<\/p>\n
Sukesh. C. Khajuria calls for strengthening enforcement of drug quality standards\u00a0and rationalization of maximum retail price (MRP) under the Existing Legal Framework<\/p>\n
Jammu, May 12<\/p>\n
Sukesh C. Khajuria, a senior social and health activist, has submitted a representation to the Union Health Minister drawing his attention towards the matters of significant public importance\u00a0concerning the quality of pharmaceutical products and the regulation of their pricing within India.<\/p>\n
The quality of drugs is beyond the understanding of common man. It is the responsibility of the state\u00a0and centre government to ensure the availability of quality drugs to the public and the market is free\u00a0from the counterfeit, spurious and substandard drugs.<\/p>\n
Highlighting serious concern over instances of substandard, spurious, or non-uniform quality\u00a0medicines continue to be reported from time to time, Sukesh C.Khajuria wrote that such\u00a0occurrences pose a direct threat to public health, compromise patient safety, and erode public\u00a0confidence in the healthcare delivery system.<\/p>\n
He further said that these issues herein arise in the context of the effective implementation of the\u00a0statutory provisions contained in the Drugs and Cosmetics Act, 1940, the Drugs and Cosmetics Rules,\u00a01945, and the Drug (Prices Control) Order, 2013 (DPCO). While these enactments provide a\u00a0comprehensive regulatory framework, there appears to be a discernible gap in their uniform\u00a0enforcement, particularly with respect to ensuring consistent drug quality standards and rational\u00a0pricing across the pharmaceutical sector, he said.<\/p>\n
On the pricing system, the health activist said that it has been observed that there exists a wide and\u00a0often unjustified variation in the Maximum Retail Price (MRP) of identical or therapeutically\u00a0equivalent drug formulations marketed under different brand names. This disparity imposes an\u00a0unwarranted financial burden upon patients, particularly those belonging to economically vulnerable\u00a0sections of society.<\/p>\n
He submitted that the Maximum Retail Price (MRP) of medicines inherently incorporates profit\u00a0margins at multiple stages of the supply chain, including that of the manufacturer, distributor,\u00a0wholesaler, and retailer. Each such intermediary contributes to the cumulative escalation of the final\u00a0price. Further, the cost structure of medicines comprises not only raw materials and labour but also\u00a0substantial expenditure on advertising, publicity, and sales promotion. Such promotional expenses,\u00a0in certain instances, extend beyond conventional marketing practices and may include indirect or\u00a0concealed expenditures such as sponsored foreign travel, expensive gifts, cash incentives,\u00a0Continuing Medical Education (CME) programs, seminars, and other hospitality-related benefits\u00a0extended to medical practitioners and associated stakeholders. These factors significantly inflate the\u00a0overall cost of medicines without corresponding enhancement in therapeutic value, he highlighted.<\/p>\n
Sukesh C.Khajuria pointed that \u00a0online retail platforms and certain distribution channels frequently\u00a0offer discounts ranging from 10% to 50% on the MRP, thereby indicating the extent of price inflation\u00a0within the prevailing system. Moreover, under the Pradhan Mantri Bhartiya Janaushadhi Pariyojana\u00a0(Jan Aushadhi Kendras), generic medicines are made available at prices substantially lower\u2014often\u00a0between 50% to 90%\u2014than branded equivalents. These medicines are supplied under the aegis of\u00a0the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India, and\u00a0adhere to WHO-GMP standards while being tested in NABL-accredited laboratories, thereby\u00a0ensuring their quality, safety, and efficacy, he added.<\/p>\n
In this regard, Khajuria pointed to the role of the National Pharmaceutical Pricing Authority (NPPA) is\u00a0of critical importance in ensuring compliance with the provisions of the DPCO and maintaining price\u00a0discipline in the pharmaceutical market. He submitted that there is a pressing need to further\u00a0strengthen its enforcement mechanisms, monitoring capabilities, and administrative oversight to\u00a0effectively address irrational pricing practices.<\/p>\n
He also proposed that the technical expertise of the Institute of Cost Accountants of India (ICWAI)\u00a0now officially known as the Institute of Cost Accounts of India (ICMAI) located in Kolkata , with a new\u00a0headquarters in New Delhi From 2025-26 , may be formally leveraged to introduce a structured and\u00a0independent cost-audit mechanism. Such involvement would facilitate scientific determination of\u00a0pricing, validation of cost structures, and enhanced transparency, thereby contributing to more\u00a0equitable and evidence-based drug pricing policies.<\/p>\n
Sukesh C.Khajuria \u00a0prayed that the Union Health ministry should strengthen regulatory surveillance\u00a0and enforcement under the Drugs and Cosmetics Act, 1940 to ensure strict adherence to prescribed\u00a0drug quality standards, augment the functional capacity and enforcement powers of NPPA to\u00a0enable more effective monitoring and control of pharmaceutical pricing, institute \u00a0an independent\u00a0cost-audit framework, with the involvement of professional bodies such as ICWAI, for rational\u00a0fixation of MRPs based on actual and verifiable cost structures, prescribe stringent penalties and\u00a0initiating strict legal action against manufacturers, distributors, or entities found engaged in the\u00a0production or sale of substandard or overpriced medicines and enhancing transparency and public\u00a0accountability through mandatory disclosure of drug pricing methodologies and periodic publication\u00a0of quality compliance reports.<\/p>\n
He concluded by asserting that the representation has been submitted in the larger public interest\u00a0with an objective to safeguard the fundamental right to health and ensuring access to safe, effective,\u00a0and affordable medicines for all citizens and hoped that necessary and appropriate action would be\u00a0taken at the earliest.<\/p>\n
A copy of the said representation addressed to the hon\u2019ble union health and family welfare minister\u00a0Shri Jagat Prakash Nadda has also been forwarded to the chairperson, National Pharmaceutical\u00a0Pricing Authority (NPPA) & the Drugs Controller General of India (DCGI), Central drugs Standard\u00a0control organisation (CDSCO).<\/p>\n","protected":false},"excerpt":{"rendered":"
Sukesh. C. Khajuria calls for strengthening enforcement of drug quality standards\u00a0and rationalization of maximum retail price (MRP) under the Existing Legal Framework Jammu, May 12 Sukesh C. Khajuria, a senior social and health activist, has submitted a representation to the Union Health Minister drawing his attention towards the matters of significant public importance\u00a0concerning the …<\/p>\n","protected":false},"author":4,"featured_media":8737,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[92,62,33,1284,3200,91],"tags":[4025,1195,3970],"class_list":["post-8736","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-featured","category-health","category-international","category-international-political-national","category-jammu-kashmir","category-national","tag-quality-of-drug-manufacturing-in-india","tag-senior-social-activist-sukesh-c-khajuria","tag-union-health-minister-jp-nadda"],"yoast_head":"\n