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Policy Matters

Industry worried over draft guidelines for clinical trials of ASU drugs

PB, Mumbai:

The Ayurveda, Siddha, Unani (ASU) industry vehemently opposes to the provisions enlisted in the draft guidelines regarding good clinical practices and clinical trials of ASU drugs, stressing that if implemented it will have strong implications on the growth prospects of the industry. They are also worried over the government’s inability and lack of interest in involving the stakeholders opinion while framing such rules for the industry.

The latest circular from the Department of Ayush mandates for clinical trials for all the existing and new ayurvedic medicinal products under the proprietary and patented criteria. Sources inform that the Department is contemplating to implement this draft guidelines from April onwards, which unfortunately will pose a great problem.

Expressing concern over the future of the traditional medicines in the country, an industry insider pointed out, “There is no need for clinical trials for traditional medicines especially for the ones that are already well established in the market from years, since their active profile is already known and used in traditional medicines from centuries. The government would have understood this if that they had a better understanding of ASU sector. Unfortunately for us neither do they have any background information of the industry which they are representing nor do they involve the stakeholders in any of their meetings to guide them.”

Industry is afraid that if this guideline gets implemented it will have a huge impact on around 7000 small and medium scale manufacturers across the country who do not have enough resources to invest on clinical trials. Experts from the industry said that the Department of Ayush which is supposed to address the problems of the industry is only adding its trouble by drafting such anti industry guidelines. “On top of that they are not even ready to involve the stakeholders in any of their decision making discussions while drafting these guidelines,” he stressed.

He said, “The industry is not against any progressive or positive ideas that promises to benefit the sector, but what the government is trying do through this guidelines is anything but that. This draft guidelines is an example of their  lack of interest in helping the industry towards growth. This is a very complicated issue affecting an industry at large thus rather than making a rash decision the Government should consider taking a calibrated approach towards this issue after requisite discussions and deliberation with the stakeholders.”

Many in the industry claim that the Department of Ayush has hardly put any efforts to understand the needs of this unique industry and has simply mimicked the new molecule guidelines for modern medicines while framing the guidelines for traditional medicines.

It is understood that ADMA and other associations representing traditional medicines in the country are in the process of submitting representation to the Department soon demanding them to change some features in the present guidelines before implementing it.



3 thoughts on “Industry worried over draft guidelines for clinical trials of ASU drugs

  1. Industry must sugest some way for the scientific validation of the claims about its safety and efficacy acceptable to all scientific community involved in drug research which is fundamental of patent and properitery medicine.Industry may also consider the slow death of system due to reducing quantity of manufacturing of classical medicines which are in public domain,Mushroom growth of patent medicine based on publicity and exploitation of public sentements without providing the pharmacopoeial data,testing standerds,safety data,data on efficacy not to talk of mode of action ,precaution and adverse drug reaction of thease chemical mixed so called natural products widely sold in the market.Is it going to save the credibility of system?Are we preseving the heritage which was brought by our ancient seers protected and handed over to our free india?Is the industry realises that scientific standerdisation of the system in terms of required scientific data of safety and efficacy on established acceptable international norms is essntial to establish the system at internatinal.and national platform.Can any product become patent or properietery just by mixing of certain classical products and nomenclating it attractively without any support of authentic clinical trial.Preparation of produt with the help of chemicals without generation of scientific data for safety and efficacy and post launch survillance is just a licence to kill without leaving any proof to be caught.Is it not strange to note that the industry desirous of clinical trial permissions are worried to follow the guide lines for the same despite of the fact that guidelines have many relaxations looking after the infrastructure facilities and competence available.Industry should not try to kill the milking cow rather provide nutrtitious food to get more pure milk to get nutrition and growth.Industry must co operte the regulatory authorities for bringing the acceptable standerds of patent and properietery ASU medicines so that the hypothesis becomes reality on scientific objective parameters

    Posted by janardan | December 30, 2011, 8:36 pm
  2. How these guidelines are a threat to AYUSH industries when there is no clause of essentially of conducting clinical trial on textual Ayurvedic medicines (so called classical medicines)? Introduction of these guidelines would rather be a check on introduction of irrational formulations created to earn immediate profit without any scientific (modern or ancient) reasoning and logic.These guidelines will definitely promote the use of classical formulation by manufacturers and end users which have a documented safety and efficacy.

    Posted by Dr. Neeraj | December 31, 2011, 3:27 am
  3. I wann to tell one thing to the industry. if tommarrow some big companies start to produce the products with the same name and spelling along with ingredients still the so called Industry will become simple mute spectators? cause u know 80 to 90% of firms who produce the so called patent and proprietary medicines do not have any legal capacities to contest since they do not have any valid copy right / name registration / trademark registration certificates leaving aside IPR registgrations, with any authorized agency? Clinical trais are very very long way to go? Certainly there worry is noticeble.


    Posted by Dr.Anand | January 2, 2012, 1:49 pm

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