEDICINE.

00

7

MICROBIOLOGY.

6,00,000

8

PHARMACOLOGY.

00

The Department of Medical Education plays a pivotal role in developing medical and para-medical personnel to cater to the state’s health needs. The department also has a role to play in establishing and maintaining well-equipped teaching institutions, which are the premier referral centres from peripheral hospitals. Research is another area of activity for the medical education department. The directorate facilitates comprehensive medical and dental education via various medical, dental and paramedical colleges in the state of Uttar Pradesh. On the other hand, it also provides standard medical facilities to the patients. The Department of Medical Education was bifurcated in the year 1981 from the Department of Medical Health Services. 

To view the letter, click the link below

https://medicaldialogues.in/pdf_upload/hims-urged-to-lower-tuition-fees-for-non-clinical-departments-in-neet-pg-2024-270844.pdf

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Dr Raghuvanshi To Continue as DCGI Amidst Search For Successor, 18 Candidates Vie For Top Post

New Delhi: As the government continues its search for a new Drugs Controller General of India (DCGI), it has decided to extend the tenure of the current regulator, Dr Rajeev Singh Raghuvanshi.

Despite multiple deadline extensions, the Ministry of Health has received 18 applications for the post. However, the Appointments Committee of the Cabinet (ACC) has been asked for additional time to complete the selection process. On January 17, the ministry issued a memorandum titled “Re-employment of Dr Rajeev Singh Raghuvanshi as Drugs Controller (India), Central Drugs Standard Control Organisation (CDSCO) on contract basis,” notifying the tenure extension.

Dr Rajeev Singh Raghuvanshi, who is set to retire on February 28, brings extensive experience and expertise in regulatory systems and international pharmaceutical dynamics. The ministry has described him as an “asset” to the organisation and emphasised the necessity of his leadership during this transitional period.

Requesting “considerable time” for the thorough examination of applications, the ministry highlighted that “Dr Raghuvanshi’s in-depth knowledge of industry, government regulatory systems, and international pharmaceutical dynamics is an asset for the organisation.”

The DCGI heads CDSCO, the apex health regulatory body in India, overseeing the regulation of medicines, vaccines, cosmetics, and medical devices, as well as the implementation of the Drugs and Cosmetics Act. The regulator also plays a pivotal role in establishing national reference standards and ensuring global alignment in regulatory practices.

Why Extend the Current DCGI’s Tenure?

Dr Raghuvanshi took charge as DCGI on February 23, 2023, and also holds the additional charge of secretary-cum-scientific director of the Indian Pharmacopoeia Commission (IPC). Anticipating his retirement, the government advertised the DCGI position in August 2024. However, the initial response was insufficient, prompting an extension of the application deadline to November 23.

Also Read: Rajeev Singh Raghuvanshi takes charge as new Drugs Controller General of India

As per News18, in total, 18 applications were submitted, but the health ministry noted that the “entire process is likely to take considerable time.” In an office memorandum, it stated, “These applications are being scrutinised. Thereafter, a proposal will be submitted to UPSC for selection of a suitable candidate for the post.”

The Ministry’s Justification

The health ministry has underscored the risks of leaving the position vacant, noting that “keeping the position vacant would adversely impact the industry.” It praised Dr Raghuvanshi’s leadership, stating, “Under his able leadership, substantial reforms have been brought out in CDSCO. At present, further regulatory reforms are being undertaken in CDSCO, which include global benchmarking, automation of the regulatory processes, and alignment with global standards.”

Highlighting the importance of continuity, the memorandum added, “Keeping in view the importance of activities being undertaken by CDSCO, the post cannot be kept vacant as the same would adversely impact the country’s effort to develop a world-class pharmaceutical ecosystem consisting of components from production of affordable quality generics to latest technology-based products like CAR-Ts and gene therapies for India and the world.” It concluded, “Continuity in leadership in CDSCO is, therefore, necessary.”

The ministry has sought the ACC’s approval for Dr Raghuvanshi’s re-employment on a contractual basis for one year.

No Pressure of Deadlines

A senior health ministry official, speaking to News18 on condition of anonymity, revealed that among the 18 candidates are names like Dr VG Somani, Dr A Ramkishan, Dr A Visala, Dr Jai Prakash, and Dr Eswara Reddy. The official stated that “the ministry is going through the work done by all candidates in the past as the position of DCGI has evolved and become very crucial.”

