- 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.
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 clinical trial data required to approve diabetes drugs in India are sub-standard and do not meet international guidelines set by the WHO.’
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.
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unpublished trials and a commercial drugs sales database (PharmaTrac) for the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
- Size: several hundred to several
- Duration: at least six months
- Design: whether the combination is
better than the individual drugs
- Side-effects: the pros have to
outweigh the cons.
None of the 25 trials reviewed met all the four WHO criteria.
- Only two trials had more than 500
- Only 10 trials lasted at least six
- 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
While all the 5 best-selling diabetes
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
- 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