Saturday, March 16, 2013

Truth of Generic medicines

Drugs still being approved without clinical trials
By Dinesh C. Sharma in New Delhi
IT’S ‘ business as usual’ at the drug controller general’s office despite the criticism it was subjected to in the report of the parliamentary standing committee on health last year.
The drug controller is still approving new drugs without clinical trials using its undefined discretionary powers — the very practice for which it was reprimanded by lawmakers.
As many as 15 new drugs have been recommended for approval without any clinical trial and nine of them have been approved since the committee’s recommendation came in May 2012.
Drugs can be approved without clinical trials on Indian patients only in case of medical emergencies or when there is no alternative available.
The drug controller general works through a set of 12 drug advisory committees which screen applications from drug companies.
Between May and November 2012, these committees approved 15 new drugs without asking for clinical trials and nine of them got the final seal of approval from the drug controller.
These drugs are Degarelix, Abiraterone acetate, Plerixafor, Eribulin mesylate, Mucotrol, Crizotinib, Etravirine, Nelarabine, Fingolimod, Tolvaptan, Rilpivirine, Vemurafenib, Lipiodol UF, Cabazitaxel and Panitumumab.
The terms of reference of the drug advisory committees do not specifically mention any powers to approve drugs without clinical trials. There is no standard operating procedure for giving such approvals.
What’s worse, a health ministry- appointed panel wants this practice to continue. An opinion poll conducted by the panel among selected medical experts has come out with the conclusion that drugs can be approved without India- specific clinical trials being done.
“ This is making mockery of the regulatory system”, said Dr Anand Rai, petitioner in the ongoing litigation on clinical trials in the Supreme Court.
THE REGULATION MESS
Parliamentary panel pointed to loopholes in drug regulation including approval of drugs without any clinical trials on Indian patients
Instead of acting on this, the health ministry set up an expert panel to review recommendations of the parliamentary committee
The panel conducted an opinion poll among select medical experts and concluded that the practice should continue, with minor cosmetic changes
Nine drugs have been approved without clinical trials on Indian patients between May and Nov 2012
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