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Experts bat for mandatory clinical trials & harmonised standards to make govt's efforts to promote Ayush products abroad a success
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Arun Sreenivasan, New Delhi
October 31 , 2018
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The Central government’s measures to promote Ayurveda and other traditional systems of medicine in foreign countries would prove futile unless there is an active effort to harmonise standards, introduce mandatory clinical trials and popularise a voluntary product certification scheme introduced by the Ayush ministry to enhance consumer confidence, industry experts say.
The ministry has been striving to ensure that Ayurveda and other traditional medicinal systems get recognition abroad. Ayush Mark, an initiative to voluntarily certify the quality of herbal products, was introduced to boost exports. Discussions are currently on with the United States Pharmacopeia Convention (USP) for harmonising the standards of herbal products and formulations. But many in the industry remain sceptical about these initiatives.
The ‘Ayush Premium Mark’ scheme was introduced to ensure that herbal products based on Ayurveda, Unani, Siddha and Homoeopathy comply with guidelines set by Quality Council of India. However, according to industry observers, this seal of approval, which was expected to help industry tap emerging trade and export opportunities, remains mostly ineffective as the general public and foreign regulators remain unaware of this rating. Only a few alternative medicine manufacturers have opted for the certification programme. “This is a voluntary certification scheme, and unless there is acceptance from foreign countries and regulators, none will go for obtaining this Ayush mark,” Shashank Sandu, Joint Secretary of Ayurvedic Drug Manufacturers Association, told Pharmabiz.
The government’s recent decision to issue licences for patented or proprietary Ayurvedic, Siddha and Unani products without insisting on clinical trial or safety study reports is also seen by researchers as a regressive move that could seriously harm the credibility of these systems of medicine overseas.
“Human trials are important for the alternative medical field to gain acceptance in the international community. We have to create the required infrastructure to conduct such trials. Watering down regulations might help manufacturers in the short term, but would eventually boomerang on them,” said Dr Sadath Dinakar, the newly elected general secretary of Ayurveda Medical Association of India.
The Indian Council of Medical Research (ICMR) has been pitching for making clinical trials mandatory for all the alternative medicines to ensure patient safety. A study conducted by the pharmacology department of All India Institute of Medical Sciences on 78 alternative medicine formulations had found that heavy metal content was above the WHO limit in all of them. In herbal formulations, lead in 19.6 per cent, cadmium in 21.4 per cent, mercury and arsenic in 5.3 per cent were above acceptable levels.
The Ayush ministry’s plan to develop pharmacopoeial standards by partnering with USP is welcomed by domestic manufacturers as a step in the right direction. “It will definitely promote our products in the foreign market. But we need to review our regulatory framework too. Licensing a proprietary drug without even a safety study will hurt the ASU sector and blight its universal acceptability,” Sanjay Srivastav, Director of Maharishi Ayurveda Products, a Delhi-based ayurvedic drug manufacturer and exporter.
It may be noted that an in-depth review by the government has recently revealed many chinks in the regulatory armour of states and union territories that could seriously undermine the efficacy of ASU&H drugs. The review has shown that the provisions of the Drugs and Cosmetics Rules of 1945, Drugs and Magic Remedies (Objectionable Advertisements) Act of 1954 and various orders and directives issued by the Central government are not being enforced. The review was conducted on the basis of data obtained from a series of workshops on regulations conducted in New Delhi, Chennai, Shillong, Pune, Chandigarh and Bhubaneswar.
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