If 2015 saw a marketing blitzkrieg to showcase yoga to the world, this year was about dedicating it and other AYUSH practices for treatment of diabetes. Quality concern in herbal medicine, however, remains a challenge that needs to be addressed through validation and proper enforcement of regulation. Faced with questions about scientific basis of traditional medicines, the AYUSH Ministry entered into an agreement for improving international acceptability and branding of AYUSH systems.
Benchmarks for training in yoga and practice in ayurveda, unani medicine and panchakarma will help ensure the highest standards in quality, safety and effectiveness of traditional medicines, the ministry said. India also partnered with the US to initiate research efforts on traditional medicines for cancer treatment and the first US-India workshop on traditional medicine was held.
Recently, yoga as an “ancient Indian practice” was inscribed on UNESCO’s representative list of Intangible Cultural Heritage of Humanity. On International Yoga Day celebrations in Chandigarh, Prime Minister Narendra Modi appealed to all that yoga must be devoted to fighting diabetes.
“All people belonging to the field of yoga must continue with their yoga activities but diabetes must be the main focus,” he said. Following which a yoga protocol to fight diabetes mellitus, developed by a committee of experts, was unveiled in October. This protocol includes various exercises and diet regimen that a patient can follow.
Continuing with the theme, a national protocol was also launched for treating diabetes through ayurveda. These guidelines prescribe medicines for different symptoms. The protocol also includes a list of fruits and vegetables a diabetic patient should or should not eat. It also recommends an active lifestyle, physical exercise, yoga in order to avoid falling prey to diabetes.
The emphasis on diabetes also landed the ministry in a major controversy after a misleading advertisement of an ayurvedic medicine, AYUSH-82, for diabetes gave a false notion that diabetics could avoid using insulin after taking the drug for a few months.
This was in contravention of Drugs and Magic Remedies Objectionable Advertisements Act-1954 which disallows advertisements of cure for chronic illnesses like diabetes. The advertisement was subsequently pulled off air in October. Questions have also been raised about research and clinical trial methods for AYUSH-82 before making tall claims.
AYUSH Minister Shripad Yesso Naik admitted that quality concern with traditional medicines was a huge challenge. “Many questions are raised about the scientific basis of traditional medicine, their quality, safety and efficacy. It is true that the facet of the traditional and complex herbal formulation can’t be explained fully on the conventional parameters used for testing of chemical drugs.
“But for the sake of safety and consumers to use these medicines with confidence, it is necessary to ensure quality of products,” he said.
If you’ve swapped coffee for golden turmeric milk, mouthwash for coconut oil pulling and start your day with a glass of warm lemon water, then you are tapping into ancient art of Ayurveda. Dry body brushing (to improve circulation and stimulate detoxification), tongue scraping at dawn (to remove build up on the surface of your tongue), daily self massage (to nourish your tissues and calm your mind) and, of course, yoga are other Ayurvedic practices showing up in the morning routines of 21st century wellness warriors.
While it’s been around for some 5,000 years, the holistic Indian health science of Ayurveda (Sanskrit for the science of life) is stronger than ever. Ayurveda taps into two of any modern day health enthusiast’s favourite D words: digestion and detoxification.
In Ayurveda, your “agni” or digestive fire is a sign of your overall wellbeing. And while raw juices, salads and acai smoothie bowls are also trending on social media, Ayurvedic converts believe cooked foods such as kitchari (mung bean and rice stew) are easier to digest.
Dosha is another D word you need to know if you want to delve into Ayurveda. There are three doshas: kapha (earth)
vata (wind) and pitta (fire) that influence your emotional and physical constitution. And while everyone has all three elements, one usually dominates. So the trick is to balance them with specific foods, herbs and practices. You can figure out your dosha type here practitioner.
Dylan Smith of Vital Veda says there are ten indicators of good health in Ayurveda – and if you are not experiencing all of them then it’s time to get proactive.
“Ayurveda is about prevention, so when you start to notice symptoms, act before the disease progresses,” he says.
The ten indicators of good health in Ayurveda:
1. Proper digestion of food: After eating you should feel light and energised.
2. Good appetite: Hungry at proper meal times.
3. Falling asleep easily when going to bed at night.
4. “Jumping” out of bed feeling awake each morning.
