The Drug Technical Advisory Board (DTAB) for Ayurveda, Siddha and Unani (ASU)'s decision to make expiry date mandatory on Ayurvedic drug labels has created confusion and panic among the industry circles, especially Ayurvedic proprietary medicine manufacturers in Kerala.
Reacting to the news in Pharmabiz.com on the move, informed sources said the decision could have far-reaching consequences even affecting the very existence of this industry, and causing closure of numerous small-scale units.
Sources point out that more than 90 per cent of the drug manufacturers in the SSI sector lack dedicated sales and distribution network to retrieve the drugs after the prescribed period, if expiry date becomes mandatory. This will force most of the manufacturers to concentrate only on local sales than sending the drugs to different parts of the country and abroad for sale.
At present, apart from the Sitaram Ayurveda Pharmacy, Thrissur, no other manufacturers is known to be printing expiry date for Ayurvedic drugs. That also, Sitaram started printing labels with two year expiry date for a few of its Arishtams (formulations) only recently, based on in-house scientific studies which revealed the pH value of the formulation slightly varied after two years since manufacturing. However, the studies had not revealed much change in the efficacy of the drug.
Further, the experts point out the move even sabotages one of the basic principles of Ayurveda on efficacy of drugs. It is a time-tested fact for many centuries that the efficacy of most of the Ayurvedic drugs will increase when stored for many years, and this has been mentioned in numerous classical texts.
From the perspective of an industry in the modern ages, the industry was yet to study and create adequate scientific data on efficacy after various periods since manufacturing. This was mainly because no adverse drug reaction has been reported so far for any of the drugs manufactured by the traditional firms like Kottakkal, note sources.
Interestingly, the Ayurvedic pharmacopoeia, formulated about two decades ago has not even mentioned about the shelf life of Arishtams (formulations), which can be manufactured and stored for indefinite time. However, it says the shelf life for Choornams could be for a period of one year, and Kashayams for two years. However, this was suggested two decades ago considering the industry status then, when manufacturing, storage and packaging methods lacked any advanced technological support, noted sources.
Sources felt it was injustice to compare Ayurvedic medicines with the same parameters applicable for allopathic drugs. While a 'drug' like Vicks manufactured by a multinational giant was sold as an FMGC product without any expiry date, the move to impose expiry date on Ayurveda was to kill the growing industry, they alleged.