What you should know about the Indian government ban of 344 FDC drugs- PART II

On March 10, 2016, Indian government brought a notification banning 344 Fixed Dose Combination drugs. The ban included some popular branded products widely used in India and manufactured by well known companies-gave it the news value. A two part article is made by the author to dispel the doubts and confusion of ordinary people on the matter. While PART I dealt on what is FDC, the ban notification, its background and justification; the present PART II deals with other related points.

Introduction to Part II

My previous article "What you should know about the Indian government ban of 344 FDC drugs"- PART I , deals with, what are FDC s, why some FDC s are termed irrational and why the 344 FDCs are banned by notification by the Indian Government. I also mentioned that as at writing some drug manufacturers have obtained stay on the ban.
This present second part deals with some more points which will be in the mind of an ordinary reader and need some clarification.

Are FDC drugs allowed in other countries

This is what comes immediately to a reader's mind. We are habituated in relating and comparing ourselves with other countries.
A news report quoted a senior AIIMS doctor as saying "These drugs have been proven to be harmful for us. Most of the countries worldwide have already banned them. Moreover, this toxicity - proven in many of these drugs - decreases the body resistance to fight any disease."
Most of the studies conducted revealed that most of the FDC drugs marketed in India are not permitted and unavailable in US , UK or many other developed and developing countries.
It is also very pertinent to note here the report by the Parliamentary committee,59th report on CDSCO, submitted in May 2012 which gives an alert when it says:
"Of the cases scrutinized, there were 13 drugs (33%) which did not have permission for sale in any of the major developed countries (United States, Canada, Britain,European Union nations and Australia). None of these drugs have any special or specific relevance to the medical needs of India." We should note here that parliamentary committee scrutinized only very small sample number. But expert studies have taken more examples and have found startling facts.

If they are irrational and likely to be harmful why they are approved first

It is very strange when we come to know that most of the FDCs very easily available in India are either unapproved or available using the loopholes or ambiguities in the rules. Moreover the time taken for court cases to come to a final stage also is being used by the manufacturers to continue with their business. A section of the medical fraternity are also not update in their knowledge of the happenings in the pharma field and are unaware of the fact of some medicines banned in other countries. Then it is just imaginable in the case of ordinary people.

In India drugs sanction became a concurrent subject after Independence. States and Centre have the powers to sanction and prohibit. Even though long since 1961 approval from Central Drugs Standard Control Organization (CDSCO) was required , companies used the ambiguity or lack of specific clarity in the laws and used to get approval from state authorities. State drug control authorities, without clearance from CDSCO due to some ambiguity presumed. This was cleverly exploited by the companies. Obtaining permission from one state they marketed it all over India.
However this ambiguity was rectified in 2002 by an amendment to the rules. But even after that unapproved FDCs went increasing. That gave rise to many independent studies in the matter and occupied the government attention also.

How pharma companies circumvented or exploited weaknesses in system and benefited

A patented drug becomes open for other manufacturers for the generic item once the paten validity and exclusivity expires. The manufacturers then make and market FDC combinations with the patented drug before the generic version of the main single ingredient arrives in the market. They then cleverly shift the focus and importance towards the FDC drugs and continue keeping intact or even increasing their market share and revenue.

Who is to be blamed for the present situation

If we have to hear a retired drug expert, then neither the government nor the drug industry has to be blamed fully or squarely on them. His view is that the central government should take out the authority for approvals from state governments as a first step. That may invite political and legal issues. So until then only measures like the present one can be resorted with mixed effects and reactions.

How the ban will affect common people and doctors

An online rediff.com report dated 18 th March headlines "60% doctors support govt's recent drug ban list" For the general public, initially it may be a feeling of non-availability of medicines till day habituated and familiar for many years. They may have some psychological adjustment difficulty. But as the present day communication facility is far better and varied, people may try to get more details and have awareness on the whole matter. Already they would have started thinking on right lines due to the multiple reports for the last few days.

As it concerns one's personal health, people will at last come in support of the govt action and even want further stringent actions.

Conclusion : what next to be expected

The pharmaceutical manufacturing companies have reacted predictably. They have approached courts and some of them have obtained stay. It is reported that Madras High court has not given stay in the case filed by South Indian drug manufacturers Association. We can expect more reports on the matter in due course.
As of now we cannot say what will be ultimate decision by courts. However as the matter has now become a matter of public interest, the general public also will be watching with interest the developments. We can even expect public also intervening or filing cases to safeguard the interest. Now that the government has found a specific direction, supported almost unanimously by experts, it has to worry only about the legal aspects. If the Parliament and legislatures show will, there can be remedies to any legal defects, if any, found by courts.
Big drug companies will be exposed of their hypocrisy, that while they willingly shell out huge amounts as penalty or compensation for making poor quality drugs in other countries, they go on questioning Indian government for any and every action taken in public interest. There are now about 1700 products under study and scrutiny.
We hope the drug companies also fall in line and put the people's health in priority than their greed for profit. We hope that doctors will not fall victims to prescribe irrational combinations and stick to medical ethics and keep themselves updated with the developments in medical and pharma field. . We expect that the general public will keep eternal alerts and be always up-to-date on awareness about use and misuse of medical drug formulations. Let the present ban attempt trigger such positive results.

For more details on the topic, read "What you should know about the Indian government ban of 344 FDC drugs- Part I"

(Thanks courtesy: Inputs for writing this two-part article are sourced from the web site of CDSCO, Ministry of Health and Family welfare Government of India, web sites of newspapers The Hindu, Business Standard, Economic Times, PLOS Medicine website, PLOS. org, and print edition of various newspapers)

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Author: Kailash Kumar30 Mar 2016 Member Level: Platinum   Points : 2

Post ban on 344 FDCs or combination drugs, now crackdown on herbal and ayurvedic medicines whose efficacy and safety is not proven is being anticipated by the media. It is likely that the Ministry of AYUSH (Ayurveda, Yoga, Unani, Siddha and Naturopathy), Government of India, will make clinical trials mandatory for every new ayurvedic drug entering the market. The ban on popular cough syrups like Corex has opened doors for herbal and allopathic, non-codeine cough syrups. Presently none of the ayurvedic and herbal drugs undergo any clinical trials and only a license from the state regulatory bodies is required to market such products. Fingers are being raised on the Baba Ramdev's Patajali Ayurved also.
The popular drugs included in the ban are Vicks Action 500 Extra, cough syrup Corex, Saridon and D Cold Total.

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