Sunday, October 18, 2015

History of Clinical Research Regulation in India

All regulatory bodies has the responsibility to provide access to the safe, effective and quality, medication to their people.  The Central Drugs Standard Control Organization and Drug Controller General of India are bequeathed to protect the citizens from the exposer of unsafe medication. Either it is through clinical research or marketing. The growing clinical research after the product patents rights for the pharmaceutical industries as per the trade related aspects of intellectual property rights agreement and adverse drug reaction monitoring, rights and safety of Patients, compensation after adverse event clinical research and of the marketed drugs have raised many ethical and regulatory issues.
The regulatory measures has to be dynamic and ever evolving in consonance with the developing technologies. Indian regulations have also experienced this a lot of change from british era. Last three years were little disturbing and this lead to loss of opportunity and mistrust in Pharmaceutical domain. But now regulation is well organized, systematic and compliant to international regulatory standards for pharma products, medical devices, traditional herbal products and cosmetics.
Now question arise why Indian regulators took so much time in this reform? To understand this we have to understand the history of Clinical research. It started in British Raj when most of the drugs were imported from foreign countries. Post First World War, the demand for drugs had increased tremendously and that led to the cheap, substandard, spurious and adulterated drugs into the market. To control in market, Government passed the Poisons Act 1919. This Act regulates possession of substance or sale of substances as specified as poison. The Poisons Act was followed by The Dangerous Drugs Act 1930. This act regulates the opium plant cultivation, manufacture and possession of opium, its import, export, tranship and sell of opium.
In response to widespread ‘Gigantic Quinine Fraud’; the Government, then, formed a Drug inquiry committee under Sir Ram Nath Chopra also known as ‘Chopra Committee’ whose recommendations later on tabled amidst growing protest in legislative assembly as ‘The Drug Bill’ later on amended to the Drugs and Cosmetic Act 1940 (D and C Act) and Drugs and Cosmetic rules of 1945. This also established the Central Drugs Standard Control Organization (CDSCO), and the office of its controller, the Drugs Controller General (India) (DCG(I)).  The CDSCO in the Directorate General of Health services, is a division in Ministry of Health and Family welfare, Government of India, headed by Drug Controller General of India (DCGI). It has four zonal, three sub-zonal and seven port/airport offices and six laboratories to carry out its activities. The Drugs and Cosmetic Act, 1940 came into force from 1st April 1947. In year 1948 Pharmacy Act came into existence to regulate the profession of pharmacy in India and in 1955 Drugs and Magic Remedies rule came into existence for control the claim and advertisement.
In 1962, government extended the regulatory provisions to the cosmetics, and finally the Act came to known as Drugs and Cosmetic Act 1940. Drugs and Cosmetic Act has been divided in Chapters, Rules and Schedules and is amended from time to time to control the safety, efficacy and quality of the drugs. It is an act to regulate the import, manufacture, distribution and sale of the drugs and cosmetics. Manufacture and sale is under the respective states governments and union territories through their respective drug control organization, whereas setting standard, import, marketing authorization and monitoring of adverse drug reactions of a new drug is under Central Government. Under Chapter Two of this Act, one statutory board and a committee have been framed called Drugs Technical Advisory Board (DTAB) and Drug Consultative Committee (DCC) separately for Modern Scientific System of Medicine and Indian traditional system of Medicine and a provision of Central Drug Laboratory at Central Research Institute, Kasauli for testing drugs has been made in this act. DTAB comprises of technical experts who advises central and state governments on technical matters of Drug regulation. Amendment, if any, to Drug and Cosmetic are made after consulting this board.
During this period the market share was dominated by multinational companies and very few Indian manufacturers were present. The Indian Pharmaceutical industry was in an early stage of growth. Focus for pure research and development was very little due to lack of patent protection. Due to very high import dependency on drugs, the cost of drugs was very high as well as market availability was comparatively low. In 1955, government has passed Drugs Prices Control Order, 1955 (DPCO) (under the essential commodities Act). Due to which many essentials drugs were unavailable in Indian market. To save Indian companies and to provide medicine Indian population at low cost Indian government introduced Indian Patent Act of 1970. This new act replaced the Indian Patents and Designs Act of 1911.   
The Indian Patents Act of 1970 originally had provisions for ‘process’ patents only. Now, local companies began manufacturing products/ drugs using different manufacturing process by reverse engineering. Due to this new drugs were available cheaply as well as many more substitute drugs were available in the market against costly imported new drugs. This has resulted in 1) increase the exports to countries like Russia, Africa, China, and South America. 2) Export of Bulk drug post patent expiry.
