The Drugs Controller General of India (DCGI) is an official of the CDSCO who is the final regulatory authority for the approval of clinical trials in the country. Its mission is to safeguard and enhance public health by assuring the safety, efficacy and quality of drugs, cosmetics and medical devices. CDSCO is an arm of the Ministry of Health and Family Welfare, Government of India. Its equivalent counterparts elsewhere include the United States Food and Drug Administration (US FDA), Health Canada and the European Medicines Agency. The Central Drugs Standard Control Organization (CDSCO) is the National Regulatory Authority in India. THE NATIONAL REGULATORY BODY – THE CENTRAL DRUGS STANDARD CONTROL ORGANISATION AND THE DRUGS CONTROLLER GENERAL OF INDIA The present article details these requirements giving their historical evolution, the key bodies in India that govern or oversee research along with 'must know' and 'good to know' for the conduct of clinical trials in the country. ![]() Regardless of the nature of the research (Regulatory Clinical Trials or IISs), knowledge of the regulatory requirements is an essential imperative for researchers. Anaesthesiologists are uniquely positioned to carry out translational research given the data-rich environment in which they practice and this research can be used successfully to guide evidence-based practice of the discipline as also public health policy. The past three decades have also seen remarkable advances in the field of anaesthesia, some of which include pulse oximetry, end-tidal gas monitoring, introduction of propofol and the laryngeal mask airway. ![]() In these IISs, he dons the dual mantle of an investigator and 'sponsor' and thus directly becomes responsible for ensuring regulatory compliance.Īnaesthesia as a speciality straddles several diverse disciplines that include various branches of surgery and medicine as well as critical care and pain management among others. Here, the academician raises funds for the study through his efforts from various sources including possibly the pharmaceutical industry. Academicians, however, also carry out their own research and these studies are called as 'Investigator initiated studies' (IISs). The pharmaceutical industry funds or 'sponsors' the studies and ensures compliance with the country's regulatory requirements. These studies (called clinical trials or regulatory studies) are conducted with the academician as the principal investigator largely in academic centres. Drug development research is primarily funded by the pharmaceutical industry including the process of human testing (Phase I-IV studies). Drug development research, in particular, is long and arduous and bringing a single new drug costs on an average USD 1.78 billion and takes approximately 13.5 years from discovery to the market. Research, however, is a laborious, time and labour intensive task that can take months or even years to reach fruition. Good research contributes to evidence-based medicine and thus better and improved patient care with the ultimate goal of promoting health. While all of these can provide a great measure of satisfaction, a key driver to sating intellectual curiosity remains research. The academician is the life line of any medical college, hospital or university as he/she performs the quadruple functions of patient care, teaching, administration and research. The present article outlines regulatory requirements for academic research giving their historical evolution, the key bodies in India that govern or oversee research, along with “must know” and “good to know” facets for the conduct of clinical research in the country. In the past decade, several changes have dotted the regulatory landscape in the country and have changed the way in which academic research is carried out. ![]() Hence, the investigator must make sure that he/she complies with the country's regulatory requirements. These are called as “Investigator- initiated studies” and these may not have the funding support of the pharmaceutical industry. Academicians often carry out research that is based on observations in practice or in response to their patient's needs. Of these, research, though long and difficult, is extremely fulfilling. The academician forms the backbone of any medical college, hospital or university and shoulders the quadruple responsibilities of patient care, teaching, administration and research.
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