As per the recommendations of the Prof Ranjit Roy Choudhury committee, the Drugs Controller General of India (DCGI) has renamed new drug advisory committees (NDACs) as subject expert committees (SECs).    

Prof Ranjit Roy Choudhury committee was constituted by the Union health ministry last year to formulate policy, guidelines and standard operating procedures (SOPs) for approval of new drugs including biologicals, clinical trials, banning of drugs and to formulate guidelines and SOPs on the functioning of new drug advisory committees (NDACs).  The committee submitted its recommendations to the ministry late last year.

As per the action on the committee recommendations, all the 12 NDACs will be renamed as subject expert committees (SECs). The members for their meetings will be drawn randomly from a large pool of experts.  Applications of clinical trials and new drugs will initially be evaluated by the SECs and their recommendations will be reviewed by Technical Review Committee (TRC). The TRC is proposed to be constituted under DGHS consisting of experts from each areas like clinical pharmacology, regulatory clinical toxicology/pathology, medicinal/pharmaceutical chemistry, pharmacy and immunology including clinicians, basic scientists, involved in drug development and subjects specialists (drug indication-wise). CDSCO will grant approval of clinical trials and new drugs based on the recommendations of TRC.

“Henceforth, in all correspondence related to evaluation of application of clinical trials, new drugs, etc, the term subject expert committees (SEC) should be used in place of NDAC”, the DCGI in his directive said.

Earlier, in its report the Prof Ranjit Roy Choudhury committee noted that, interaction with the pharmaceutical industry and NGOs highlighted that there are a plethora of NDACs-- 12 in all, advising the DCGI on new chemical entities (NCEs)/new biological entities (NBEs), new generic drugs and similar biologic approvals. Each committee consists of 10 to 15 subject-specialty experts having little experience of regulatory data review; some committees have even not met for over a year.

Further, a committee sometimes does not take a decision if just one or two members do not attend the meeting.  On the other hand, sometimes decisions are taken when only two members are present. There is therefore a significant slowdown in consideration of applications and grant of approval for different phases of clinical trials or marketing and manufacture of new generic drugs, similar biologics or NCEs/NBEs. This concern of the entire pharmaceutical industry appears genuine. Delay in approvals was also highlighted by the Parliamentary Committee and hence needs immediate redressal.

This committee feels that it is essential to clear pharmaceuticals applications speedily to maintain vibrancy and the global impact of this Rs.1200 billion industry. It is therefore proposed to constitute one broad expertise-based Technical Review Committee instead of the existing 12 NDACs to ensure speedy clearance of applications without compromising on quality of data and rules and regulations.