Subject: India / Potential Ban on Supplements.

mira4bai4

I received this in an email tonight and may well be of major concern to all travellers to India and many residents as well. If anyone has any muscle this may be a good time to use it.

To: Executive Committee

We have received a note below from the Indian association, HADSA, regarding threats of a complete ban on the sale/importation of supplements in India. We are currently working to gain additional information on the situation and will update in due course. For your information, Dr Prakash was the adviser to the Indian Minister of health who participated in our conference in Thailand a few years ago.

Thanks very much for your help
Simon
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Dear Dr. V. Prakash,

Today HADSA had a disappointing meeting with FDA Commissioner Maharashtra State on his showcause notice to dietary supplement/nutraceutical manufacturers. Day before yesterday issued an order giving 3 months time frame to companies who are manufacturing/marketing dietary supplements in the state of Maharashtra. He directed HADSA to seek either court directive for a stay against his order or approach concerned ministries in New Delhi to pass regulations for dietary supplements. He said he has informed Secretary, Ministry of Health and DGHS on this order and have their support.

Further he also indicated that he will persuade Ministry of Health to inform other state FDA's to ban dietary supplements from their respective states.

He has said he will issue notice to Asst. Commissioner customs Mumbai Sea and Air ports to ban import of any dietary ingredients labelled as food raw material. He said he had consulted all concerned parties before deriving at this decision. Our repeated appeal to him to consider the recommendations of Dr. Mashelkar Committee report didn't move him. He is very firm that unless he doesn't receive directives for dietary supplements FDA Maharashtra will enforce his order effective from 1st July 2005.

FDA commissioner through his own admission today said he doesn't care for the so called nutraceutical manufacturers and their products and nether is he concerned if consumers get any benefit from dietary supplements. When we informed him that India's two premier R&D organization i.e. CFTRI/CSIR are supporting requirement for regulation, he said CSIR and CFTIR should concentrate only on doing quality research and should not interfere or get involved with proposing regulation for this category of product. It is the prerogative of Ministry of Health to decide if dietary supplements/nutraceuticals are required by Indian consumers and what kind of regulation are required to regulate these products. After informing him that industry and various industry associations including HADSA has been pursuing dietary supplement / nutraceutical regulations since 2000 with the Ministry of Health and nothing has happened so far, he sarcastically mentioned that even if we keep on pursuing these regulations for next 10 years nothing is going to happen. He was applauded and supported by his other Joint commissioners at FDA Maharashtra including Dr. Venkatswarlu, Deputy Drug Controller, West Zone. This was shocking.

It looks like all efforts gathered by CFTRI/CSIR and supported by various segments of industry as well as regulatory agencies is going waste and as per this commissioner, if Ministry of Health implement nation-wide ban on dietary supplements and import of dietary ingredients, it's a black day for Indian consumers who still have a choice for healthy living through dietary supplements/nutraceuticals. I don't know how much support this commissioner has for what he is currently doing in Maharashtra from Ministry of Health.

Similarly with this order the relevance of future nutraceutical summits will also meet a natural death. HADSA has limited reach within Ministry of Health and Food Processing and it seems these two Ministries are at loggerheads on the issue of Integrated Food Law which includes regulating dietary supplements/nutraceuticals. HADSA will keep on trying our efforts for regulating supplements/Nutraceuticals, but in the meantime I would like to address this issue to CFTRI and CSIR for their support and advise. We will also raise this issue at IADSA, CODEX and other international forums and ensure that if this order is implemented will it contravene post-WTO/Trade Barrier issues by India. Similarly if FDA Maharashtra state impose customs ban or encourage it's additional drug controller at customs to practice trade barrier through Form 10 registration requirement for Indian importers importing dietary ingredients from Mumbai ports, then it will have a cascading effect, followed by other overseas countriesfollowing same policy while importing dietary ingredients/botanicals from Maharastra /India.

Sincerely
Dr.Bhushan Karnik
Treasurer,
HADSA
Mumbai-400097, India
Tel: 91 22 28496260-61
Fax : 91 22 28496099
Email : hadsa@vsnl.net , inhadsa@vsnl.net

mira4bai4

If this proposed ban on supplements does come into being it will mean that

A: No dietary supplements will be imported into India
B: No ingredients for the manufacturing of dietary supplements will be imported
C: Only a small amount of dietary supplements will be available in India
D: Foods fortified with dietary supplements for the less privileged will not be available
E: The price of dietary supplements will be extremely expensive
F: People with health conditions living in India will not have access to dietary supplements
G: Travellers will have to carry their own supplies but also run the risk of them being confiscated at the airports
H: Expats will not have access to dietary supplements as any quantity imported (6 months supply) would be banned.

