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Lack of clinical trial data to prove efficacy hampers exports of Ayurveda products: Dr Joy Varghese
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Peethaambaran Kunnathoor, Chennai
June 27 , 2023
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Absence of an unambiguous report of clinical trials of traditional medicines hampers the exports of Ayurveda products from India to foreign markets.
The clinical database can be easily prepared provided the Union Ayush Ministry and the state governments together plan for collection of all the data about patients, medications and treatments available with the Ayurveda dispensaries, hospitals, medical colleges and research centres, opines, Dr. Joy Varghese, senior Ayurveda scholar and former CEO of the Kerala Ayush Cluster, Care Keralam.
If a database proving the efficacy and safety of a traditional drug is readily available with the Government of India, there will be no hurdle in registering the product in foreign countries and get approvals. A registry of databases can be easily created through a networking process between the department of ayush and the healthcare centres. The data collected from the healthcare centres can be used for analytical studies to prepare the clinical report.
“The compiled healthcare database of patients which includes the medications used in the therapeutic management and the net result of the treatments can be taken as valid evidence for medical decision-making to prove the efficacy and safety of the drugs. There is no requirement of additional studies on humans as these data contain sufficient information and evidence of pharmacological and clinical investigations”, he observes.
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Pointing out his plan to approach the Union Ayush Ministry with a proposal for conducting clinical trials for traditional medicines, Dr Varghese said he had earlier put this suggestion before the Union Ayush Ministry and also to the Government of Kerala, but not taken forward.
“I prepared five dossiers, two with the funding of the Union Ayush Ministry and three with the support of the state government. But all of them are entangled in red tape even today and no action has been taken on any dossier either by the Union Ayush Ministry or the state government, although lakhs of rupees were spent on the projects. The dossiers have answers to all the questions of foreign drug regulatory agencies for registration purposes. The dossiers will help to get approvals for certain Ayurveda medicines in Europe, Middle East and the USA. They are actually the clinical trial reports and were prepared based on the suggestion of Sam Pitroda,” he told Pharmabiz in an interview.
According to Dr K S Preeya, the director of the ISM department in Kerala, there are about 818 Ayurveda government dispensaries, 130 hospitals, 14 district hospitals, three Ayurveda medical college hospitals and 259 Ayurveda health centres of NHM providing healthcare through Ayurveda system in the state. Dr. Joy Varghese said through a computerized network with all these institutions the government can compile huge data of patients, diseases, medications and treatment methods. The government has to prepare a protocol and the doctors should follow the same to give medicines to the patients. The results, period of treatment, disease conditions, patient details etc should be documented for the data collection. The government sponsored Ayush cluster, Care-Keralam at Koratty in Thrissur district has all the facilities to conduct the process validation, analytical study, animal studies including toxicity study and efficacy study. The net result of these studies will serve the purpose of clinical trials.
In addition to the hospitals, the state and central research centres working in Kerala can also be used as sources of data. With the help of the drug manufacturing units, an industry-academic tie up can be made to support the data collection. In this mission, the Ayurveda institutions from both government and private sectors should be involved. Further, selected private Ayurveda hospitals can also be advised to contribute their part.
He said once the clinical trial data is ready with the government, the newly emerging Ayush Export Promotion Council (AYUSHEXCIL) can take it with the drug regulatory agencies in foreign countries to register the traditional drugs from India for marketing. He said currently, the traditional medicines from India are marketed in some foreign countries either as dietary supplements or health supplements. But, the country needs a certification for our traditional medicines in the label as ‘drugs’ in all the countries in the world which can be easily attained with the clinical trials reports.
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