Pharmabiz
 

ADMA seeks observer status for India at EU to resist ban on ISM drugs

Suja Nair Shirodkar, MumbaiThursday, April 28, 2011, 08:00 Hrs  [IST]

The Ayurvedic Drug Manufacturers' Association (ADMA) has urged  the union government to seek observer status for India at the European Union (EU) meetings relating to the ban on traditional medicines that may  take effect from May 1 this year. It would soon submit a representation to the government on this issue so that necessary steps can be taken.

As an observer, India would be allowed to be part of the meetings and deliberations that will take place to discuss the future course of this issue.

The EU's Traditional Herbal Medical Products Directive which was passed in 2004  states that every herbal medicines that is sold over the counter will need to have either a Traditional Herbal Registration or a marketing authorisation. The Indian Ayurveda, Siddha & Unani (ASU) industry is apprehensive that if this ban comes into force it will badly effect the industry.

However, what the industry is really concerned about is the lack of interest from the Indian government to represent the country and raise this issue at the international level. According to Shashank Sandu, treasurer, ADMA, “Till now there have been  no evidence to prove that herbal medicines present significant risk to the public under previous and present legislation, when policed properly, then how is it justified that it should be completely banned if it is not registered.

Moreover the ASU industry will not be able to tackle the huge expenses relating to licensing and registration. It is the responsibility of the government to raise this issue and defend our position.”

He further pointed out that the industry as whole is surprised by the governments attitude towards the ASU industry. “This is a grave issue which effects the ASU industry as a whole as a sizable chunk of our revenue comes from exports to the European nations and if this ban takes effect it will severely impact the industry. We hope that the government would seek observer status as soon as possible so that we will be able to represent our cause and prove to the EU that the Indian drugs are efficacious and safe for use,” Sandu said.

Having observer status will grant India the privilege to allow one government representative and one representative from the industry to be present at all the EU meeting relating to the controversial EU directive.

Sandu informed that the Indian government should have taken this step long back which it did not do so. However he states that every thing is still not lost, since according to Dr Gerhard Franz, chairman of the expert group on traditional Chinese herbs of the European Pharmacopoeia Commission whom ADMA members had met at a meeting in the US, India still can apply for observer status.

Interestingly, China has already leveraged this privilege long back and have been representing its cause to the EU. Many in the industry feels that though the Indian government have taken some progressive steps for the ASU industry it is not reaping much benefits for the industry as it is not implemented properly.

It is a general opinion among many in the industry that it should take a cue from its Chinese contemporary who is taking every initiative to propagate and monopolies the market with its traditional medicines by providing growth opportunity for its manufacturers with subsidy and other benefits.

 
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