REGISTERED No. D. 221 रजिस्ट्री सं ० डी० 221
भारत को राजपत्र The Gazette of Jadia
बनाबारम
EXTRAORDINARY
भाग II-- लण्ड 3--उपखण्ड ( ii )
PART I- Section 3 Sub - section ( il)
प्राविकार से प्रकाशित
PUBLISHED BY AUTHORITY
सं ० 455]
नई दिल्ली , बुत्रधार , सितम्बर 20 , 1967/भाग 29 , 1889
No.455] NEW DELHI , WEDNESDAY , SEPTEMBER 20 , 1967/BHADRA 29 , 1889
इस भाग में भिन्न पृष्ठ संख्या की जाती है जिससे कि यह अलग संकलन के रूप में रखा जा सके ।
Separate paging is given to this Part in order that it may be filed as a separate compilation .
MINISTRY OF PETROLEUM AND CHEMICALS
ORDER
New Delhi , the 20th September 1967
8.0. 3416. In exercise of the powers conferred by sub - section ( 1 ) read with clauses ( c ) and ( e ) of sub - section ( 2 ) of section 3 of the Essential Commodities Act, 1955 ( 10 of 1955 ) , the Central Government hereby makes the following Order further to amend the Drugs Prices (Display and Control ) Order , 1966 , namely :-
1. ( 1 ) This Order may be called the Drugs Prices (Display and Control ) Third Amendment Order, 1967.
(2) It shall come into force at once .
2. In the Drugs prices ( Display and Control ) Order , 1966 ,-
(1 ) after paragraph 6 , the following paragraphs shall be inserted , namely :-
"BA . Form for obtaining approval of the Central Government . For the purpose of obtaining the approva' of the Central Government under paragraphs 3 and 6, the manufacturer , importer or distributor of a drug shall supply in the Form appended to this Order all relevant particulars in respect thereof to the Central Covernment .
6B . Paragraph 6 not to apply to certain drugs .- ( 1 ) Where a new drug , not included in the price- lists published by any manufacturer, importer or distributor ofof drugs immediately before the enforcement of this Order, has improved therapeutic value elther by incorporation of at least one new therapeutic ingredient developed by original research
(1575) THE GAZETTE OF INDIA EXTRAORDINARY
[PART II- 1576
or by adoption of manufacturing techniques evolved by appreciable development research , the manufacturer , importer or distributor of such new drug may, after supplying in the Form appended to this Order all relevant particularsars in respect thereof in the Central Government , introduce such new drug for sale or include the price of such new drug in his price - list .
(2) The Central Government may , after due scrutiny of the particulars received by order, fix a price for the new drug other than the price included by the manufacturer , importer or distributor of drugs in the price - list referred to in sub - paragraph ( 1 ) and thereupon the price of the new drug shall , with effect from such date ( not earlier than the date of communication of the order of the Central Government ) , as may be specified in the Order stand modified accordingly :
Provided that where no such order is made by the Central Government with- in a period of four months from the date of receipt of the relevant particulars referred to in sub - paragraph ( 1 ) , the price of the new drug shall be deemed to be the price of such drug as included by the manu- facturer , importer or distributor of drugs in his price - list referred to in the said sub - paragraph.
Explanation . A mere change in dosage or formulation in the preparation of a drug the price of which has been included in the price- list published by any manufacturer , importer or distributor of drugs immediately before the enforcement of this Order , shall not be deemed to consti- tute a new drug within the meaning of sub -paragraph ( 1 ) .
(3) Where a question arises whether a drug constitutes a new drug within the meaning of sub - paragraph ( 1 ) , it shall be decided by the Central Government ."
(ii ) after paragraph 11 , the following Form shall be inserted , namely:
"FORM
Particulars to be furnished under paragraphs 6A and 6B
[See paragraphs 6A and 6B of the Drugs Prices ( Display and Control ) Order , 1966 ]
NOTE ( 1 ) Please fill a separate form for each drug .
(ii ) Please enclose a copy of the latest price list of your company if you have not sent one to the Government already . If a copy has already been sent give reference in the forwarding memo .
PART I
1. Name of the company and address of the registered office and factory,
2. Name of the drus [ Please indicate also the generic name / chemical name of the active ingredient ( s ) ] .
3. Type , composition , and specification of pack .
4. ( a) Is the drug claimed to be a new drug as defined in paragraphs 6B of the Control Order ? If so , furnishish particulars in Part II .
