India, Science and Technology:  2008

S&T and Industry

 

 

 

Indian Herbal Sector

 

 

Kirti Joshi

 

The recent upsurge in use of herbal medicines has led to a sudden increase in herbal manufacturing units. In India, there are about 14 well-recognized and 86 medium scale manufactures of herbal drugs. Other than this about 8,000 licensed small manufactures in India are on record. In addition, thousands of Vaidyas also have their own miniature manufacturing facilities. The estimated current annual production of herbal drugs is around Rs. 3500 crores. This section gives an overview of the rapidly growing Indian herbal industry followed by the legal parameters encompassing the manufacturing of herbal drugs.

 

Introduction

India has perhaps the world’s oldest as well as largest tradition of systems of medicine.  The term Indian Systems of Medicine covers both the systems which originated in India as well as outside but got adopted in India in course of time. These systems are Ayurveda, Siddha, Unani, Homoeopathy, Yoga, and Naturopathy. They have become a part of the culture and traditions of India. India with its strong base in traditional knowledge on herbal medicine and vast plant biodiversity has a great potential in this sector.

The codified Indian system of medicine puts to use raw drugs obtained from around 2,400 plant species. The number of raw drugs in trade is still less i.e. 1289 botanicals obtained from 960 plant taxa. The highest proportion of the traded medicinal plant species is used under the Ayurvedic system.

 

Infrastructure

Presently India has a network of 61,561 hospitals, providing traditional Indian systems of medicine and Homoeopathy. Out of which 3,204 hospitals are under AYUSH with a total of 61,583 beds. In 2007, more than 75% of these beds were occupied by patients receiving Ayurvedic treatment, which is by far the most commonly practiced form of traditional medicine in India. There are 21,437 dispensaries of traditional medicine. The health services provided by this network largely focus on primary health care. The sector has a marginal presence in secondary and tertiary health care. In the private and not-for-profit sector, there are several thousand AYUSH clinics and around 250 hospitals and nursing homes for in patient care and specialized therapies like Panchkarma. There are 725,338 registered traditional medicine practitioners and homeopaths, who are both institutionally (506,229) and non-institutionally (219,109) qualified. There are 13 government assisted pharmacies and over 5,000 licensed pharmacists.

 

AYUSH Health Network Hospitals 61561 Dispensaries 21437 Registered Medical Practitioners 725338 Institutionally qualified RMP 506229 Non institutionally qualified RMP 219109

 

Education and research

For all the systems namely AUS & H there are recognized and running undergraduate and post graduate courses. These courses are being imparted in Ayurved/Unani/ Siddha colleges affiliated to various Universities of the country. At present 240 Ayurved, 39 Unani, 07 Siddha and 185 Homoeopathy colleges are running in various states of the country with an admission capacity of 29,387 students.

Recently approval for Diploma Course in Nursing, Compounder and Pharmacy at the National Institute of Siddha (NIS), Chennai with annual intake of ten students has been given. In the National Institute of Ayurveda (NIA), Jaipur also Diploma course in Nursing, Compounder and Pharmacy with 20 seats annually has started. A proposal for enacting a law to establish a Central Pharmacy Council to regulate and standardize pharmacy education under Indian Systems of Medicine is also under consideration. A Bill to this effect has been introduced in the Parliament. Recent acts promulgated related to education are depicted in the box.

There are four research councils which are the apex bodies for research in the concerned systems of medicine and are fully financed by the government. Out of the four councils, three are autonomous bodies while CCRYN is a society registered under Society Registration act under Department of AYUSH, Ministry of Health and Family welfare.

 

 

 

 

Demand generation

In the last few decades there has been an exponential growth in the field of herbal medicine. It is getting popularized in developing and developed countries owing to its natural origin and lesser side effects. If we look at the data on consumption of botanicals, it foretells the huge demand of herbal drugs. Large quantities of botanicals in India are consumed by the herbal industry (177,000 MT) and by millions of rural households (86,000 MT) that depend for their primary healthcare on this resource. In addition, a large quantity of botanicals (56,500 MT) is exported from the country. With majority of population subscribing to herbal drugs there is boom in indigenous medicinal sector. According to a study conducted by ICMR (Padam Singh et al., 2005), it concluded that 33% people preferred ISM&H for common ailments while only 18 % preferred them in case of serious ailments in the country. 

