Health In Focus
  • India’s top selling diabetes drugs found to be sub-standard and do meet the international standards set by the World Health Organization.
  • Fixed dose combinations (FDC), the choice of drugs used to treat diabetes in India is not recommended to treat type 2 diabetes.
  • The sub-standard drugs not only increase potential risks for patients but also questions the integrity of the drug regulatory system in India.

The data based on which India's top selling diabetes drugs have been approved by the drug regulatory system in India is of poor quality, finds new study. The requisite trial data that is required to approve any drug fell short of the international standards set by the World Health Organization (WHO), according to the study published in the journalBMJ Global Health.

Diabetes Drugs in India

Often referred as 'the diabetes capital of the world', India has nearly 60 million people affected with type 2 diabetes and the number is on the rise. Two thirds of all diabetes drugs sold in India are fixed dose combinations or FDCs which often contain metformin and one other drug.
Two-thirds of All Diabetes Drugs Sold in India Below International Standards

It is important to note that national and international guidelines do not recommend FDCs for treating type 2 diabetes. This is due to the fact that these drugs require constant monitoring and adjustment of doses in order to maintain adequate blood glucose control.

The drug regulatory system in India, the Central Drugs Standard Control Organization (CDSCO), approves more than 100 new medicines each year based on clinical data results. However, the new study set out to scrutinise the clinical trial data for the top five bestselling FDCs in the country.

Study Overview

The study acquired data on the top five bestselling FDCs in India from 25 published and unpublished trials and a commercial drugs sales database (PharmaTrac) for the 12 months from November 2011 to October 2012.

All the trial data were reviewed for four WHO standards set for FDC approval.
  • Size: several hundred to several thousand participants)
  • Duration: at least six months
  • Design: whether the combination is better than the individual drugs
  • Side-effects: the pros have to outweigh the cons.

Study Findings

None of the 25 trials reviewed met all the four WHO criteria.
  • Only two trials had more than 500 participants
  • Only 10 trials lasted at least six months
  • Only one trial was designed to show whether the combination was better than the individual drugs alone
  • No study assessed the balance between the pros and cons.
  • Only three trials had been conducted in India! (Taking into consideration that the drug was aimed for the Indian population)
While all the 5 best-selling diabetes drugs were approved by the CDSCO, 3 of them were already sold and marketed before they were submitted for regulatory approval.

Moreover, four out the five FDCs were on the list of 'FDCs banned by the Ministry of Health and Family Welfare' in March 2016. However the ban was overturned by the Delhi High Court and the decision was upheld by the Supreme Court in 2017. But the extensive lobbying by multinational companies that pushed for the verdict is not a hidden fact.

18 of the 25 clinical trials were sponsored by multinational corporations or conducted by pharmaceutical companies which prompts us to question the independence of the CDSCO and the approval process.

"The poor quality of available published trials and their funding sources raise concerns about the motivation for conducting these trials and whether the sponsors are using them for seeding or marketing purposes to gain a foothold in country markets," said the authors of the study.

The study recommends that CDSCO go public on the data it used to approve these drugs and tighten regulations that promote irrational FDCs from entering the market.

Reference :
  1. Valerie Evans, Peter Roderick, Allyson M Pollock. Adequacy of clinical trial evidence of metformin fixed-dose combinations for the treatment of type 2 diabetes mellitus in India. BMJ Global Health, (2018) DOI: 10.1136/bmjgh-2016-000263

Source: Medindia

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