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Going generic: Menace to chaos: Good intention, poor applicability

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Dear all,

All of us are aware of the recent generic medicine related notification and the prevailing confusion and chaos related to it.

Who benefits from this fiasco?

Let me try to put the records straight. 

I was and still am a strong proponent of generic medicines.
Most of us are.

I am aware of the standard practice in the developed countries.
Most of us are.

For that you need to have quality controlled, cheap and widely available generic drugs!

And you need to stop manufacturing of ALL brands (except the brands which are actually research products of any company, like Sporanox of Janssen or Adaferin of Galderma ).

But here in India we allow hundreds of 'me too' brands along with the original one as the original brand is costly and not affordable by public in general.

The same molecule is allowed to be marketed under different brands and under different price tags and that too sometimes bynthe same company!

Now here comes another twist in the tale.

The upper and upper middle class Indians who are widely traveled, read, connected and has relatives in some developed countries have become aware of a new word 'Generic'.

This has become a fashionable word.
And any government would love to polish its own image as sensitive, aware and knowledgeable !

So, let there be 'generics' and there was 'generics'.

This is not for the same reason we fought for generics two/three decades back, not for the same perspectives either!

So, to make the matter even more complicated, if not worse, in recent years
we have 'generics' here produced by some shady companies without any quality control and in most of the cases this so called generics are costlier than most of the brands available in the market!

That is a sad(and mad) situation.

Now in India we have
1. Patented brands(patented and comparatively newly developed products which are the research product of the developer)

2. Hundreds of ' me too' brands(branded generics) with different brand names, different price tags and understandably different quality and efficacy. But they are supposed to be passed through stringent quality control.

3. Government promoted 'Generic generics' almost without any quality control and mostly with higher price tags.

We allow all these three categories to continue simultaneously at the same time which is the crux of the critical situation we are in.

How can a doctor or patient ensure the quality if pure generic drug by salt name is forced ? Then the patients will be at the mercy of the chemist who will simply sell the brand with maximum profit.

Now, without making these 'generic generic' and branded generics(me too) producing companies accountable and without stopping these hundreds of 'me too' brands(which the government is not in a position to do) there is no point puting the trained and qualified medical fraternity in the firing squad and pretend that the problem will be solved this way.

1. Is MCI an agency to deal with this? Why not  Drug controller general?

2. Do we have a centralised drug control policy? Who has given license to these 'me-too' brands? 

3. Is MCI of state medical councils are well equipped to deal with this situation?

4. Are our central and state drug controllers equipped to deal with situation?

5. Was the stake holders(doctors-patients-industry-administrators) taken into confidence before issuing this notification?

6. Is a forwarded message on Whatsapp legally valid and binding?

7. Are all the practising doctors been notified individually by registered posts with A/D?

8. Who ensures the quality control of the so called 'generic-genrics' available in the fair priced shops? How fair priced are they?

9. Does this notification mandates the doctors to stop prescribing all brands? Or this is optional?

10. If qualified doctors are not allowed to write the brands(including patented brands) then who will prescribe these? Quacks?

11. There are thousands of generic generics available. Who decides which one is most effective/safe and cost effective? The chemist shop owners?

12. Who suffers when a wrong medicine is supplied based on the generic prescribed?

Till all these and many other issues are clarified and a proper law is enacted taken all stake holders into consideration this superficial and oversimplified notification will be example of another non applicable government order frozen in limbo.

We need to put the horse before the cart and not the other way!

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