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Strategies for Introduction of EC in India : Expert Viewpoints

Role of regulatory bodies
– Dr Ashwini Kumar, DCI, GOI

As a regulator, we are supposed to translate the views of the expert bodies whatever the concerns expressed by the bodies for a particular field or a particular product, so that these are properly articulated for the safety of women.

I personally feel that for these types of products, quality is very critical because a slight difference in the quality can be disastrous. it is not a simple pain-killer or an ordinary type of medicine, in the sense that self-medication is generally understood when we talk of a product as a prescription drug or a non-prescription drug. Generally, a non-prescription drug is one which is safe and is used for a self-limiting disease; the usual concept from the regulatory point of view is to use a safe drug as a non-prescription drug. Emergency Contraception is a kind of a drug which, though can be a non-prescription drug because of its social reasons and a wider acceptance, but, at the same time, the quality is a critical issue. As a regulatory personnel, my concern is more and more towards the quality as and when this product is approved, the manner in which it is approved and the manner in which it is made available to the masses.

In that context again, we will have to take a view whether such products should be allowed to be manufactured by any licensed manufacturing unit in the country, or they should be limited to a few licensed manufacturing units after a very critical auditing of their facilities, and also ensure very rigorous monitoring of quality of the yield. This is the message that I get after listening to the debates and after listening to the concerns of the medical experts. The other issue from the regulatory point of view that I would like to share with the enlightened audience is that it is like an obligation on us to ensure the safety, quality and efficacy of a product. This is the first thing at the stage of the approval when any drug is allowed to be marketed that all the three components are ensured.

But the matter does not end here, and as I already said, for these type of products, all these issues of safety, efficacy and quality continue to be a matter of concern till it is available on the counter or on the shelf, or it is being used. All these components will be decided in consultation with the experts when we finally approve any drug to be used as Emergency Contraception.

Now coming to this interesting debate on prescription and non-prescription again, it is a kind of dilemma. I find the various experts in this field have diametrically opposite views. If I had been a regulatory authority without listening to this debate, I would have simply referred the issue to experts, and whatever they said would have been the regulatory scheme for us. But now having listened to this debate, may be we will have a wider consultation to decide what should be the actual status of Emergency Contraception drugs in India.


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