The Indian Drug Manufacturers Association (IDMA) in a letter submitted
to the deputy director of national pharmaceutical pricing authority
(NPPA) has sought explanation from NPPA on its recent notification on
ciprofloxacin and tinidazole tablets and its implication on the
industry. IDMA strongly feels that the revised price is unjust,
inequitable and harmful to manufacturers of this formulation as the
implementation of the notification will result in creation of two sets
of manufacturers of ciprofloxacin based formulations, which will result
in huge disparity in the prices of the same product and result in
complete disharmony in the trade.
Daara Patel, secretary general,
IDMA points out that normally, variations in the price of formulation
are consequential to any revision in the price of bulk drugs. However in
this instance, the price of bulk drug ciprofloxacin has not changed
since it was fixed pursuant to the notification No. 227(E) dated
20.03.1997. Whereas the price of the ciprofloxacin based combination
formulation has now been revised vide Notification S O 2500 (E) dated
11/10/2010, from the earlier fixed price of Rs.67.94
as per NPPA notification No S O1354 (E) dated 25.11.2003.
IDMA
feels that there is lot of anomalies in the said notification. The
present ceiling price of ciprofloxacin based formulations vide
Notification No S O 1354 (E) dated 25.11.2003 is Rs.67.94
per strip. The revised ceiling price as per the present notification No
S O 2500 (E) dated 11-10-2010 is Rs.25.70
per strip which does not appear to be based on the bulk drug of
ciprofloxacin fixed in 1997 under the said Notification.
Patel
informs, “We fail to understand the rationale and the legality of such a
drastic reduction of 62 per cent in the ciprofloxacin based formulation
while retaining the bulk drug price of ciprofloxacin fixed in 1997
constant.”
The letter further states that since the litigating
manufacturers are exempt from this notification, it gives them the
liberty to enjoy under their existing prices and destroy the market.
This act would force the manufacturers to stop production of the said
formulation as they would not be able to even break even, and allow the
litigators to hog the market with higher priced formulations thus
defying the very tenet of the principle of making available drugs at
reasonable prices to patients.
Patel informs, “The implementation
of the notification will lead to two section of manufacturers, one who
have obtained stay order or interim relief from the Court, they shall be
able to continue to market their product at the their prevailing MRP
and other manufacturers who will be required to revise their price based
on the present said notification issued by NPPA.”
IDMA has urged
the pricing authority to suspend the notification till the High Court
gives a verdict on all the cases pending before the Court in the matter
of ciprofloxacin based formulation since, a ruling by the High Court on
behalf of petitioners in respect of a notification would apply to all
manufacturers who are affected by such a notification.
It warns
that the impact of the present price reduction vide the said
notification would lead the manufacturers to suffer a loss on their
formulation and may even lead to stoppage of this life saving
formulation by all manufacturers of similar formulations.