The Union government is concerned over the misleading advertisements, tele-marketing, multi-level marketing, direct selling and e-tailing of Ayush drugs which are posing new challenges. The advertisements with tall claims are seen to lure desperate patients.
In this regard, Union Minister of State for Ayush Shripad Yesso Naik stated that efforts to amend the Drugs and Magic Remedies Act were underway. “The Law department has already approved it. Medicines sold through such advertisements while misguiding the public ought to be stopped,” the minister said during the recently concluded BRICS conference in Bengaluru.
Concurring with the minister was Maharashtra governor Vidyasagar Rao who expressed concern over the fact that many ayurvedic and traditional medicines were being sold in the market through commercial advertisements in media claiming to cure diseases like diabetes without scientific evidence or clinical trials to support the claims. He further appealed that the government must take strict action against such advertisers to protect public interests.
“Now the medical and scientific experts in the Aysuh sector have the responsibility to preserve legacy and ensure that its credibility is not compromised for cheap publicity or short term economic gains. In the long run such inept efforts are likely to bring disrepute to Indian traditions and knowledge heritage. The traditional knowledge systems like Ayurveda, Siddha and Unani are deeply rooted in Indian culture,” said Prof. Bhushan Patwardhan, Professor, Interdisciplinary School of Health Sciences and director, Center for Complementary and Integrative Health (CCIH), Savitribai Phule Pune University.
Now the government regulations and surveillance are required to ensure that gullible patients are not exploited. What is being sporadically done under the pretext of herbal drug development is certainly not in line with the basic principles, ethos and practice of Indian traditions. It is hoped that the new Consumer Protection Act 2015 Bill is cleared soon and the law will take strict course to put a stop to blatant cheating through misleading commercial advertisements claiming cure for many incurable diseases,” noted Prof. Patwardhan in the Journal of Ayurveda and Integrative Medicine 2016.
The country requires assured quality, safe, affordable and effective ASU drugs. Globally, there is increasing consensus among scientific community that mere pharmacological interventions with drugs are not sufficient for management of non communicable diseases (NCDs). The physiological interventions through lifestyle and behavioural modifications are gaining much more recognition. Health protection, disease prevention and simple yet effective medicines are the real strengths of Aysuh systems. The ASU community has unique leadership opportunity to offer novel healthcare models through yoga, meditation, panchakarma and principles of swasthavritta for safer and affordable public health to the Indian and global community, added Prof. Patwardhan.
Ayurveda has huge potential for natural product drug discovery of the new phyto-actives as novel chemical scaffolds. Admittedly, scientifically robust path of discovery and development of evidence based ASU drugs is not an easy task, he pointed out in his article on ‘Ayurvedic drugs in case: claims, evidence, regulations and ethics’ in JAIM.
There is need to opt for robust documentation of prevailing practices to show tangible benefits of ayurvedic drugs in clinical management of diseases. This approach should bring clinical experiences, case records, and textual information from classical traditional practice as an evidence of benefits. Such efforts could stall creation of misleading ads as Ayush drugs will be backed by evidence based systems which will be in place, said Prof. Patwardhan.
The Union Ministry of Ayush and the Indian Space Research Organisation (ISRO) will soon launch a collaborative project ‘Telemedicine in Ayush (Tele-Ayush) Project’ for taking the excellent healthcare facilities to the people living in the poorest and remotest areas of the country, where conventional methods of transport and help usually fail to work.
This joint effort will make it possible for doctors and healthcare professionals to save many lives in areas where basic life sustenance is a daily problem. Precious lives are needlessly lost just because there was no doctor at hand when the situation required. The Tele-Ayush project aims at providing feasible healthcare services to the neediest beneficiaries in the country, making the best use of satellite technology, which will be provided by ISRO.
The Ayush Ministry’s initiative in this regard is significant as healthcare in India has always been a major issue to tackle, chiefly due to the sheer scale of the numbers. India’s mammoth population, coupled with the vast and varied terrain, which separates the rural and urban areas and the lack of basic, adequate facilities in rural and remote areas has made it a gargantuan task to provide quality and efficient healthcare to the people residing in such areas. While their urban brethren continue to enjoy the choicest medical care and attention, India’s poor and underprivileged do not have access to basic life necessities, let alone healthcare. Keeping this in mind, the Ministry of Ayush and ISRO have come together to launch this collaborative project.
