FDC medicines: A new flank could open up on the cut-off date

As the furore over fixed dose combination drugs goes into another loop of litigation, it may well open a new flank in terms of regulatory scrutiny on these drugs.

Fixed dose combination (FDC) medicines involve two or more medicines in a single pill, and for over 10 years at the least, a battle has been raging on whether science or commerce dictates a company's decision to market an FDC.

The discussion has been through many courts and expert committees and in December 2017, the Supreme Court directed the Government to have another sub-committee appointed by the Drug Technical Advisory Board to assess 349 combination products. The sub committee headed by Nilima Kshirsagar was in addition to an elaborate assessment process that FDCs had already been put through under the Kokate Committee.

With this being the multiple level of scrutiny, the end to this discussion seemed nigh.

And earlier this month, the Health Ministry notified the ban on 328 drugs that covered a range of therapeutic areas including antibiotics, anti-inflammatory, analgesic and diabetes drugs.

About a handful of companies have approached the Delhi court on this as well, a move that has the pharmaceutical industry and health advocacy groups locking horns again. The sparring point being, whether it was right to risk public health over a technicality - that their combination drug was approved before 1988 (the Government's cut-off date beyond which combination products are not being assessed).

In fact, says industry watchers, the latest round of discussion could end up putting pre-1988 drugs also under the scanner.

Ban and breathers

Close on the heels of the ban on 328 combination drugs came a breather from the SC on 15 drugs including Abbott's Phensedyl, a combination reportedly approved before 1988. More followed, including Piramal Enterprises Saridon. Companies like Wockhardt approached the Delhi High Court on its anti-inflammatory drug -- Ace Proxyvon, banned for not having a therapeutic value. But late last week, it was also given interim reprieve.

“This is willful litigation,” says S. Srinivasan with the All India Drug Action Network and LOCOST, a maker of essential medicines. “When a product is declared as not safe or efficacious for human consumption, should the management peddle such a harmful product because it has been in the market before 1988,” he asks, terming the behaviour of these companies as “irresponsible”. However, he adds, the latest development could open up for inspction combinations approved by the regulator before 1988 as well.

Business Line contacted companies including Wockhardt and Piramal Enterprises on the FDC related development, but did not receive a response.

Good combination, bad combination

Countering criticism that companies were selling unscientific or irrational combinations of medicine to push up their revenue, an industry insider said that companies were going to court on products that had a regulatory approval or have been in the market prior to 1988.

Besides, in some conditions like HIV or TB, combination drugs have proved beneficial by improving compliance by reducing the pill-burden or the number of pills a patient had to take.

An AIOCD-AWACS pharma market research report pegs the market impacted by the ban at Rs 1,040 crore, a fraction of the Rs 1.2 lakh crore pharmaceutical market. And while reports from two years ago indicated that companies like Abbott, Pfizer, Sun Pharma, Lupin etc stood to be affected, latest reports pegged Macleods with the highest impact at Rs 293 crore, Mankind at Rs 65 crore, Alkem at Rs 58 crore and Micro Labs at Rs 32 crore.

“There has been a quiet spurt of combinations coming into the market,” said an industry representative who did not want to be named. Since this discussion has been on for some years, some companies have changed the troubled formulation, while others have exited the product. For example, Pfizer has since discontinued its earlier formulation of cough syrup Corex and Abbott has line-extension products of Phesedyl that do not have the controversial codeine ingredient.

But with pro-health groups saying that FDCs account for half the domestic drugs market and half that segment being irrational, the battle on combination drugs seems far from over.