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<\/strong><\/p>\nSource<\/strong>-This post on Issue of patent and proprietary medicine in India <\/strong>has been created based on the article \u201cPatanjali controversy and the lure of a magic cure: Safety standards dangerously fail consumers<\/strong>\u201d published in \u201cIndian Express<\/strong>\u201d on 1 March 2024.<\/p>\n UPSC Syllabus <\/strong>– GS Paper 2 –<\/strong> Issues Relating to Development and Management of Social Sector\/Services relating to Health, Education.<\/p>\n News <\/strong>– The article highlights the lack of safety standards for Ayurvedic medicines and the issue of misleading advertisements. Issue of patent and proprietary medicine in India – Lure of a magic cure<\/strong><\/p>\n Background <\/strong>– The Supreme court has criticized Patanjali Ayurveda, for making misleading claims in advertisements about its products curing diseases.<\/p>\n The difference between classical medicine and patent and proprietary medicine is explained in Drugs and Cosmetics (D&C) Act.<\/p>\n 1) Classical ASU medicine<\/strong>-It refers to drugs that are manufactured strictly in accordance with the authoritative ancient texts (granthas or samhitas) listed under the D&C Act.<\/p>\n 2) Patent and Proprietary (P&P) medicine<\/strong>-It refers to manufacture of ASU drugs by modifying the classical recipe and introducing new combinations. Patanjali and several other companies have been proactively promoting their Patent and Proprietary (P&P) drugs.<\/p>\n Read more- Perils of misleading advertisements<\/a><\/p>\n 1) Advertising drugs intended to treat or cure certain diseases is prohibited under Drugs and Magic Remedies (Objectionable Advertisements) Act 1954, which applies to all systems of medicine<\/strong>.<\/p>\n 2) Drug manufactures have to follow the Good Clinical Practice Guidelines issued by the Ministry of Ayush<\/strong>. This is done to document evidence of safe and effective use.<\/p>\n 3) To obtain a manufacturing license<\/strong>, citing scientific sources is essential and if unavailable, pre-clinical or clinical trials are required to be produced.<\/p>\n 4) The Ayush Ministry had mandated the registration<\/strong> of all medical research projects with the Indian Council of Medical Research\u2019s CTRI \u2014 Clinical Trials Registry of India database without distinction<\/strong> between allopathic or ASU (Ayurveda, Siddha and Unani) research.<\/p>\n 1) Limitation of Drugs and Magic Remedies Act<\/strong>– It does not have the power to check the license of products, to check if the products are evidence based or not.<\/p>\n 2) Misconception in minds of consumers<\/strong>– The consumer assumes that all ASU products are natural <\/strong>and consequently safe. Attracted by advertisements, consumer purchases P&P medicine over the counter without consulting any Vaidya or medical practitioner<\/strong>.<\/p>\n 3) No requirement of license<\/strong>-Unlike allopathic drugs, selling ASU medicine requires no sale license<\/strong> and all pharmacists, and even general stores and groceries, can sell these drugs without any knowledge of the drug use and dosage.<\/p>\n 4) Lax implementation by state drug controllers<\/strong>– The two Drug Acts are not administered properly by state drug controllers due to vacancies or mishandling by non-qualified persons<\/strong>.<\/p>\n <\/p>\n Read More UPSC Topics-<\/strong><\/p>\nWhat is the difference between classical and patent and proprietary medicine?<\/strong><\/h2>\n
What are the regulations regarding Patent Proprietary (P&P) drugs?<\/strong><\/h2>\n
What are the issues associated with the regulation of Patent and Proprietary (P&P) drugs?<\/strong><\/h2>\n