In 1994, Government signed the agreement on Trade Related Aspects of Intellectual Properties (TRIPS) to provide minimum protection to the Intellectual Property by the member states of World Trade Organization (WTO). India amended the Patent (Amendment) Bill before 2005 and extended its weak process patent to strong TRIPS competent ‘Product’ patent system for pharmaceutical products.
The Indian government, realizing the potential of clinical research for new therapies, has modified and amended Schedule Y to the Drug and Cosmetics Rules of 1945. Schedule Y establishes a set of guidelines and requirements for clinical trials. However, Schedule Y was written with the generics industry in mind but increase entry of foreign pharmaceutical companies after the introduction of strict patent rules in the area of clinical research led the government to introduce many changes. The government recognized the importance of their regulation and thus developed Ethical and Regulatory Guidelines. The Indian Council of Medical Research (ICMR) issued the Ethical Guidelines for Biomedical Research on Human Subjects in 2000 and CDSCO released Indian Good Clinical Practice (GCP) guidelines in 2001.
With the application of Product patent in 2005, recognizing individual's innovations through the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement, which India had signed in 1995, became effective. Indian companies began to respect Intellectual Property rights, consistent with international standards. With the increasing faith in the system, companies flooded the market and more global trials came. Lately, to decrease the review time of application from 16 weeks to 10 weeks the CDSCO has introduced the fast tracking of clinical trials in 2006. The DCG (I) created two categories of applications; Category: (A) Those also being conducted in countries with competent, mature regulatory systems, and Category: (B) Everything else.
Trials that fell into category A (received approval in the U.S., Britain, Canada, Germany, South Africa, Switzerland, Australia, Japan and countries in the European Medicines Agency (EMEA)) would be eligible for fast tracking in India, with approval taking no more than two to four weeks. Trials in category B would fall under more scrutiny; with approval taking 12 weeks once an application is considered under Category B, it, in any case, cannot be shifted to Category A. Nearly all global trials are in the Category A.
In 2011, Drugs and Cosmetics (First Amendment) Rules was implemented. It mandates registration of Clinical Research Organization (CRO) for conducting Clinical Trials (CT). Schedule Y suggests requirements and guidelines for registration of Clinical Research Organizations. Although amendment to Schedule Y, registration of Contract Research Organizations, registration of Clinical Trials, Speeding up review process, Pharmacovigilance (PV) programme for India and Inspection of clinical trial sites have been started. However due to casual approach in marketing approval, unethical steps taken by some pharmaceutical companies and medical practitioners has reiterated the need to amend the regulations. DCGI slowed down their actives related to approval of studies as per the guidance of Supreme Court and Government of India and started concentrating on the regulatory framework.
DCGI further amended the policies for to improve the quality of clinical research. It took three years to design this:
  • Sponsors, investigators, the regulator and Ethics Committees are responsible for ensuring that the design of placebo-controlled trials is appropriate, efficient and ethical;
  • The Ethics Committees will have to be registered under DCGI
  • Investigators are limited to working on a maximum of three trials simultaneously;
  • If a new chemical entity is approved in the innovator or “well-regulated” country for a disease prevalent in India, and the clinical trial included Indian participants, CDSCO advises that “approval should be sought from CDSCO” and “these NCEs should be marketed in India speedily.” CDSCO also specifies that if a foreign trial included Indian participants, the number would have to be “adequate” for considering approval of the drug in India;
  • Waiver of clinical trials in Indian populations with drugs already approved outside India will only be considered in cases of national emergency, extreme urgency and epidemic, and for orphan drugs for rare diseases and drugs for conditions/diseases for which there is no therapy;
  • Generics and biosimilars marketing “in other countries like USA” for over four years and have a “satisfactory report” can be approved in India after abbreviated trials;
  • Consideration of new drug applications will take into account ethnic differences in metabolism etc.;
  • If two or more countries remove a drug from their market on the grounds of safety and efficacy, the continued marketing of the drug in India “will be considered for examination and appropriate action” by CDSCO; and
  • Manufacturers, sponsors and CROs are advised to provide compensation for any drug-related anomaly detected at a later stage.
  • CDSCO is also re-organizing the structure of the committees involved in the drug approval process.  The New Drug Advisory Committees will now become the Subject Expert Committees, whose recommendations will be reviewed by a newly formed Technical Review Committee (TRC).  The TRC will be under the direction of the Directorate General of Health Services (DGHS), which will draw the membership of the committee from experts in such areas as clinical pharmacology, clinical toxicology/ pathology, and scientists involved in drug development. 
As we all understand that regulatory improvement is continual process and no system is perfect. DCGI still needs a lot of improvement to ensure safety and wellbeing of Indian population along with promoting introducing new product.

