Over 340 drugs to go off the shelves soon

Some of the popular brands that would be impacted include Phensedyl (Abbott), Tixylix (Abbott), Gluconorm PG (Lupin), Ascoril D (Glenmark), Solvin Cold (Ipca), D Cold Total (Paras Pharma).

The Centre is one step closer to banning 343 “irrational” fixed-dose combination (FDC) drugs that were potentially harmful to consumers.

The market size of the banned drugs is estimated to be around Rs 2,000-2,200 crore and will impact the country’s top drugmakers.

Patient advocacy groups say more FDCs, worth Rs 20,000-25,000 crore, are under scanner.

An FDC drug is one that contains two or more active ingredients in a fixed-dosage ratio.

In March 2016, the ministry of health and family welfare had implemented a ban on 349 FDCs based on recommendations of the Chandrakant Kokate committee that found these drug combinations to be irrational and posing health risks.

In December, the Supreme Court referred the matter to the Drug Technical Advisory Board (DTAB) for a fresh review after drugmakers challenged the ban.

The DTAB, in a meeting held in New Delhi on Wednesday, re-inforced the ban on 343 of the 349 drugs.

It, however, felt restricted use could be allowed for six FDCs.

The DTAB would forward its report to the health ministry in the next 7-10 days, said a top government official.

These FDCs roughly contribute to 1.8 per cent of the overall domestic drug market.

The FDC segment is clocking a slower growth rate (4.7 per cent in June) compared to the rest of the domestic drug market (8.6 per cent).

They cover around 6,000 brands mainly from firms like Abbott Healthcare, Mankind Pharma, Wockhardt, Alkem, Lupin, Glenmark, Sun Pharma, Eris Lifesciences and Ipca, among others.

Abbott, perhaps, would take the largest hit. It has an exposure of around Rs 545 crore in these FDCs.

An Abbott spokesperson said the company was awaiting communication from DTAB on the matter.

Abbott is followed by Macleods Pharma (Rs 295 crore) and Mankind Pharma (Rs 134 crore), according to market research firm AIOCD AWACS.

Anticipating the ban, the companies were bracing up.

Pfizer, for instance, has changed the formulation for its popular cough syrup Corex and launched it as Corex T.

Some companies even weeded the products out of their domestic portfolio.

"Only mid-sized firms were selling these drugs, and would be impacted. We had a couple of products in this list and we stopped selling them long time back," the chief of a leading drugmaker said.

S Srinivasan, co-convenor of the All India Drugs Action Network, a patient advocacy group, said they had a public interest litigation in the Supreme Court since 2003 on similar matters.

"These 343 FDCs are only the tip of the iceberg. Over and above the Kokate committee recommendations, there are FDCs that are sold in the country that are potentially harmful to patient health," Srinivasan said.

“The bigger uncertainty would be the additional 944 FDCs that were identified by the Kokate committee as being irrational. Perhaps the DTAB may look at these products now,” Emkay had said in a recent research note.

Some of the popular brands that would be impacted include Phensedyl (Abbott), Tixylix (Abbott), Gluconorm PG (Lupin), Ascoril D (Glenmark), Solvin Cold (Ipca), D Cold Total (Paras Pharma).

Photograph: Shailesh Andrade/Reuters