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Tag: CDSCO

  • Cough syrup linked deaths in Uzbekistan: Drugs Control Organisation initiates probe

    By PTI

    NEW DELHI: The Central Drugs Standard Control Organisation (CDSCO) has initiated a probe in reference to the demise of 18 youngsters in Uzbekistan allegedly linked to a cough syrup manufactured by an Indian agency, official sources stated on Thursday.

    The well being ministry of Uzbekistan has claimed that the kids who died had consumed cough syrup ‘Doc-1 Max’ manufactured by Noida-based Marion Biotech.

    Hasan Harris, authorized consultant of Mario Biotech, stated the governments of each international locations is wanting into the matter and inquiring.

    “There is no problem from our end and no issue in testing. We have been there for the past ten years. Once the government report will come, we will look into it. For now the manufacturing has stopped,” Harris stated.

    According to the ministry, chemical ethylene glycol was present in a batch of syrup throughout laboratory checks.

    Sources stated the Drugs Controller General of India has sought extra data concerning the incident from the Uzbek regulator.

    An inspection collectively performed by the central medication regulatory crew of north zone and state medication regulatory crew was additionally taken throughout which samples of the medication have been additionally lifted.

    Earlier this 12 months, demise of 70 youngsters in Gambia was linked to cough syrups manufactured by Haryana-based Maiden Pharmaceuticals following which the Haryana based mostly unit was shut for violation of producing requirements.

    However, later the samples examined in a authorities laboratory in India have been discovered to be complying with specs.

    NEW DELHI: The Central Drugs Standard Control Organisation (CDSCO) has initiated a probe in reference to the demise of 18 youngsters in Uzbekistan allegedly linked to a cough syrup manufactured by an Indian agency, official sources stated on Thursday.

    The well being ministry of Uzbekistan has claimed that the kids who died had consumed cough syrup ‘Doc-1 Max’ manufactured by Noida-based Marion Biotech.

    Hasan Harris, authorized consultant of Mario Biotech, stated the governments of each international locations is wanting into the matter and inquiring.

    “There is no problem from our end and no issue in testing. We have been there for the past ten years. Once the government report will come, we will look into it. For now the manufacturing has stopped,” Harris stated.

    According to the ministry, chemical ethylene glycol was present in a batch of syrup throughout laboratory checks.

    Sources stated the Drugs Controller General of India has sought extra data concerning the incident from the Uzbek regulator.

    An inspection collectively performed by the central medication regulatory crew of north zone and state medication regulatory crew was additionally taken throughout which samples of the medication have been additionally lifted.

    Earlier this 12 months, demise of 70 youngsters in Gambia was linked to cough syrups manufactured by Haryana-based Maiden Pharmaceuticals following which the Haryana based mostly unit was shut for violation of producing requirements.

    However, later the samples examined in a authorities laboratory in India have been discovered to be complying with specs.

  • CDSCO and State Drugs Control Administrations to conduct joint inspection of drug manufacturing items

    By Express News Service

    NEW DELHI: The Central Drugs Standard Control Organisation (CDSCO) has began conducting a joint inspection of recognized drug manufacturing items together with State Drugs Control Administrations in a risk-based method, the Union Health Ministry mentioned on Tuesday. 

    The transfer comes a month after an in depth inspection on the drug manufacturing unit of Maiden Pharmaceuticals in Haryana discovered a number of violations of Good Manufacturing Practices (GMP). 

    Maiden Pharmaceuticals, which has two manufacturing items in Sonepat, Haryana, was named by the World Health Organisation (WHO) as a provider of 4 contaminated cough syrups that allegedly killed almost 70 kids in Gambia.  The WHO raised a worldwide alert in October in regards to the firm’s 4 cough syrups and mentioned they’re “potentially linked with acute kidney injuries” and deaths amongst kids.

    According to the Union Health Ministry, joint inspections are being performed all around the nation as per the usual working procedures. A committee of two widespread medicine controllers has been arrange at CDSCO to watch the method of inspection, reporting and subsequent motion to make sure compliance with the Drugs and Cosmetics Act 1940 and its guidelines. 

    ALSO READ | Panel to analyse WHO report on Gambia youngster deaths linked to Indian cough syrups; Haryana halts manufacturing

    “This will ensure high standards of quality compliance concerning drugs manufactured in the country, ” mentioned the ministry in an announcement.

    The step was taken underneath the route of Union Minister of Health and Family Welfare and Chemicals and Fertilizers, Dr Mansukh Mandaviya.

    An motion plan for nationwide inspection of producing items recognized to be prone to manufacturing Not of Standard Quality (NSQ)/adulterated/spurious medicine was made earlier than finishing up assessments. The ministry, nevertheless, didn’t title the manufacturing items recognized for the inspection.

    “The objective of drug regulation is to ensure the safety, efficacy and quality of the drugs available in the country. The drug control administration must ensure that manufacturing units comply with the Drugs & Cosmetics Act, 1940 and Rules thereunder, especially to the requirements of Good Manufacturing Practices (GMP), ” the assertion additional added.

    NEW DELHI: The Central Drugs Standard Control Organisation (CDSCO) has began conducting a joint inspection of recognized drug manufacturing items together with State Drugs Control Administrations in a risk-based method, the Union Health Ministry mentioned on Tuesday. 

    The transfer comes a month after an in depth inspection on the drug manufacturing unit of Maiden Pharmaceuticals in Haryana discovered a number of violations of Good Manufacturing Practices (GMP). 

