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 doze combination (FDC) drugs.
In fact, over the last weekend, the government through a notification outlawed 343 such combination drugs, including cough syrups Corex (from Pfizer) and Phensedyl (Abbott). And the sweep of the ban sent the pharmaceutical industry into a huddle, as they explored 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 Centre’s 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.
But this 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 doze 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 out in 2007 was a 7-in-1 pill, raising several questions, including that of safety and compatibility of these different drugs with each other.Good combinations
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 critical 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 companies may be pulling out data and documentation to support their products in the market that have suddenly been outlawed, the FDC issue is far from resolved. And some companies are already knocking the doors of the Courts. The government officials familiar with this ban were unavailable for comment.
But this stand-off between the government and the industry hopefully results in greater transparency being brought into the Health Ministry’s decision and working, a clear regulatory framework for the industry to operate in and safer products in the marketplace for patients and consumers.