Messrs Kakasian Pharmaceuticals (Pvt.) Limited, Ferozepur Road, Lahore has filed this petition under Article 199 of the Constitution of Islamic Republic of Pakistan, 1973, to challenge the reports dated 6-11-2000 and 17-4-2001 as well as order dated 5-7-2002 passed by respondent No.4, whereby the registration of the petitioner's drug labelled as Oxytocin-10 injection for veterinary use has been cancelled with the prayer that the report and the orders as mentioned above as being violative of the criteria specified by the provisions of Drugs Act, 1976, are liable to be set aside.
2. Some relevant facts for the purpose of disposal of this writ petition are that the petitioner being a private limited company was maintaining veterinary drugs/medicines including injections and powders under a valid licence. Its produce labelled by oxytocin injection for veterinary use was being manufactured and sold throughout the country without any complaint since 1997. Federal Inspector of Drugs, (respondent No.1) on 15-9-2000 obtained sample of the above mentioned injection from the factory of the petitioner at Lahore for test analysis. The petitioner was intimated vide letter dated 23-11-2000 sent by respondent No.1 based upon the report dated 6-11-2000 by respondent No.2, that since the sample contained suspended particles visible to the naked eye, therefore, it was "substandard and adulterated" as per Drug Act of 1976. On receipt of this letter the petitioner vide his letter dated 16-12-2000 challenged the report as mentioned above as a consequence of which on 19-2-2001 respondent No.4 referred the sample to respondent No.3 for its analysis whereupon the petitioner was asked to supply the specification including the method of testing the product on which the petition provided the requisite information but respondent No. 3 without applying the requisite specification prepared the report dated 17-4-2001 declaring therein the sample as substandard for having fibre's and particles. On basis of this report respondent No.4 issued a show-cause notice dated 8-5-2001 to the petitioner in response to which reply was submitted alleging therein that the reports are illegal and invalid on many grounds. On 18-3-2002 the petitioner received a letter dated 16-3-2002 with a direction to appear before the Expert Committee, on which the Chief Executive of the petitioner-Company, a non-technical person rushed to Islamabad and requested for adjournment to bring the Technical Expert but without affording any opportunity of hearing the, registration of Oxytocin-10 Injection was cancelled vide order dated 5-7-2002. Therefore, the reports and the order as mentioned above have been challenged with an allegation that same are without applying the criteria specified by the provisions of Drugs Act, 1976.
3. Whereas in the report and parawise comments mainly after reflecting on the collection of sample and the reports as discussed above, it has been submitted that the sample was declared as substandard as particles and fibres were found in the vial and it was also declared as unsteriled therefore, after issuance of show-cause notice, the representative of the petitioner was heard by the Committee of Central Licence and Registration Board on quality assurance on 18-3-2002 and that the matter was recommended for cancellation of drug registration, recall of product from the market and Panel Inspection of the firm, as a consequence of which the recommendations of the Committee were approved by the Board, therefore, this writ petition be dismissed in the public interest.
4. I have heard the learned counsel for the parties and. Have gone through the copies of the relevant record attached with this petition.
5. Learned counsel for the petitioner after advancing lengthy arguments concluded mainly that the reports dated 6-11-2000, 17-4-2001 issued by respondents Nos.2 and 3 declaring the sample manufactured by the petitioner as "adulterated and substandard" have no legal affect as both are violative of the definition of adulterated and substandard as prescribed in section 3 of the Drugs Act, 1976 and that the petitioners Technical Expert was not provided an opportunity of personal hearing whereas the Chief Executive of the petitioner was not an Expert on this subject, therefore, the reports as mentioned above, and the order dated 5-7-2002 are liable to be set aside. He referred to the cases reported in "Hafiz Khalil v. The State 1996 PCr.LJ 1183 (Peshawar), Provincial Quality Control Board and others v. Irza Pharma and others 1992 M LD 481 (Lahore) in support of his arguments which have been opposed by the learned Deputy Attorney-General who submitted that the reports of the Expert are worth reliance and that the procedure for cancellation was followed strictly as provided in the Drugs Act, 1976 and the rules, therefore, this writ petition be dismissed.
6. It is obvious that the point for examination is as to whether the reports as mentioned above could be made foundation for cancellation of the drug maintained by the petitioner. First of all the report prepared the Central Drug Laboratory, Karachi worth examination to which relevant part "Remarks" is as under:--.
"The sample contains suspended particles which are visible to the naked eye, therefore, it is "substandard and adulterated" as per, Drugs Act, 1976."
And the column of description in the said report was given as under:-- "Colour less solution in transparent vial containing suspended particles visible to the naked eye. "
And in the column of details of result/analysis (with protocol test/analysis the detail was given as under:-- "Test/analysis conducted as per protocols given in BP, 1998."
Details of result of Test or Analysis Test Report No.3-M of 2001
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 (i.e)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.
NomenclatureNorflox-50 Injection Batch No. 447 Date of manufactureMay, 2000 Date of Expiry:Use within 2 years.
Manufacturer:Kakasian Pharma Pvt.Ltd. Lahore.
Description:Light yellow coloured solution in amber colour vial withparticles, 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.
RemarksNorfloxacin 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. "