Ayurvedic Medicine Manufacturers Organization of India (AMMOI) has vehemently opposed the recently released proposed draft notification on Schedule Z issued by the Department of Ayush stating that it is not prepared in tune with the demand and need of the industry thus making it unsuitable to evaluate the safety and efficacy of ayurvedic drugs. The association further stressed that since the draft lacks proper study and does not consider the dynamics of the Indian traditional medicines it is not capable of validating fundamental ayurvedic principles like dosha, dooshya, prakruti, rogavastha, agni, etc.

The draft of Schedule Z as prepared by the sub-committee of Ayurveda, Siddha, Unani Drug Technical Advisory Board (ASUDTAB) proposes to make clinical trials compulsory for all the patent or proprietary (P&P) medicines to examine shelf life of ASU medicines. Once implemented, ASU manufacturers will have to supply all the information and data for all the application for the grant or renewal of a licence to manufacture for sale of any P&P medicine in form 24-D and such information and data as required by Appendix I or Appendix IA of Schedule Z to licensing authority along with a requisite fee.

Expressing their concerns over the sustainability of the industry in the aftermath of the implementation of the proposed Schedule Z, AMMOI pointed out that it will not be feasible to implement this on the ASU sector as the industry will not be able to cope up with the economical burden coming along with it.

According to Dr Ramanathan Devaraj Iyer, general secretary of AMMOI, “With respect to the infrastructural capabilities both at the industry as well as at the regulatory level we are far behind from other counterparts thus it it technically impossible to implement it at this stage. First, we need time to come into terms with this huge change that the government is expecting us to undergo as it will be a huge additional economical burden on us, considering that we already have a lot on our plates to deal with."

He further informed that even though ayurveda has been an indigenous industry it has been unsuccessful in establishing and expanding itself to its full potential due to the numerous problems that already has been threatening the growth prospective of the industry. He added, “To make matters worse the government instead of supporting us are only adding to our woes which will have a devastating impact on the whole industry. Considering all this factors we feel that it is highly impractical to implement this law at this juncture as it will only further inflict the ayurvedic science and ayurvedic industry as a whole.”

Further he stressed that before introducing clinical trial methods suitable for ayurveda, steps should be taken to ensure capacity building and infrastructure development of the industry and regulatory authorities. While in the meantime, essential clinical trials in 30 people, as in pilot studies existing now, should be conducted properly for necessary category of medicines and the labels of those medicines should mention this. “We suggest that the government first try to improve the present regulatory condition rather than just keep on adding to newer ones, without having the means to manage the cuurent one. Steps should be taken to fill these gaps with extra mural schemes that will facilitate and aid to the industry to develop its infrastructure and capacity building measures.”

AMMOI further suggested that the drug control authority of each state should have an advisory panel consisting of experts in clinical research and health science research with ayurvedic medicine manufacturing industry background and meeting of this panel should be conducted at an interval of one month only then should they consider taking this huge step.