Ayurvedic manufacturing industry in India is by far fragmented and still a domain of tiny and small industry sector except for 50 medium units and four large units. Though about 9000 units have obtained license to manufacture Ayurveda, Unani and Siddha drugs in India, only 1000 companies are active. Of them about 170 units having a turnover of over Rs 3 crores fall under small industry category and the rest all fall under tiny industry category. About 15 mainstream pharma companies have a division for ayurvedic medicines. Companies manufacturing phytopharmaceuticals/ plant extracts follow IP/BP/ USP or Commission- E monograph or British herbal pharmacopoeia or Japanese codex. In India, Pharmacopoeia standards for about 150 plant drugs only have already been worked out and published.
The Rs 4500 crore turnover ayurvedic manufacturing industry use 960 plant species as raw materials of which 178 are highly utilized, more frequently in formulations by most of the companies. The herbal extraction units and the phytopharmaceuticals have a turnover of about Rs 500 crores which include products like colchicin, sennoside, vincristin etc,. All along the focus have been these plant drugs but the industry also uses about 50 mineral ores, chemical substances, close to 45 animal origin ingredients and 20 marine derivatives. Commodities like jaggery, honey, ghee, milk and various vegetable oils are used both as functional ingredients and as base ingredients. In fact , in value terms , plant products constitute only 10 per cent while mineral products constitute 20 per cent, animal origin five per cent and the rest made by commodities. Of the plant products used in proprietary formulations, herbal extracts constitute about 50 per cent.
The ingredients used either fall into free trade category or restricted product category. The free category plant products are mostly procured from traders in mandis. The mandis receive them from various wild collection groups living in the fringe of the forests who collect them either from forest region or from wastelands, road borders, tank bunds and common community land. Some plants like Eclipta alba are also collected from agricultural lands where they grow as weeds. Studies carried out by different agencies have confirmed that the density of a particular plant has significantly come down in a given area and thereby collection cost has also increased tremendously.
Immature plant parts are also collected and drying is done mostly before cleaning/washing on the roads leading to contamination including heavy metal contamination as vehicles run over them. When collected either from agricultural fields or from adjoining areas, pesticide residue becomes inevitable. Ayurveda uses 338 roots as ingredient which requires destructive collection and they are slowly becoming sparse, increasing the cost and non-availability for industry leading to substitution and adulteration mostly guided by the trade source.
About 15 per cent plant ingredients of ayurvedic formulation industry are now cultivated and procured from farmer clusters. Plants that are from cultivated source are mostly annuals where the grower gets returns within six months. Here again there is a network of traders who procure them from farmers and sell them to the industry. About 60 per cent requirement of the phytopharmaceutical, herbal extraction industry is fulfilled by cultivation
Some products like cannabis, opium which were used earlier have slowly withdrawn as narcotic license are required. Plants like Petrocarpus marsupium, Salacia oblanga, Sassurea lappa, Saraca asoka are endangered and industry face an acute shortage. Still the group called Astavarga species is nebulous.
Ingredients of wild origin like sandalwood, red sanders, deer horn, elephant teeth, musk, civet, marine products like coral, coral reef, Amber which can be procured only with legal permission from the wild life department or forest corporations and almost most companies have stopped manufacturing formulations with these ingredients. Like growing medicinal plants it is possible to grow Musk deer and Civet cat under captivity and ingredients made available to industry. Deer horn –Shringi is shed by deer at regular intervals and forest department itself can collect the fallen ones and provide to authentic users may under a quota system based on consumption.
Licorice, long pepper, galangal roots, dry ginger, guggul, asafetida- hing are imported. No company imports them directly and relies mostly on traders and importers. There are wide variations even in Organoleptic in these materials based on the source from where they are imported.
Mineral origin ingredients used include ores of gold, silver, mercury, iron, zinc, and copper, Manashila, Shilajit, and Navachar. The biggest challenge now is the fact that the actual chemical composition of many salts mandated in traditional literatures is currently not fully understood identity is inconclusive and controverted. Most of the chemical ingredients originally used to be ores while currently technical grade materials imported into the country are used. Ingredients like Manashila and salt petre- Vediuppu are restricted in trade due to their explosive nature. Crystalline salts of Navachar revered by Siddha manufacturers are literally not available.
Government of India in the Tenth and Eleventh Plan has given more momentum to strengthen the industry particularly the quality standards of ayurvedic medicine. This momentum is triggered by the JAMA publication on the safety of ayurvedic drugs first published in 2004. Various research institutes under Indian council of Medical Research, Regional Research Laboratories and Indian institute of Chemical technology of CSIR, Central Council of Research in Ayurveda and Siddha and certain private universities are given time-bound projects for development of quality standards both for ingredients and finished products. Various amendments have been made to the rules of the Drug and Cosmetics Act, mandating quality testing particularly for heavy metals, residual pesticides, and microbial contamination apart from assays. Projects have also been assigned to make available marker compounds to be used as bench mark. Dept has also provided adequate funds to the states to establish drug testing laboratories for testing ayurvedic ingredients and products. Facilities have also been extended to private manufacturers to establish in-house quality control laboratory. Dept of Ayush has also provided funds to the states to strengthen the state licensing and monitoring structure to monitor GMP implementation in letter and spirit. One of the major initiatives under the ayurvedic cluster scheme of the department is establishing a warehouse for certified quality raw material for ayurvedic industries. At least seven projects each for about Rs16 crores have been sanctioned and work is already under way. National Medicinal Plants Board with a outlay of Rs 750 crores in the current plan period is actively engaged in bringing into cultivation as many plants as possible so that quality raw material from authentic plant variety high in secondary metabolites of right maturity and exact plant part is available. All these efforts are likely to pay off in the next few years.
The next task include establishing the exact identity of many botanical drugs which are called ‘Sandigda dravia’ – controversial drugs and also develop standards for inorganic, marine and animal products which have never been attempted so far and make them available to the industry either promoting ex-situ conservation and captive growing.
The author is Gen.Secy,
Centre for Tarditional Medicines and Research (CTMR)