Monday, July 20, 2015

Medical device clinical trials

 Vatsal Chhaya: To begin with, I am a biomedical engineer but have explored my vocational career in a different, rather challenging domain - health technology assessment and implementation research! Why so? I would not hesitate to say that so called "technical domain"- the most common fate with Biomedical Engineer- did not attract my mind much. Because to me, it was always more or less similar to what the electronics engineer does!

It would not be overstatement if I would say that Biomedical engineering is considered very superficially in most of undergraduation and graduation programmes. To be specific, I would say from my personal experience that hardly any college would be there which actually focuses on medical device policy related aspects. I would like to bring to discussion this new paradigm with 6 rarely explored aspects on Biomedical Engineering.

 Medical device clinical trials

Unlike Pharmaceutical technologies, there are no dedicated established centers- MEDICAL DEVICE CROs in ample amount which could satisfactorily facilitate a medical device product evaluation and commercialization nor clinical evaluation guidelines in medical devices sector i.e. ISO-14155, ICH-GCP in adaptation oriented towards medical devices are taught in institutions so as to enable the students take such projects and come up with an excellent guideline document for producing local, national or global impact.

Medical device related health economics: The education could be imparted with Intended Learning Objective (ILO) of providing insight to economic evaluation of clinical effectiveness or diagnostic accuracy of medical devices with respective cost dimensions. This may comprise projects like preparation of costs database, estimation of budget for reimbursement schemes on medical device failure and so on.

Medical Technology Surveillance: There is little guidance available in field of post-marketing surveillance of medical devices especially in India. Unlike PvPI and hemovigilance, no such programme is available for medical devices. A model or strategy for the same could be invoked for purpose of brainstorming in students.

Regulatory Affairs and Standardization: Understanding how to put boundaries to innovations while their diffusion is something highly expected to be taught. It is fact that MATLAB,LABVIEW related digital image processing projects are promoted always but no project is seen which might have explored ethical issues related pros and cons associated with image processing i.e. violation of PNDT act, misdiagnosis of any abnormality or disorder. Moreover, there is less education provided on CE marking, Medical device standards, Medical device testing.

Intellectual Property Rights: No course I came across so far incorporates this aspect from project perspective i.e. project on assessing IPR issues faced by device manufacturers, comparison of device patentization framework of different countries, petty patents.

Bridging translational gap: It is hard fact that even after outstanding project model, there is no support in terms of how to accelerate it for professional growth with commercialisation purposes. Most of projects are just for sake of completion and not with realization and/or continuation of further journey. Such lacking in system is also proposes threat of plagiarised projects (ready-made models/circuits in markets) or “frog-in-well” approach during project.

I believe if this type of thinking could be done "apriori", then biomedical engineering’s value could be realised like never before. And also I believe that these aspects, when ingrained in curriculums, it would be “pride” rather than “speechlessness” or “cluelessness” when somebody would ask the reason for choosing this branch.

I would be happy to see as many as comments and suggestions for this post.

Let's start our journey for evidence-based-medical device research and development !!

Thursday, February 26, 2015

Genelife Clinical Research: 5th Anniversary

As Genelife Clinical Research is growing 5 year old on February 26, 2015, with the steadfast confidence of Clients, Consultants and employees have shown to Genelife Clinical Research by entrusting to her services. When our company was founded in 2010 with a very small team, we could hardly foresee our growth to an international company with a staff of 32 within this short span of time. Many people predicted we will not last a year in the industry because we were too idealistic and simple to cope with business environment. Fortunately, we survived not only the initial phase but also the most difficult phase of Indian Clinical Research industry. When I started this organization I had a clear vision for success. I wished to create an amazing environment and hire the smartest people. Together we will build a beautiful system to delight the customers and makes the world just a little bit better. I started working night and day to make my vision “to be most respected CRO” reality, but the things did not go as planned due to some external and financial issues. Fortunately, we came out of that with some unexpected luck and trust of our clients. Every member of Genelife team have worked hard to make sure Genelife’s success and celebrate 5th anniversary.

