Additionally, herbal extracts and powders are comparatively cheaper than synthetic drugs and formulations and act as an alternative for the lower-income segments of the society who cannot afford allopathic drugs. India stands tall in this field due to a rich history and expertise of traditional medicine. Significant markets for AYUSH are Western Europe, the US, Japan and Southeast Asia with a sizeable potential for increase.
Among the top 10 destinations of India’s herbal products, the US leads the list. US has imported herbal products worth Rs 202 crore every year since 2007-08. In the US, as many as 42 per cent of people are adopting ‘complementary or alternative medicine’ (CAM) approaches to help meet their personal health problems. New surveys show that four in every 10 people in the US have used CAM in the last year. Organisations like the Food and Drug Administration (FDA) and American Medical Association and American Association of Medical Colleges are taking note of evidence-based CAM to curtail healthcare costs.
In 2009, the market for AYUSH was estimated at Rs 8,000 crore including drugs, over-the-counter and wellness products, treatment and herbal extracts and it has been growing at 20 per cent year-on-year. The export of these products took a jump from Rs 617.87 crore in 2005-06 to Rs 1335.01 crore in the year 2009-10 and are expected to reach Rs 16,250 crore in 2014. Total exports share is mostly in around 26 clusters pan India with over 20,000 ayurvedic proprietary formulations and 1,000 classical formulations. With 9,493 licensed manufacturing units (mostly micro and small), the significant herbal and AYUSH products according to 2009-10 list of India’s 30 top exports include medicaments of ayurvedic systems, Psyllium husk (isobgul husk), saps and extracts, senna leaves and pods, other plants and parts of plants used in pharmacy, insecticidal/fungicidal purpose, medicants of homoeopathic systems, Lactus and Lactus syrup containing 99 per cent or more Lactus , Vinca rosea (herbs), Zedovary roots, Cascara sagrada bark, kuth root, sarsaparilla, Tukmaria and medicants of bio-chemic systems.
Recently, Union Minister for Health and Family Welfare, Ghulam Nabi Azad, mentioned in the Lok Sabha that Expenditure Finance Committee (EFC) chaired by Secretary (Expenditure) has approved a proposal on October 4, 2010 to create 40 posts in the proposed Central Drug Controller’s Office for (AYUSH), including 25 regular and 15 contractual/ outsourced posts and to support engagement of 330 scientific manpower in the state drug testing laboratories. The Department of Expenditure has allocated Rs 80 lakh in the annual plan 2012-13 for creating 40 posts in the proposed Central Drug Controller’s Office (AYUSH).
Dr Namyata Pathak Research Associate Kasturba Health Society & Vaidya Scientist Fellow |
Giving the background to this decision Dr Namyata Pathak, Integrative Ayurveda Physician and Research Associate, Kasturba Health Society – Medical Research Centre, ICMR Advanced Centre for Reverse Pharmacology in Traditional Medicine says, “AYUSH industry has a turnover of Rs 10,000 crore of which Rs 9,500 crore is patent and proprietary (P&P) products. The rest are all classical products which were not allowed to be branded until now. They have set up pharmacopeial standards, but have issues in implementing these due to many small to medium scale manufacturing houses. They were going to assist the process by setting up AYUSH clusters, where the smaller industries could get certificates of analysis from common testing labs.” She continues that I do not know how far that has been successful and whether this new proposal is an extension of that. Setting up regulatory posts is welcome, but the requisite process and minimal, optimal requirements need to be transparent. It literally is a ‘jungle out there’. I only hope it does not provide more opportunity for corruption by poorly paid, poorly informed ‘drug controllers.’”
Ranjit Anand Puranik Executive Director, Shree Dhootapapeshwar |
Ranjit Anand Puranik, Executive Director, Shree Dhootapapeshwar and Ex-General Secretary, Ayurvedic Drug Manufactures Association (ADMA) comments, “Currently, there are around 10,000 drug manufacturing units in India and nearly 9,000 AYUSH manufacturing units. I feel the budget allocated is very less in comparison to the pharma sector. It is going to be a tough war between the AYUSH regulatory authority and Drugs Controller General of India (DCGI) because traditional medicines are extremely expensive and the cost involved in monitoring these are much higher.”
As a science and as an alternative treatment option, ayurveda is gaining momentum. Herbal medicine is being researched and recommended by doctors around the world. In India, the ayurvedic market size is touted to be at around Rs 5,000 crore in India, as per recent reports. The Department of AYUSH has been promoting Ayurveda through various initiatives. A good example is the AROGYA expo, which is in its sixth year.
