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.