The official also noted, “There are candidates who are currently not eligible to take charge due to certain issues on the personal or legal front. Those candidates are likely to become eligible in a few months to become part of the race. We want to give the charge to the most deserving officer without taking pressure of the deadlines.”

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Drug Alert: CDSCO Flags 51 Formulations As Not Of Standard Quality

New Delhi: In its latest drug alert, the apex drug regulatory body, the Central Drug Standard Control Organization (CDSCO), has flagged 41 medicine batches for failing to qualify for a random drug sample test for December 2024.

These include Cefotaxime Sodium Injection IP 1 g manufactured by Bengal Chemicals and Pharmaceuticals, Aspirin Gastro resistant Tablets IP 75mg manufactured by Unicure India, Diphenhydramine Hydrochloride, Ammonium Chloride, Sodium Citrate & Menthol Syrup (Beedryl Plus) manufactured by Zenith Drugs, and Calcium with Vitamin D3 Tablets (CITCAL TABLETS) manufactured by Uniplus Biotech and others.

Furthermore, the list includes Thyroxine Sodium tablets IP (THYROX -25) manufactured by Macleods Pharmaceuticals and Pantoprazole gastro-resistant tablets IP 40 mg (PANTIN) manufactured by Hetero Healthcare.

The alert further mentioned that as part of the continuous regulatory surveillance, drug samples are picked from sales/distribution points, analyzed, and lists of Not of Standard Quality (NSQ) drugs are displayed on the CDSCO portal on a monthly basis. The purpose of displaying the NSQ list is to make stakeholders aware of the NSQ batches identified in the market.

Not of Standard Quality (NSQ) drugs are the drugs that fail to meet the quality standards or specifications are known as Not of Standard Quality (NSQ) drugs. (Further, the term ‘standards of quality’ is defined under Section 16 (1) (a) of Drugs & Cosmetics Act, 1940, that the ‘standards of quality’ mean that the drug complies with the standards set out in the Second Schedule of the said Act.)

A few of the reasons why the drug samples tested failed were the failure of the assay, failure of the dissolution test, failure of pH, particulate matter, and description.

The samples collected were tested in five laboratories: RDTL Chandigarh, CDL Kolkata, CDTL Mumbai, CDTL Chennai, and RDTL-Guwahati.

Also Read:Drug Alert: 41 Drug samples including Cipla’s TOFAJAK tablets fail To Qualify CDSCO Test

NOT OF STANDARD QUALITY (NSQ) ALERT FOR THE MONTH OF DECEMBER – 2024

A. CDSCO/Central Laboratories

S.No

Product/Drug Name

Batch No.

Manufacturing Date

Expiry Date

Manufactured By

NSQ Result

Reported by CDSCO

Laboratory

1.

Cefotaxime Sodium Injection IP 1 g

DP24029

04/2024

03/2026

M/s. Bengal Chemicals & Pharmaceuticals Ltd., At-620, Diamond Harbour Road, Behala Indl. Estate, Kolkata-

700034.

Test of Clarity of solution, Particulate matter

Central Drugs Laboratory, Kolkata

2.

Meropenem Injection IP 500 mg (Merohuge 500 )

A4ITX004

08/2024

07/2026

M/s. Shamshree Lifesciences Limited, Plot No. 11, Industrial Area, Katha- Bhatolikalan, Baddi-

173205, H.P.

Test of Clarity of solution, Particulate matter

Central Drugs Laboratory, Kolkata

3.

AMIKACIN SULPHATE INJECTION IP

250 mg (AMIKACIN SULPHATE INJECTION IP

250 mg/ 2 ml for

IM/IV Injection)

17800124

01/2024

12/2025

M/s. Karnataka Antibiotics And Pharmaceuticals Limited, Plot No-14, Peenya II Phase, Bengaluru-560058, Karnataka.

Particulate mattter and Description

Central Drugs Laboratory, Kolkata

4.