 

Industry

The recent surge in in use of herbal medicines has led to a sudden increase in herbal manufacturing units.  This can be corroborated from the huge requirement of raw materials by the industry. The turnover of AYUSH industry is estimated to be more than Rs 8800 crore. The domestic market of Indian systems of medicine & Homoeopathy (ISM&H) is of the order of Rs 4000 Crore with a total consumption of all botanicals to a figure of 177000 MT, which is expanding day by day. The total annual turnover of the Ayurvedic drug manufacturing industry is estimated to be around Rs.3, 500 Crore. Besides this, there is also a growing demand for natural products including items of medicinal value/pharmaceuticals, food supplements and cosmetics in both domestic and international markets. India with its diversified biodiversity has a tremendous potential and advantage in this emerging area.

 

 

 

 

Manufacturing units

There is a complex of large number of manufacturing units using herbal material for various purposes. Whereas the largest number of such manufacturing units are registered as ‘pharmaceuticals’, there are others that are engaged in making plant based cosmetics and food supplements. Even within the pharmaceutical units, there are manufacturers of Ayurveda, Siddha, Unani and Homeopathic formulations (Figure 1) with a few even making western medicines. Another group of manufacturing units is engaged in making extracts and distilling oils for use by other industries and for exports. Raw materials for all these diverse industries are largely derived from wild sources.

 

Fig 1: Proportion of manufacturing units of different systems

Source: Dept of Ayush (data as on 01/04/07)

 

 

Fig 2: Herbal manufacturing units

Source: Demand & supply, NMPB 2008

 

 

There are total of 9,493 manufacturing units, of which mostly are small scale units (8,000) having an annual turnover of less than one Crore. Some of the well known industrial houses with annual turnover of more than 50 Crores are Dabur, Zandu, Himalaya, Shree Baidyanath, Arya Vaidya Shala etc. Though the number of manufacturing units with higher turnover is less, still they are the ones which consume about 35 % of the total raw material used.

 

EXIM scenario (2005-06)

The annual demand of botanical raw drugs in the country was estimated at approx 320 MT for 2005-06. Around 70% of the Indian exports from the AYUSH sector consist largely of raw materials and are estimated to be of the order of Rs 1000 crore per annum. The balance consists of finished products including herbal extracts.

 

Fig 3: Percentage of plant species under different systems of medicine

Source: Demand & Supply, NMPB 2008

 

Export:  The total quantity of exported medicinal plants including plant extracts was 57880 MT. Psyllium exports constituted 35.6 % of total exports of medicinal plants followed by Senna (18.9%). The total value of plant raw drugs exported (excluding extracts) was Rs. 354.8 Crores corresponding to a quantity of 56,500 MT. The annual export of India’s herbal sector added to Rs. 807 Crores as per DGCIS data. This includes exports worth Rs. 354.80 Crores relating to plant raw drugs, Rs.161 Crores relating to plant extracts and Rs. 291 Crores to medicants of AUS and H. It shows that the finished herbal products constitute nearly 36 % of the total exports of India s herbal sector and the balance 64 % exports are in the form of raw materials and extracts. On comparing the export data with previous year shows a sizeable increase of Rs. 185 Crores i.e. nearly 30 %.

Import: Total 40 (number) commodities were enlisted for import. The consolidated figures of such imports amounted to 37,483 MT (Rs.173 Crores) and Gum Arabic constituted the largest proportion by quantity (12,731 MT;   34 %).

 

Government stand

Ayurveda, Unani, Siddha, Naturopathy, homeopathy, and yoga are all recognized by the Government of India. The first step in granting this recognition was the creation of the Central Council of Indian Medicine Act of 1970 while the Central Council of Homeopathy (CCH), constituted in 1973. The primary areas of work for the Department are education, standardization of medicines, enhancement of availability of raw materials, research and development, information dissemination, communication, and the involvement of traditional medicine and homeopathy in national health care. The Indian Government seeks the active and positive use of traditional medicine and homeopathy in national health programs, family welfare programs, and primary health care.

 

Dept. of AYUSH

The Indian systems of Medicine & Homoeopathy (ISM&H) were given an independent identity in the Ministry of Health and Family Welfare in 1995 by creating a separate Department, which was renamed as Department of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy (AYUSH) in November 2003. The department is entrusted with the responsibility of developing and propagating officially recognized systems, namely, Ayurveda, Yoga, Naturopathy Siddha, Unani, and Homoeopathy. The Department has set up four Research Councils, seven National Institutions to offer educational and research facilities in these fields. In order to formulate standards for drugs, Pharmacopoeia Committees for each of these systems were also set up. They are supported by the Pharmacopoeia Laboratory for Indian Medicine, and Homoeopathy Pharmacopoeia Laboratory. Two statutory Councils, the Central Council of Indian Medicine and the Central Council of Homoeopathy (CCH) were also established for laying down and maintaining uniform standards of education as well as to regulate the professional practices in the fields of Indian Systems of Medicine and Homoeopathy, respectively.

