Every country exercises strict control on medicines’ market access. Typically, this requires successful completion and adequate presentation of results from phase I through phase III clinical trials, bringing forward the findings of medicine’s safety and efficacy. The USFDA approves approximately 40 new medicines for the US market each year through this process. (1) In India, this number is more than 100 new medicines annually; however, there is not enough published evidence on submitted applications or summaries of approved medicines. Therefore, concerns are being raised about the safety and efficacy around medicine approvals in India in the absence of appropriate clinical trials. (2,3)
For instance, a recent study, which evaluated the clinical evidence on the safety and efficacy of the most common metformin fixed dose combinations (FDCs) for T2DM in India, has highlighted the growing national and international concerns about the Indian drug regulatory system. Findings from this study further show high numbers of unapproved medicines and their irrational combinations floating in the market. This study has assessed the basis of efficacy and safety of top-selling metformin FDCs in India against four WHO criteria from clinical trial guidelines for the approval of FDCs. In India, only five FDCs have been approved by the Central Drugs Standard Control Organization (CDSCO); while, in reality, the Indian FDC-diabetes market contributes to the two-third of all diabetes medicine sales. (4) Furthermore, evaluation of published and unpublished clinical trials of these approved FDCs seemed to show underpowered and poor quality evidence of safety and efficacy for the treatment of T2DM. (5)
The overall lack of available India-specific evidence heightens the need for its generation by publishing the unpublished trial results with Indian patients. India has in place the only required registration with Clinical Trials Registry – India, the national clinical trials database, since 2009. Moreover, the unpublished trials listed in this registry merely provide basic trial information with no results or outcomes reported. The lack of trials on Indian patients, in particular, is of concern, considering CDSCO’s guidelines for drug approvals acknowledge the importance of conducting trials on the Indian population to determine safety and efficacy.4
Additionally, the Government, with an aim to achieve Universal Health Coverage (UHC) in order to reduce huge out-of-pocket (OOP) health expenditure and ensure affordable access to essential health care for the entire population, has identified a key priority of ensuring value for money in the health budget. This requires a systematic process for generating policy-relevant evidence that can inform policy decisions regarding health resource allocation, i.e. clinical effectiveness studies, cost-effectiveness studies, budget impact studies, along with ethical, social and political feasibility studies. (6) Needless to say that the healthcare payers, regulatory authorities, and health technology assessment (HTA) agencies also make decisions on relative efficacy of the new products based on evidence generated from clinical trials. (7)
In most western countries along with the United States, the consumer rarely pays for the product—the payer is generally a third-party private or governmental insurer. Before approving a new medical entity (medicines/medical technologies) for reimbursement, private and governmental payers analyze clinical and economic data to determine the clinical value and cost-effectiveness of the new product as compared with currently available treatments. (8) Indian health system, on the other hand, is characterized by a vast but under-utilized public health infrastructure and a largely unregulated private market catering to greater need for curative action; where high OOP health expenditures hinder access to healthcare. (9)
We believe it is high time even insurance companies start asking for robust evidence in order to provide reimbursement of better healthcare technologies and easier access to care. India needs to bring about a major reform in its health insurance policies, wherein a keen eye for detail is given to the published trial data on safety and efficacy of a drug or relevant evidence about a medical technology.
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- U.S. Food and Drug Administation. New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products.
- Ministry of Health and Family Welfare, Department of Health and Family Welfare. Gazette of India, 10 March 2016. New Delhi, 2016.
- McGettigan P, et al. Regulatory upheaval and irrational medicines in India: a study of fixed-dose combination drugs. PLoS Med 2015; 12:e1001826.
- Evans V, et al. Adequacy of clinical trial evidence of metformin fixed-dose combinations for the treatment of type 2 diabetes mellitus in India. BMJ Glob Health 2018; 3:e000263.
- Shimpi RD, et al. Comparison of effect of metformin in combination with glimepiride and glibenclamide on glycaemic control in patient with Type 2 diabetes mellitus. Int J PharmTech Res 2009; 1:50–61
- Prinja S, et al. Health Technology Assessment for Policy Making in India: Current Scenario and Way Forward. Pharmacoecon Open 2018; 2(1):1-3.
- Dang A, et al. Real world evidence: An Indian perspective. Perspect Clin Res 2016; 7:156:160.
- Gold M. Getting reimbursement for your product in the United States. June, 2003.
- Prinja S, et al. Universal Health Insurance in India: Ensuring Equity, Efficiency, and Quality. Indian Journal of Community Medicine : Official Publication of Indian Association of Preventive & Social Medicine. 2012; 37(3):142-149.