Indian Cough Syrup & Deaths in Gambia

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    In News

    • Recently, the Haryana state government decided to “completely stop” the production of medicines that caused deaths in Gambia.

    More about the news

    • WHO Alert:
      • WHO has issued a medical product alert for four contaminated medicines identified in The Gambia. 
        • The four medicines are cough and cold syrups produced in India.
    • Issue:
      • These medicines have been potentially linked to 66 deaths among children in Gambia.
      • The drug has been identified as containing a significant amount of a toxin that damages kidneys irreversibly.
    • India’s probe:
      • The cough syrups manufactured by the pharmaceutical company was approved for export. 
        • It is not available for sale or marketing within the country.
      • India’s drug regulator – The Drugs Controller General of India had also initiated a probe.

    Indian Pharmaceutical industry

    • The Pharmacy of the World:
      • The Indian Pharmaceutical industry is the third largest in the world by volume
        • The Indian Pharmaceutical Industry has been using its powers very responsibly. 
        • It has made a name for itself and India is being called “The Pharmacy of the World” in some circles.
    • Export:
      • India exported pharmaceuticals worth Rs 175,040 crore in the financial year 2021-22, including Bulk Drugs/Drug Intermediates. Also, India is one of the major producers of Active Pharma Ingredients (API) or bulk drugs in the world. 
      • India exported Bulk Drugs/Drug Intermediates worth Rs 33,320 crore in the financial year 2021-22.
    • Imports:
      • However, the country also imports various Bulk Drugs/ APIs for producing medicines from various countries. 
        • Most of the imports of the Bulk Drug/APIs being done in the country are because of economic considerations.
    • What is driving the growth?
    • Talent pool:
      • India has a huge talent pool with trained pharmaceutical professionals having degrees in B Pharmacy, D Pharmacy, M Pharmacy. 
    • Generic drugs:
      • The ability of the pharmaceutical industry to develop generic drugs at a much-reduced price is mainly due to trained professionals in the industry. 
    • Manufacturing:
      • India has a huge manufacturing base of pharmaceutical products giving it way more flexibility in producing generic drugs. 
      • India is home to 3000 drug companies and more than 10,000 manufacturing units.

    Potential of the Indian Pharmaceutical Industry

    • According to the Indian Economic Survey 2021, the pharmaceutical industry in India is expected to reach USD 120-130 Billion by 2030. 
    • Industries related to the pharmaceutical sector:
      • The other industries related to the pharmaceutical sector like biopharmaceuticals, bio-services, bio-agriculture, bio-industry, and bioinformatics are likely to reach USD 150 Billion in 2025 as compared to USD 70 Billion in 2020.
    • According to EY and FICCI, Innovation and R&D, Healthcare Delivery, Manufacturing & Supply Chain, and Market Access are the opportunities that will drive growth in the years to come. 

    Drugs and Cosmetics Act, 1940

    • The Act regulates the import, manufacture, and distribution of drugs in India.
    • The primary objective of the act is to ensure that the drugs and cosmetics sold in India are safe, effective and conform to state quality standards.

    New Drugs, Medical Devices and Cosmetics Bill, 2022

    • For the first time, regulations for conduct of clinical trials for new drugs and medical devices have been brought under the draft New Drugs, Medical Devices and Cosmetics Bill, 2022 
      • The bill seeks to replace the existing Drugs and Cosmetics Act of 1940.
    • New definitions:
      • The draft bill introduces various new definitions or provisions like bioequivalence study, bioavailability study, clinical trial, clinical investigation, controlling authority, manufacturer, medical device, new drugs, over the-counter (OTC) drugs, adulterated cosmetics, etc. for more clarity and smooth functioning and implementation.
    • Drugs Technical Advisory Board (DTAB) and Medical Devices Technical Advisory Board (MDTAB):
      • It proposes the constitution of a separate Drugs Technical Advisory Board (DTAB) and Medical Devices Technical Advisory Board (MDTAB), comprising experts from various associations to advise the central government in technical matters.
    • Central Licensing Authority:
      • In the interest of public health or extreme urgency of drugs, the central government is empowered to make provisions for Central Licensing Authority to waive the requirement of conducting clinical trials for manufacture or import of new drugs or investigational new drugs in the country.

    Drugs Controller General of India

    • Drugs Controller General of India (DCGI) is the head of department of the Central Drugs Standard Control Organization of the Government of India 
    • It is responsible for approval of licences of specified categories of drugs such as blood and blood products, IV fluids, vaccines, and sera in India. 
    • Drugs Controller General of India, comes under the Ministry of Health & Family Welfare.
    • DCGI also sets standards for manufacturing, sales, import, and distribution of drugs in India.

    Source: TH