{"id":15214,"date":"2021-05-14T00:00:00","date_gmt":"2021-05-14T00:00:00","guid":{"rendered":"https:\/\/www.nextias.com\/current_affairs\/uncategorized\/14-05-2021\/counterfeit-drugs-in-india\/"},"modified":"2021-05-14T00:00:00","modified_gmt":"2021-05-14T00:00:00","slug":"counterfeit-drugs-in-india","status":"publish","type":"post","link":"https:\/\/www.nextias.com\/ca\/current-affairs\/14-05-2021\/counterfeit-drugs-in-india","title":{"rendered":"Counterfeit Drugs in India"},"content":{"rendered":"<p><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong><u>In News<\/u><\/strong><\/span><\/span><\/span><\/p>\n<p><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">Recently, courts have passed <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>strict orders against fake drugs<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"> and hoarding and black-marketing of medicines and medical devices.<\/span><\/span><\/span><\/p>\n<ul>\n<li style=\"list-style-type:disc\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>Hoarding <\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">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.<\/span><\/span><\/span><\/li>\n<li style=\"list-style-type:disc\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>Black marketing<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"> 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.<\/span><\/span><\/span><\/li>\n<\/ul>\n<p><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong><u>Fake Drugs<\/u><\/strong><\/span><\/span><\/span><\/p>\n<ul>\n<li style=\"list-style-type:disc\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">These are a type of <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>counterfeit medicines<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"> which do not contain any <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>active pharmaceutical ingredients<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"> (APIs).<\/span><\/span><\/span>\n<ul>\n<li style=\"list-style-type:circle\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">API is any<\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong> substance or combination of substances<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"> used in a <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>Finished Pharmaceutical Product<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"> (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.<\/span><\/span><\/span><\/li>\n<\/ul>\n<\/li>\n<li style=\"list-style-type:disc\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">The <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>problem <\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">of fake drugs is <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>not new and has been flagged several times <\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">earlier as well.<\/span><\/span><\/span><\/li>\n<li style=\"list-style-type:disc\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">Countries that have<\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong> weak governance<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"> or are <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>affected by war or unrest<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"> mostly face the problem of fake drugs circulating.<\/span><\/span><\/span>\n<ul>\n<li style=\"list-style-type:circle\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>Africa <\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">is the<\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong> continent with the highest proportion of fake<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"> medicines.<\/span><\/span><\/span><\/li>\n<\/ul>\n<\/li>\n<li style=\"list-style-type:disc\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>Impacts<\/strong><\/span><\/span><\/span>\n<ul>\n<li style=\"list-style-type:circle\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">Fake drugs hamper efforts to control the disease<\/span><\/span><\/span><\/li>\n<li style=\"list-style-type:circle\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">Severe impact on overall healthcare, causing adverse side effects or worsening the spread of diseases.<\/span><\/span><\/span><\/li>\n<li style=\"list-style-type:circle\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">It is difficult to quantify morbidity and mortality effects of fake drugs, but they are certainly substantial.<\/span><\/span><\/span><\/li>\n<\/ul>\n<\/li>\n<li style=\"list-style-type:disc\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>Unregulated websites<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">, which allow people to buy drugs without a prescription, make these products <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>available worldwide<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">.\u00a0<\/span><\/span><\/span><\/li>\n<li style=\"list-style-type:disc\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>Fraudulent agents<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"> sell fake drugs illegally under the name of a certain pharmaceutical company that is almost always unaware of it.<\/span><\/span><\/span><\/li>\n<\/ul>\n<p style=\"text-align:center\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><img decoding=\"async\" src=\"https:\/\/lh3.googleusercontent.com\/z-NDTbWQXuIN5stSJ3DM5ZacT5BaWnZjR-YKU3YYraBCKkrxDEuRN1idYIVEYpq2ufga7sOA5gPebuT2QSyxA2BDzCY5IiKByjbVKS2leu_VId9e6YblLKsM0ksFMty2aG6moXiO\" style=\"height:347px; width:462px\" \/><\/span><\/span><\/span><\/p>\n<p style=\"text-align:center\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">(Image Source: <\/span><\/span><\/span><a href=\"https:\/\/slideplayer.com\/slide\/3914641\/\" style=\"text-decoration:none\" target=\"_blank\" rel=\"noopener\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#1155cc\"><u>SP<\/u><\/span><\/span><\/span><\/a><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">)<\/span><\/span><\/span><\/p>\n<p>\u00a0<\/p>\n<p style=\"text-align:center\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><img decoding=\"async\" src=\"https:\/\/lh6.googleusercontent.com\/k7jeyYU5YnGk0XCwm6nyaszwPREBnz-IvnQmfmPxcVK9qzadBVlNnvtJ1SkBYnX5WHp4u6CV6Iljiam4XrNxeO-G83-nEmS8yCDl20jg_BuC4lt9NtBZ75SsH53ZAkWCk6EG898c\" style=\"height:542px; width:509px\" \/><\/span><\/span><\/span><\/p>\n<p style=\"text-align:center\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">(Image Courtesy: <\/span><\/span><\/span><a href=\"https:\/\/www.nature.com\/news\/health-agency-reveals-scourge-of-fake-drugs-in-developing-world-1.23051\" style=\"text-decoration:none\" target=\"_blank\" rel=\"noopener\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#1155cc\"><u>nature<\/u><\/span><\/span><\/span><\/a><\/p>\n<p><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong><u>Data Analysis<\/u><\/strong><\/span><\/span><\/span><\/p>\n<ul>\n<li style=\"list-style-type:disc\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">An estimated <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>one in 10 medical products <\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">in low- and middle-income countries is substandard or falsified, according to the <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>World Health Organization<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"> (WHO).