Rabeprazole Injection IP

AGI-23216

06/2023

05/2025

M/s. Alliaance Biotech, 440/3, Vill-Katha, Badddi, Solan (H.P.) – 173205

Sterility, Clarity of Solution, Particulate matter,

Identification,

Central Drugs Laboratory, Kolkata

Assay of Rabeprazole Sodium and Description”. The sample is deemed to be spurious as per section 17B of Drugs and

Cosmetics Act

5.

Rabeprazole Injection IP

AGI-23217

06/2023

05/2025

M/s. Alliaance Biotech, 440/3, Vill-Katha, Badddi, Solan (H.P.) – 173205

pH, Clarity of Solution, Particulate matter, Assay of Rabeprazole Sodium and

Description

Central Drugs Laboratory, Kolkata

6.

Tranexamic Acid Tablets IP 500 mg (Clip 500 )

054A003

01/2024

12/2025

M/s. FDC Limited L-56 & L-57, Phase-II-D Verna Industrial Estate, Verna-403722, Salcete,

Goa

Related Substances

Central Drugs Laboratory, Kolkata

7.

Fexofenadine Hydrochloride Tablets IP (MANOFEX-180 )

CT24250327 A

05/2024

04/2026

M/s.CMG BIOTECH PVT.LTD, (Unit-II)Plot

No-58, Phase-III, Industrial Area, Sasarpur Terrace, HP-

176501

Dissolution

Central Drugs Laboratory, Kolkata

8.

Rabeprazole Sodium Injection IP

MD23H20

08/2023

07/2025

M/s. Martin & Brown Bio Sciences, K.No. 918/419, Malkumajra, Nalagarh Road, Baddi, Dist. Solan (H.P.)- 173205

pH, Water, Clarity of Solution, Particulate matter, Assay of Rabeprazole Sodium and

Description

Central Drugs Laboratory, Kolkata

9.

Lignocaine Hydrochloride Gel IP 5% w/v (30 g)

G406

09/2024

08/2026

M/s. Gnosis Pharmaceuticals Pvt. Ltd., Nahan Road, Village Moginand, Kala-

Amb, Distt.Sirmour,

pH

Central Drugs Laboratory, Kolkata

H.P.-173030

10.

Cold Plus Syrup (Cold Plus Syrup)

4EL02283

09/2024

08/2027

M/s. Ciron Drugs & Pharmaceuticals Pvt. Ltd., N- 118,119,113,119/1,

119/2 & 118/1,

M.I.D.C., Tarapur,

Boisar, Dist-Palghar- 401506, Maharashtra

Assay of Phenylephrine Hydrochloride

Central Drugs Laboratory, Kolkata

11.

Omeprazole Lyophilized Powder for Injection (I.V) (OMERA 40mg

Lyophilized Powder for

Injection )

0ZI2415AC

06/2024

05/2026

M/s. CELON LABORATORIES PVT. LTD., Plot No-2,

ALEAP Industrial Estate, Gajularamaram, Medchal District-500 090, Telangana State,

India

Test of Water by KF

Central Drugs Laboratory, Kolkata

12.

BUPIVACAINE HYDROCHLORI DE INJECTION

IP 0.5%

BCV22315

12/2023

11/2025

M/s. Nandani Medical Laboratories Pvt. Ltd., 221/5, Bicholi Hapsi,

Kanadia Road, Indore

Particulate mattter and Description

Central Drugs Laboratory, Kolkata

13.

AXBEX

Suspension (Multivitamin Mulltimineral & Antioxidant

Suspension)

A21410

05/2024

10/2025

M/s. Ozone Pharmaceuticals Ltd., Katha, Baddi-173205, Himachal Pradesh

Identification & Assay of Cholecalciferol

Central Drugs Laboratory, Kolkata

14.

AXBEX

Suspension (Multivitamin Mulltimineral &

Antioxidant Suspension)

A21411

05/2024

10/2025

M/s. Ozone Pharmaceuticals Ltd., Katha, Baddi-173205, Himachal Pradesh

Identification & Assay of Cholecalciferol

Central Drugs Laboratory, Kolkata

15.

Thyroxine Sodium tablets IP (THYROX-25)

16240148D

05/2024

04/2026

M/s. Macleods Pharmaceuticals Ltd., Plot No-2209, GIDC,

Sarigam, Dist-Valsad- 396155, Gujarat

Dissolution

Central Drugs Laboratory, Kolkata

16.

