Regulatory Requirements for Herbal Medicines in India

Read this article to learn about the Regulatory Requirements for Herbal Medicines in India. After reading this article to learn about: 1. Introduction to Regulatory Requirements for Herbal Medicines in India 2. Standards of Drugs as per Existing Leg­islature of India 3. Standards of Ayurvedic Drugs 4. Standards of Siddha Drugs 5. Standards of Unani Tibetan System of Drugs and others.

Introduction to Regulatory Requirements for Herbal Medicines in India:

Herbal medicines are being used in India since Vedic age and it has been documented in Rig-Veda. It has been mentioned in Charak Samhita. In­itially herbs have been used by the people tradi­tionally from their experience and gradually a group of experts evolves who were called as apoth­ecaries.

Herbal medicines are also used since long back in other different countries like China. In In­dia herbal medicines are being used in Ayurveda, Siddha, Unani and Homoeopathic system of med­icines. Ayurvedic system is being practiced since 6000 B.C., Chinese herbal medicines is being prac­ticed since 5000 B.C. whereas the modern sys­tem of medicines started since 1800 A.D.

This was popular may be because of the expe­rience and abundant availability of plants in India due to its varied agro climatic zones. We are hav­ing around 45,000 species of plants in the Indian conditions, out of which 15,000-20,000 plants have proven medicinal value.

The traditional sys­tem utilizes around 7,000-7,500 species in its for­mulations. Ayurveda uses 2000, Unani 1000, Sid­dha 1300, Tibetan 500 and 200 varieties in the modern medicine. Interest on herbal products has been increas­ing since last few decades not only in underde­veloped and developing countries, but also in the developed countries.

A large number of big pharma companies started to redirect their business strategy by investing large amount of finance in research and manufacturing of herbal medicines. Some Govt. institutions are also emphasizing on research on herbal medicines.

Herbal medicine has a Global market of US$ 80-100 billion and this market is expected to reach US$2500 billion by the year 2010 and US$.5 trillion by the year 2050 according to the World Bank report.

The Indian herbal drug market is about $ 1 billion and the export of herbal crude extract is about $ 80 mil­lion. We have about 7800 manufacturing units engaged in manufacturing of herbal drugs in India, which are consuming 200 tons of herbs annually.

Initially there was no regulation for control­ling the quality of herbal medicines and the prac­titioners relied on their experience on proper iden­tification of the plant. Gradually some regulation developed and the first organized regulation on quality is the Drugs and Cosmetics Act 1940 and Drugs and Cosmetic Rules 1945.

This act initially prescribed the standards of Ayurvedic, Siddha and Unani medicines and laid down rules and regula­tion on manufacturing.

Standards of Drugs as per Existing Leg­islature of India:

Standards of medicines are prescribed in the Drugs and Cosmetic Act 1940 and individual mono­graphs has been prescribed in the respective Phar­macopoeias. Recently the Govt. of India has pub­lished 4 volumes of Ayurvedic Pharmacopoeia en­compassing standards of 326 drugs, which is gross­ly inadequate in comparison to the number of herbs used in the Ayurvedic system of medicines.

A positive step has been taken in this direction by publishing of the Herbal Pharmacopoeias, having standards of 52 drugs (IDMA, 2002).

Unfortunately neither the herbal products nor the herbal Pharmacopoeias have any statutory standing in our country. That there are a large number of herbal products in the market though it is difficult to categorize these prod­ucts as per the Drugs and Cosmetics Acts and Rules. Some herbal drugs are also marketed as food or nutritional supplements, with medicinal claims.

Keeping this problem in mind, status of herb­al products was surveyed through different sourc­es including Pharmacopoeias of different coun­tries.

In some countries herbal products are con­sidered as drugs, e.g. China, UK, Canada, Ger­many, etc. while some countries do not grant herb­al products, the status of drugs e.g. USA, Nether­lands etc. They consider it as nutritional supple­ments, and have framed definite legislation for it e.g. USA.

In India there are some gray areas in case of status of herbal drugs (Table 3.1.I) and there exists no definite policies about food supplements. Re­cently Govt. of India has published Food Safety act to resolve this problem.

As per the experts this said act has not been im­plemented and failed to resolve the problem. Sometimes mere mentioning of a drug in some textbooks is considered sufficient as per existing legislature, whereas the texts are not properly de­fined.