Dr Vijendra Prakash Sr. Manager—Regulatory Affairs, The Himalaya Drug Company |
Dr Vijendra Prakash, Senior Manager—Regulatory Affairs, The Himalaya Drug Company supports the move. He says, “The setting up of Drug Control cell at the Centre will strengthen the executive structure for the department of AYUSH. The Drug Control cell would be responsible for framing regulations and policies for the entire industry. The State Drug Licensing Authorities will oversee the implementation of these policies and regulations at the state-level. This structure will benefit the companies applying for product license and the licensing authorities.”
He further stresses the point that the government needs to build awareness for ayurveda and promote its benefits, globally. Like the IT industry in India, the ayurvedic industry should also be promoted. The government should extend its support by giving subsidies and tax rebates to ayurvedic manufacturing companies in India.
Prakash further says that stringent quality and product regulations need to be put in place within the framework of traditional medicine to ensure that well-researched and scientifically validated drugs are reaching the market. The government should provide generous subsidies to small and medium enterprises (SMEs) in the ayurvedic sector. This will help SMEs to develop quality products that are both safe and efficacious, which can compete with drugs in the organised market.
Challenges to meet the global standards
Arun Kedia, Managing Director, VAV Life Sciences emphasises, “In spite of India being recognised world over as source of alternate medicine source with a strong manufacturing base, the lack of globally accepted standards for AYUSH products and non-documentation of our traditional skills are the basic issues that need to be solved for India to be a world leader in AYUSH products.” He revealed that a recent study covering 90 traditional medicine manufacturers found that 62 per cent of them did not conduct any safety tests on their drugs while another eight per cent performed the tests on some products. Questions encountered on safety-efficacy of AYUSH are a matter of concern, which need to be addressed by elucidating authentic manufacturing procedures as described in the classical texts. Quality control and standardisation have been the thrust area in the manufacturing process. Good Manufacturing Practice (GMP) is a system to ensure that products are consistently produced and controlled according to quality standards. It is designed to minimise the risks involved in any pharma production that cannot be eliminated through testing the final product. There is a need to develop specific GMP guidelines for AYUSH products. GMP will cover all the steps of the manufacturing process starting form evaluation of raw materials, processing, validation of manufacturing process, standard operating procedures, evaluation of storage area, personnel, quality control, documentation etc. In an effort to make the complementary medicine manufacturing units to become GMP compliant, Department of AYUSH will be spending Rs 26 crore towards quality control. The Health and Family Welfare ministry has made mandatory GMP compliance for licensing of AYUSH drugs.
Many countries including the EU, US, Canada, Japan, etc. work on mutual recognition agreements with countries with equivalent levels of GMP and registration standards. India is not a signatory to many of these mutual recognition agreements hindering the exports of the country’s exports. Quality assurance is a significant demand of AYUSH importers and therefore, a GMP certification for AYUSH products exported from India would establish quality credentials of these products, and is strongly recommended.
Apart from GMP compliance from industry, setting up of in-house quality control laboratories, development of common drug testing facilities for industry clusters of small and medium scale units etc will be instrumental in enhancing exports.
IPR issues
After standardisation and quality control procedures are completed for a formulation, it can be patented and the intellectual property rights of the product will be preserved so as to benefit the system to which it belongs. This will help protect the country from and give an edge over the other products which have not gone through such standardisation procedures. Such patented quality products will have national as well as international market.
Clinical trials
Clinical evaluation to assess the efficacy of a formulation will also help ensure global acceptance of AYUSH products. The efficacy of the said product can be tested jointly by traditional practitioners and modern physicians. Such clinical trials will increase the confidence of consumers in traditional medicines. The choice of investigating centres is also very important for carrying out such trials. Approval from institutional ethics committees is an important part of clinical trials. These trials can be merged with the safety and toxicological tests to ensure safety of the users in the long run. Equally important is evaluation of data generated by the clinical trials to validate the safety and efficacy. From a regulatory point of view, recommendation of the expert group to take the product forward to attract pharma companies is essential. Safe and effective products can be documented in suitable drug dossiers mentioning all method of preparation, good agricultural and collection practices, full description of the plant material as per modern scientific parameters preferably by a taxonomist, pharmacognosy, chemical finger printing, standardisation and quality control of the raw material, determination of microbial pesticides, heavy metals, production source of the finished product, batch to batch variation, stability study and shelf life.
Thus, while the segment AYUSH is definitely growing there are lot of challenges that need to be tackled before it achieves its optimum potential and propels India into the big league.