 

Regulations

Globally, there have been concerted efforts to monitor quality and regulate the growing business of herbal drugs and traditional medicine. Health authorities and governments of various nations have taken an active interest in providing standardized botanical medications. Government of India has also plunged into this opportunity and initiated some regulations in this sector.

To ensure and enhance the quality of ASU medicines, the Government of India has notified Good Manufacturing Practices (GMP) under Schedule ‘T’ of the Drugs and Cosmetics Act 1940 which also ensures raw materials used in the manufacture of drugs are authentic, of prescribed quality and are free from contamination.  The guidelines for Good Agricultural Practices (GAP) seek to lay down a cultivation programme designed to ensure optimal yield in terms of both quality and quantity of any crop intended for health purposes. It puts forth a standard for production of raw material that goes in to the making of the ASU medicines and standardizes the production processes from farm to factory. As a matter of fact it can be seen that there is a direct correlation between efficacy of an herbal drug with the quality of raw material used and the process of manufacturing. It is of paramount importance that no compromise is made on quality. Quality of raw material being watched over by following GAP and GACP, for manufacturing and marketing the prepared drugs, government has formulated the Drugs and cosmetics act, 1940.  It is an act to regulate the import, manufacture, distribution and sale of drugs and cosmetics. This act was basically initiated for chemical drugs but later in the year 1969 a separate chapter relating to Ayurveda, Siddha and Unani drugs was inserted by act 13 of 1964. Laws are partly same as those for conventional pharmaceuticals. Later on this was again modified with some substitutions in the year 1983, 1987, 1994 and 2002. The schedules and rules pertaining to Ayurveda, Siddha and Unani systems in the act are:

Schedules:

• First Schedule substituted by act 13 of 1964 came into force w.e.f 1-2-1969. The schedule lists the standard Indian pharmacopoeias to be followed for manufacturing Ayurveda, Siddha and Unani drugs. About 57 books of Ayurveda (with insertions in 1987, 1994, 2002), 29 of Siddha (1987), 13 of Unani Tibb system are listed.
• Second Schedule came into force w.e.f 15.09-64. It states about the standard to be complied for manufacturing drugs. (Subs. by Notifn. No. G.S.R. 885, dated the 4th August, 1973, Gazette of India, Pt. II, s. 3(i), p. 1643.)
• SCHEDULE-E(1) : List of poisonous substances under the Ayurvedic (including Siddha) and Unani Systems of Medicine (Added by Notfn. No. 1-23/67-D dt. 2-2-1970) differentiated into vegetable, animal and mineral origin.
• SCHEDULE T:  Good Manufacturing Practices (GMP) for ayurvedic, siddha and unani medicines. (Ins by G.S.R. 561 (E) dt 23-06-2000 and subs. by G.S.R. 198(E), dt. 7.3.2003.). Under Schedule “T” of the drugs and cosmetics act 1940, the government has made it mandatory for all manufacturing units to adhere to GMP.

Rules:

• Rules: Part XVI (Parts XVI, XVII and XVII added by S.O. 642, dt. the 2-2-1970 (w.e.f. 21.2.1970) Manufacture for sale of ayurvedic (including siddha) or unani drugs. It notifies about how to acquire license, loan for establishing a unit and also on the identification of raw materials and its purity.
• Part XVIA: Approval of institutions for carrying out tests on ayurvedic, siddha and unani drugs and raw materials used in their manufacture on behalf of licensees for manufacture for sale of ayurvedic, siddha and unani drugs (Ins. by G.S.R. 701(E), dt. 27-7-2001 and subs. by G.S.R.73 (E), dt. 31-01-2003.)
• Part XVII: Labelling, packing and limit of alcohol in ayurvedic (including siddha) or unani drugs. (Subs. by G.S.R. 904(E), dt. 2.11.1992.)
• PART XVIII: Government analysts and inspectors for ayurvedic (including siddha) or unani drugs.
• PART XIX: Standards of ayurvedic, siddha and unani drugs (Ins. by G.S.R. 519(E), dt. 26.6.1995.)

