Panel on Drugs and Cosmetic Rules decides to form 7 sub-groups

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A committee formed to examine and recommend amendments in the Drugs and Cosmetic Rules has decided to form seven sub-groups for individual reviewing of various segments like drugs and clinical trials.
The committee has also set January 31 as the deadline for suggestions from various stakeholders.
"The committee decided that for review of the provisions of the rules, it should be segregated into different segments like drugs, medical devices, clinical trials, biologicals, blood banks and cosmetics.
"Further, the rules related to each sector may be reviewed by a sub-group and the proposed amendments would be recommended.
"Each sub-group would have a nodal person from the industry and a resource person from the Central Drugs Standard Control Organisation (CDSCO)," the minutes of the recent meeting of the committee put up by Health Ministry said.

The government had recently constituted a high-level committee to examine and recommend amendments to the Drugs and Cosmetics Rules, 1945.

"The timeline for giving first round of suggestions and comments for amendment in the said Rules would be January 31, 2015," the minutes stated.
The committee chaired by Joint Secretary (Regulation), Department of Health and Family Welfare met on January 21 and had participation of various industry associations as well.
The committee noted that after the first draft of amended rules is prepared, it would be made available in the public domain and all the stakeholders would again get the opportunity to furnish their comments.

"Consultation with the stakeholders would be an ongoing process and it would be ensured that all the associations, and other stakeholders are included in the process," the minutes said.
Representatives of Industry associations suggested that co-opting academicians and experts from reputed institutes such as AIIMS, Tata Memorial Cancer Hospital, Christian Medical College and others including those who are engaged in the conduct of clinical trials.
The committee has been formed to revisit the Drugs and Cosmetics Rules, 1945 and make recommendations for amending it to make these rules contemporary while keeping in view the requirements of quality, safety and efficacy of medical products, an earlier ministry order had stated.