Pharmaceuticals
are both boon and bane depending upon its use and misuse. For
instance, clinical trials of experimental drugs in India is going
more on the side of a bane that is emerging as a potential threat and
havoc to human lives in India.
So much so that the Supreme Court of India has
directed Health Ministry of India to monitor and regulate all
clinical trials of experimental drugs in the country until further
notice. The Court has also showed its unhappiness with the growing
use of clinical trials of experimental drugs in India without much
monitoring and said that this scenario has caused “havoc”.
Supreme Court did not stop here and it revoked the
power of the Central Drugs Standard Control Organisation (CDSCO)
under the Drugs Controller General of India (DCGI) in this regard as
well. CDSCO has been the apex agency for monitoring clinical trials
in India so far.
The Court has also directed the health secretary to
file an admissible affidavit within four weeks after it refused to
accept one filed by deputy drugs controller. The Court refused to
admit such affidavit because in October the Court made its intentions
clear that it may bar clinical trials in India unless the Health
Ministry provides information within a month regarding deaths during
such programmes. The Court also sought explanation regarding
compensation and general practices when new drugs are tested on
Indians.
Surprisingly, no laws were in place between 2005 and
2012 for new chemical entities and yet the government was approving
trials very casually. If this is not enough, illegal
and unregulated online sales of prescribed medicines in India
are happening right under the nose of Indian Government. Online
pharmacies in India are violating Indian laws and Indian
Government is least interested in curbing this practice.
We have weak 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.
