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4 THEGAZETIE OFINDIA: EXTRAORDINARY [PARTII-SEc. 3(i)]

MINISTRY OF HEALTH ANDFAMILYWELFARE

(Depaltment 01'Ayurveda, Yoga and Naturopathy, Unani, Siddha and Uomoeopathy)

NOTIFICATION

New Delhi, the 9th July,2008

G.S.R.512(E).- Whereas the draft of certain rules further to amend the Drugs and CosmeticsRules, 1945 was published as required by section 33-N of the Drugs and Cosmetics Act, 1940 (23 of1940), in the Gazette of India, Extraordinary, dated the 19thOctober, 2006, vide Number GSR 651 (E)inviting objections and suggestions from persons likely to be affected thereby and notice was giventhat the said draft will be taken into consideration after the expiry of a period of forty-five days fromthe date on which copies of the Official Gazette containing the said notification were made availableto the public;

And whereas, the said Gazette was made available to the public on the 18thOctober, 2006;

And whereas, objections and suggestions received from the public on the said draft rules Drugs &Cosmetics Act, 1940 (23 of 1940) have been considered by the Central Government;

Now, therefore, in exercise of the powers conferred by section 33-N of the Drugs & CosmeticsAct, 1940 (23 of 1940) the Central Government, after consultation with the Ayurveda, Siddha andUnani Drugs Technical Advisory Board, hereby makes the following rules further to amend theDrugs and Cosmetics Rules, 1945, namely:-

1.

2.

3.

(1) These rules may be called the Drug and Cosmetics (First Amendment) Rules, 2008.(2) They shall come into force from the date of their publication in the Official Gazette.

In the Drug and Cosmetics Rules, 1945 (herein referred to as the said rules), after rule 157,the followin.g rule shall be inserted, namely: -1/157A. Maintaining of records of raw material used by licensed manufacturing unit ofAyurveda, Siddha and Unani drugs in the preceding financial year. Each licensedmanufacturing unit of Ayurveda or Siddha or Unani drugs shall keep a record of rawmaterial used by each licensed manufacturing unit of Ayurveda, Siddha or Unani drugsthe case may be in the performa given in Schedule TA in respect of all raw materialsutilized by that unit in the manufacture of Ayurveda or Siddha or Unani drugs in thepreceding financial year, and shall submit the same by the 30th day of June of thesucceeding financial year to the State Drug Licensing Authority of Ayurveda, Siddha andUnani drugs and to the National Medicinal Plants Board or any agency nominated by theNational Medicinal Plant Board for this purpose"

In the said rules, after Schedule T, following Schedule shall be inserted; namely: -

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"Schedule TA .

(See rule 157 A)

Form for record of utilization of raw material by Ayurveda or Siddha or Unanilicensed manufacturing units during the financial year.

IdentifJea'ti/onPar:ti(?ulars:'. . .

'Mant!-jacturingLiC£nse NOH, .,. , ." ..~t ...,.. 'n.,,"" ... ,.. ... .t...lssuelfby ... ... ... ... ."... .n... ... '.'''' '" ... ... .,. ,.. '.. , ......

Name: ",M ..,..,. n .,.. ....~... ,. ." ',' "... ... ,....

Addr~$s: "".,'''''' , ,..,..,. '" ,.. , ....., , ,

State: . t'...:,t'."'''''' . Piil(illo4'e: ,.o..;..

''U~lepbon~:,.,.".. , n""" ". '.,. " ",." ,., ..", 'Fax: , ,... ... ... ""','"'''''''' "w ...', .....

Eroa:j'l;..,:.""..'", . ,. . " "'. ',..,'. " "".'"'' '"''''','''

1. Quantity of Medicinal Plants/ExtractslEssential Oils/Metals/ Animal By.Products/MineraisUsed During 1st April, to 31st March, of the proceeding year (For .Productions at theidentified facility) , '

* Ayurvedic Formulary of India/ Ayurvedic Pharmacopoeia of India(b .

* Ayurvedic Formulary of India/ Ayurvedic Pharmacopoeia of India

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Name as in Botanical Used/per Tra Forest Culti- Impo- Total Whole Root Leaf OthersAFJ/API" Name annum dersjMan Collec-. vators rted pli1itts

(in Kgs.) ufacturers tors '

-

, Extracts UsedName of Extracts Quantity Sources of Supply

Common Name as Botanical Name Used/ per In-House Export Imported Totalin AFJ,IAPI" . annum (in Suppliers

KKS.)

,6 THE GAZETIE OFINDIA:EXTRAORDINARY [PARTII--SEC.3(Q]

(c) MetalsfMinerals Used

(d) Animal By-Products Used

2. Shortage of raw.material(s)jinputs during the preceeding year.

I Yes [~

If yes, please indicate name(s) of such raw material(s) by level of importance starting frommost important to least important, reason for shortage [availability, quality or any other (pleasespecify)]

~o. K.l1020/2/2006-DCC(Ayush)]

SHIVBASANT,Jt. Secy.

Foot Note: ThePrincipal rules were published in theGazetteofIndia vide notificationnumberF. 28-1O/45-H(1),datedthe21st December, 1945 and subsequently amended vide notification number G.S.R. No. 678(E) dated31-10-2006.

Printed by the Manager, Govt. of India Press, Ring Road, Mayapuri, New Delhi-! 10064and Published by the Controller of Publications. Delhi-II 0054.

Name of Mineral Quantity ----.. Sources of SupplyUsed/per. Manufactures Traders Importers Total

CommOI'IName Chemical Name annum (in (Domestic)Kgs.).

Name of By-Product Quantity ources of SupplyUsed/per Manufactures Traders Importers Total

Common Name Biological! Chemical annum (in (Domestic)Name (if any) Kgs.)

II

Name of Raw Material Appro. Qty of Reasonshortage (in Kgs.)

Name of the drug and part used as Biological/ChemicalNamementioned in official (ifany)

formulary / Pharmacopoeial! ScheduleI books