Five year is long time as well as short time, compared to a big companies like Quintiles, we are still adolescent. On the other hand, five years in a sector that is constantly and rapidly advancing is an achievement, we can be proud of. It means we have managed to establish ourselves in this sector. We have claimed our rightful place here. This reflects with the kind of work we are doing. Currently we are having maximum approved studies in India with one of the best operations tools to run these projects. Deliverability has been our strength for retaining all business we have.

Since inception Genelife Clinical Research capitalized on the company's vision “to become the most respected CRO”. In these 5 years we have translated our knowledge into a full portfolio of drug development which empowers clients to close the gap between their requirement and regulatory needs. In near future, we aim to expand our horizons into the field of BA/BE, Pharmacovigilance as well as studies conducted in other Regulated market in and outside India. Keeping past experiences as well as future dreams in our mind, Genelife Clinical Research shall strive hard to reach the highest peaks with positivity, quality and excellence and make a noteworthy contribution in the field of Clinical Research. 

Kind Regards,

Dhirendra V. Singh
Managing Director
221, Nirman Industrial Estate, Chincholi Bunder, New Link Road, Near Chincholi Fire Station, Malad (West), Mumbai-400064. INDIA

Wednesday, September 10, 2014

Genelife Chem

Genelife Clinical Research is starting its division Genelife Chem. Genelife Chem will be a collaborative drug discovery partner based out in, Pune, India. Like Genelife Clinical Research the Vision of this Genelife Chem will be “To be the most respected partner". We are setting up this new venture with state of art infrastructure and one of best talent in Asian subcontinent to partner with innovators in their early drug discovery and development programs etc. We have experiences Chemists to devise the synthetic strategy and deliver the desired molecule with excellent purity and structural integrity.  

With this note, we would like to introduce you with the services we are offering in drug discovery & development space under flexible business models. At present our main focus is chemistry that is the backbone of most of the life science programs.

Services: Structure-based design; Fragment optimization; hit to lead; Synthetic organic chemistry; Library design and multiple parallel synthesis; Synthesis of reference compounds; Non-GMP and GMP scale-up synthesis; Route scouting; optimization of reaction conditions and critical process parameters.

In 1st week of inception only, Genelife Chem has entered into a joint drug discovery collaboration with one of the biotechnolgy company based in USA to develop kinase inhibitors. Genelife chem will be responsible to provide synthetic and medicinal chemistry expertise while the collaborator holds the responsibility of biological screening of new chemical entities against a kinase panel.

Genelife Chem is looking forward to serve the client in best possible way in order to earn same trust, faith and support which its parent company has achieved. 

Kind regards,
Dhirendra V. Singh

Tuesday, June 10, 2014

Medicinal Plants In Health Management

The struggle of a man against disease and death is as old as the history itself. On the basis of skill, knowledge and practices based on the theories, beliefs & experiences indigenous all civilizations has developed their own treatment system which is now called as traditional treatment system. The base of almost all such treatment system is plants. Various as scholar and medical men, since the vedic period dawn to the present century, have contributed a lot on the use of medicinal plants in health care.

Plants are the most ancient source of drugs and the plant based medicaments, the countrymen’s prime therapeutic weapon, are still is front line today for treating a large number of diseases. According to Professor N.R. Fransworth the plants are “The sleeping giants of drug development today and will represent in future as first class source for new medicaments.

The most established traditional system is Ayurveda. The objectives of Ayurveda are Dhatu Samya, Swastha Vritta and Atura Vritta. Proper cure of a disease entirely depends upon rational interaction of four limbs of therapies or chikitsa chatushpada and drug is one of the components of therapy. The material Media of Ayurveda is very vast. It comprises of Plants, animals and metals and aquatic products but plant drugs occupy a large area for the prevention and promotion of health and treatment of Disease.
It may be noted that Ayurveda (sanskrit Ayur : life, Veda : science, Knowledge) is the ancient Indian system of health management which is still widely practiced in the sense of “holistic’ approach, especially for metabolic disorders. Ayurvedic medicines are mostly based on plant materials. The entire mountainous region of the country is considered a vast repository of medicinal herbs. It has been estimated that the sources of 80% Ayurvedic medicines are found in the western Himalayas.

