B K D RAJESHWARI Vs. STATE OF KERALA

JUDGEMENT

(1.) This O. P. is filed by Smt B. K. D. Rajeswari said to be the Proprietress of Ancient Pharma engaged in manufacturing traditional medicines in Siddha system praying for issue of a writ of certiorari quashing Ext. P4 order dated 26-6-1981 issued by the Drugs Inspector (Ayurveda), the 2nd respondent herein, prohibiting the Depot Sales Manager of the petitioner at Jews Street, Ernakulam, from disposing of 4 items of medicines mentioned therein. The petitioner alleges that this order is one issued without jurisdiction as the 2nd respondent is not empowered to pass an order of this nature under the pro-visions of the Drugs and Cosmetics Act, 1940 (Act 23 of 1940) hereinafter referred to as 'the Act'. This order also is assailed on the ground that it does not give any reasons or show or indicate under what provision this order was issued. Another ground of attack against the order is that neither R.125(2) nor R.161(1) of the Rules framed under the Act, applies to the facts of this case.

(2.) It is alleged that the factory of the petitioner was established in the year 1968 at Madurai and she has been manufacturing mainly 4 medicines viz., Egnol, Famopolin-B, Anciema Capsules and Anciema Cream and in the year 1979, she started manufacturing Dystrep, Boraxine and Linfe-rox also. All these medicines are manufactured by the petitioner on the strength, of the licence issued to her under the Act and the Rules framed thereunder. According to the petitioner, these 4 medicines mentioned in Ext. P4 have been sold not only in the State of Tamil Nadu but also in the States of Kerala and Karnataka and Tamil Nadu Government has not so far imposed any restriction on manufacturing these medicines or told the petitioner that these medicines require approval of the Central Government under R.125(2) of the Rules.

(3.) A counter affidavit has been filed on behalf of the respondents wherein it has been contended that the 2nd respondent is a Drugs Inspector (Ayurveda) duly appointed under the provisions of the Act and it was in exercise of his powers under S.22 of the Act that he issued Ext. P4 which is valid and legal. It is also stated that Famopolin-B is a contraceptive coming within the scope of Sub-r.(2) of R.125 of the Drugs and Cosmetic Rules (for short the Rules) framed under the Act and the petitioner has failed to get the approval of the Central Government as contemplated under the said Rules and as such it is all illegal. It is also stated in the counter affidavit that the medicine Femopolin-B was labelled with a slogan "for Family Planning' with a red symbol also on the label. The further averment in the counter affidavit is that the other 3 items of Drugs mentioned in Exhibit P4 were freezed on the ground that the 'true list' of all the ingredients together with the quantity of each ingredients was not displayed on the label of the said Drugs and the petitioner has thereby violated R.161(1) of the Rules.