Drugs Current Affairs - 2019
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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.
The Union Ministry of Home Affairs (MHA) has extended the Anti-Narcotics Scheme for 3 more years to combat illicit trafficking in drugs and psychotropic substances.
The scheme was first launched in October 2004 for period of five years. It was later extended twice in subsequent years. It aims to assist states and Union Territories financially which are contributing in controlling inter-state and cross-border drug trafficking. The main strategy under the scheme includes reduction of both supply and demand of drugs and psychotropic substances. The supply reduction will include enforcement activities and demand reduction will involve rehabilitation and de-addiction measures.
The financial assistance for narcotics control has been extended, with an estimated budget of Rs. 21 crore. It will be provided to all anti-narcotics agencies for strengthening their enforcement capabilities to combat illicit trafficking in narcotic drugs and psychotropic substances. It is also proposed to be provided for all capacity building activities, including training of personnel.
There are approximately 40 lakh drug addicts in the country. The most common drugs of abuse are ganja, hashish, opium and heroin. Moreover there is serious abuse of pharmaceutical preparations like ‘buprenorphine’, codeine based cough syrups and painkillers like ‘proxivon’. In certain regions of country, drug abuse already has become severe social-economic problem affecting vulnerable age groups.