Standards of Ayurvedic Drugs:

Standards required to be complied with in and Cosmetics Rules, which are given in the table manufacturing for sale or distribution of Ayurvedic, Siddha and Unani Drugs are laid down in Drugs and cosmetics Rules, which are given in the table below.

Till date, only four volumes of Ayurvedic Phar­macopoeia having monographs of about 326 herbs have been published, which is quite inadequate with respect to the huge number of herbs used in the Ayurvedic system of medicines.

Mere mentioning of preparation method in a list of 57 texts, are sufficient for manufacturing such Ay­urvedic drugs. All of these books are old texts ex­cept the Ayurvedic Formulary of India (Part I) and Ayurvedic Pharmacopoeia of India. There is am­ple scope of misuse of this provision, as 55 books out of 5 7 are not properly defined in the legislature.

The monographs cover only a few parame­ters, which are considered to be quite inadequate for standardization. Monographs of herbs in British Herbal Phar­macopoeia prescribe chemical characterization involving TLC, GC and PC electrophoresis, where­as no such modern methods are required in the Ayurvedic Pharmacopoeia.

Minimum pharmaco­logical characterization is required, which is quite inadequate, compared to characterization speci­fied by other Pharmacopoeias. No standards for combination products are prescribed in statute, except Asavas and Aristas. Only alcohol content of these two products is giv­en in D and C Act.

Standards of Siddha Drugs:

As per the Drugs Act, simply mentioning of man­ufacturing process in a list of 30 books allows pro­duction of Siddha Drugs. Amongst these 30 books, 29 are old texts and Siddha Formulary of India (Part I) is the only book published by the Govt. of India recently.

Standards of Unani Tibetan System of Drugs:

As per the Drugs Act mere mentioning of manu­facturing process in a list of 13 books allows pro­duction of Unani and Tibetan drugs. Amongst these 13 books, 12 are old texts and the only mod­ern book is National Formulary of Unani Medi­cine (Part I) published by Govt. of India.

Schedule T for Good Manufacturing Practice:

To manufacture good quality Ayurvedic, Siddha and Unani medicines Good Manufacturing prac­tices have been made mandatory by incorpora­tion of revised Schedule T in the year of 2003.

Important features of Sched­ule T are as follows:

(i) Raw materials to be used in manufacture of medicines must be authentic, of prescribed quality and free from contamination.

(ii) Manufacturing process is as prescribed to maintain the standard.

(iii) Adequate quality control measures to be adopted.

(iv) Drugs released for sale shall be of acceptable quality.

(v) To achieve the objectives listed above, the firm is required to maintain the following con­ditions stringently—

(A) Well designed factory premises with suf­ficient space required to be provided.

(B) Proper machineries require to be pro­vided.

(C) Quality control laboratory require to be provided with required instruments and well qualified personnel.

(D) Shall evolve methodology and proce­dures for following the prescribed process of manufacture.

(E) Which should be properly documented and kept for reference and inspection.

Standards of Homoeopathic Medicines:

Standard of Homoeopathic medicines has been prescribed in Second schedule of the Drugs and Cos­metics Act, 1940, which is given in Table 3.1.III.

In addition to this, three more parameters are re­quired to be controlled for mother tincture, which are identification of crude drugs, total solids and alcohol content.

For the first category presently we have eight volumes of Pharmacopoeia prescribing the mon­ographs including identity, purity and strength of several raw materials. But no standard for finished product was included till publication of fifth volume in the year of 1987.

Sixth and eighth volume included standards of few finished products of Mother Tinctures and Mother solutions. Standards include a few preliminary criteria like pH, wt. per ml, al­cohol percentage, X max and identification, which are considered inadequate for proper quality con­trol at this age when sophisticated techniques like HPTLC are easily available.

Schedule M1: In order to ensure proper qual­ity of Homoeopathic medicines manufacture, Schedule M1 was introduced in 1987 specifying requirement of technical staff, manufacturing plants, testing equipment etc. Experts feel that this is quite inadequate in this age of science.

Recently Government of India has taken an initiative to implement Good Manufacturing Prac­tices (GMP) and a guidelines has already been pub­lished, which is effective from 2^nd October 2008.

This guideline is more detailed and prescribed minimum requirement of manufacturing areas, equipment’s, minimum qualification required for the personnel engaged in manufacturing and qual­ity control, documents to be maintained etc. for manufacturing quality medicines.