    Maiden Pharmaceuticals, which has two manufacturing items in Sonepat, Haryana, was named by the World Health Organisation (WHO) as a provider of 4 contaminated cough syrups that allegedly killed almost 70 kids in Gambia.  The WHO raised a worldwide alert in October in regards to the firm’s 4 cough syrups and mentioned they’re “potentially linked with acute kidney injuries” and deaths amongst kids.

    According to the Union Health Ministry, joint inspections are being performed all around the nation as per the usual working procedures. A committee of two widespread medicine controllers has been arrange at CDSCO to watch the method of inspection, reporting and subsequent motion to make sure compliance with the Drugs and Cosmetics Act 1940 and its guidelines. 

    ALSO READ | Panel to analyse WHO report on Gambia youngster deaths linked to Indian cough syrups; Haryana halts manufacturing

    “This will ensure high standards of quality compliance concerning drugs manufactured in the country, ” mentioned the ministry in an announcement.

    The step was taken underneath the route of Union Minister of Health and Family Welfare and Chemicals and Fertilizers, Dr Mansukh Mandaviya.

    An motion plan for nationwide inspection of producing items recognized to be prone to manufacturing Not of Standard Quality (NSQ)/adulterated/spurious medicine was made earlier than finishing up assessments. The ministry, nevertheless, didn’t title the manufacturing items recognized for the inspection.

    “The objective of drug regulation is to ensure the safety, efficacy and quality of the drugs available in the country. The drug control administration must ensure that manufacturing units comply with the Drugs & Cosmetics Act, 1940 and Rules thereunder, especially to the requirements of Good Manufacturing Practices (GMP), ” the assertion additional added.

  • Apollo Hospitals Bhubaneswar begins antibody cocktail remedy

    Express News Service
    BHUBANESWAR: Apollo Hospitals in Bhubaneswar started the monoclonal antibody cocktail remedy on a Covid affected person on Monday.

    The Central Drugs Standards Control Organization (CDSCO) has permitted the emergency use of the Covid monoclonal antibody cocktail.

    Sources mentioned the 82-year-old man from Bhubaneswar with comorbidities was administered the antibody cocktail (Casirivimab and Imdevimab) on Monday. The affected person was admitted to the hospital on May 29 three days after he examined constructive for the virus.

    The determination to manage the antibody cocktail was taken by a board of docs led by Director (Medical Services) of Apollo Hospitals Dr Ashish Chandra.

    Consultant doctor Dr Paresh Jena mentioned the affected person tolerated the medicine and his situation is bettering. “The patient with comorbidities, including heart disease and old brain stroke, was admitted on day 5 of the Covid symptoms. The Covid monoclonal antibodies were given on day 6. We are the first hospital in the State to begin the combination medication,” he mentioned.

    ALSO READ | Test positivity charge declines however excessive share of RATs huge concern in Odisha

    The antibody cocktail has been beneficial for the therapy of gentle to average Covid-19 in adults and paediatric sufferers of 12 years or older, weighing at the least 40 kg and who’re at excessive threat of growing extreme illness and don’t require oxygen.

    The benefit of the cocktail to be administered as soon as, Dr Jena mentioned, is that it may be used on comorbid sufferers with coronary heart and renal illnesses, most cancers and different such sicknesses.

    “It will prevent the condition of the high-risk patients from worsening further by reducing the risk of progressing to severe disease and fatality by 70 per cent besides shortening the duration of symptoms by four days,” he mentioned.

    With well being specialists advocating for rational use of the Covid-19 monoclonal antibody cocktail, the docs on the hospital are optimistic that the provision of antibody cocktail may help in minimising illness severity, and play a key position in therapy of excessive threat sufferers earlier than their situation worsens. It is, nonetheless, not beneficial for sufferers who’ve average or extreme illness with hypoxia.

    “We hope the cocktail antibody will benefit more comorbid patients with mild symptoms on whom Covid treatment gets delayed due to their other serious comorbid conditions. We are looking forward to patients taking advantage of the treatment,” mentioned senior public relations officer Rakesh Ray.

  • UK Drug Regulators Agree To Enhance Corporation, Share Information Under New Deal

    India and the United Kingdom announced a new memorandum of understanding between India’s Central Drugs Standard Control Organisation (CDSCO) and the United Kingdom Medicines and Healthcare Products Regulatory Agency (UK MHRA) on Wednesday, December 16. As per the agreement, the two nations will hold more frequent discussions on UK-India vaccine and pharmaceutical regulations, improving standards, and sharing information to control the trade of unlicensed products.

    In addition to the MoU, India and UK also announced a new partnership to help scientists in the two nations unlock the power of data, including the data within our genes, to deliver better diagnostics and enhanced life-saving treatments for cancer, diabetes, maternal health challenges, and rare diseases.

    The announcement comes following UK Foreign Secretary Dominic Raab’s meeting with Prime Minister Narendra Modi earlier in the day. Raab, who is on a four-day visit to India amid tense Brexit negotiations at home, stressed the importance that the UK government attaches to elevating relations with India. 

    PM Modi and Raab discussed the vast potential of the India-UK partnership in the post-Brexit world, and the launching of a ‘vaccines hub’ which will share best practice for clinical trials and foster innovation besides helping in the shared fight against COVID-19 pandemic.

    In a tweet after the meeting, PM Modi said he was looking forward to UK Prime Minister Boris Johnson’s visit to India to be the Chief Guest at the Republic Day celebrations next month. Accepting PM Modi’s invitation, UK Prime Minister Boris Johnson expressed that he is ‘absolutely delighted’ to be visiting India.