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Chronicle Pharmabiz

Clinical trial applications for CGTP made online mode

As part of its ongoing efforts to streamline the processes through digitisation, the Central Drugs Standard Control Organisation (CDSCO) has switched over from offline acceptance of clinical trial applications for cell and gene therapeutics products (CGTP) to online mode.

1 min  |

July 17, 2025

Chronicle Pharmabiz

ISB-MIHM reveals attitudes on AI for TB diagnosis

INDIAN School of Business (ISB) with researchers at the Max Institute of Healthcare Management (MIHM) have uncovered significant insights into healthcare providers' attitudes toward artificial intelligence (AI) in tuberculosis (TB) diagnosis, highlighting both opportunities and challenges in implementing AI-based healthcare solutions in India.

1 min  |

July 17, 2025

Chronicle Pharmabiz

BDMAI to launch e-marketing portal for APIs, pellets

THE Bulk Drug Manufacturers Association of India (BDMAI) is planning to launch an exclusive e-marketing portal for the Indian active pharmaceutical ingredients (API), intermediates, pellets and pharma services to offer their products and services to the national and international markets.

1 min  |

July 17, 2025

Chronicle Pharmabiz

DCC agrees with proposal to amend entry on liquid antiseptics under Sch K

THE Drugs Consultative Committee (DCC) has agreed with a proposal to amend the Drugs Rules, 1945 to bring in changes to the extent and conditions for exemption of liquid antiseptics for household use from wholesale license and hospital grade antiseptic from retail sale license under the Schedule K of Drugs Rules, 1945.

1 min  |

July 17, 2025

Chronicle Pharmabiz

US FDA accepts Milestone's Cardamyst for review

MILESTONE Pharmaceuticals Inc., a biopharmaceutical company developing and commercializing innovative cardiovascular solutions, announced that the US FDA has accepted for review of Milestone’s response to issues raised in the Complete Response Letter (CRL) for Cardamyst (etripamil) nasal spray, an investigational, novel therapy for the treatment of patients with paroxysmal supraventricular tachycardia (PSVT).

1 min  |

July 17, 2025

Chronicle Pharmabiz

Suraksha Diagnostics ties up with United Imaging

SURAKSHA Diagnostics, a leading diagnostics service provider in Eastern India has announced its collaboration with United Imaging, a global leader in advanced imaging technologies, with an aim to establish more than 20 new imaging centres across Eastern India.

1 min  |

July 17, 2025

Chronicle Pharmabiz

Klotho's KLTO-202 gets US FDA orphan drug status

KLOTHO Neurosciences, Inc, a gene and cell therapy company focused on the treatment of neurodegenerative and other aging-related diseases, announced that the US FDA has granted orphan drug designation to the company's novel secreted-Klotho (s-KL) promoter, gene and delivery system (KLTO-202, or s-KL-AAV. myo) for the treatment of amyotrophic lateral sclerosis (ALS).

1 min  |

July 17, 2025

Chronicle Pharmabiz

India's expertise in robotic surgeries draws global patients

INDIA'S growing expertise in robotic-assisted surgeries is becoming a major driver for international medical tourism.

2 min  |

July 17, 2025

Chronicle Pharmabiz

India's 500+ pharma GCCs signal shift in global drug discovery landscape

INDIA is using its technology edge with artificial intelligence (AI) and machine learning (ML) to bolster its pharma global capability centres (GCCs) growth.

2 min  |

July 17, 2025

Chronicle Pharmabiz

New standard input output norms announced for key pharma products

In a move aimed at boosting pharma exports and enhancing transparency in international trade, the Directorate General of Foreign Trade (DGFT) has announced the introduction of new Standard Input Output Norms (SIONs) for key pharma productsazithromycin dihydrate and ceftazidime powder.

1 min  |

July 17, 2025

Chronicle Pharmabiz

'Indian pharma grapples with quality culture'

As global regulatory scrutiny intensifies, pharmaceutical companies are facing increasing pressure to not only meet compliance standards but to embed a robust quality culture into their very core operations.

2 min  |

July 17, 2025

Chronicle Pharmabiz

Govt extends e-submission of CoPP till August 15

THE DCGI has extended the deadline for mandating online submission of WHO-GMP Certificate of Pharmaceutical Product (CoPP) till August 15, 2025 following concerns raised by various industry associations.

1 min  |

July 17, 2025

Chronicle Pharmabiz

Next-gen hematology analyzers improve diagnostic accuracy

THE field of hematology, which focuses on the study of blood and its disorders, is foundational to clinical diagnostics.

4 min  |

July 17, 2025

Chronicle Pharmabiz

Dr Lal PathLabs strengthens genomics capabilities

DR Lal PathLabs has expanded its genomics capabilities by adding Illumina's NovaSeq X Series to its dedicated genomics division, Genevolve.

1 min  |

July 17, 2025

Chronicle Pharmabiz

Ayush, herbal products exports grew 0.5 per cent in May

EXPORT of Ayush and herbal products has reported a marginal growth of 0.5 per cent during the month of May, as compared to almost 1 per cent growth on a Year-over-year (YoY) basis, reported in the same month a year ago.

2 min  |

July 17, 2025

Chronicle Pharmabiz

Telangana DCA intensifies anti-counterfeit drug drive

As a followup to last week's seizure of 'Levipil 500' (levetiracetam 500 mg) tablets from two premises in Hyderabad and Karimnagar, the DCA in Telangana arrested Manish Kumar, partner-cum-competent person of Arvind Pharma Distributors in Hyderabad's SBI Staff Colony, on July 8, 2025, for dealing with spurious (counterfeit) drugs.

