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Pharmaceuticals


       UNDER-THE-SKIN INJECTION
       Roche’s quick-acting cancer injection gets India

       nod with Phase IV trial condition

          The technical committee constituted  with a condition that the company would  tor, which blocks the immune system’s
       for supervising clinical trials on new  conduct a Phase IV clinical trial in India.  natural brakes to help immune cells
       chemical entities has reportedly cleared                           fi ght cancer.
       Swiss drug fi rm Roche to import and mar-  “Switching from intravenous (IV)
       ket cancer drug  Atezolizumab injection  to subcutaneous (SC) administration of   The technical committee under the
       (Tecentriq) through subcutaneous (SC)  Atezolizumab can potentially reduce costs  Director General of Health Services (DGHS)
       route - under the skin injection – for Indian  due to decreased healthcare professional  was formed in 2013 following the direc-
       patients.                         time and improved patient convenience,”  tions of the Supreme Court. Atezolizumab
                                         a government offi  cial was quoted as say-  is indicated for the treatment of patients
          The decisions is expected to provide  ing in an Economic Times report. “Tecen-  with locally advanced or metastatic non-
       relief to patients in the country as the new  triq may be administered by a healthcare  small cell lung cancer (NSCLC) after prior
       subcutaneous injections will cut treatment  professional outside of the hospital, in a  chemotherapy. It is a monotherapy for the
       time  to  nearly  seven  minutes  from  the  community care setting or at a patient’s  fi rst line treatment of patients of metastatic
       30-60 minutes in the standard intravenous  home,” he added.        NSCLC.  The committee has asked the
       (IV) infusion, besides saving on costs.                            company to submit Phase IV clinical trial
                                           Atezolizumab is an immunotherapy  protocol to CDSCO within three months
          The panel’s permission has been given  called an immune checkpoint inhibi-  of grant of marketing authorisation.

       TACKLING RUMOURS
       No ban on paracetamol drug: Govt. informs Parliament


          The Central Drugs Standard Control  is not in receipt of information about   The Minister also informed the Upper
       Organisation (CDSCO) has not banned  rumours” of the regulatory body banning  House that the government has rolled out
       the commonly used paracetamol drug in  paracetamol.                the free drugs service initiative under the
       India, the Government told Rajya Sabha.                            National Health Mission (NHM) under the
                                           While  156  fi xed-dose  combinations  Union Health Ministry. She also pointed
          Replying to a written query in Rajya  (FDCs), including some involving para-  out that this aims to ensure availability of
       Sabha, Union Minister of State for Chemi-  cetamol, have been banned in public  essential drugs and reduce out-of-pocket
       cals and Fertilisers Ms.  Anupriya  Patel  interest, the standalone drug paracetamol  expenditure of patients visiting the pub-
       said, “The Ministry of Health and Family  remains approved and widely available,  lic health facilities, including government
       Welfare has informed that the CDSCO  the Minister clarifi ed.       hospitals and rural primary health centres.
       FINANCIAL PERFORMANCE
       Emcure Pharma posts strong Q1 net profi t growth

          Pune-based Emcure Pharmaceuticals  to  19.2  percent.  Gross  profi t  stood  at  percent on the back of early traction from
       has reported a strong performance for the  Rs. 1,299-crore, representing a 14.7  new products.  The domestic business
       fi rst quarter ended June 30, 2025, regis-  percent increase over Q1FY25.  also posted a 9.4 percent YoY growth at
       tering a 15.7 percent year-on-year (YoY)                           Rs. 995-crore, led by key therapies and
       increase in revenue from operations at   Emcure’s  international  business  supported by new initiatives in dermatology
       Rs. 2,101-crore and a 40.8 percent rise in   remained a key growth driver, growing  and over-the-counter (OTC) segments.
       net profi t at Rs. 215-crore.      22.1 percent YoY to Rs. 1,106-crore. The  During the quarter, Emcure expanded
                                         Rest of the World segment rose by 41.9  its strategic partnership with Sanofi  and
          The company delivered a consolidated  percent,  Canada  posted  a  16.4  percent  will now market and distribute Sanofi ’s
       EBITDA of Rs. 404-crore, up 20.1 percent  increase driven by new launches and  oral anti-diabetic portfolio along with its
       YoY, with EBITDA margins improving  market share gains, and Europe grew 12.8  cardiovascular range.


       144                                                                    Chemical Weekly  August 19, 2025


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