5. Normal functioning of the five sense organs. Our senses should not or only minimally deteriorate over a lifespan.
6. Elimination of wastes: Daily bowel motions before any food or drinks. Also regular and comfortable elimination of sweat, urine and menses for women.
7. Healthy ratio of muscle, bone and fat tissues, not overweight nor emaciated.
8. Natural strength, immunity should be maintained.
9. Natural colour of skin should be maintained.
10. Peace and contentment of mind
This article originally appeared on Vogue.com.au
The Union ministry of Ayush will soon amend the Drugs and Cosmetics Rules, 1945 to prohibit misleading advertisements of Ayurveda, Siddha & Unani drugs.
Presently, there are no regulatory provisions for pre-censorship on advertisements. Action is taken whenever violation of Advertisement Code is brought to the notice of the Ministry of Information and Broadcasting or the advertisement is found to be in contravention of the provisions of Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954 and Rules thereunder.
In fact, the Ministry in consultation with Ayurveda, Siddha and Unani Drugs Technical Advisory Board (ASUDTAB) had already framed and notified draft rules for prohibition of misleading advertisements of Ayurveda, Siddha and Unani drugs in the Official Gazette vide GSR No. 396(E) dated 4th April, 2016 to amend the Drugs and Cosmetics Rules, 1945.
At present, complaints about the misleading content of the advertisements of ayurvedic medicines received in the Ministry of Ayush from any source are forwarded to the concerned State Licensing Authorities with the direction to take necessary action in accordance with the provisions of Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and Drugs & Cosmetics Act, 1940 and Rules thereunder. In several cases, the state authorities have reported to have taken actions.
The ministry is now amending the law as it is aware of the sale and advertisement of ayurvedic medicines through TV channels which are required to adhere to the Advertising Code prescribed under the Cable TV Networks (Regulation) Act, 1995 and Rules framed thereunder.
At present, there are some mechanisms in place for quality control of products sold or promoted through advertisements. Ministry of Information and Broadcasting has constituted an Inter-Ministerial Committee to look into the violations of advertisement code suo-moto or whenever violations of the advertisement code are brought to the notice of the Ministry in respect of private TV channels. The Inter-Ministerial Committee meets periodically and recommends actions in respect of alleged violations reported. An advisory was also issued by the Ministry of Information and Broadcasting on 21.8.2014 advising all TV channels not to telecast advertisements which were found to be violating the provisions of Cable Television Networks Rules, 1994, Advertising Standards Council of India (ASCI) Code and also Drugs & Magic Remedies (Objectionable Advertisement) Act, 1954.
As part of the self-regulatory initiative of the industry, Advertising Standards Council of India (ASCI), a voluntary body of advertisement industry, promotes self-regulation of advertisement content by monitoring and deciding on complaints against advertisements making misleading, false and unsubstantiated claims of the products including ayurvedic medicines.
In line with the functioning of the Drugs Technical Advisory Committee under the ministry of Ayush, a state level technical committee is recommended to be constituted in every state to advise on technical matters related to licensing and quality control of ASU drugs.
A proposal in this regard has been made by the Ayurveda, Siddha, Unani, Drugs Technical Advisory Board (ASUDTAB) in the draft rules framed by the ministry for the amendment of D&C Rules.
The draft rules to be inserted in the amendment of the Drugs and Cosmetics Rules, 2016 proposes that all the state governments must constitute a ‘State Technical Committee (STC- ASU) for Ayurveda, Siddha and Unani Drugs’ to advise the state government on technical matters related to licensing and quality control of ASU drugs.
In the draft notification issued by the ministry it is clearly mentioned that the committee should consist of experts with post graduate qualifications in either of the ASU category and one each from pharmaceutical chemistry, pharmacognosy, clinical pharmacology and ASU pharmacy.
Once the Committee comes into effect, the state licensing authority should consult the STC for licensing of all the drugs defined under Section 3 (a) of the D&C Act. As per the draft notification, the SLA has to dispose off the application of the manufacturer within two months from the date of submission with all required documents. The STC is constituted under Rule 152 A (6) of the D&C Rules. Further, it is proposed that the SLA should be supported by Drug Testing Lab accredited by the National Accreditation Board or a Laboratory approved under the Drugs and Cosmetics Rules, 1945.
