At an industry event a little more than a year ago, KL Sharma, joint secretary with the Health Ministry, had told local representatives with the pharmaceutical industry that the Government would be “ruthless” in enforcing laws governing fixed dose combination (FDC) drugs.
In fact, over the last weekend, the Government has through a notification outlawed over 300 such combination drugs, including cough syrups Corex (from Pfizer) and Phensedyl (Abbott). And the sweep of the ban has thrown the pharmaceutical industry into a huddle, as they explore their next course of action.
The thinking behind the Government’s action also lies in Sharma’s observation at the same industry meet last year. He had asked industry representatives why some of them were taking State level approvals on their combination products, when they knew Central approvals were required.
The concern over taking local approvals on combination drugs is that it could pave the way for irrational or unsafe combinations to make its way into the consumer’s medicine cabinet at home.
The worry over combination drugs is not a new one, and the Government for instance had undertaken a clean up exercise in 2007 when it weeded out several irrational, “absurd” combinations out of the market.
A fixed dose combination is a drug that combines two or more drugs into a single pill or product. But the critical question behind such a combination is whether it was science or commerce that drove the combination. For instance, one of the 120 absurd combinations pulled off in 2007 was a 7-in1 pill, raising several questions including that of safety and compatibility of these different drugs with each other.
But that does not mean all FDCs are born of “greed”. For instance, in treating HIV/AIDS and tuberculosis, combination drugs have helped reduce the pill burden on a patient, increased the convenience and improved adherence to the regimen prescribed by the doctor. And this is of critical importance when it comes to keeping drug resistance under control. (Resistance to a drug is a worry plaguing TB, for instance, and it occurs when patients stop taking their medicines for reasons including the trouble in keeping track of the several medicines that need to be taken).
In patient interest, the Government needs to be more transparent in listing out what drugs are being banned and why. For instance, it is worrisome if a drug that has been in the market for over three-four decades is banned overnight for being unsafe. Cough syrups are commonly prescribed by doctors. While controlling its abuse is something no one would disagree with, the Government has created a fresh scare around it by totally banning it.
While the industry may be pulling out all its data and documentation to support their products in the market that have suddenly been outlawed, it is clear that the FDC issue is far from resolved. Industry word is that companies are already knocking the doors of the Courts.
Government officials familiar with this ban were unavailable for comment.
But as matters come to a head between Government and industry, hopefully the exchange will bring in greater transparency around the Government’s working, a clear regulatory framework for industry to operate in and safer products in the marketplace for patients and consumers.