Dexamethasone Sodium

119

06/2024

05/2026

M/s. Hindustan Medicines Pvt. Ltd.,

Free Dexamethasone,

Central Drugs Laboratory, Kolkata

Phosphate Injection I.P.

BARAUNI-851112.

Particulate matter, Sterility, Extractable

volume and Description

17.

Amikacin Sulphate Injection

I.P. (AmikaVen- 500 Injection)

L-24A-23I

01/2024

12/2025

M/s. Inmac Laboratories, Bangsipura-142033 (Pb)

Particulate mattter, Assay/content of Amikacin and

Description

Central Drugs Laboratory, Kolkata

18.

Aspirin Gastro- resistant Tablets IP 75mg

ANET1121

08/2023

07/2025

M/s. Unicure India Ltd., C-21, 22 & 23, Sector-

3, Noida- 201301, Distt. Gautam Budh Nagar

(U.P.)

Test of Dissolution Buffer Stage

Central Drugs Laboratory, Kolkata

19.

Absorbent Cotton Wool IP

331

07/2024

06/2026

M/s. Vandana Surgi Pharma (P) Ltd., GA- 26, RIICO Industrial Area, Bijaynagar- 305624, (Raj)

Acidity or alkalinity, Absorbency Sinking Time, Absorbency Water-holding Capacity, Foreign Fibres, Fluorescence, Water soluble substances, Neps and Sulphated

ash

Central Drugs Laboratory, Kolkata

20.

Noscapine, Chlorpheniramine Maleate, Guaiphenesin & Sodium Citrate

Syrup

NGC-091

12/2023

11/2025

M/s.Medipol Pharmaceuticals India Pvt. Ltd., 1199/3, Bhud, Baddi, Dist-Solan, H.P., India

Description

Central Drugs Laboratory, Kolkata

21.

Diphenhydramine Hydrochloride, Ammonium Chloride, Sodium

Citrate & Menthol Syrup (Beedryl

40183

02/2024

01/2026

M/s. Zenith Drugs Limited 72/5 & 72/3, 72/4, 74/1/1, 75/1/1,

Muradpura (Orangpura)

Dhar Road, Near Kalaria Indore 453001

Assay of Menthol and Description

Central Drugs Laboratory, Kolkata

Plus)

(MP), India

22.

Bupivacaine Hydrochloride in Dextrose Injection USP 4 ml

17B24005

09/2024

08/2026

M/s. Radiant Parenterals Ltd., 242/4, 5 &6, G.I.D.C., Estate at & Post Waghodia,

Dist-Vadodara , Gujarat-391760

pH and Bacterial Endotoxins

Central Drugs Laboratory, Kolkata

23.

Bupivacaine Hydrochloride in Dextrose Injection USP 4 ml

17B24004

06/2024

05/2026

M/s. Radiant Parenterals Ltd., 242/4, 5 &6, G.I.D.C., Estate at & Post Waghodia, Dist-Vadodara ,

Gujarat-391760

pH, Bacterial Endotoxins and Sterility

Central Drugs Laboratory, Kolkata

24.

Diphenhydramine Hydrochloride, Ammonium Chloride, Sodium Citrate & Menthol

Syrup (Beedryl Plus)

40186

02/2024

01/2026

M/s. Zenith Drugs Limited 72/5 & 72/3, 72/4, 74/1/1, 75/1/1,

Muradpura (Orangpura) Dhar Road, Near Kalaria Indore 453001

(MP), India

Assay of Menthol and Description

Central Drugs Laboratory, Kolkata

25.

Telmisartan Tablets I.P.. (TELMOPI-40)

23I-T2003

12/2023

11/2025

M/s. Orison Pharma International, Vill. Khari, Mauza Ogli, Kala Amb, Distt. Sirmour – 173030

(H.P.)

Dissolution

RDTL, Guwahati

26.

Acyclovir Dispersible Tablets IP (Zovibact 800 mg)

SRTH230874 B

08/2023

07/2025

M/s. SYSTOLE REMEDIES PVT. LTD.,

Vill. Ogli, Kala Amb, Teh. Nahan, Distt. Sirmour (H.P.) – 173

030

Uniformity of dispersion & Disintegration

RDTL, Guwahati

27.

