Circular No. 26/26/94-CX dated 30/3/94

Subject:- Production of End-Use certificate in respect of other bulk drugs - Representation from the Drug Manufactures Association, Bombay-

I am directed to invite your kind attention to Board"s Circular No. 8/90-CX.3 dated 6.6.90 which clarified that for the purpose of availing exemption in terms of Notification No. 31/88 (Now 6/94-CE dated 1.3.94) in respect of "other bulk drugs", it would be necessary to insist upon "end- use certificate" in order to satisfy that the bulk drugs have actually been put to the use as specified in Drug (Price Control) Order, 1987. The Board, vide Circular No. 11/92-CX.3 dated 4.11.92, further clarified that as the bulk drugs specified in the Second Schedule to the DPCO are generally meant for use in the manufacture of medicines only, end-use certificate in respect of such bulk drugs may not be insisted upon.

2. The Indian Drugs Manufacturers Association has represented that there are a number of "other bulk drugs" which are not listed in the First Schedule or Second Schedule to the DPCO. Hence, range officers are insisting upon end-use certificate in respect of such other bulk drugs. They have also submitted a list of other bulk drugs where the major use is not for medicinal purpose. The Association has represented that only these drugs, should be subjected to end-use certificate condition.

3. The Board has carefully considered the request of the Indian Drug Manufacturers Association and consulted the Drug Controller of India who has opined that end-use certificate may be insisted upon only in respect of other bulk drugs mentioned in the restrictive list submitted by IDMA (Annexure -I), .since these drugs have other usage besides medicines. The Board hereby clarifies that the end-use certificate may be insisted upon only in respect of other bulk drugs mentioned in this list (Annexure-I).

4. Field formations and trade interests may be informed suitably. Receipt of this Circular may please be acknowledged.

Sd/-
(Rajiv Bhatia)
Under Secretary to the Govt. of India.

F.No. 120/1/92-CX.3 (PT.II)

										Annexure I

List of Drugs Appearing in the Indian Pharmacopoeia but where the major use is not 
for Medicinal Purpose

	— Absorbent Lint    		       -Acacia Powder 
	— Aluminium Sulphate              	— Ammonium Chloride 
	— Arachis Oil                     	— Beeswax 
	— Calcium Carbonate               	— Calcium Chloride
	— Calcium Hydroxide               	— Castor Oil 
	— Cellulose Acetate                    -Citric Acid 
	— Citric Acid                          	— Clove Oil 
	— Edetate Disodium                    	— Emulsifying Wax 
	— Ethyl Alcohol                        	— Ethyl Chloride 
	— Ethyl Olcate                         	— Eucalyptug Oil 
	— Ferrous Sulphate                     	— Hydrochloride Acid 
	— Hydrogen Peroxide                  	— Iodine 
	— lactic Acid                          	— Lithium Carbonaic 
	— Magnesium Chloride                	— Magnesium Carbonate 
	— Menthol                            	— Microcrysialline Celllulose 
	— OleicAcid                           	— Paraffin 
	— Plaster or Paris                     -Polyehylene Glycol 
	— Polysorbate                         	— Potassium Bromide 
	— Potassium Chloride                  	— Potassium Iodide
	— Potassium Permanganate		— Propyllne Glycol
	— Saccharin 				— Shark Liver Oil
	— Shellac				— Silver Nitrate
	— Sodium Acetate			— Sodium Bicarbonate
	— Sodium Corboxymethyl Cellulose	— Sodium Chloride 
	— Sodium Citrate			— Sodium Hydroxide
	— Sodium Lauryl Sulphate		— Sodium Metabisulphite
	— Sodium Phosphate			— Sodium Thiosulphate
	— Starch				— Stearic Acid
	— Talcum				— Thymol 
	— Titanium Dioxide			— Tragacantii
	— Urea					— Vanillin
	— Water(Purified)			— Wool Tat
	— Yeast (Dried)				— Zinc Chloride
	— Zinc Oxide				— Zinc Stearate
	— Zinc Sulphate				

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