News Excerpt
In a bid to ensure that all medical devices meet certain standards of quality, the Union Health Ministry recently notified medical equipment used on humans or animals as "drugs" with effect from April 1, 2020, which means that now all imported, as well as locally manufactured medical devices sold in India will be required to clearly specific safety and quality standards before they are introduced in the India market.
The Ministry, through a gazette notification, also released the Medical Devices Amendment Rules, 2020, for mandatory registration of medical devices to ensure that all medical devices meet certain standards of quality and efficacy.

Pre-Connect
•    In line with the steady growth of the industry and in line with the ‘Make in India’, initiative by the Indian Government, the Central Drugs Standard Control Organization (CDSCO), published the new Medical Device Rules, 2017, which came into force on Jan. 1, 2018.
•    The new rules have been formulated to promote domestic manufacturing and to regulate import and manufacturing in line with the GHTF (Global Harmonization Task Force) guidelines.
•    These modifications in the medical device rules of 2017 also enable Indian manufactures to export the finished high quality products from India to the world.

About The Central Drugs Standard Control Organisation (CDSCO)
    CDSCO which is under Directorate General of Health Services, Ministry of Health & Family Welfare is the National Regulatory Authority (NRA) of India.  
    CDSCO is constantly thriving upon to bring out transparency, accountability and uniformity in its services in order to ensure safety, efficacy and quality of the medical product manufactured, imported and distributed in the country.
    Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of Drugs, Conduct of Clinical Trials, laying down the standards for Drugs, control over the quality of imported Drugs in the country and coordination of the activities of State Drug Control Organizations by providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.
    Further CDSCO along with state regulators, is jointly responsible for grant of licenses of certain specialized categories of critical Drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera.

Challenges faced by Medical Device industry
    In the past, the absence of a clear and consistent regulatory framework and lack of adequate incentives and funding for manufacture devices in India has kept the industry from realizing its full potential.
    High tax rates imposed on domestic manufacturers have made investment unappealing to some foreign companies, especially given the comparatively low amount of tax levied on imported medical goods.
    It is therefore hardly surprising that foreign firms often choose to access India’s medical market without establishing a direct presence, many companies establish factories in neighboring countries and export devices into India.

Why was the move required?
    For much of the last one year, the health sector has been at the centre of attention following revelations about faulty hip implants marketed by pharma major Johnson & Johnson.
    This has caused major embarrassment to the government, too, as it exposed the lack of regulatory teeth when it came to medical devices.
    The matter dragged on, exposing the regulatory loopholes until finally the company agreed in court to pay Rs 25 lakh eachto the 67 people who had had to undergo revision surgeries because the implants were defective.
    In fact, even after Johnson & Johnson agreed in a Texas court to shell out $1 billion to settle about 6,000 lawsuits filed by patients in the US who used its “defective” pinnacle hip implants for 10 years from 2003 to 2013 before the product was withdrawn, in India it had for a very long time maintained that it had not received any adverse events report in the product.

Way Forward
The Indian pharmaceutical industry is the world’s third largest by volume of drugs. The Industry’s journey to annual revenues of about USD 38 billion today can be attributed to world-class capabilities in formulation development, the entrepreneurial ability of the firms and the vision of the industry to establish India’s footprint in large international markets such as the United States. Indian pharmaceutical companies need to take bold strategic moves into uncharted geographies, products and technologies to reclaim its position as a world-class provider of affordable high-quality drugs. Government support in the form of investments, policy support and regulatory interventions is integral to drive this innovation-led growth. IPA can help accelerate the impact by facilitating greater collaboration between the two.

United States Food and Drug Administration (USFDA)
The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. The FDA also provides accurate, science-based health information to the public.

Other Recent Issues
Recently, 12 children died in Udhampur district of Jammu due to poisoned cough syrup (Coldbest-PC)& many more are fighting for their life in a hospital. A team of doctors attributed the deaths to the presence of diethylene glycol in the cough syrup which was consumed by all the dead children. Diethylene glycol is an anti-freezing agent that causes acute renal failure in the human body followed by paralysis, breathing difficulties and ultimately death.This is the fourth mass glycol poisoning event in India that has been caused due to a pharmaceutical drug.

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