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[Cites 0, Cited by 0] [Section 6] [Entire Act]

Union of India - Subsection

Section 6(1) in Drugs (Prices Control) Order, 2013

(1)where the average price to retailer of a scheduled formulation, arrived at as per the formula specified in sub-paragraph (1) of paragraph 4, has the effect of,-
(a)no reduction in average price to retailer with respect to the prices to retailer of the schedule formulation; and
(b)there are less than five manufacturers for that formulation having one percent or more market share, the ceiling price shall be calculated as under:-
(i)in the event of other strengths or dosage forms of the same scheduled formulation is available in the list of scheduled formulation, the average price to retailer shall be calculated as under:
Step1: First the Average Price to Retailer of such scheduled formulation i.e. P(s) shall be calculated as under:
P(s) =| Pm{1-(Pi1+Pi2+...)(N*100)}| Where,
Pm = Price to Retailer of highest priced scheduled formulation under consideration.Pi = % reduction in Average Price to Retailer of other strengths and dosage forms (calculated as in step1 of sub-paragraph (1) of paragraph 4) in the list of schedule formulations w.r.t the highest priced formulation taken for calculating the average price to retailer of such strengths and dosage forms.N = Number of such other strengths or dosage forms or both in the list of schedule formulationsStep2. Thereafter, the ceiling price of the scheduled formulation i.e.P(c) shall be calculated as under:P(c) = P(s).(1+M/100), whereP(s) = Average Price to Retailer of the scheduled formulation as calculated in step1 hereinabove andM = % Margin to retailer and its value=16
(ii)in the event of other strengths or dosage forms of the scheduled formulation is not available in the schedule but there are other scheduled formulations in same sub-therapeutic category as that of the scheduled formulation, then the Ceiling Price shall be calculated as under:
Step1: First the Average Price to Retailer of such scheduled formulation i.e. P(s) shall be calculated as under:
P(s) =| Pm{1-(Pi1+Pi2+...)(N*100)}| Where,
Pm = Price of highest priced formulation taken for calculating the average price to retailer of the formulation under consideration..Pi = % reduction in Average Price to Retailer of other schedule formulations (calculated as in step1 of sub-paragraph (1) of paragraph 4) in same sub-therapeutic category as that of the scheduled formulation under consideration w.r.t the highest priced formulation taken for calculating the average price to retailer.N = Number of such other schedule formulations in same subtherapeutic category as that of the scheduled formulation under consideration.Step2. Thereafter, the ceiling price of the scheduled formulation i.e.P(c) shall be calculated as under:P(c) = P(s)*(1+M/100), whereP(s) = Average Price to Retailer of the scheduled formulation as calculated in step1 above andM = % Margin to retailer and its value=16Explanation. - where the scheduled formulation under consideration is coming under more than one sub-therapeutic category, the Average Price to Retailer of the scheduled formulation shall be calculated after taking into consideration the percentage reduction in Average Price to Retailer of other schedule formulations under all such sub-therapeutic categories and the lowest average price to retailer shall be taken for calculating the ceiling price of the scheduled formulation under consideration;
(iii)in case the other strengths or dosage forms of the scheduled formulation are not available in the schedule and there is no sub therapeutic category of the scheduled under consideration, the ceiling price shall be calculated as under:
Step1: First the Average Price to Retailer of such scheduled formulation i.e. P(s) shall be calculated as under:
P(s) =| Pm{1-(Pi1+Pi2+...)(N*100)}| Where,
Pm = Price of highest priced formulation taken for calculating the average price to retailer of the formulation under consideration.Pi = % reduction in Average Price to Retailer of other schedule formulations (calculated as in step1 sub-paragraph (1) of paragraph 4) in same therapeutic category as that of the scheduled formulation under consideration w.r.t the highest priced formulation taken for calculating the average price to retailer.N = Number of such other schedule formulations in same therapeutic category as that of the scheduled formulation under consideration.Step2. Thereafter, the ceiling price of the scheduled formulation i.e.P(c) shall be calculated as under:P(c) = P(s).(1+M/100), whereP(s) = Average Price to Retailer of the scheduled formulation as calculated in step1 above andM = % Margin to retailer and its value=16Explanation. - where the scheduled formulation under consideration is coming under more than one therapeutic category, the Average Price to Retailer of the scheduled formulation shall be calculated after taking into consideration the percentage reduction in Average Price to Retailer of other schedule formulations under all such therapeutic categories and the lowest average price to retailer shall be taken for calculating the ceiling price of the scheduled formulation under consideration.