A medicinal plant is any plant which is one or more of its organs substances that can be used for therapeutic purposes or which are precursors for chemo pharmaceutical semi-synthesis. The definition makes it possible to distinguish between the medicinal plants that are already known whose therapeutic character or a precursor of certain molecular have been established scientifically and the other plants which are regarded as medicinal but have not yet been subjected to thorough scientific study. Researches for the identification, development and utilization of plants should be given high priority for the development of Indigenous system of health care in order to reduce drug bills and develop more acceptable and more readily acceptable to the people and with better coverage.

The following are the some of the examples of plants which are used in primary health care extensively specially in the Rural Area:
Ocimum sanctum
Promotes immunity
Semicarpus anacardium
Anti-cancer agent
Wiothania somnifera
General nervine tonic
Emblica officinals
Rejuvenate (resayana)
Hydsrocotyl ariatica
Improves memory and intelligence
Convulvulus pluricalis
Improves memory and intelligence
Acorus colamus
Improves speech in children
Collesterus pariniculala
Improves mental health
Terminalia Arjuna
Most effective cardio tonic
Albebia lebeck
Curcuma longum
Picrorrhiza Kurroa
Jaundiced Hepatitis
Boerhavia diffusa
Kidney disorders
Gitavia deligiosa
Bladder disorders
Mucona Pruriens
Asparagus racimosus
Sida cardifolia
Baby tonic
Haviscus Rosa cyanosus
Antifertility agent
Ptericorpus Marsupium
Ant diabetic
Holerene Antidysenterica

Some of the drugs which have come to light in our experience to have significant action and the observation have been also supported. Scientific observations are as follows

Psychotropic drugs : A group of drugs which have been observed as medhya drugs and few others have shown to have definite action on brain called as psychotropic drugs e.g.
  • Shankhapushupi      -           Convolvulus Pluricaulis choisy
  • Mandukharmi           -           Centella Asiatica
  • Brahmi                      -           Bacopa – monnieri
  • Ashwagandha          -           Withania somnifera Dunal
  • Vacha                        -           Acorus calamus
  • Jyotismati                  -           Calastrus paniculatus
  • Jatamansi                  -           Nordostachys Jatamansi
The drugs have a true tranquilizing effect on brain without inducing any hangover or dullness of brain. These are helpful in inducing sleep and freshness of brain for better performance, thus improving the intellectual activity and memory also. These plants also help as to come out of severe complexes, depression and antisocial trends e.g. suicide, hemisuidal, homicidal etc.
By their virtue of having effect on psychic they are also effective for the management several psychosomatic disorders. Heart disease, hypertensions peptic ulcer, ulcerative colitis are some of the notable disease of this group. These drugs have also anabolic effect on general metabolism. Cardio vascular drugs: cardio vascular disease is a great cause of mortality like cancer in the western countries. But the developing countries are no more exception. The incidence of high B.P., heart disease, and obesity is in increasing in China and India. Usually the people have a feeling that it is disease of affluent society and the treatment as only possible by the modern drugs. But none of them is true; there is description of this disease in Ayurvedic literature which is referred to be a contribution of 500 B.C. The treatment of heart disease is still in practice in Indian system of medicine. The effective drugs of cardiovascular system are as follows:
Arjun                          :Teminalia Arjuna
Gugulu                       : Balsamodendron mukul
Pushkarmula             : Inulr Recemosus
Shalpharmi                : Desmodium gangetiun
Karbir                         : Theretia Nereifolia
Kutha                          : Holerrbena – Antidysenterica
Rasona                       : Alliun – Sativum 
Thus a good number of cardio vascular drugs are in our urmamentorium of medicinal plants which can be developed as potent drugs in future.
Respiratory System:
According to Ayurveda respiratory system is the chief site of Kapha hence the disease also produce the symptoms of Kakha. Vata is also involved simultaneously in some disease as Bonchial Asthma. It is a well-known fact that if is a disease having ofstruction branch opathy. Obstruction may be because of the Oedoma/ inflammation of the mucosa or due to bronco – construction, forma is allergic inflammation due to excess of histamine like substances and the latter is because of the predominance of anticholenergic substance. Allergic manifestatias may produce several symptoms of respiratory tract disorder e.g. Allergic Rhinitis, Nasopharongitis Brynchitis etc. The following drugs have been found to be useful for amelioration of the above pathology.
Tulsi                   :Olimum sanctum
Sirisha               :Albizzia Leffeck benth
Kantkari             :Solan um xanthocarpum
Vasa                   :Adhatoda Vasca
Madhuyasti        :Curucuma Longa
Sunthi                 :Zingiber Feivale
Bibhitaka           :Terminalia Belerica
Tulsi is supposed to be most pious plant in Indian culture. No worship is complete without offering the tender leaves to God and then same is distributed among the masses for beneficial effect on health. The evidences are in favour that it is an immunostimulant thus providing increased general resistance for the prevention of disease. It is antipyretic, antinflamatery, expectorant and milid bronchodiloty thus of great help to the patient of upper respiratory and bronchial disease. Sirisha is known as an established drug for allergic disorders and branchal asthma. Charak has described it to be most effective vishghna (antitoxic drug). On Pharmacological study it is found to be antihistaminic and steroidogenc, plasma cortisol is increased within a week after the administration of the drug Active Principle is known to be a Saponin.
All above drugs may be used alone or in combination for the treatment of several types of respiratory system disease. Shirisadi compounds containing Shirisha, Kanthari, vasa and Madhyuasthi is popularly used as shiristi chey (tea). Sunthi.