GLIMEPIRIDE TABLETS IP (GLIMP-1)

SPT240261

02/2024

01/2026

M/s. SALUS PHARMACEUTICALS,

480/211, Harraipur, PO Gurumajra, Teh. Baddi,

Distt. Solan (H.P.) 173205

Dissolution

RDTL, Guwahati

28.

Zinc Sulphate Dispersible

Tablets IP 20 mg

LMT240811

07/2024

06/2026

M/s.Life Max Cancer Laboratories, Plot No.

106 & 106 A, Sector6A,

Uniformity of dispersion &

Disintegration

RDTL, Guwahati

IIE, SIDCUL,

Haridwar249403 (U.K)

29.

Glimepiride Tablets I.P. 1 mg

LMT240339

03/2024

02/2026

M/s.Life Max Cancer Laboratories, Plot No. 106 & 106 A, Sector6A, IIE, SIDCUL,

Haridwar249403 (U.K)

Dissolution of Glimepiride

RDTL, Guwahati

30.

INFUSION SET- NV (INFUSION SET – NV)

KT-033

03/2024

02/2027

M/s.MEDIVISION HEALTHCARE, 84/4

Span Industrial complex. Second Floor, Phase-1, “F” Road, Opp. Kotak Mahindra Bank, G.I. D.C. Vatva,

Ahmedabad- 382445, Gujarat

Sterility

RDTL, Guwahati

31.

Compound Sodium Lactate Injection I.P. (RL)

03BF2472

04/2024

03/2027

M/s.Paschim Banga Pharmaceutical,, NH- 31,TIN Mile Hat, Sonapur Hat, PSChopra, Dist. Uttar

Dinajpur, PIN- 733214 (WB)

Sterility and Particulate Contamination

RDTL, Guwahati

32.

Compound Sodium Lactate Injection I.P. 500 ml (Ringers Lactate I.P.) (RL)

03BF2474

04/2024

03/2027

M/s.PASCHIM BANGA PHARMACEUTICAL (A

Unit Of FARISTA VANIJYA PVT. LTD.), NH-31, TIN MILE HAT, SONAPUR HAT, P.S. CHOPRA, DIST: UTTAR DINAJPUR,

PIN 733 214 (W.B.)

Sterility

RDTL, Guwahati

33.

Calcium with Vitamin D3 Tablets (CITCAL

TABLETS)

470823

08/2023

07/2025

M/s.Uniplus Biotech (P) Ltd., 4 km. Meerut Road, Assoda 245101

Dissolution (calcium) and Assay of Vitamin

D3

RDTL, Guwahati

34.

Calcium 500 mg with Vitamin D3 250 IU Tablets IP

LMT240346

03/2024

02/2026

M/s.Life Max Cancer Laboratories, Plot No.

106 & 106 A, Sector6A, IIE, SIDCUL, Haridwar-

Assay of Vitamin D3 and

Dissolution for calcium

RDTL, Guwahati

249403 (U.K)

35.

Co- trimoxazole Tablets I.P. (D.S.=Double Strength)

PT30119

05/2023

04/2025

M/s.Omega Pharma., Khasra No. 482, Village

– Saliyar, Roorkee – 247667. Distt-Haridwar

(Uttarakhand)

Dissolution (Trimethoprim and

Sulphamethoxazo le)

RDTL, Guwahati

36.

PRIMAQUINE PHOSPHATE TABLETS IP 2.5

mg

T-1338

07/2023

06/2025

M/s.Jackson Laboratories Pvt.Ltd, 22-24, Majitha Road, Bye Pass, Amritsar-143

001(India)

Dissolution and Assay

RDTL, Guwahati

37.

PANTOPRAZOL E GASTRO- RESISTANT TABLETS IP 40mg (PANTIN)

GT24502A

06/2024

05/2027

M/s. Hetero Healthcare limited, AIIDC Industrial Growth Centre, Changsari, Niz Sindurighopa (Village), Sila Sindurighopa

(Mouza), Kamrup (Dist) Assam-781101

Dissolution of Buffer Stage

RDTL, Guwahati

38.

Albendazole Tablets I.P.

