Counterfeit Drugs in India

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    Recently, courts have passed strict orders against fake drugs and hoarding and black-marketing of medicines and medical devices.

    • Hoarding is stocking up items in anticipation of shortage or scarcity of items and it, in itself is not a crime but selling hoarded drugs without a licence is.
    • Black marketing means charging a premium when there is a shortage as prices will be higher than expected. A black market occurs when the price at which a product is sold is higher than an administratively determined price.

    Fake Drugs

    • These are a type of counterfeit medicines which do not contain any active pharmaceutical ingredients (APIs).
      • API is any substance or combination of substances used in a Finished Pharmaceutical Product (FPP), intended to furnish pharmacological activity or to otherwise have direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to have direct effect in restoring, correcting or modifying physiological functions in human beings.
    • The problem of fake drugs is not new and has been flagged several times earlier as well.
    • Countries that have weak governance or are affected by war or unrest mostly face the problem of fake drugs circulating.
      • Africa is the continent with the highest proportion of fake medicines.
    • Impacts
      • Fake drugs hamper efforts to control the disease
      • Severe impact on overall healthcare, causing adverse side effects or worsening the spread of diseases.
      • It is difficult to quantify morbidity and mortality effects of fake drugs, but they are certainly substantial.
    • Unregulated websites, which allow people to buy drugs without a prescription, make these products available worldwide
    • Fraudulent agents sell fake drugs illegally under the name of a certain pharmaceutical company that is almost always unaware of it.

    (Image Source: SP)

     

    (Image Courtesy: nature

    Data Analysis

    • An estimated one in 10 medical products in low- and middle-income countries is substandard or falsified, according to the World Health Organization (WHO).
    • A study estimated that one-third of drugs sold in India are fake.
    • According to the Pharmaceutical Security Institute (a non-profit trade association set up to tackle the problem of counterfeit medication), India and Turkey have large illegal medicine distribution networks.
      • India plays the role of “Pharmacy to the World” because of its extensive production of drugs and vaccines to combat viruses.
    • India is also the world’s leading producer of fake drugs, according to research by the Organisation for Economic Co-operation and Development (OECD) and the European Union’s Intellectual Property Office.
    • Just one-fourth of the 12,000 manufacturing units in India have been found to comply with the WHO’s good manufacturing practices.

    (Image Courtesy: FT)

    Challenges

    • In 2003, Mashelkar Committee noted that although the Drugs and Cosmetics Act 1940 has been in force, the level of enforcement in many States has been unsatisfactory.
      • The non-uniformity in the interpretation of the provisions of laws and their implementation and the varying levels of competence of the regulatory officials are the main reasons for this less than satisfactory performance.
    • It also highlighted other concerns like
      • Inadequate or weak drug control infrastructure at the State and Central level.
      • Inadequate testing facilities.
      • Shortage of drug inspectors.
      • Non-uniformity of enforcement.
      • Lack of specially trained cadres for specific regulatory areas.
      • Non-existence of data banks.
      • Non-availability of accurate information.
    • Most of the prosecution cases pertaining to offences related to fake drugs remain undecided for years.
    • Although India’s supply chain of legitimate drugs is robust, there is a lack of checks and controls when patients go to buy them and other related enforcements.
    • As per 2019 statistics, India had only 47 drug testing facilities under the National Good Laboratory Practice programme.

    Suggestions

    • There should be a separate provision for speedy trials of such offences with severe, sure and swift punishment.
    • Pharmaceutical products should not be produced in the equivalent of garages and good manufacturing practices.
    • Drugs inspectors should register FIRs, arrest and prosecute (for cognizable crimes) for related crimes.
    • The government must focus on quality and ensure that patient safety takes precedence over geography for medicines, in order to give patients the safest option available, whether it comes from the domestic market or overseas.
    • Manufacturing units in India should comply with the WHO’s good manufacturing practices, the mandatory quality regulations that drug makers must adhere to.
    • The Drugs Controller General of India (DCGI) should work closely with local drug control authorities and pharmaceutical companies to get to the root of the problem.
      • A joint effort is needed so that well-defined protocols are followed to help combat the crisis of fake drugs and ensure the safety of patients.
    • It is important for the DCGI to do a proper quality check and clearly state whether the drug tested falls under the category of a poor quality or fake drug.
    • Counterfeit drug sellers at the retail level that should be held responsible as they procure these from dubious suppliers.
    • India needs a regulatory mechanism that not only promises an influx of innovative drugs from around the world, but also ensures that the patients have access to superior quality products.

    Preventive Measures

    • Assistance is provided under the World Bank assisted Capacity Building Project to upgrade testing facilities and to establish new drug testing laboratories so as to enhance the capacity of laboratories to test large numbers of samples.
    • The Drugs and Cosmetics Act, 1940 has been amended by the Drugs and Cosmetics (Amendment) Act, 2008 for providing more stringent penalties to those involved in the trade of spurious drugs. Some offences have become non-bailable.
    • There are specially designated courts and regulatory infrastructure has been strengthened.
    • The Whistleblower Scheme was launched by the Ministry of Health and Family Welfare in August 2009 to reward any individual who gives information related to fake drugs.

    Drugs Controller General of India

    • It is the apex department of the Central Drugs Standard Control Organization (CDSCO) of the Government of India.
      • CDSCO is a regulatory body for Indian pharmaceuticals and medical devices.
    • It comes under the Ministry of Health and Family Welfare.
    • Functions:
      • Approval of licences of specified categories of drugs such as blood and blood products, IV fluids, vaccines and sera in India.
      • Sets standards for the manufacturing, sales, import, and distribution of drugs in India.

    Source: FE