Recently, the
Supreme
Court of India asked the Indian government to monitor and regulate
all clinical trials of experimental drugs in India. The
Apex Court was anguished over the manner in which clinical trials of
experimental drugs in India are handled by Indian government and its
departments.
In particular, the Apex Court was angry with the
Central Drugs Standard Control Organisation (CDSCO) that has failed
to perform its duty properly. So much so that the Apex Court revoked
the power of the CDSCO for its failure to monitor and regulate
clinical trails of experimental pharmaceuticals in India.
Meanwhile, the government is considering the report
of an expert committee set up to examine the issue of alleged
approval of drugs without clinical trial by CDSCO. The Department
related Parliamentary Standing Committee in its Report on the
functioning of CDSCO has raised various issues pertaining to
functioning of the organisation, including alleged approval of drugs
without clinical trials.
In the proceeding before the Apex Court it came to
the light that no laws were in place between 2005 and 2012 for new
chemical entities and yet the government was approving trials very
casually.
However, till now none have raised any objection
regarding the illegal
and unregulated online sales of prescribed medicines in India
that is happening right under the nose of Indian Government. Such
sale of prescribed medicines by e-commerce portals that also without
following the laws of the land is really perilious for the end
consumers. Online
pharmacies in India are violating Indian laws and Indian
government is least interested in curbing this practice.
The problem is aggravated in the absence of strong
and effective health related laws in India, including those
pertaining to online
sales of prescribed medicines in India. We have no
dedicated data
protection laws in India and privacy
laws in India. Even data
exclusivity laws in India need to be formulated. A
regulatory
framework for data exclusivity In India can be really
helpful in this regard.
The health ministry of India in general and the
Indian government in particular must take immediate action regarding
these situations otherwise serious ramifications may occur.
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