Recent Updates That Will Attract New Trials In India

The DCGI (Drug Controller General of India), who is responsible for the approval of licenses of specified categories of drugs, and lays down the standard and quality of manufacturing, selling, import, and distribution of drugs, has brought forward a few changes in the clinical trials rules and regulations, which are sure to attract more and more new trials in India. The alterations and updates made are stated below.

• The turnaround time for approvals of all global clinical trials has been given a deadline of 180 days.
• Instead of just one New Drug Advisory Committee, the approval of new drug clinical trials will be decided upon by the Subject Expert Committee, after which the recommendations will be reviewed by the Technical Review Committee. Finally, it is the Central Drugs Standard Control Organization that will grant approval. This entire procedure will thus decrease the turnaround time of clinical trial approval.
• The Investigator will undertake a maximum of three trials to ensure more accountability and the least possible chances of negligence in clinical trials.
• All individuals subject to trials will be provided with primary care for any kind of illness they experience during their trial participation.
• The last update has been revised over the compensation for trial related injuries, and an order has been released confirming the compensation for trial related injuries or death to be paid to the trial subject or nominee.
• The Phase-I clinical trial is exempted for medical devices, but the procedure for clinical trial approval, accreditations of investigators, ethics committee, sites, and other conditions will remain the same.
• Academic studies will be conducted after approval by the Institutional Ethics Committee, but any new drug or the new usage of an existing drug will require approval of the Drug Controller General of India.
• Any generics of biosimilars that have been marketed in the USA for more than 4 years and have a satisfactory report would be approved for marketing in India after short trials.
• Clinical trial for new drugs that are already approved in other countries can be waived in India if it is for extreme urgency, extreme diseases, or national emergency.
• It two or more countries have removed a drug from the market on the grounds of safety and efficacy, then the continued marketing of the drug in India will be subject to examination and action.
• The SEC will review all the factors that are responsible for deciding if they are ethnically sensitive or insensitive, before giving any clinical trials approval.
• The Central Drugs Standard Control Organization considered that there should be an existing therapy to compare the test drug related to placebo control, to ensure that it is appropriate, efficient, and ethical.
• If the Indian population is participating in global clinical trials, for an indication that is prevalent in India, the sponsor or innovator should market the NCE in an expedited way by manufacturing. This should be confirmed in the form of an application submission.
• The Central Drugs Standard Control Organization requires post-marketing surveillance of drugs, rational use of drugs, adverse drug reactions monitoring, and drug utilization studies, for which is will work with the Indian Council of Medical Research to sponsor the related studies.

With all of these alterations made in the rules and regulations of Indian clinical trial procedures, the country will definitely see a rise in the number of clinical trials being performed here. And with this rise, there will also be a rise in the career opportunities for clinical trial professionals. Join the league and get yourself enrolled with Avigna Clinical Research Institute, one of the top clinical research institutes in Bangalore, which will provide you with the best quality training, along with 100% placement guarantee in the best CROs, pharmaceuticals, and Biotech companies.

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