Clinical research or clinical trials are conducted as an attempt to produce novel drugs and to assure that there are no clinical side effects. Yet some discrepancies and many news about negligence makes it way.
Besides strong warnings by the
parliamentary standing committee on health, novel drugs continue to
be approved for marketing in the country without holding any clinical
trials on Indian patients to test their safety and
Officials of the Indian health ministry admitted that approximately 26 novel drugs were given approval since 2010 without any conduction of any proper clinical trials on local population to test their significance.
Its reported that eight novel drug molecules of biologicals and non biologicals were given approval by the country's apex drug regulator, the Central Drugs Standard Control Organization (CDSCO).
Reports say that 13 such novel drugs were approved in 2010 and three more got approval in 2011.
Officials said that new drugs have been approved without clinical researches after taking adequate caution.
They said that such drugs are used in medical emergencies and where trials are not possible in the country due to lesser patient output and many times owing to the rarest nature of the diseases.
The officials stated that it is only after taking expert opinion that such drugs got approval.
To mention. the approval to 26 new drugs without local trials came within two years of the parliamentary panel exposing how 38 novel drugs that were approved without trials on Indians between January 2008 and October 2010.
The committee for the while came down heavily on the drug controller for allowing untested drugs to be used in India. It is reported that many such novel drugs did not fall in the category of emergency medicines.
The report had focused nation's poor drug regulatory state and soughed immediate corrective measures.
Following the report, the health ministry introduced several adoptive measures aimed to ensure safety of drugs.
The CDSCO has also written to states to prove and give evidence within 18 months the safety of all such fixed dose combination drugs which have been approved by states directly without seeking prior approval of the apex drug regulator.
In latest developments, the Indian Government has introduced a series of steps that would help promote more clinical trials in the country.
In a circular issues, Central Drug Standard Control Organization said if a novel drug has already got approval outside India after conducting clinical /toxicological studies on animals, such studies are not needed to be repeated while approving their proposal for import or manufacture in India unless there are some specific concerns.
The move was initiated in wake of concerns raised by people which complained of repeat tests and data submissions to authorities in CDSCO meetings with top officials from the health ministry.
In another decision, the Drug Controller General of India told that Ethics Committees can also approve requests for new clinical research sites and new investigators to be added to a clinical trial without CDSCO’s acknowledgement as long as the ethics committees conduct has no issues.
The new norms say clinical researchers will no longer need the permission of the Drug Controller General of India for “academic/research purposes that are non-regulatory in nature. But , the Ethics Committee is still required to inform the DCGI of the study and the DCGI will have 30 working days to object to the decision to not seek its approval.
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