India on 15th May 2013 notified Drug
Price Control Order 2013 that will bring down prices of essential
medicines, increase the number of drugs under price control. The order is effective
from 31 May 13.
The government will regulate
the rates of 652 medicines, a substantial increase over the 74 bulk drugs and
their formulations that were previously under price control.
The new
order authorises the National Pharmaceutical Pricing Authority (NPPA) to
regulate prices of essential medicines as listed in the National List of
Essential Medicines (NLEM) 2011. -
The current method of fixing
prices on a cost-plus basis will be replaced by market price-linked cap for
each drug.
Prices would be capped by taking the weighted average
price of all brands having at least 1% or more market share (by volume)
It has clarified that
players selling below the price caps cannot raise prices.
A
new drug developed using indigenous R&D and granted patent under Indian law
can seek exemption from price control from the date it starts commercial
production in the country.
Second,
if a pharma company discovers a new process to make an existing drug and gets a
patent for it under Indian law, it can apply for a five-year relaxation from
price regulation. This privilege would kick in for the drugmaker from the time
it starts manufacturing the drug for the domestic market.
Drug makers will have to
maintain records relating to the sales of APIs (Active Pharmaceutical
Ingredients) and bulk drugs, manufactured or imported.
The order dated 15th
May 13 can be downloaded from:-
No comments:
Post a Comment