MT-24G01

07/2024

06/2026

M/s.MARTIN & BROWN BIOSCIENCES PVT. LTD., K.No. 918/419,

Malkumajra, Nalagarh Road, Baddi, Dist.

Solan (H.P.)-173205

Dissolution

RDTL, Guwahati

39.

Calcium & Vitamin D3 Tablets IP (CALCI-D)

CDD23089

11/2023

10/2025

M/s. Danish Healthcare

(P) Ltd, 76/27-28,

Industrial Estate, Maxi Road, Ujjain-456 010

INDIA

Assay of Vitamin D3

RDTL, Guwahati

40.

Alprazolam Tablets IP 0.5 mg

BT1224

01/2024

12/2025

M/s.Brilliant Life Sciences Pvt.Ltd. , At Chuval Tagarwa, Teh Detroj Dist.

Ahmedabad(Gujarat)

The Sample does not conform to IP Standards with respect to Test

for Dissolution only

CDTL, Chennai

41.

Valsartan Tablets IP 80mg(Valsalar-

80 Tablets)

VSR1-05

04/2024

03/2026

M/s. Lark Laboratories

(I) Ltd., At, SP-1192 E,

RIICO Indl Area, Phase

The Sample does not conform to IP

Standards with

CDTL, Chennai

IV, Bhiwadi-Rajasthan

respect to Test for Dissolution

only

42.

Nutrisacc Bolus

MVNUR2403

02/2024

02/2026

M/s. Maven iLab Pvt.Ltd., No.19 Byraveshwara Industrial Area, Andrahalli Main Road Hegganahalli,

Bangalore-560091

Disintegration test and Assay of Iron, Magnesium, Calcium, Vitamin B3,Zinc and Vitamin A

RDTL, Chandigarh

43.

Duloxetine Gastro-resistant Tablets IP 20 mg

T26904

01/2024

12/2025

M/s Quest Laboratories Limited, Plot No. 45, Sector-III, Pithampur, Dist.Dhar-454775

(M.P.)

Description and Dissolution

RDTL, Chandigarh

44.

Bortezomib Injection IP (BORTEWIN 2

mg Injection)

L24BZ08A7

08/2024

07/2026

M/s. MEDION BIOTECH PVT.LTD.,

Village-Kaundi, Baddi, Solan, Himachal

Pradesh, 173205

Assay of Bortezomib

RDTL, Chandigarh

45.

Rabeprazole Gastro-resistant Tablets IP 20 mg (Robijick – 20)

T- 1047

06/2023

05/2025

M/s.Jackson Laboratories Pvt. Ltd., 22-24, Majitha Road, Bye Pass, Amritsar –

143 001 (India).

“Dissolution (Acid stage) & (Buffer stage) and Description”

CDTL, Mumbai

46.

Ramipril & Metoprolol Succinate Tablets (Ramigan -MT 2.5/ 25 Tablets)

AOT23322

06/2023

05/2025

M/s.ASTONEA LABS

PVT. LTD., Vill. Haripur Teh. Ranipur Rani, Distt. Panchkula, Haryana, India –

134204

“Assay of Ramipril”

CDTL, Mumbai

47.

Sertraline Hydrochloride (USP/ EP)

SER240002B FP

05/2024

04/2025

M/s.Exemep Pharmaceuticals., Block No. 628 (A & B), ECP Canal Road, Village : Luna, Tal : Padra, Vadodara

391440, INDIA

“Related substances”

CDTL, Mumbai

48.

Pantoprazole Gastro-resistant

UC-23001C

07/2023

06/2025

M/s.Ultra Drugs Pvt. Ltd., (Unit- II) HS No.

“Dissolution of Domperidone”

CDTL, Mumbai

and Domperidone Prolonged- release Capsules

IP (Unipraz – DSR)

211, K. No. 77/1, 78/1

Vill. Katha, Baddi, Distt. Solan (H.P.)

49.

Paracetamol Paediatric Oral Suspension IP (MYPAR)

S404115

04/2024

03/2026

M/s.ION Healthcare Pvt. Ltd., Baddi- Barotiwala Road, Baddi, Distt. Solan

(H.P.)- 173 205.

“Related substances”

CDTL, Mumbai

50.