This is all of the vitamins, minerals, powders and tablets that many of us take daily, take for granted and we plan our travels with. So while we could survive on the different foods in India we could also take a multivitamin to ensure that we enjoyed it. When we got sick and eventually we able to eat again we have vitamins and minerals to rebuild the system. Well maybe not for much longer although I seriously think the person instigating this whole scenario has a screw loose.

And I will have to add that if this thin does happen there goes my future business plans in India.

Indojingai

What exactly is their beef with the supplements??
Carcinogenic or what?

Generally speaking, Doctors in India (atleast mine) always prescribes a few multi-vitamins and other supplements with antibiotics.

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mira4bai4

It is the Food & Drug Adulteration Commissioner Maharashtra that is causing this problem, medical people know the merits of dietary supplements. Kind of reminds me of the banning of bar dancers in Maharashtra, they don't care how it affect the health and well-being of others. Ignorance is Bliss!!!!!

aramkrishnan

Hi there,
I'm A.ramkrishnan, FDA commisioner, maharashtra. I spoke to the delegation from Delhi that comprised manufacturers and importers of nutraceuticals. I'm sorry to say that doctor Karnik has totally filed a wrong and misleading report regarding our orders on nutraceuticals. We had merely said that we do not yet have a legislation in place on the lines of HADSA, in America. So, there cannot be any basis for validating the claims or testing of the ingredients contained in the imported dietary suppliments marketed through doctors with thereupatic claims. To say that I don't care for CFTRI or CSIR is totally wrong. however, it is the ministry of health today which lays down guidelines for import of food and drugs and the present position is that nutraceuticals fall in the category of drugs.
Further, the reality is that, dietary suppliments are imported as food by deleting all the claims on the label so that it can qualify as food. Later the importer uses all the literature to promote these products to be sold through medical shops on prescriptions. This is unethical on the part of importers.
Available literature say that botanical plants used as raw materials in the manufacture of nutraceuticals can cause cross contamination that can have cascading on the quality of the products. You all would appreciate that when these products, sold at fancy prices several times the prices at which they are imported; consumers need protection from regulators so that they are not cheated or taken for a ride.

A.Ramkrishnan
FDA Commisioner
Maharashtra
9122-2659-0548

soulstation

The FDA's efforts are laudable...there has to be some regulation. They have already taken to task Giant Baby Oil Cos like Johnson & Johnson as their products were based on paraffin - supposedly unfit for babies.

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Nick-H

An official response on IM? Is this a First?

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Indojingai

hmmm... either M4B4 instigated an official response or this forum is under observation by the Government agencies.

Alan D

hmmm...... Makes you wonder about all those "Where can I get good drugs in Goa/Manali/Delhi?" type of questions

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mira4bai4

First I would like to say that ~ actually lost for words which is strange for me.

No, I sincerely appreciate your reply and am completely blown away by the fact that your attention was brought to the post. My intention for posting the information was to (clutching at straws) get this issue out in the open and somehow through various networks get some logic back into the discussion and reach a resolution that is best for India.

I personally have a vested interest in the outcome as I which to set up a business that will rely on the importation of such products from South Africa but also become involved in manufacturing and exporting products in the future. My interests are that an agreement is reached quickly that meets the highest standards so that my business operation can work in the best professional manner in an industry of excellence.

To me it seems a pretty easy solution if the concern is the validation of labelling and strict adherence to that labelling for the use of the product, this is called regulation of the end sale of the product. The problem comes from the very vague regulations and descriptions in the EXIM Classifications and the fact that for years some products could have a 160% Excise charge and others a 40% Excise charge for essentially the same product but based on the description. Making a standard 16% across the board would take care of a great deal of mislabelling and reduce the cost to the consume.

Ignorance is bliss for some and painful for others, the worst attribute along with pettiness is the failure to see the obvious and act on it for the benefit of all especially the consumers, those that are destitute and in dire need. We all have a duty in this regard to do our very best to ensure that the rules or of a high standard, implemented and adhered to. This could have been done 12 months ago with little or no fuss.

GoanCanuck

Time to head to the bunker.

mira4bai4

An interesting aspect of the FDA Commisioner is that A Ramkrishnan on the 11th May, was shifted to a new position in the Medical Education Dept. Most interesting timing.

Anyway if the whole situation results in correct licensing for local and imported nutraceutical products and not a blanket ban then it is fine, I am happy about starting from scratch provided the cost is not prohibitive as this will only drive up the retail price even higher.