Patent Protection to be Exploited Fully:

Despite possessing huge natural wealth, India has not shown promising performance in the field of the thriving $ 80-100 billion global herbal mar­ket. A few countries—China, Russia, Europe pan and even USA have marched ahead with nu­merous international patents on medicinal plants.

If India can fully exploit its .natural resources, skilled manpower and potential traditional knowl­edge and couple them with its technical powers then India can march ahead to compete with glo­bal players by partly substituting costly modern medicines with modern herbal drugs.

If India can concentrate her efforts to develop the heritage herbal products and processes it seriously, it will be hard to hold back the progress.

It is unfortunate that some of the Indian prod­ucts have been patented by different companies which are being used in India since a long time like- Neem, Amla, Kurchi, Sarpagandha, Calen­dula, Sankhapushpi, Jamun, Anar, Bagbherenda, Karela.

Fortunately, Government of India has tak­en initiative to challenge the patent granted on turmeric to an US University and as a result U.S. patent (No. 5,401,504) on the use of turmeric (Cur­cuma longa L., Zingiberaceae) for healing was invalidated because it was not a novel invention. This is an encouraging victory for Indian activists campaigning to protect indigenous wisdom.

Un­der World Trade Organisation (WTO) rules, pat­ents are provided for inventions that qualify for their novelty, non-obviousness, and utility.

The tur­meric patent failed to satisfy the criteria of novel­ty as turmeric paste has been used to treat wounds and stomach infections for centuries by Indians. The turmeric patent was just one of the hundreds that the developed countries have claimed by ig­noring indigenous and existing knowledge.

In order to prevent grant of patents based on Indian traditional knowledge, Government of In­dia has undertaken an ambitious project of creating a Traditional Knowledge Digital Library (TKDL). This is a joint venture of the Council of Scientific Research and Central Council for Re­search in Ayurveda and Siddha.

This project is in­tended to cover about 35,000 formulations avail­able in 14 classical texts of Ayurveda to convert the information into patent compatible format. The work has been initiated with a co-operative set up of 30 Ayurveda experts, 5 information Tech­nology experts and 2 Patent examiners.

The digit­al library will include all details in digital format about international patent classification, traditional research classification, Ayurveda terminology, concepts, definitions, classical formulations, dos­es, disease conditions and references to docu­ments.

Steps to be taken to Improve the exist­ing Efforts of Standardization:

1. Control on Quality of Raw Materials:

Quality of medicines of herbal origin mainly depends on quality of raw materials. Presently, a major part of the raw materials are procured from wild origin, which have almost no control on parameters of cultivation or collection etc.

Controlled cultiva­tion could be a parameter of the quality control. If Good Cultivation Practice and Good Harvesting Practices are developed and implemented raw ma­terials of good quality can be ensured.

European Guidelines for Good Agricultural Practice (G.A.P.) of Medicinal and Aromatic Plants, Good Agricul­tural and Collection Practice for Medicinal Plants (GACP), Japan, Good Agricultural Practice for Tra­ditional Chinese Medicinal Materials, People’s Republic of China etc. have been published for this purpose.

Recently World Health Organiza­tion has also published Good Agricultural and Col­lection Practice (GACP) which may be practiced in case of cultivation and collection of Medicinal plants (20).

2. Research for Developing Quality Control Methods:

It is a fact that quality control of herbal drugs is not developing sufficiently, especially for combination products. Research on developing standardization methods involving modern instru­mentation is urgently required. Though a few at­tempts have already been made, more emphasis is required in this area.

Monographs of more plants require to be incorporated in the existing Ay­urvedic Pharmacopoeia. More stringent specifi­cations including use of sophisticated instruments are to be incorporated. Research and development of marker compounds and Metabolomics are or­der of the day, and stress must be laid in this area.

3. Clinical Trial:

In the third world countries like India, there is always a lack of enthusiasm noted for conduction of clinical trials, and also there is a dearth of coordination and effort to translate and utilize the results of clinical trials within various working groups and professionals.

While most modern clinicians and researchers believe in rig­orous screening and clinical trials, most special­ists in traditional medicine are convinced of 100% efficacy of their drugs and consider clinical trials as redundant.

This attitude is much more preva­lent in India than in China, where institutes of tra­ditional medicine have established their drugs on scientific basis rather than on the rationale of drug. For proper conduction of clinical trials, there is a requirement of experienced clinical pharmacists, pharmacologists, as well as experts in traditional system of medicines.