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).
http://www.rediff.com/business/report/over-340-drugs-to-go-off-the-shelves-soon/20180726.htm