Earlier, the Ministry had constituted a Working Group, under the chairmanship of Dr. R. K. Manchanda, DG, Central Council for Research in Homoeopathy, for the development and propagation of Tele-Ayush. The Working Group was asked to deliberate on specific points and submit a report. These points include gather the detailed requirements from the Ministry of Ayush; gather information on the technicalities of implementation; a detailed budgetary analysis for the entire project; ascertain resource requirement (human, hardware/software, infrastructure, etc.); a feasible time-line for development and deployment; and a thorough analysis and study of the entire project.
In its report submitted to the government recently, the Working Group recommended that the Ministry can utilize the existing infrastructure (dispensaries etc.) for providing healthcare services in remote and rural areas; Tele-Ayush can also utilise the ISRO’s existing telemedicine nodes located across country; CHCs and PHCs can be strengthened and developed by providing the services and expertise of Ayush doctors; these can also be used as specialized centres for providing exclusive healthcare services to people; Ayush doctors/paramedics can be further trained by CME programmes conducted through the TM network; they can act as consultants at the PHCs and CHCs as required and provide valuable help to the already practising doctors and healthcare personnel; smaller research units of the Councils, or Ayushgrams, can be implemented in rural/tribal areas which can function as nodes for the public outreach programmes with the provision and deployment of adequate manpower; and National/All India Institutes and Central/Regional Institutes of Research Councils of Ayush systems can also operate as nodes for specialized consultations.
On the role of the Ministry of Ayush, the Working Group recommended to Identify super specialist nodes (SS Nodes) & patient nodes for providing telemedicine consultation services by the Ministry; Preparation of TM consultations weekly schedule well in advance and to be sent to all concerned, like doctor end nodes, patient nodes, TM hub at ISTRAC Bengaluru and DECU/ISRO; Monitor and send monthly network utilisation report to DECU/ISRO; Arrange maintenance of civil, electrical and other supporting infrastructures at the user location; Arrange safe custody of items supplied and installed, identification of the custodian for each TM node and maintain the inventory which should be verified periodically; Arrange lodging complaint with local police in case of theft/loss of any item and to send one copy of FIR to DECU/ISRO; Enter into separate MoUs between themselves and the user agencies where TM nodes are to be installed for operations, safekeeping, maintenance payments after one year of phase-1 etc; Identifying local dedicated site coordinators at the telemedicine centres for enabling smooth setup of facilities; The selected centres to provide required civil infrastructure like room (10′ x20′), space for antenna, power, UPS, furniture, etc; and Providing manpower support for the smooth operation of the telemedicine nodes and identification of the doctors/medical staff for supporting teleconsultations, both at the patient nodes and selected super specialist nodes.
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Types of Clinical Trials – Based on Investigational Product.
A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use.
In simple terms – Investigational Product or IP is the medicine/treatment on which a clinical trial is conducted. Based on what Investigational Product is used, clinical trials can be classified as follows.
Chemical Entity Clinical Trials.
These are clinical trials conducted on Allopathy medicines. Chemical Entities can be NCE (New Chemical Entity) which means a newly discovered Allopathy medicine. They can also be FDC (Fixed Dose Combination) i.e. combinations of various drugs in one tablet – multiaction tablets.
Medical Devices Clinical Trials.
As per CDSCO, Medical Devices can be classified as follows based on risk.
Class A: Low Risk: Eg: Thermometers, Tongue depressors.
Class B: Low-Moderate Risk: Eg: Hypodermic needles.
Class C: Moderate -High Risk: Eg: Bone fixation Plate
Class D: High Risk: Eg: Heart Valves, Defibrillators, Stents.
Clinical trials on medical devices are predominantly conducted for BIOCOMPATABILITY – how the human body reacts or accepts a foreign body which is intending to diagnose, treat or manage a disease or disorder.
AYUSH Clinical Trials:
Clinical trials on Ayurveda, Siddha, Homeopathy, Naturopathy, can be done on both medicines, cosmetics and even supplements.
Vaccine Clinical Trials:
Vaccine clinical trials can be of two types.
Prophylactic: Developing a new vaccine and doing clinical trial on the vaccine to verify if it prevents a disease or disorder.
Therapeutic: Sometimes attentuated vaccines maybe given as a way of boosting the body’s immune system against a particular disease.
Biologics Clinical Trials:
Clinical trials on medicines or treatments that are derived from biological sources. Eg: Stem cells, Monoclonal antibodies, gene therapy etc.
Clinical Trials on Treatment Systems:
Clinical trials may be done to verify the efficacy and safety of a change in a particular treatment modality. Eg: A new surgical methodology development, cross interaction treatments between different systems of medicine or even developing new treatment systems such as acupressure, acupuncture etc.