2003 PLP 3056 (YLR)

Date of Expiry: Use within 2 years. Manufacturer: Kakasian Pharma Pvt. Ltd. Lahore. Description: Light yellow coloured solution in amber colour vial with particles, Does not comply with USP

24. Sterility test Unsterile. Assay: Stated found limit percentage. Norfloxacin 50mg/ml 35.89 mg/ml 90 -110/% 71.78% Does not comply with USP

24. Remarks Norfloxacin injection is not an Official preparation. The manufacturer was repeatedly directed to supply complete specification/method of testing but be failed to respond within stipulated time. As desired by Dy. Drugs Controller (QC), Assay for Norfloxacin Injection was performed by applying USP

24. Conclusion: The sample is of substandard quality on the basis of test performed. "

7. It is obvious that in accordance with the above mentioned reports the defect pointed out in the drug of the petitioner was that it was substandard and adulterated. These reports are worth reliance if the same are in accordance with the definition of Adulterated Drug Substandard Drug as given in section 3 of the Drugs Act (XXXI of 1976) which read as under: (3) (a). "adulterated drugs" means a drug:‑‑‑ (i) which consists in whole or in part of any filthy, putrid or decomposed substance or which contains any foreign matter, vermin; worm, Rodent or Insect: or (ii) which has been manufactured packed, or held under unsanitary conditions whereby it may have been contaminated with dirt, filth or any other foreign matter or whereby it may have been rendered injurious to health, or (iii) the container of which releases any poisonous or deleterious substance which may render the contents injurious to health; or (iv) which bears or contains as an. ingredient a substance other than the prescribed substance; or (v) with which any substance has been mixed or packed so as to reduce its quality or strength or for which any substance has been substituted wholly or ill part. 3(zz) "substandard drug' means a drug which is not of specifications. " 7‑A. The perusal of the reports and the definitions of the adulterated drug and the substandard drug would show that the report issued by the Central Drug Laboratory at Karachi does not indicate any filthy, putrid or decomposed substance or which, contains any foreign matter, vermin, worm, rodent or insect or the drug has been manufactured, packed or held under unsanitary conditions whereby it may have been contaminated with dirt, filth or any other foreign matter or whereby it may have been rendered injurious to health and simply remarking that the sample contained suspended particles which are visible to the naked eye would not be sufficient to declare the drug as substandard and adulterated and so far the second report issued by the Drugs Control and Traditional Medicines Division, National Institute of Health, Islamabad, is concerned it has been mentioned in the column of remarks that manufacturer was repeatedly directed to supply complete specification/method of testing but he failed to respond within stipulated time and on basis of the test the sample was found of substandard quality and whereas the order dated 5‑7‑2002 is concerned, it indicates that Muhammad Iqbal Khan Executive of the Firm was provided an, opportunity of personal hearing who was not a Technical Expert. Therefore, it looks that the entire exercise was completed with delay in collection of samples and preparation of the reports against the relevant provisions or the Drugs Act and that of giving of opportunity of hearing to the representatives of the firm who was not an expert, therefore, the circumstances require the re‑start of the same exercise but in accordance with law and to be positively concluded by both the parties within two months from the date of drawing samples.

8. In, view of above, reports dated 6‑11‑2000 and 17‑4‑2001 and also the order dated 5‑7‑2002 are set aside with the direction to decide the matter afresh in the light of the observations as made above by collecting the fresh samples in accordance with rules.

9. Till then status quo in all respects in connection with drug as mentioned above shall be maintained. Writ petition stands disposed of. M.H./K‑233/L Order accordingly.