India's top drug regulator Drugs Controller General of India (DGCI) on Friday allowed Sun Pharmaceutical to conduct clinical trial for the first phytopharmaceutical or plant-based drug AQCH to treat COVID-19 patients. According to the company, the clinical trials will be conducted across 12 centres in India in 210 patients.
"Typically a clinical trial takes a long time, we are expecting ACQH clinical trial will be done in three months or it might take some more time. This is a multicentric clinical trial so not only Delhi but several places in India will take patients for the trial," he added.
Dr Mande said that June 5, 2020 marks a red-letter day in India's history of modern medicine. He said the modern drugs and pharmaceuticals paradigm has evolved over the last 100 years and cited J. Drews, Science (2000) 287, 1960-64.
According to this paradigm, any disease occurs due to a cause, which can be corrected by externally providing a chemical which can suppress that cause. This external chemical is what we call as a "drug" or "medicine".
The efficacy of the "drug" against the disease is typically established by conducting Randomised Controlled Trials (RCT) with all appropriate controls. Over the years, more than 2500 medicines have been approved all over the world to treat different diseases. While the paradigm has evolved identifying one cause of a disease, and one chemical entity to correct that cause, the traditional system in many countries/cultures which has used extracts from natural sources has by and large been ignored, said Dr Mande.
Thus, the traditional system of medicines which used various natural sources and their extracts has not found use in modern medicine. Due to increasing debates and concerns over the years, the US FDA in 2005 finally recognized a class of medicines termed as "botanicals", which are plant-derived natural extracts and complex mixture of compounds. Botanical drugs are not necessarily purified chemical entities to treat a disease. The same class of drugs was also adopted in India as "phytopharmaceuticals" in 2015. Yet, till date, no clinical trial (RCT) of any phytopharmaceutical has been undertaken in India.
"Today, the situation has changed. The clinical trial of extracts from Cocculus hirustus (in Hindi called as Patalgarudi) spearheaded by Sun Pharma has begun to mitigate COVID-19. This is led by the ICGEB, Delhi and CSIR-IIIM, Jammu on the academic side. Thus, CSIR is once again playing a stellar role in modern medicine by attempting to change the paradigms," said Dr Mande.
Further Dr Mande added that the entire tribal belt in India starting from Gujarat Maharashtra, Chhattisgarh and Jharkhand has been using extracts from this plant for treating various ailments.