22.7.1 SINGLE LIST OF PRICE CONTROLLED DRUGS &
The system of
price control may be operated through a Single list of price controlled
drugs and formulations based thereon with a MAPE of 100 per
22.7.2 SPAN OF
(i) The criterion
of including drugs under price control will be the minimum annual turnover
of Rs.400 lakhs.
of popular use, in which there is a monopoly situation will be kept
under price control. For this purpose if for any bulk drug, having an
annual turnover of Rs. 100 lakhs or more there is a single formulator
having 90% or more market share in the Retail Trade (as per ORG) a
monopoly situation would be considered as existing.
(iii) Drugs in
which there is sufficient market competition viz. at least 5 bulk drug
producers and at least 10 formulators and none having more than the 40%
market share in the Retail Trade (as per ORG) may be kept outside the
price control. However, a strict watch would be kept on the movement of
prices as it is expected that their prices would be kept in check by the
forces of market competition. The Government may determine the ceiling
levels beyond which increase in prices would not be
will kept a close watch on the price of medicines which are taken out of
price control. In case, the prices of these medicines rise unreasonably,
the Government would take appropriate measures, including reclamping of
(v) For applying
the above criteria, to start with, the basis would be the data up to 31st
March, 1990 collected for the exercise of the Review of the Drug Policy.
The updating of the data will be done by the National Pharmaceutical
Pricing Authority as detailed in para 22.7.4 (i).
engineered drugs produced by recombinant DNA technology and specific
cell/tissue targeted drug formulations will not be under price control for
5 years from the date of manufacture in India.