 

XI Five year plan

The XI five year plan also gives emphasis on developing herbal sector. Around 6000 species of medicinal plants are documented in published medical and ethno-botanical literature. Wild populations of several hundreds of these species are under threat in their natural habitats. In the Tenth Plan, a National Medicinal Plants Board (NMPB) was established for supporting conservation of gene pools and large scale cultivation of medicinal(five year plan). However, there have been no official efforts so far to conserve these resources. The key challenges in the Eleventh Five Year Plan are to conserve gene pools of red listed species, support large-scale cultivation of species that are in high trade, involve forestry sector in plantation of medicinal tree species, and establish modern processing zones for post-harvest management of medicinal plants. The key interventions and strategies in the Eleventh Five Year Plan are:

• Ensuring conservation of medicinal plants gene pools as well as promoting cultivation of species in high trade and establishment of medicinal plants processing zones.
• Strengthening regulatory mechanism for ensuring quality control, R&D, and processing technology involving accredited laboratories in the government and non-government sector.

 

IPR issues

There have been several examples wherein the knowledge embodied in traditional practices relating to medicinal plants, traditional cultural expressions/folklores, cultural artefacts and genetic resources of communities in India has been misappropriated or attempts have been made to do so.  The application of existing IPR laws and existing frameworks have given rise to several issues, which has required a strong movement to protect the biopiracy by institutung machanisms both at the national and the international level. At the moment India does not have any specific legislation for protecting TK. The modalities of it are still emerging and evolving. The Legal protection accorded to traditional knowledge in India is through:

• India’s patent laws with the Amendment Act of 2005 which contains provisions for mandatory disclosure of source and geographical origin of the biological material used in the invention while applying for patents and also allowed the composition of a drug to be patented.
• The Indian Biodiversity act 2002 which follows the Convention for Biological Diversity’s guidelines regarding benefit sharing.
• India has established a central authority “National Biodiversity Authority”to monitor and control foreign access to Indian biological resources including traditional medicine. 
• Development of a database called “Traditional Knowledge Digital Library ”(TKDL) that will document as well as establish the prior art to hinder patenting Indian knowledge. This task has been entrusted to NISCAIR, a CSIR laboratory.

At the international level, the Inter-governmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore under World Intellectual Property Organization (WIPO), is considering various concerns and issues of misappropriation of TK and looking for  ways & means and principles for protection of TK. 

 

Absence of regulatory regime

In olden times, vaidyas used to treat patients on individual basis, and prepare drug according to the requirement of the patient. But the scene has changed now; herbal medicines are being manufactured on a large scale in mechanical units, where manufacturers come across many problems such as availability of good quality raw material, authentication of raw material, availability of standards, proper standardization methodology of single drugs and formulations, quality control parameters, etc. Currently the regulatory regime formulated does not encompass all these issues as the country is still in the developing stage of a strict formulatory. To become well poised and a major player it has to work upon the gaps therein by revamping & redefining the laws. 

 

Loss to the country

The rich heritage of traditional systems of medicine and vast repository of natural resources puts India at a promonent position in global scenario of herbal sector. But to revitalize these traditions, the route employed is being considered as erratic. Medicines produced in large scales are generally being compromised on their quality resulting in poduction of substandard or spurious drugs. And with the absence of regulation there is no way to keep a rein on it.  This has projected indigenous medicines in a bad repute. The concept of vaidyas prescribing and formulating medicines according to the need of an  individual has been replaced by University educated doctors prescribing OTC medicines. The holistic and individualistic approach, one of the keystones of the systems remains now critics aver, antiquated. The traditional lineage of vaidyas is being lost. So present day need is to revive the systems along the lines of prevalent traditions and promote the usage of herbal medicnes otherwise our heritage will be lost, resulting in a great loss to the country.

 

 

Acknowledgement: The author greatly acknowledges Dr. V. K. Gupta, NISTADS for the invaluable suggestions and inputs given for the topic IPR issues.

 

 

References

• Singh, P., Yadav, R.J. & Pandey, A. (2005). Utilization of indigenous systems of medicine & homoeopathy in India. Indian J.Med Res 122, Aug 2005, pp137-142
• Ved D.K. & Goraya, G.S. (2008). Demand & Supply of Medicinal plants in India, NMPB,  New Delhi & FRLHT, Bangalore, India
• Drugs and Cosmetics Act 1940 (URL: cdsco.nic.in/html/Drugs&CosmeticAct.pdf)
• World Intellectual Property Organization. (Website: www.wipo.int/)

 

 

 

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