(b) If it is not a new drug , as above, is it a drug proposed to be introduced by you as an addition to your list ?
(c) ( 1 ) Is the drug already included in your price list , for which a price revision Is now sought?
(ii ) If so, indicate-
composition and specification of pack under which it isis being (a) the type co marketed by you .
(b) the date of its introduction
(c) the existing prices (wholesale and retail )
(d) the basis on which these prices were fixed
(e) number and date of Government Order . if any, approving these prices .
THE GAZETTE OF INDIA EXTRAORDINARY
SEC. 3 ( ii) ]
1577
( If 5. Give the following details in respect of comparable drugs in the market. there is more than one comparable drug , please furnish details of each of the drug) :-
Sl . No.
Name of the manufacturer
Name of the drug
Wholesale price
Retail price Approx date of intro- duction
Type . com-
position &
pack under
which
marketed
I
2
4
3
6
5
7
6. The wholesale and retail prices for which approval is sought ( furnish parti- -culars in Part III )
7. What was the percentage of sales of this drug to the total turnover of your company during the las two years ?
PART II
[To be filled in for ' new drug' referred to in paragraph 6B of the Drugs Prices (Display and Control ) Order , 1966 ]
1. Does It contain a new therapeutic ingredient developed by original research ? If so, give the chemical and generic name of the ingredient .
2. Has there been any scientific publication about the new ingredient ? If so , enclose a copy of the publication .
3. Is the new ingredient, the subject of any patent? If so , give details .
4. Has any developmental work / research been carried out for the evolution of the drug? If so , give details.
5. Is there any medical literature about the drug? If so , enclose copies .
6. Indicate the specific advantages of this drug over any existing comparable drugs in the market .
7. Give details of the trials carried out to substantiate the claims .
8. Has approval under the Drugs Act if necessary , been obtained for the in- troduction of this drug?
9. Has this drug been introduced in any country ? If so. give particulars .
PART III
Cost and price data
NOTE .-( i ) Please fill this Part separately for each pack.
(it) In the case of revision of price of existing drugs , please fill in this part to give the particulars valid for
(1) 1963 or the date on which the price revision proposal was earlier accepted by Government ;
(2) 30-6-1966 ; and
(3) the date of present claim for price revision .
THE GAZETTE OF INDIA EXTRAORDINARY
[PART 11- 1578
A. Specification of the pack
Unit
B. Ex - factory cost :
Quantity consumed
Total cost
Cost to factory per unit
Rs .
Rs .
( i) Cost of materials:
(a) Imported ( specify items )
(b) Indigenous * ( specify items)
(c) Container
(d) Other packing materials
TOTAL
(U) Conversion charges ( inclu- sive of processing , quality control , packing and de- preciation; indicate basis , if necessary in a separate sheet)
( iii) Royalty and service fees , if any.
(iv) Excise duty
Ex-factory Cost
C. Promotion and distribution expenses ( indicate , if neces- sary on a separate sheet , the basis on which the incid- ence has been arrived at)
D. Pront ( indicate , if necessary on a separate sheet the basis on which the incidence has been arrived at ) .
TOTAL
E. Selling commission
F. Wholesale price
G.Retailers margin
H. Retail price
*In the case of imported and indigenous raw materials please furnish particulars In Part IV.
THE GAZEITE OF INDIA EXTRAORDINARY
11)סל (
1579
PART IV
Break up of Material cost to Factory
(a) Imported materials
Unit
CIF Description of material
Cost to factory Clearing ard other charges
Customs
duty
Rs .
Rs .
Rs .
R.
(b ) Indigenous materials
Uit
Easic price
Cost to lactory
Sales Tax
and Octroi
Description of material
Rs .
Tran pon charges
Rs .
R
R.
Signature of the Manufacturer , Importer or Distributor of drugs "
[No. 18-13/ 66 - Ch . III ]
M RAMAKRISHNAYYA , Jt Secy
PRINTED IN INDIA BY THE GENERAL , MANAGER , GOVERNMENT OF INDIA PRES龙 , NEW DELHI AND PUBLISHED BY THE MANAGER OF PUBLICAMONS , PRI HI, 1967