OZONE PHARMACEUTICALS LTD. v. UNION OF INDIA AND ANR.

1. The petitioner has filed the present petitions impugning anotification (S.O. 4711(E) dated 07.09.2018 - hereafter 'the impugned notification') issued under Section 26-A ofthe Drugs and Cosmetics Act, 1940 whereby the manufacture, sale and distribution ofthe FixedDose Combination (FDC) of Glimepiride +Pioglitazone +Metformin has been subjected to certain conditions (three in number). The said conditions are set outbelow:- 2018:DHC:8694

(i) the manufacture, sale or distrftution ofte said dmg shall be in the strength of Glimepiride (lnig/2mg) Pioglitazone (15mg) +Metformin 500mg (Ii^^ediate Release or Sustained Release or Extended Release) Tablet only;

(ii) the said drug shall be used for treatment of type-2 diabetes mellitus (T2DM) when diet, exercise along with monotherapy and dual therapy does not achieve glycaemic target; and fiii) in respect, of the said drug, the label and all the promotional literature including the package insert shall mention the precautions for individual drugs ^ respectively.

2. The petitioneris notaggrieved bythe firsttwo conditions, as itclaims that it had satisfied the same. However, the petitioner is aggrieved by the third condition, which requires the petitionerto ensure that the label and all promotional literature including the package insert mention the precautions for the individual drugs respectively.. The petitioner states that the impugned condition [condition no. (iii)] is arbitrary andum-easonable, asthepetitioner'spackagingduly discloses all the necessary particulars. It is further claimedthatthe impugned notification * was not communicated on y'" September, 2018 but was uploaded on 13/14.09.2018.

4. Ms Richa Kapoor, the learned counsel appearing for the petitioner earnestly contended that whilst the petitioner will change the labels on the drugs manufactured hereafter, it would not be able to change the labels on the stock already manufactured by it.

5. FDC is acombination ofmore than one drugs. Clearly, the customer purchasingthe saiddrug mustbe informedofthe precautions for eachofthe said constituent drugs. This Court does not find the impugned condition [condition no. (iii)] to be arbitrary or unreasonable. On the contra^-, the requirement to inform the customers about all the precautions.appears to be reasonable and necessary. Thus/this Court finds no reason to interfere with the decision ofthe Central Government.

6. The contention, that the peititioner has already manufactured stocks and, therefore, the said condition should not be applied to stocks already manufectured, is:uri^ersuasive. It is apparent that the-condition to mention the precautions ofeach drug onthe label and promotional literature has been imposed iii the interest ofthe.public and this Court finds no reason to dilute the said requirement in any manner. Having_ stated the above, it is understandable that it may be difficult for the petitioner to-change the label ofthe stocks that have already been"despatched to the retailers. In this case, the petitioner must make all efforts to ensure that the promotional literature and package inserts are provided to the retailers so that the customers are duly informed of the precautions to be taken in respect of each of the constituent drugs.

7. The petitions are dismissed with the aforesaid observations. All pending applications stand disposed of.

SEPTEMBER 24,2018 pkv VIBHU BAKHRU, J