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DCGI to expand list of expert panels & SECs to advise in matters relating to approval of new drugs

Ramesh Shankar, Mumbai
Monday, November 27, 2017, 08:00 Hrs  [IST]

The Union health ministry will soon expand the list of experts included in the expert panels and Subject Experts Committees (SECs) to advise the Drugs Controller General of India (DCGI) in matters relating to approval of new drugs including biological, medical devices, clinical trials and other related issues.

To evaluate applications related to approval of new drugs, the CDSCO maintains panels of medical experts of various therapeutic areas, who advise DCGI in evaluation of such applications. For evaluation of these applications, SECs are constituted by including experts from these panels.

Oncology, gastroenterology, pulmonary, gynacology, orthopaedic, analgesic, anaesthetic, hematology, radiodiagnosis, vaccine, cardiology, opthalmology, hepatology, urology, dermatology, dentistry, nephrology, endocrinology, neurology, antiviral, pharmacology, psychiatric, antimicrobial, bio- medical engineering, pediatric, rheumatology, veterinary sciences,  biostatistician, toxicology, phytopharmaceuticals, cell and cell based therapy, gene therapy and other related areas are the different therapeutic areas in which the health ministry needed professionals for expanding the list of experts for their inclusion in the SECs.

Now, the CDSCO is in the process of expanding the list of experts from various government hospitals, institutions, national laboratories and research institutes for inclusion in these panels. It has invited applications from experts and professionals for their inclusion in these expert panels/subject expert committees.

These SECs advise the DCGI in matters relating to in-depth evaluation of non-clinical data including pharmacological toxicological data, clinical trial data (Phase 1, 11, III, and IV), etc. furnished by the applicant for approval of new drug substance of chemical and biological origin and new medical device to be introduced for the first time in the country including vaccines & r-DNA derived products; subsequent approval of biological products including vaccines & r-DNA derived products already approved in the country; global clinical trials; Fixed Dose Combinations of two or more drugs to be introduced for the first time in the country; and causality analysis, safety of drugs or any other technical matter in the opinion of Ministry of Health and Family Welfare or DCGI which requires expert advise.

The SECs also advise the DCGI for preparing Guidelines for clinical trial industry in evolving acceptance criteria for marketing approval of new drugs of different therapeutic categories. The SECs will also advice the DCGI for defining roadmap for research industry for appropriate development of new drugs relevant to Indian population.

While considering approval of new drugs and clinical trial of NCEs/GCTs, the SEC's will examine essentiality and desirability of new drugs in terms of Assessment of Risk versus Benefit to the patient; Innovation vis-a-vis existing therapeutic option; and unmet medical need in India.

 

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KRISHNASWAMI RAMABADRAN Nov 28, 2017 4:42 AM
I suggest the SEC should include OCIs who have expertise in the therapeutic areas. For e.g. I have more than 30 years' of global drug development experience in the United States in multiple therapeutic areas. I can assist the union health ministry in pharmacology of central nervous system drug development including opioids and NSAIDs etc. Hope CDSCO considers OCI experts as well.
 
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