India has over the years seen a sharp decline in clinical
trials. This is inadequate for a country with the second highest population and
the highest disease burden in the world. However, the rules have been changing
since some time, which has been changing the scenario. With the new rules and regulations, confidence is being seen among stakeholders.
With the older rules, India was always on a decline of
clinical trials. Worldwide clinical trials kept on taking place, but India was
not a part of those trials. This came as a very bad phase for India as the
country is 16% of the world’s population, and has 20% of the global disease
burden! The European Union has 30% of clinical studies in the world, the US has
40% of clinical studies, and China has ten times the number of studies India
has.
On March 19, the Ministry of Health and Family welfare
announced the new set of rules, according to which the time for approving
applications has been reduced to 30 days for drugs manufactured in India, and
90 days for drugs manufactured outside the country. And, in case there is no
communication regarding the same within 30 days, the trial will be deemed to
have been approved. Earlier, it took almost 6 to 18 months to approve a
medicine! Thus, it is clear that the main reason for India to fail the success
of clinical trials is the speed of approvals. The rules brought forwards now will
be applied to not only clinical trials, but also bio-availability or
bio-equivalence studies, new drugs and regulation of ethics committees related
to clinical trials and biomedical health research. The rules got amended to
become more balanced with protected rights, safety, and well-being of the
patients, while also facilitating the conduct of ethical clinical trials in the
country.
Clinical trials in India went through a very challenging few
years, and it is still in the process of rebuilding the trust and confidence of
sponsors in placing trials in India. Today, India is the only country where
there is audio-visual recording of informed consents. And, there is also a
formula to determine compensation to be awarded for any trial-related injury.
Also, as per the current set of rules, Indian companies are given incentives to
innovate. In addition, lots of efforts for years went into educating people on
various levels to make them understand the benefits of clinical research.
Patients are an important part of a clinical trial process. They
need treatments to make them feel better. Clinical trials help the patient to
have lesser symptoms, while controlling the progress of the diseases to some
extent. After all, research doesn’t mean only clinical trials; it means
understanding the population. Thus, public awareness and education is important
in clinical research. The public needs to understand the role that clinical
trials play in the drug development process, and the ethical and legal
framework under which they are planned, conducted, and reported. In addition,
it is also important to spread awareness about clinical research within the
medical community. The government should also invest in good governance so that
adherence to regulations and ethical processes can be monitored and
non-compliance, if any, can be appropriately addressed, thus building
confidence across all stakeholders. Indian regulators have taken several steps
to restore the balance and bring about transparency in regulations that govern
clinical research in the country.
With
such importance being given to clinical trials in the country today, the Indian
clinical research industry sure has a bright future. You can set up a career in
the field and have a bright future too by enrolling yourself at one of the best
clinical research institutes in Bangalore
– Avigna Clinical Research Institute. Here, you will be mentored by qualified and
experienced professors, and will gain a legitimate certificate that can help
you fetch a job in the best companies in and out of the country.
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