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Pharma industry, trade concerned over issue of growing expired drugs with no set rules
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Nandita Vijay, Bengaluru
August 08 , 2017
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Pharma industry and trade are in a dilemma how to handle the issue of
increasing stocks of date expired drugs in the absence of a dedicated
set of rules for the same. Although there have been recommendations to
clear date expired drugs at the earliest, these medicines continue to
get accumulated in companies or at trade outlets.
Date expired
drugs are now like a spanner in the works. The trade is not fully
reimbursed for the unsold and date expired drugs by the manufacturer.
Furthermore, the obligation of its safe disposal is on the manufacturer.
States like Karnataka adhere to the State Pollution Control Board norms
for its disposal. The GST regime calls to maintain records of batch
wise details of sales. Here stocks of date expired medicines have thrown
a wrench in the works.
According to Dr. BR Jagashetty, former
National Adviser (Drugs Control) to MoHFW & CDSCO and former
Karnataka state drugs controller, Union government should frame a set of
dedicated rules on date expired return/disposal from pharmacy outlets
to the concerned manufacturers. The manufacturers need to discard and
dispose them off as per the directions of Ministry of Environment’s
Pollution Control Boards.
As on today Rule 65 (17) states that
such date expired drugs should not be sold. The Drugs & Cosmetics
Act has no exclusive provisions for return or disposal of the same.
Usually this is an understanding between the company and the trade.
Therefore, there is need to frame regulations for the same. The pharma
manufacturers should be made liable for the same. The companies have to
return huge sums of money for the remaining stocks of date expired drugs
and also look at ways to discard them in the right manner, he added.
This
is where the Trace & Track regulations come to play. Then it will
be far easier to lay hands on the return and disposal of date expired
drugs, noted Dr Jagashetty.
From an industry perspective, Harish K
Jain, secretary, Karnataka Drugs & Pharmaceutical Manufacturers
Association, said, “Date expired drugs is a serious issue and one has to
live with it. There is no escape. Currently, quantity of date expired
drugs is estimated to be around 1.5% to 2% of the total drugs in the
market. The need of the hour is to ensure that these drugs are not sold
to patients because it lacks safety, efficacy due to reduction of
potency along with dissolution/disintegration failure. There is need for
100% voluntary compliance. Equally important is security and disposal
of these drugs according to pollution control norms at authorized
centres with proper records maintained which is the least companies need
to comply, he added.
Many a time date expired drugs result in a
conflict between trade and companies. Progressive companies have adopted
two pronged strategy. First is to close inventory monitoring &
management at the distribution level. Second, to adequately compensate
distribution channels for the loss, noted Jain.
Companies
generally factor the cost of this compensation while fixing the prices.
There is also need for companies to encourage R&D to increase the
shelf life to reduce expiry dated drugs. This could be as simple as
change of packaging from PVC Film to PVC/PVDC Film, said Jain.
Representing
the pharmacy trade, Ravindra Kumar MJ, Member, Karnataka Chemists &
Druggists Association, said it is the manufacturers or C&F Agents’
basic responsibility to ensure date expired drugs are being taken back
and disposed in the right manner and this is being practiced in
Karnataka.
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