E-DRUG: Drug regulation in India-the time is ripe for change
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[The Lancet editorial below points at a worrying state of affairs in India's drug regulatory authority (CDSCO).
The parliamentary standing committee on Health and Welfare has issued a 118
page (6MByte!) report which is available at:
http://164.100.47.5/newcommittee/reports/englishcommittees/committee%20on%20health%20and%20family%20welfare/59.pdf
One of the remarkable observations:
" 2.2 The Committee is of the firm opinion that most of the ills besetting
the system of drugs regulation in India are mainly due to the skewed priorities and perceptions of CDSCO. For decades together it has been according primacy to the propagation and facilitation of the drugs industry, due to which, unfortunately, the interest of the biggest stakeholder i.e. the consumer has never been ensured.
Taking strong exception to this continued neglect of the poor and hapless
patient, the Committee recommends that the Mission Statement of CDSCO be formulated forthwith to convey in very unambiguous terms that the organization is solely meant for public health."
Below the editorial comments from the Lancet - copied as fair use. WB]
The Lancet, Volume 379, Issue 9829, Page 1862, 19 May 2012
doi:10.1016/S0140-6736(12)60792-2Cite or Link Using DOI
Drug regulation in India-the time is ripe for change
To say that India's drug regulatory authority, the Central Drugs Standard
Control Organisation (CDSCO)-whose remit includes new drug approval,
licensing of manufacturing facilities, and regulation of drug trials-is not
fit for purpose seems a gross understatement. A damning 118-page report from the Indian Parliamentary Standing Committee on Health and Family Welfare documents its successive failings. It describes a vast, geographically disseminated organisation that is dangerously understaffed: nine officers at headquarters deal with 20 000 applications, more than 200 meetings, 700 parliamentary questions, and 150 court cases per year. There is also a dearth of medically qualified staff, poor support infrastructure, a seeming lack of coordination between departments, and a scarcity of decent computer systems.
It is therefore not surprising that, of 42 approved drugs randomly chosen
for investigation by the Committee, some had not passed through the correct
regulatory channels. But the fact that 11 had no phase 3 studies done, 13
"did not have permission for sale in any of the major developed countries",
and there was "no scientific evidence to show that.33 drugs are really
effective and safe in Indian patients" points to problems at the very
foundations of CDSCO. Its mission of meeting "the aspirations.demands and
requirements of the pharmaceutical industry", rather than the protection of
patients, is a very shaky foundation indeed.
The Committee's report has several suggestions for improvement. However,
rather than trying to overhaul an organisation that is failing so
catastrophically, India should seize this opportunity to wipe the slate
clean and form a new drug regulatory body.
A smoothly running, professional drug regulatory body is essential to
ensure, first, that high-quality, adequately assessed drugs are available to India's population and, second, that India's drug industry is regulated well enough to contribute successfully to India's domestic and export sectors. It should go without saying that whatever action India takes, the philosophy of the drug regulatory body should be the protection of patients, wherever they are.
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Full report:
http://164.100.47.5/newcommittee/reports/englishcommittees/committee%20on%20health%20and%20family%20welfare/59.pdf