<\/span><\/span><\/span><\/li>\n<li style=\"list-style-type:disc\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">A study estimated that <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>one-third of drugs sold in India are fake<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">.<\/span><\/span><\/span><\/li>\n<li style=\"list-style-type:disc\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">According to the <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>Pharmaceutical Security Institut<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">e (a non-profit trade association set up to tackle the problem of counterfeit medication), <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>India and Turkey <\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">have large illegal medicine distribution networks.<\/span><\/span><\/span>\n<ul>\n<li style=\"list-style-type:circle\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">India plays the role of \u201c<\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>Pharmacy to the World<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">\u201d because of its<\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong> extensive production of drugs and vaccines<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"> to combat viruses.<\/span><\/span><\/span><\/li>\n<\/ul>\n<\/li>\n<li style=\"list-style-type:disc\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">India is also the <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>world\u2019s leading producer of fake drugs<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">, according to research by the <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>Organisation for Economic Co-operation and Development<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"> (OECD) and the <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>European Union\u2019s Intellectual Property Office<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">.<\/span><\/span><\/span><\/li>\n<li style=\"list-style-type:disc\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">Just <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>one-fourth of the 12,000 manufacturing units<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"> in India have been found to <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>comply with the WHO\u2019s good manufacturing practices<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">.<\/span><\/span><\/span><\/li>\n<\/ul>\n<p style=\"text-align:center\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><img decoding=\"async\" src=\"https:\/\/lh4.googleusercontent.com\/vEBI499gYCeceFliwV4pBvCrdFeoc7buZt6d5PxvPYzzIn8FpappKx1sG3GkdlpV-22e-Ag2R8QTx0CGSpwHvwz-dvWC7YJumyX-KjJquFn1WPvthoaAz4qZlFotTGTHyy1d6IRP\" style=\"height:343px; width:482px\" \/><\/span><\/span><\/span><\/p>\n<p style=\"text-align:center\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">(Image Courtesy: <\/span><\/span><\/span><a href=\"https:\/\/www.ft.com\/content\/1bb3c839-d796-46f8-a2cd-519122a5908c\" style=\"text-decoration:none\" target=\"_blank\" rel=\"noopener\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#1155cc\"><u>FT<\/u><\/span><\/span><\/span><\/a><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">)<\/span><\/span><\/span><\/p>\n<p><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong><u>Challenges<\/u><\/strong><\/span><\/span><\/span><\/p>\n<ul>\n<li style=\"list-style-type:disc\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">In <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>2003<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">, <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>Mashelkar Committee<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"> noted that although the <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>Drugs and Cosmetics Act 1940<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"> has been in force, the<\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong> level of enforcement<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"> in many States has been <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>unsatisfactory<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">.<\/span><\/span><\/span>\n<ul>\n<li style=\"list-style-type:circle\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">The <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>non-uniformity in the interpretation<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"> of the provisions of laws and their implementation and the<\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong> varying levels of competence<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"> of the regulatory officials are the main reasons for this less than satisfactory performance.<\/span><\/span><\/span><\/li>\n<\/ul>\n<\/li>\n<li style=\"list-style-type:disc\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">It also highlighted <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>other concerns <\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">like<\/span><\/span><\/span>\n<ul>\n<li style=\"list-style-type:circle\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">Inadequate or weak drug control infrastructure at the State and Central level.<\/span><\/span><\/span><\/li>\n<li style=\"list-style-type:circle\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">Inadequate testing facilities.<\/span><\/span><\/span><\/li>\n<li style=\"list-style-type:circle\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">Shortage of drug inspectors.<\/span><\/span><\/span><\/li>\n<li style=\"list-style-type:circle\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">Non-uniformity of enforcement.