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ndia has a huge population, and carries the largest burden of diseases in this world, which is why it is important that patients receive good amount of healthcare and treatment. But unfortunately, this is not the case. The healthcare industry in the country is not at par with what is required. In fact, Indian patients&hellip
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Local Trials In India To Be Given Up For Faster Access To New Drugs – ACRIIndia India has a huge population, and carries the largest burden of diseases in this world, which is why it is important that patients receive good amount of healthcare and treatment. But unfortunately, this is not the case. The healthcare industry in the country is not at par with what is required. In fact, Indian patients are not given quick access to new medicines that are not available in India. To take care of this issue, and provide Indian patients with faster access to these medicines, the Indian government has decided to give up local clinical trials for new drugs that have already been approved and marketed in specific countries identified by the drug regulator. Since it has cleared the trials in a number of countries, it definitely is a safe drug. The same is the case for orphan drugs too that are used in the treatment of rare diseases. The Drug Controller General of India (DCGI) can put aside local clinical trials if the drug has already received approval and is being sold in countries of US, Australia, Canada, Japan, and European Union. Local trials can also be given up for imported new drugs, if the regulator has already granted permission to conduct a global clinical trial, and if the drug has been approved for marketing in an identified country. In addition to this new rule, it has also been decided that companies will not have to pay an application fee for seeking approval to conduct clinical trials in India. The other terms, as a part of these new rules, include fast-tracking of clinical trial approvals for other drugs within 30-90 days, and statutory norms for payment of compensation, in case of injury or death during such trials.
The DCGI Eswara Reddy says, “The new rules will promote ethical and scientific research in India, while ensuring patient safety and faster accessibility of new drugs for the Indian population. These regulations will also bring predictability and transparency in the approval process of new drugs.” In addition, a professional official also stated, “After consulting various stakeholders and making changes accordingly, we have come up with the final rules which will guide clinical trials and new drugs going forward.” Once the new notifications regarding clinical trials come into place, there will be a separate vertical, called Clinical Trials and New Drug Rules 2019, under the Drugs and Cosmetics Act, which will give more power to the regulators to monitor research. There has also recently been made a separate rules segment for medical devices. With such powerful changes being made in the Indian clinical trials industry, the standard for clinical research in the country is bound to grow. More and more sponsors will invest in India to conduct clinical trials. Make the most of this, and kick start your career in this booming field by undertaking a professional course at one of the best clinical research institutes in Bangalore. One such institute is the Avigna Clinical Research Institute, where you can earn a certification, and get the best jobs () in top CROs, Biotech companies, and pharmaceutical companies in India and abroad.
