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2008 DIGILAW 983 (BOM)

D. J. Laboratories Pvt. Ltd. v. State of Maharashtra

2008-07-10

A.A.KUMBHAKONI, BILAL NAZKI

body2008
JUDGMENT 1. After arguing for some time, the petitioners counsel wanted to withdraw this petition. We did not allow the withdrawal as during the course of arguments a Judgment has been brought to our notice of this Court reported in & Anr, delivered by the learned Single Judge. 2. The case of the petitioners is that it has been prosecuted on the basis of the Report of Public Analyst of the Drug Control Laboratory, which found some of the samples taken from the petitioners to be sub standard. Government Analyst was of the view as under: "In the opinion of the undersigned the sample referred to above is of NOT OF STANDARD QUALITY as defined in the Drugs and Cosmetics Act, 1940 and Rules thereunder for the reasons given below:- Out of 22 vials received for Analysis, 11 Vials containing colourless liquid with suspended particles visible to unaided eye in normal day light. The sample does not comply with IP 96 requirements for "Particular Matter" as given in the protocol." We are also told at the bar that the drug which was sent for analysis is a Life Saving Drug. 3. The learned counsel for the Petitioners submit that the finding of the Government Analyst that there were suspended particles visible to unaided eye in normal day light, does not make the drug "Not of standard quality". In this connection, he relies upon the Judgment of this court, of which reference has been made hereinabove. 4. In the aforesaid case, the court took upon itself the task to find out whether the drug was of a standard quality or was not of standard quality. The court noticed that the petitioners in that case were being prosecuted under the provisions of Drugs and Cosmetics Act, 1940, in respect of drug "Sodium Chloride Injection" on the ground that it was of sub standard quality as it contained extraneous particles. The court was of the view that the drug cannot be said to be below standard quality only by reason of the fact that in the process of manufacture, preparation or conveyance some extraneous substance has unavoidably become intermixed with it, in the absence of allegation of awareness of the intermixture. With respects, this view cannot be accepted. The court was of the view that the drug cannot be said to be below standard quality only by reason of the fact that in the process of manufacture, preparation or conveyance some extraneous substance has unavoidably become intermixed with it, in the absence of allegation of awareness of the intermixture. With respects, this view cannot be accepted. If standards are laid down for the medicines and that too for life saving medicine, they must be strictly complied with and it is none of the business of the courts to come to a conclusion whether the matter which was extraneous in the drug was beneficial or detrimental to the health care. Such a matter has to be left to the Experts. 5. If the petitioners thinks that by having suspended particles in the life saving drug, efficacy of drug would not be affected or the material which was found extraneous in the drug was not injurious to the user, the petitioner can always examine the Expert in the trial. Expert who has given the opinion with regard to the samples collected from the petitioners can be called to the witness box and cross-examined. But at the outset of the prosecution, this court prima facie finds that the case is made out against the petitioners for trial. 6. In this view of the matter, we hold that law laid down by this court in 2001 ALL MR(Cri) 2261 is not good law. Petition is disposed of.