Gastro – Intestinal: Statistics is evident that the incidence of gastro intestinal diseases in India is maximum. Broadly these can be classified in two groups (i) psychosomatic disease (ii) parasitic infection and a third group can be idiopathic. Among the first group peptic ulcer (parionon shula) irritable bowel syndrome and colitis are the common clinical entities available in our country. Ion the second group amoebiasis, giardiass and other worm infections are common e.g. round work, Hook worm, thread worm. There is a concept of Jatharagni in Ayurveda. Apart from that it also seems to help the absorption and metabolism. In case of hyperseoretion/Hyposecreation absorption becomes poor and the metabolism registers at a lowereble. So the malsecretion and malaobsoption syndrome are related to each other and produce several disease of G.I. tract which are often known as adiopathic e.g. Amlaphita, graham etc.

A good number of drugs have been worked out and found to be useful for the treatment of these disorders or follows :
Patola –    Gastritis
Nurikela – Pepticulcer
KLutaja –  Colis
Karanj –    Amoebiasis
Bilwa –      Amoebiasis
Palas –      Beeja – worm infections
Most of these drugs stimulate and digestive and help in regeneration of villi for a better absorption which leads to acceleration of metabolism. Some of the drugs are proved to be antihelimenthic and antiparasitic others offer symptomatic relief to the gastro intestinal symptoms.
Liver Dis-function:
The most common disease of liver is infective hepatitis (kamala) Though it is a fact that it is a self limiting disease and takes about 4 weeks to become alright but it has got a very deterimented effect on health, if the pathology continues come residual symptoms perrists it may turn into cirrhosis of liver which is fatel in due course of time.
Otherwise of the infection is fulminating it may take acute turn and patient may pass towards acute hepatic failure characterized by anasarca, hemorrhage, renal and curdic failure and the patient may succumb in no time.

Even in the normal course of the disease there can be four stages on the first week there is no jaundice, there is fever and loss of appetite and general weakness usually the cough and cold may be present with the beginning of the process. In the second week Jaundice is marked urine, stool, skin, nails, eyes everything becomes yellow, in the third week there may be inflammation of file canaliculi colangitis leading to intrapepaic obstruction and regurgitation of file in the blood producing a more deep Joundice and whiteclay colourd stool, in the fourth week the pathology may resolve  or pass to the stage of complication. Otherwise also, it the resolution is not complete the lesion may perrist as residual pepatitis. The following drugs hae been found to have a cholaratic effect and helping in the complete resolution of hepatitis, so these drugs have preventive as well as curative effect in patients of hepatitis.                                                                 
Kalmegh – Androgaphis panculata 
 Bhringraj – Eclipta alba
Amalaki – Emblica officinalis
Sarpankha – Tephrosia purpurea.

In clinical trial all these drugs in combination or as single drug can be used kalmegha and Amalaki combination are under clinical trial in our medicinal plants unit serum bilirubin comes down to normal range within to 2-3 weeks hepatitis is improved and there is no chance of having residual hepatitis in the end.

The discussion could be extended to any length but it is concluded with an optimistic note that India with its rich heritage of herbal medicine, its wealth of medicinal flora and necessary expertise in all relevant area would be able to offer leadership in the development of herbal medicine. It should, however be kept in mind that tomorrows citizens of India will have a better scientific temper and attitude and will not be satisfied to know merely that it works they will question how it works? Our development should be equipped to answer this questions.

Dhirendra V. Singh
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