New Delhi: The long waiting period in the clinical trial approval timelines is a subject that has been consistently raised in the past by the concerned stakeholders. Moreover, the delays that happen even after Subject Expert Committee’s (SEC) review, has been an issue raised recently by the many bodies of clinical research organization (CROs) including the Indian Society for Clinical Research (ISCR) besides top voices within pharma industry.
In this context, the 34th meeting of the Apex Committee was held on May 02, 2017 under the chairmanship of Mr C K Mishra, Secretary, Department of Health and Family Welfare, Ministry of Health and Family Welfare for supervising clinical trials on new chemical entities.
As per the minutes of the meeting in possession of the BioVoice News, the Committee was apprised that the system of examination of proposals in Central Drug Standards Organization (CDSCO) has since reached a maturity and, therefore, it will be appropriate that the approval processes should be streamlined.
Apart from Mr C K Mishra who is the Chairman of the Apex Committee, Dr Soumya Swaminathan, Secretary, Directorate of Health Research and Director General (DHR), Indian Council for Medical Research (ICMR), Dr Jagdish Prasad, Director General-Health Services and Mr K L Sharma, Joint Secretary Department of Health and Family Welfare attended the meet. Also present were the Special Invitees, Mr R K Vats, Additional Secretary and Director General (CGHS) Ministry of Health and Family Welfare and Dr G N Singh, Drug Controller General of India (DCGI).
After discussion, it was decided that the proposals relating to GCT should be placed before the SEC and where these are accepted or rejected by the SEC, no further approval of the Technical Committee or Apex Committee will be required.