Hydroxychloroqui ne Sulphate Tableta IP 200 mg (QUEENJAJ 200)

HCQ19K23

11/2023

10/2026

M/s. Bajaj Healthcare Ltd., R.S. No. 1818,

Manjusar – Savli Road, At & Post – Manjusar, Tal. Savli, Dist.

Vadodra – 391775,

Gujarat, India.

“Related substances”

CDTL, Mumbai

51.

DOXYCYCLINE CAPSULES IP

100 mg

HDXA08

06/2023

05/2025

M/s.Hindustan Antibiotics Ltd., At 11 W.E.A., Faridabad-

121001.

“Uniformity of weight”

CDTL, Mumbai

To view the official notice, click the link below:

https://medicaldialogues.in/pdf_upload/nsq-alert-for-the-month-of-dec-2024-1-271195.pdf

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Udupi doctor cheated of Rs 8.5 lakh for UK MPH seat, 3 arrested

What began as a hope to pursue higher education became a nightmare for a general medicine doctor from Udupi after he reportedly fell victim to an abroad PG admission scam that promised him a seat for a Master of Public Health (MPH) course in the United Kingdom. The doctor reportedly lost Rs 8.5 lakh to a group of fraudsters involved in the scam.

The group initially asked for Rs 18 lakh to secure a seat for him at a prestigious university in the UK. Therefore, they told the doctor to pay an advance of Rs 8.5 lakh. Acting on their instructions, the doctor transferred the money. However, after the payment was made, the fraudsters stopped responding to his calls leading the doctor to realise that he was ultimately scammed.

For more information, click on the link below:

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Dr A Narendra Kumar appointed as Telangana Director of Medical Education

Hyderabad: In a
historic development for Telangana’s healthcare sector, Dr. A. Narendra Kumar
has been appointed as the state’s first full-time Director of Medical Education
(DME) since its formation in 2014. The appointment was officially confirmed
through an order issued by Health Secretary Christina Z. Chongthu on Thursday.

Also Read:Dr MS Bhutani takes charge as president of IMA Jalandhar

This appointment
marks a significant milestone in the State’s healthcare administration, as the
post of DME has been managed on a temporary basis by in-charge officials for
over a decade. Dr. N. Vani, the most recent in-charge DME, held the position
from February 2024 until now. Before her, Dr Ramesh Reddy served as the
longest-standing in-charge DME, holding the role for six years before his
transfer following the Congress party’s ascent to power in 2023, reports The Hindu.

Dr A. Narendra
Kumar brings a wealth of experience to his new role, having previously served
as the superintendent of the Government General Hospital in Wanaparthy. As DME,
he will oversee medical education and healthcare services across the State,
playing a pivotal role in shaping Telangana’s healthcare future.

Additionally, the
government promoted Dr. K. Siva Ram Prasad, principal of Government Medical
College in Jagtial, to the newly created role of Director of Medical Education
(Academics).

The official page
of Osmania Medical College stated, “These appointments highlight their
exceptional expertise and leadership in advancing medical education and
healthcare in Telangana. Their vision and dedication are poised to shape the state’s future of medical education and healthcare.” The Doctor’s
Association of Telangana and the medical community extended warm
wishes to both leaders.

Also Read:Dr VP Pandey appointed as Interim Dean of MGM Medical College Indore

Dr Rajeev, a
member of the Telangana Medical Council (TGMC) told the Daily,
“Previously, the absence of a regular appointee to the Director of Medical
Education (DME) position resulted in administrative affairs being managed by
in-charge DMEs, which led to certain governance challenges. However, the
current government has resolved this issue by appointing Dr Narendra Kumar as
the regular DME, based on seniority.”

Telangana has
experienced a substantial transformation in its medical education
infrastructure. The number of government medical colleges has risen
dramatically from just five in 2014 to 34 today. This rapid expansion
underscores the importance of having a dedicated DME to ensure the quality of
medical education and the effective delivery of healthcare services.

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NMC investigates 30 doctors for accepting pharma freebies: Report

The National Medical Commission (NMC) has started its probe against 30 doctors who allegedly took pharma freebies in the form of travel and hospitality expenses from AbbVie Healthcare, Economic Times has reported.

Confirming this, a senior NMC official informed ET that the Commission has started the investigation and will take action in this regard.

For more information, click on the link below:

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