E-DRUG: Irrational FDCs in India
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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 efficacy.
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 value.
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"
Physician
UK
<drptalwar@yahoo.co.uk>