<\/span><\/span><\/span><\/li>\n<li style=\"list-style-type:circle\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">Lack of specially trained cadres for specific regulatory areas.<\/span><\/span><\/span><\/li>\n<li style=\"list-style-type:circle\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">Non-existence of data banks.<\/span><\/span><\/span><\/li>\n<li style=\"list-style-type:circle\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">Non-availability of accurate information.<\/span><\/span><\/span><\/li>\n<\/ul>\n<\/li>\n<li style=\"list-style-type:disc\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">Most of the <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>prosecution cases<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"> pertaining to offences related to fake drugs <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>remain undecided<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"> for years.<\/span><\/span><\/span><\/li>\n<li style=\"list-style-type:disc\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">Although <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>India\u2019s supply chain<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"> of legitimate drugs is <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>robust<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">, there is a lack of <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>checks and controls <\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">when patients go to buy them and other related enforcements.<\/span><\/span><\/span><\/li>\n<li style=\"list-style-type:disc\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">As per <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>2019 <\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">statistics, India had only <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>47 drug testing facilities<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"> under the <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>National Good Laboratory Practice programme<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">.<\/span><\/span><\/span><\/li>\n<\/ul>\n<p><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong><u>Suggestions<\/u><\/strong><\/span><\/span><\/span><\/p>\n<ul>\n<li style=\"list-style-type:disc\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">There should be a <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>separate provision for speedy trials<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"> of such offences with <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>severe, sure and swift punishment<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">.<\/span><\/span><\/span><\/li>\n<li style=\"list-style-type:disc\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">Pharmaceutical products <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>should not be produced in the equivalent of garages and good manufacturing practices<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">.<\/span><\/span><\/span><\/li>\n<li style=\"list-style-type:disc\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>Drugs inspectors<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"> should register FIRs, arrest and prosecute (for cognizable crimes) for related crimes.<\/span><\/span><\/span><\/li>\n<li style=\"list-style-type:disc\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">The government must<\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong> focus on quality and ensure that patient safety takes precedence over geography <\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">for medicines, in order to give patients the safest option available, whether it comes from the domestic market or overseas.<\/span><\/span><\/span><\/li>\n<li style=\"list-style-type:disc\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>Manufacturing units<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"> in India should <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>comply with the WHO\u2019s good manufacturing practices<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">, the mandatory quality regulations that drug makers must adhere to.<\/span><\/span><\/span><\/li>\n<li style=\"list-style-type:disc\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">The <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>Drugs Controller General of India<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"> (DCGI) should work<\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong> closely with local drug control authorities and pharmaceutical companies<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"> to get to the root of the problem.<\/span><\/span><\/span>\n<ul>\n<li style=\"list-style-type:circle\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">A <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>joint effort is needed <\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">so that well-defined protocols are followed to help combat the crisis of fake drugs and ensure the safety of patients.<\/span><\/span><\/span><\/li>\n<\/ul>\n<\/li>\n<li style=\"list-style-type:disc\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">It is <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>important for the DCGI to do a proper quality check and clearly state<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"> whether the drug tested falls under the category of a <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>poor quality or fake<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"> drug.<\/span><\/span><\/span><\/li>\n<li style=\"list-style-type:disc\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>Counterfeit drug sellers at the retail level <\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">that should be <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>held responsible<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"> as they procure these from dubious suppliers.<\/span><\/span><\/span><\/li>\n<li style=\"list-style-type:disc\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">India needs a<\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong> regulatory mechanism<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"> that not only promises an<\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong> influx of innovative drugs<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"> from around the world, but also <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>ensures <\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">that the patients have <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>access to superior quality products<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">.