No Remedy In Sight For War On Combination Drugs

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

FDC medicines involve two or more medicines in a single pill.

For over 10 years at 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 Centre to create 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, in line with recommendations, the Health Ministry notified a ban on 328 drugs across a range of therapeutic areas including antibiotics, anti-inflammatory, analgesics and diabetes.

But a handful of companies approached the Delhi High Court on this — a move that has the pharmaceutical industry and health advocacy groups locking horns again. The sparring point was 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).

On the contrary, say 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 Supreme Court on 15 drugs including Abbott’s Phensedyl, a combination reportedly approved before 1988. More followed, including Piramal Enterprises’ Saridon. 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 given interim reprieve as well.

“This is wilful litigation,” said 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?” However, he added, the latest development could open up for inspection combinations approved by the regulator before 1988 as well. BusinessLine contacted companies including Wockhardt and Piramal Enterprises on the FDC related development, but did not receive a response.

Good, bad combinations

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

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

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

“There has been a quiet spurt in the number of combinations coming into the market,” said an industry representative who did not want to be named.

The way out

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 discontinued its earlier formulation of cough syrup Corex and Abbott has line-extension products of Phesedyl without the controversial codeine ingredient.

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