The Central Drug Authority Bill, which was virtually rejected by the
Parliamentary panel, will be redrafted in line with the recommendations
of the panel pertaining to the exclusion of exports from its purview.
Sources
in the health ministry said that the bill would be amended in
accordance with the recommendations of the Parliamentary Standing
Committee on Health and the suggestions from the stakeholders. The
recommendations of the Prof Ranjit Roy Chaudhury expert panel on
clinical trials will be taken into consideration while revamping the
bill, sources said.
Commenting on the report of the
Parliamentary panel report, Drug Controller General of India (DCGI) Dr G
N Singh also felt that the bill had to be redrafted now.
One of
the key changes in the bill can be the exclusion of exports from the
the bill and also amendment to the definition of clinical trials. “The
Committee has been informed that the exporter has to ensure that the
pharma units whose drugs are proposed to be exported comply with the
Good Manufacturing Practices (GMP) guidelines issued by the World Health
Organisation (WHO). Hence, no further regulation on the export of such
drugs would be necessary,” according to the report of the panel.
“The
Committee is of the view that if export of drugs is brought within the
ambit of Drugs and Cosmetics Act/Rules, it will severely affect exports
of drugs and put domestic pharma manufacturing units/exporters at
serious disadvantage. The Committee therefore decided that the word
'export' may be omitted from this clause and consequential amendments
may be made to other clauses of the Bill,” it said.
“The
Committee decided that in the definition of clinical trial provided in
(af) (i) the words “any drug” should be substituted by “any new drug”,
since generally Bioavailability/Bioequivalence studies of approved drugs
are conducted in healthy volunteers with recommended doses,” the report
said.
“As regards the definition of clinical trial in respect
of cosmetics provided in (af) (ii) the words “of a cosmetic including a
new cosmetic” should be substituted by the words “of any new cosmetic”
as the cosmetics containing approved ingredients are generally
considered safe. The Committee, therefore, recommends that clinical
trials of all cosmetics may not be required to be regulated. Clinical
trials of only cosmetics having new ingredients (new cosmetics) should
be regulated,” the panel said.
“In the definition of clinical
trial in respect of medical device provided in (af) (iii) line 2, after
the words “study of a” the words “medical device” should be omitted as
the medical devices are approved in the country after ensuring their
safety and effectiveness. Clinical trials of all medical devices may not
be required to be regulated. Therefore, Committee recommends that
clinical trials of only new medical devices should be regulated,” it
added.
