India wants Ayurvedic drugs to go through the same rigorous process of testing as allopathic drugs and while companies in this traditional medicines business agree that their products need to be tested, they are uncomfortable at having to follow the same process that has been defined with modern medicines in mind.
The new testing regime will also apply to other traditional systems of medicine.
In June, the government introduced an official guideline that was based on an earlier document of the Central Drugs Standard Control Organization, the country’s drug regulatory body, on good clinical practices for clinical trials of allopathic drugs. The June guideline, according to a notification by the ministry of health, should be followed for all Ayurveda, Siddha and Unani drugs at all stages of drug development, whether prior or subsequent to the product’s registration.
This would mean that any company seeking permission to market an alternative or traditional medicine should support the claims made by the drug with data generated by tests on human subjects according to norms laid out by the government. These tests typically seek to discover or verify the clinical, pharmacological and adverse effects (if any) of the drug.
A senior official at the government’s department of Department of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy (Ayush) said the new regulatory regime would help bring a systematic approach to the way traditional drugs are developed in the country. “The objective is to ensure that the therapeutic claims made by the industry are supported with scientific data,” he added, asking not to be identified.
Firms in the traditional medicines business are concerned.
D. Ramanathan, general secretary of Ayurvedic Medicine Manufacturers Organisation of India and also managing director of Kerala-based Sitaram Ayurveda Pharmacy Ltd, said that he and his peers in the business agreed with the new norms in principle as it would help bring about standardization. “But the system should be specific to each branch of medicine, which is different in approach as far as diagnosis and treatment style, nature of products are concerned. A generalized approach will be counter-productive,” he added.
That view was echoed by the other industry body representing firms in the business of making Ayurvedic drugs.
“The current guideline appears to have been based on the guidelines on pharmaceutical products issued by drug regulator and, consequently, tilts towards allopathic approach,” said Ayurvedic Drug Manufacturers Association (ADMA), which represents around 400 large and small Ayurvedic drug makers in India. “We find the current set of guidelines a little absurd as it looks like a borrowed version, without going into the specific nature of the sector,” said Ranjit Puranik, general secretary of ADMA, and also the chief executive officer of Shree Dhootapapeshwar Ltd, one of largest Ayurvedic drug makers based in Mumbai.
Still, there is a chance that the guideline could be changed as S.K. Sharma, adviser (Ayurveda), department of Ayush, indicated: “The guideline is not finalized as yet as there are more changes anticipated.”
Currently, clinical trials on traditional medicines are conducted by a few institutes on a voluntary basis. These are mainly in the nature of confirmatory trials on the safety and efficacy of patent and proprietary medicines, most of which are made by altering approved formulations by adding or removing some ingredients.
Practitioners of Ayurveda do not have adequate expertise to conduct clinical trials following modern guidelines, said Ramanathan.