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[e-drug] Irrational FDCs in India

E-DRUG: Irrational FDCs in India

Irrational Fixed Dose Combinations (FDCs) of approved drugs is a matter of 
serious concern in India. The current (January, 2015) issue of Monthly Index of 
Medical Specialities (MIMS) has dealt with this issue in some detail in an 
Editorial. The information is reproduced below:

Combination medicines: Legal conundrum
Despite much discussion and debate, both in the Parliament and in the media, on 
the scientific rationality of some of the combination medicines,legally called 
"Fixed Dose Combinations (FDCs) of already approved drugs", there is hardly any 
movement in resolving the issue. A feeble attempt by the Drugs Controller 
General, India (DCGI) to get some 43 FDCs removed from the market was blocked 
by the Madras High Court on legal grounds.

The problem is that till 21st September 1988, FDCs were not classified as"new 
drugs" in the Drugs and Cosmetics Rules with the result that hundreds of 
combinations of already approved medicines were issued manufacturing licences 
by legally authorized state level drug controllers to thousands of producers. 
Since matters concerning drugs are under the jurisdiction of both central and 
state governments, the division of powers gives authority to DCGI to approve 
"new drugs" while state controllers are empowered to issue manufacturing 
licences for old medicines already approved by DCGI.Even when FDCs were 
designated as "new drugs," the licencing procedure followed by state drug 
controllers was not amended by the Central government. 

Consequently state drug controllers continued to issue manufacturing licences 
even after 21st September 1988. The problem was rectified 14 years later on1st 
May 2002 when the licencing procedure was changed to make it mandatory for 
state controllers to insist on prior approval of new FDCs while issuing 
manufacturing licences. By then thousands of FDC formulations had already hit 
the market. As of now FDCs account for 44% of the Rs. 62,000 crore market.

There are two burning issues: public health and legal rights of 
manufacturers.If public health is held supreme superseding rights of 
manufacturers, then it would be necessary to divide all FDCs into two 
categories: safe (though not necessarily rational) and dangerous. No one would 
object to weeding out dangerous FDCs. The problem is that DCGI has himself 
approved FDCs without determining safety and efficacy. Some of them such as FDC 
of aceclofenac with thiocolchicoside are far worse than those licenced by state 
controllers whose responsibility did not include determination of safety and 

Legally, the manufacturers of FDCs are on safe grounds. They are holding valid 
manufacturing licences and have not broken any law. Hence cancelling their 
licences is tantamount to expropriation of their property without compensation 
which is illegal. 

If DCGI gave marketing approval wrongly or if manufacturing licences were 
issued by state controllers unlawfully, then let offenders be punished by 
compelling them to pay compensation to manufacturers for loss of investment on 
land, plant, machinery, promotion etc.The legal powers of the state governments 
to prohibit manufacture of drugs,including FDCs, are limited in scope. This can 
be done only if the drugs are found to be substandard, misbranded, adulterated, 
spurious or if the manufacturer has violated any rules. On the other hand 
Central Government enjoys much broader powers. It can ban drugs in "public 
interest" if they involve risk to humans or do not have claimed therapeutic 
Since some FDCs approved by DCGI do not have therapeutic value and involve risk 
to humans, the Central Government will find itself on a very slippery ground in 
any court of law. Was it known that such FDCs lack clinical justification 
and/or posed risk to humans at the time of approval? If so; then why were they 
approved in the first place? If risks were discovered later, then why were they 
not banned soon after? Why should producers pay the price of central 
government's own mistakes and/or lethargy? The possibility that the court may 
order the central government to pay compensation to those who will suffer due 
to its lapses and delays can not be ruled out.

"Dr. Pankaj Talwar"
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