<\/span><\/span><\/span><\/li>\n<\/ul>\n<p><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong><u>Preventive Measures<\/u><\/strong><\/span><\/span><\/span><\/p>\n<ul>\n<li style=\"list-style-type:disc\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">Assistance is provided under the<\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong> World Bank assisted Capacity Building Project<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"> 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.<\/span><\/span><\/span><\/li>\n<li style=\"list-style-type:disc\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">The <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>Drugs and Cosmetics Act, 1940<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"> has been amended by the <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>Drugs and Cosmetics (Amendment) Act, 2008<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"> for providing <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>more stringent penalties<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"> to those involved in the trade of spurious drugs. Some <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>offences <\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">have become <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>non-bailable<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">.<\/span><\/span><\/span><\/li>\n<li style=\"list-style-type:disc\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">There are <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>specially designated courts<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"> and <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>regulatory infrastructure<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"> has been <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>strengthened<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">.<\/span><\/span><\/span><\/li>\n<li style=\"list-style-type:disc\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">The <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>Whistleblower Scheme<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"> was launched by the <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>Ministry of Health and Family Welfare <\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">in <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>August 2009<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"> to reward any individual who gives information related to fake drugs.<\/span><\/span><\/span><\/li>\n<\/ul>\n<div>\n<table cellspacing=\"0\" style=\"border-collapse:collapse; border:none; table-layout:fixed; width:624px\">\n<tbody>\n<tr>\n<td style=\"background-color:#fff2cc; border-bottom:1px solid #000000; border-left:1px solid #000000; border-right:1px solid #000000; border-top:1px solid #000000; vertical-align:top\">\n<p><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong><u>Drugs Controller General of India<\/u><\/strong><\/span><\/span><\/span><\/p>\n<ul>\n<li style=\"list-style-type:disc\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">It is the apex department of the <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>Central Drugs Standard Control Organization<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"> (CDSCO) of the Government of India.<\/span><\/span><\/span>\n<ul>\n<li style=\"list-style-type:circle\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">CDSCO is a <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>regulatory body for Indian pharmaceuticals and medical devices<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">.<\/span><\/span><\/span><\/li>\n<\/ul>\n<\/li>\n<li style=\"list-style-type:disc\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">It comes under the <\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>Ministry of Health and Family Welfare<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">.<\/span><\/span><\/span><\/li>\n<li style=\"list-style-type:disc\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>Functions:<\/strong><\/span><\/span><\/span>\n<ul>\n<li style=\"list-style-type:circle\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>Approval of licences<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"> of specified categories of drugs such as blood and blood products, IV fluids, vaccines and sera in India.<\/span><\/span><\/span><\/li>\n<li style=\"list-style-type:circle\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"><strong>Sets standards<\/strong><\/span><\/span><\/span><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\"> for the manufacturing, sales, import, and distribution of drugs in India.<\/span><\/span><\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<p><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#000000\">Source: <\/span><\/span><\/span><a href=\"https:\/\/www.financialexpress.com\/opinion\/fighting-fakes-in-pharma-the-problem-isnt-new\/2250926\/\" style=\"text-decoration:none\" target=\"_blank\" rel=\"noopener\"><span style=\"font-size:10pt\"><span style=\"font-family:Arial\"><span style=\"color:#1155cc\"><u>FE<\/u><\/span><\/span><\/span><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>In News 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 [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":15215,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[21],"tags":[31,62,30,26,47,39,33],"class_list":["post-15214","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-current-affairs","tag-government-policies-interventions","tag-growth-development","tag-gs-2","tag-gs-3","tag-health","tag-issues-arising-out-of-their-design-implementation","tag-science-technology"],"acf":[],"jetpack_featured_media_url":"https:\/\/wp-images.nextias.com\/cdn-cgi\/image\/format=auto\/ca\/uploads\/2023\/07\/2632078current-affairs.jpg","_links":{"self":[{"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/posts\/15214","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/comments?post=15214"}],"version-history":[{"count":0,"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/posts\/15214\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/media\/15215"}],"wp:attachment":[{"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/media?parent=15214"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/categories?post=15214"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/tags?post=15214"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}