2 min  |

July 17, 2025

Chronicle Pharmabiz

Sanofi bags GCC Workplace Awards 2025

SANOFI Global Services received two accolades that highlight its leadership in the global capability centre (GCC) landscape at the recently concluded Zyoin Group GCC Workplace Summit and Awards2025, held in Bengaluru.

1 min  |

July 17, 2025

Chronicle Pharmabiz

Kairali Ayurvedic Group opens centre in Jaipur

KAIRALI Ayurvedic Group, one of India's most trusted names in authentic Ayurveda healthcare, inaugurated its first-ever authentic Kerala Ayurveda wellness treatment centre in Jaipur, Rajasthan.

1 min  |

July 17, 2025

Chronicle Pharmabiz

AMMOI opposes IMA's call to stop initiative at JIPMER

THE Ayurveda Medicine Manufacturers' Organisation of India (AMMOI) has countered the Indian Medical Association's (IMA) request to the Union health ministry that the government should withdraw from its decision to start an integrated medical course at the Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) in Pondicherry, blending traditional medicine with mainstream healthcare.

1 min  |

July 17, 2025

Chronicle Pharmabiz

NABL urges accredited labs to adopt ILAC MRA Mark

IN a significant push towards enhancing international recognition and trade facilitation, the National Accreditation Board for Testing and Calibration Laboratories (NABL) is actively guiding its accredited Conformity Assessment Bodies (CABs) to apply for permission to use the NABL accredited CAB combined ILAC MRA Mark. This move is aimed at reducing technical barriers to trade by reinforcing the global acceptance of accredited testing, calibration, and related services.

2 min  |

July 17, 2025

Chronicle Pharmabiz

ICMR to hold workshop on clinical trials from Sept 15-19 in Pune

In a pivotal move to enhance the ethical and scientific rigor of clinical research in India, a five-day national workshop titled \"Regulatory and Operational Aspects of Clinical Trials\" will be held between September 15 and September 19 at Kalyani Nagar, Pune.

1 min  |

July 17, 2025

Chronicle Pharmabiz

Pharmexcil urges exporters to act swiftly as Botswana mandates inspection

In a crucial regulatory update that could significantly impact India’s pharmaceutical exports to Botswana, the Pharmaceuticals Export Promotion Council of India (Pharmexcil) has urged coordination on priority with Quntrol Laboratories Private Limited to comply with Botswana's newly mandated Pre-Shipment Inspection (PSI) requirement, which is effective from July 1, 2025.

2 min  |

July 17, 2025

Chronicle Pharmabiz

NPC Bill Need of the Hour

THE Central Bureau of Investigation (CBI) has recently conducted search operations at the premises of Pharmacy Council of India (PCI) president Montu Patel in connection with various allegations including accepting bribes from pharmacy institutions for approval.

2 min  |

July 17, 2025

Chronicle Pharmabiz

Agilus rolls out D-DISH test for HER2 equivocal cases

AGILUS Diagnostics, India's largest network of pathology labs, has announced the successful validation and roll out of the D-DISH (Dual-colour Dual-Hapten In Situ Hybridization) test a significant advancement in diagnosing HER2 equivocal breast cancer cases.

1 min  |

July 17, 2025
Chronicle Pharmabiz

Chronicle Pharmabiz

'Medical writing encounters premature job shifts limiting skill maturity'

INDIA has emerged as a global hub for medical writing. However, this growth is tempered by persistent challenges including high attrition rates, premature job shifts limiting skill maturity, risks of overreliance and misuse of AI tools, and rising competition from other South Asian markets, said Ashok Swain, general manager, DIA India.

2 min  |

July 17, 2025

Chronicle Pharmabiz

MTaI raises concern over MMC's recent notification on Homoeopathy

THE Medical Technology Association of India (MTal) has expressed its concern over the Maharashtra Medical Council's (MMC) recent notification allowing practitioners of Homoeopathy to prescribe modern medicines after a six-month pharmacology course.

1 min  |

July 17, 2025

Chronicle Pharmabiz

Karnataka, Germany ink MoU to strengthen ties in lifesciences

KARNATAKA has inked a 5-year MoU with the German state of Bavaria, led by Minister MB Patil and Dr Florian Herrmann, head of the Bavarian State Chancellery.

1 min  |

July 17, 2025

Chronicle Pharmabiz

'India's pharmacy practice shifting towards specialization'

INDIA'S pharmacy practice is currently experiencing a dynamic phase of evolution, marked by significant regulatory reforms and a growing emphasis on specialized roles, all aimed at aligning the profession with global healthcare standards, said Dr. Subhash C Mandal, secretary of Indian Pharmaceutical Association (IPA).

2 min  |

July 17, 2025

Chronicle Pharmabiz

Merck announces 2025 Merck Young Scientist Award

MERCK is back with its fourth edition of the Merck Young Scientist Award 2025.

1 min  |

July 17, 2025

Chronicle Pharmabiz

Clinical trial applications for CGTP made online mode

As part of its ongoing efforts to streamline the processes through digitisation, the Central Drugs Standard Control Organisation (CDSCO) has switched over from offline acceptance of clinical trial applications for cell and gene therapeutics products (CGTP) to online mode.

1 min  |

July 17, 2025