After the amendment of the Rules, the certificate of renewal of a licence in Form 25D will be issued in Form 26D. The application for renewal should be accompanied with year wise detail of the quantity of drug manufactured (batch wise details) during the past three years (in case of first renewal of New Ayurvedic, Siddha or Unani drugs), or past five years (in case of renewal of licence of drugs described under section 3 (a) and section 3 (h) of the Act) along with a consolidated safety report listing side effects, fatalities, injuries etc. related to the drug.
Similarly, the certificate of renewal of a loan licence in Form 25E will be issued in Form 26E.
An original licence in Form 25D or a renewed licence in Form 26D, unless sooner suspended or cancelled, will be valid for a period of five years from the date of its issue or renewal. The original licence issued for drug defined under section 3 (h) for New Ayurvedic, Siddha or Unani drug will be valid for a period of three years from the date of its issue. The time limit of three months will be substituted by two months and fee of Rs.500 will be substituted by Rs.1000.
In a major fillip to India’s efforts to globalise ayurveda and other traditional medicines, the US department of health and human services’ premier National Institutes of Health (NIH) and National Cancer Institute (NCI) have expressed interest in documenting ayurveda’s success stories in treating cancer.
Dr G Gangadharan, director, MS Ramaiah Indic Center for Ayurveda and Integrative Medicine, Bengaluru, who was part of an Indo-US joint delegation working on traditional medicine, said: “Some time in June, the US institutes expressed interest in documenting the success of ayurvedic treatment for cancer.” The delegation concluded in March 2016 its first meeting with the agenda ‘Collaborative Research on Traditional Medicine’.
Another integrated medicine expert with his own institute in Bengaluru, Dr Issac Mathai, who was also part of the delegation, said: “After the meeting in Delhi, the NIH and NCI teams visited the Ramaiah Centre and another facility.”
Gangadharan said several issues pertaining to traditional medicine, especially ayurveda, were discussed at the meeting and the expression of interest to document case studies will go a long way in taking this form of medicine to the world.
“While there is a lot of research in ayurveda, none of it is helping the traditional form. All of it is focused on identifying new molecules for modern medicine. The need of the hour is in proving how effective it is,” he said.
Although India has over 40,000 formulations in ayurveda, the Indian patent office has issued only 200 patents so far – of which 11% have gone to foreign entities with China leading the pack. Five patents have been granted for procedures to treat cancer and one has gone to a legal representative of a client in the US. The patent is for ‘Nutraceutical for the prevention and treatment of cancers and diseases affecting the liver’.
Although no generally accepted cure for cancer using ayurveda has been recorded officially in India, a recent test of a drug by AIIMS, Delhi showed improvement in the quality of life of cancer patients’, something the US is also aiming to enhance through President Obama’s Cancer Moonshot.
Mathai said there’s a lot of work in the field and once it materialises, partnership with the US will take ayurveda a long way.
The office of Dr Edward Trimble, director, Center for Global Health, NCI, confirmed the development. Soon after the March meeting, Trimble had said in a statement issued by the Union Ayush ministry: “The collaboration was a great opportunity to bring to the table from the US side NCI and NIH expertise in laboratory and clinical evaluation of traditional medicine and from the Indian side an impressive commitment to building the evidence base for traditional Indian medicine.”
The NIH research database shows over 3,574 papers on curcumin (a member of the ginger family) and cancer, and 1,161 papers on turmeric and cancer.
There are 2,500 studies on ginger, while there are 668 papers on fennel and 582 on cumin. According to a 2015 report of the National Center for Health Statistics (NCHS) under the Centre for Disease Control and Prevention (CDCP), the number of US citizens who have used ayurveda has jumped to 2.41 lakh in 2012 from 1.5 lakh in 2002.
An NHI factsheet on ayurveda says a few clinical trials in 2011 have shown some results for treating cancer using ayurveda. However, it says: “Most clinical trials of ayurvedic approaches have been small, had problems with research designs, or lacked appropriate control groups, potentially affecting research results.”