India is always on the lookout for developing new drugs and innovative clinical operations to make India a healthy and medically advanced country. And, the recent news that comes from the Indian clinical research industry is that three Indian science research agencies have joined hands to develop drugs on the basis of ancient Indian knowledge. This has been decided with the underlying objective of making such medicines acceptable by doctors.
As of now, modern medicine practitioners don’t prescribe such drugs as they don’t come through a rigorous scientific drug development process, which is a reality that can change the new linkage between the Indian Council of Medical Research, the Council of Scientific and Industrial Research, and the Department of Biotechnology. There are in all seven drug candidates – two from the Indian Council of Medical Research, four from the Council of Scientific and Industrial Research, and one from the Department of Biotechnology.
The modules have shown promising laboratory studies on pain management, gastric ulcers, rheumatoid arthritis, paediatric epilepsy, diabetes, neurodegenerative brain diseases, and cognitive dysfunction. The source plants for these ailments range from cannabis to brahmi and ashwagandha. The head of the Council of Scientific and Industrial Research has said that they will come out with the R&D breakthrough and execute pre-clinical studies, while the Department of Biotechnology will fund part of the research and prepare the Investigational New Drug dossier that needs to be presented to the Drugs Controller General of India. Also, the Indian Council of Medical Research will fund and conduct the clinical trials.
This new association comes three years after the Drugs Controller General of India recognized phytopharmaceuticals as a new class of drugs, apart from chemical entities and biological. These are plant-based medicines that will be approved by the Drugs Controller General of India, unlike herbal drugs that are approved by the AYUSH regulators. The United States Food & Drug Administration approved phytopharmaceuticals as a new class of drugs in 2005; and the Council of Scientific and Industrial Research launched them only about a year back. And, the agreement between the three agencies mentioned above that was signed on 31st December 2018, is being tried in the country for the first time. We now need to see how this association works up and the outcomes that result from it.
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