Ministry of Health and Family Welfare Current Affairs
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Union Ministry of Health & Family Welfare has notified four medical devices including blood pressure monitors, nebulisers, digital thermometers and glucometers as drugs under Drugs and Cosmetics Act, 1940. The decision will enable the government to ensure their quality and performance. Drug Controller General of India (DCGI) will regulate import, manufacture and sale of these devices from January 2020.
Companies which are engaged in manufacture and import of these equipment will have to seek necessary permission or license from DCGI from January 1, 2020 onward. All these devices will have to be registered under quality parameters prescribed under Medical Devices Rules, 2017 and other standards set by Bureau of Indian Standard (BIS) certification.
With addition of these four new devices, the number of medical devices falling under definition of drugs under this law goes up to 27. Prior to this, only 23 medical devices were monitored for quality by DCGI. The other medical equipments are sold without any quality checks or clinical trials. Drug Technical Advisory Body (DTAB), the country’s highest drug advisory body earlier had approved the proposal to include these four medical devices under purview of Drug law.
Union Health Ministry has proposed expanding list of medical devices in eight new categories under definition of ‘drugs’ to bring them under purview of Drugs and Cosmetics Act, 1940. The eight categories include implantable medical devices, CT scan equipment, MRI equipment, defibrillators, implants, PET equipment, dialysis machines, X-ray machines and bone marrow cell separator.
Drugs Controller General of India (DCGI)
DCGI under gamut of Central Drugs Standard Control Organization (CDSCO) is responsible for approval of licenses of specified categories of drugs such as blood and blood products, vaccines, IV fluids and sera in India. DCGI lays down standards and quality of manufacturing, selling, import and distribution of drugs in India. It acts as appellate authority in case of any dispute regarding quality of drugs. It prepares and maintains national reference standard. It brings about uniformity in enforcement of Drugs and Cosmetics Act. It trains Drug Analysts deputed by State Drug Control Laboratories and other Institutions.
Union Ministry of Health and Family Welfare issued advisory to all states and Union Territories to not allow manufacture, sale and advertisement of e-cigarettes and other Electronic Nicotine Delivery Systems (ENDS). It also has issued warning that use e-cigarettes and other ENDS devices pose great health risk to public at large, especially to children and pregnant women. Punjab, Karnataka, Kerala, Mizoram, Jammu and Kashmir, Uttar Pradesh and Bihar already have prohibited manufacture, import, sale and distribution of e-cigarettes and ENDS.
e-cigarettes and ENDS
ENDS are devices that heat solution to create aerosol, which also frequently contains flavours, usually dissolved into propylene glycolor and glycerin. e-cigarettes (electronic cigarettes) are most common prototype of ENDS. These devices do not burn or use tobacco leaves but instead vaporise solution, which user then inhales. The main constituents of solution are nicotine, propylene glycol (with or without glycerol and flavouring agents).
Health Ministry Advisory
According to World Health Organisation (WHO) report on Global Tobacco Epidemic 2017, 30 countries like Mauritius, Australia, Singapore, South Korea, Sri Lanka, Thailand, Brazil, Mexico, Uruguay, Bahrain, Iran, Saudi Arabia and UAE have already banned ENDS.
ENDS including e-cigarettes, heat-not-burn devices, vape, etc. are great health risk to public at large, especially to children, adolescents, pregnant women and women of reproductive age. ENDS are not approved as NRTs (nicotine-replacement therapies) under Drugs and Cosmetics Act and rules made thereunder.
ENDS solutions and emissions contain other chemicals, some of them considered to be toxicants. They contain nicotine, addictive component of tobacco products. In addition they contain metals, including lead, chromium and nickel and chemicals like formaldehyde with concentrations equal to or greater than traditional cigarettes.
Use of ENDS may affect development of foetus during pregnancy. It may contribute to cardiovascular disease to people who use ENDS. Moreover, nicotine may function as ‘tumour promoter’ and seems to be involved in biology of malignant diseases. Foetal and adolescent nicotine exposure have long-term consequences for brain development, potentially leading to learning and anxiety disorders.