The Union Health Ministry through CDSCO - office of the DCGI, has banned 344 FDCs vide notification dated 10th March 2016. To add insult to injury, the drug inspectors have started hounding the trade from the zero hour itself. From the Ministry down to the drug inspectors, must appreciate that removing banned drugs (for whatever right or wrong reasons) from the market is not like deleting a 'content' on the computer. This trend started by NPPA, who had a practical approach of allowing new prices from the next manufactured batch, switching over to “only 15 days” for changeover in the market. While this is a procedural and implementation hurdle, the major negative impact of this ban is as follows:

It is indeed a shocking purely mechanical decision without application of mind.  While the background of the Kokate Committee recommendations is accepted as fair, the implementation needed to consider the date of introduction of the combination drug in the market place, the period for which the drug is in the market, the pharmacovigilance data including therapeutic benefits of the combination drug to the patient as well as reported 'side effects' if any. While it is not possible to discuss the 'irrationality' of this sweeping ban in such a short space and span, quoting one or two familiar examples will highlight the magnitude of irrationality of the ban, putting the patients at risk with denial of natural justice. Ergotamine combinations have been the drug of choice for the alleviation of suffering for acute migraine patients. This drug combination has been in the market ever since one can remember. In olden times, APC tablets comprising Aspirin, Phenacetin and Caffeine was a pharmacopoeial drug and the most widely used analgesic-antipyretic. However, after Phenacetin was banned, Phenacetin was replaced by Paracetamol as the drug of choice thereafter. Combo of Paracetamol with Caffeine continued thereafter. Ergot alkaloids are well known to be effective in Migraine. So are the alkaloids of Belladonna, both being of natural origin. Combining Ergotamine and Belladonna extract with Paracetamol and Caffeine, proved very effective in treatment of Migraine. This combination therapy for relief from Migraine is widely in use for last several decades. Govt. Notification GSR No. 304(E) dated 07.06.1991 permits FDCs containing Ergotamine Tartrate + Caffeine + Analgesic + Antihistamine for the treatment of Migraine headaches. The said dosage form generically remains approved as per this notification. As early as in March 1976, the combination of Caffeine 100mg + Ergotamine tartrate 1mg + Analgin 250mg + Trifluoperazine HCl 1mg was approved in March 1976. This combination got discontinued after Analgin went out of use.

The ban puts this very effective medicine out of the market. The drug combo is not irrational; the decision to ban is irrational. There are many similar patient-friendly useful combinations, availability of which to patients have adversely been affected by the recent ban. It is also unfair to subject rational combinations in market for many decades, to go for clinical trials. Many of the rational combinations with consumer acceptance must be allowed to continue and be exempted from the ban.  Needless to say the truly irrational ones must be banned justifiably.

India has emerged over the years as a leader not only in generic pharmaceuticals, but also in combination therapy. Even the US FDA, followed India in combination therapy, in areas such as diabetics (Metformin combinations). While India will take time to achieve success in new drug discovery and introduction of NCEs and NMEs in the market place. India is well-poised to dominate the global market through rational combo therapy. Blanket ban like this do immense, irreversible harm and loss of reputation to Indian combo drugs, which have great global potential. Banning combination drugs including in liquid forms will take the industry, both pharma as well as medical profession, back to the sixties when medicines were all compounded by a compounder. It is in this context that IDMA has released a press release which reads as follows:

Whilst we agree that proven irrational formulations need to be weeded out, we are rather surprised and shocked that 344 FDCs have been banned in one go by the Govt. As these FDCs have been in wide use for long, sudden stoppage of supplies thereof will cause tremendous vacuum to take care of health problems for lakhs of patients all over India. As in the past, minimum 12 months’ time period should be provided for phasing out any formulation unless they pose an imminent health risk.

It may be noted that many of these FDCs are being marketed since before 1988 and are licensed by the SLAs under D&C Act and also by the DCGI and have been prescribed with satisfaction by doctors. They have been in wide use for many years without any adverse reports. Consequently, in practical patient healthcare terms, there is no justification now for rushing and causing shortages & serious health problems to the vast suffering public.

Govt order to ban 344 FDCs en bloc is arbitrary and unfair. Even though vague show causes notices without details were received in some cases, no opportunity for personal hearing has been given to any manufacturer. The many issues raised by manufacturers in reply to show cause notices have also not been answered by the govt. In banning 344 FDCs suddenly, there are factual errors, which must be corrected as otherwise manufacturers concerned will be unnecessarily put to huge losses which is a national waste.

What is alarming is that the govt has banned these products worth Rs 5000 crore for manufacture, distribution as well as sale with immediate effect. One can well imagine the amount of wastage and hardship the manufacturers, stockists etc. will have to face in calling back the products. The amount of time, money and energies that would be spent in destroying these products as per procedure will be huge. We also have to consider the loss incurred due to wastage of the raw and packaging materials that are lying in the factories for manufacture.

The whole policy in regard to FDCs should be considered by govt in a positive, judicious and practical manner, taking into account potential therapeutic benefits, convenience of compliance and tremendous benefit of lower drug cost.

For example many cough formulations have been banned. The doctors will have to write different liquids to treat cough and cold instead of writing one cough syrup. Logically the FDCs are evolving from a doctors’ prescription trends only. Doctors will have two issues; one is to find alternative for their current prescription and other one is to counsel their patients who are coming back to them.

Doctors’ prescribing to patients individual drugs (instead of FDCs) will result in tremendous increase in treatment cost as well as inconvenience to patients. This is against the govt objective of reducing medical costs for poor people. A matter like this affecting the health of millions of people cannot be rushed the way it is being done now. It is unfortunate that whilst many countries including USA are moving towards FDCs to reduce medical costs for public, our country is being led to going in the opposite direction.

Practically all SMEs would be so badly hit by the ban that they may have to close down which will lead to unemployment. When the govt is promoting Make in India concept the current situation will be against the Indian companies particularly small and medium companies.

In all our workshops, seminars and interactive sessions we have been getting assurance from the govt that Industry will be heard and will be given a chance before the final decision is taken, but it has not happened. Hence industry feels let down.

Indian pharma have been consistently outperforming and providing the best quality medicines at affordable prices for healthcare of the people of India and world at large. Today every third tablet consumed in the world is manufactured in India. Indian pharma manufacturers are conscious of their responsibilities.

Corrective action should be initiated without any fear of loss of face or ego-issues in the best interest of the patients and the pharma industry, which is currently truly global.