Shifa Laboratories Pvt. Ltd Through Muhammad Younas Malik vs Gop etc.

Stereo. HCJDA 38.

Judgment Sheet.

IN THE LAHORE HIGH COURT LAHORE.

JUDICIAL DEPARTMENT

Writ Petition No. 25589 of 2013.

Shifa Laboratories (Private) Limited.

Versus Govt. of the Punjab etc.

Judgment.

Date of Hearing 20.11.2013._____________ ___ Petitioner by Sh. Muhammad Nawaz Advocate. ___ Respondents by Mr. Kashif Javed Chaudhary, Advocate.

Rana Shamshad Khan, Assistant Advocate General Punjab alongwith Mauzzam Ali Khan, Secretary Provincial Quality Control Board, Health Department Govt. of Punjab.__ Jamil Anwar, Director Drug Testing Laboratories Lahore and Miss. Sajida Parveen Govt. Analyst DLT, respondent No.8.

Abid Aziz Sheikh J:- Through this Constitutional petition the petitioner has challenged the proceeding initiated by the respondents based upon test reports dated 01.06.2013 and 11.06.2013 by respondent No.8 and test report dated 30.08.2013 signed by respondent No.9, (whereby the Drug Paracetamol Tablet, supplied by the petitioner is found to be sub-standard), to be declared unlawful and unconstitutional. The petitioner is also seeking a direction against the respondents for the payment of the agreed amount of the drugs received by the respondents, under the contract between the parties.

2.The brief facts necessary for the adjudication of this case are that the petitioner company deals with the manufacturing of pharmaceutical under a licence granted by

the Central Licensing Board and Registration for the manufacturing of registered Drugs issued by the Drugs Registration Board Ministry of Health, Government of Pakistan, as existed at that time and now under the Drugs Regulatory Authority of Pakistan the petitioner company alongwith other registered Drugs is also manufacturing Paracetamol Tablets 500 mg. For the purchase of Paracetamol Tablets tenders were invited by the respondents No.2 and 3 on behalf of respondent No.1. The petitioner participated in the tender process and being successful bidder his offer for supply of 9965000 Paracetamol Tablets 500 mg at the rate of Rs.0.39 per tablet was accepted and the purchase order was issued to the petitioner for the total value of Rs.3886350/-. The petitioner manufactured and supplied the entire items of Paracetamol Tablets to respondent No.4 and request was made for the payment, however, the petitioner was informed that according to the test report dated 01.06.2013 and 11.06.2013 by respondent No.8 the drugs samples were found substandard. The petitioner also received a notice dated 15.06.2013 for the replacement of drugs / Paracetamol Tablets being sub-standard. The petitioner submitted his reply on 06.08.2013 and requested for re-test of the drugs / Paracetamol Tablets under section 22 (5) of the Drugs Act, 1976 from the National Institution of Health, Islamabad (NIH). On the request of the petitioner matter was referred to NIH Islamabad, who gave its report dated 30.08.2013 and concluded that the sample is of sub- standard quality on the basis of the tests performed. Thereafter the petitioner again received a notice dated 12.09.2013 for the replacement of substandard Paracetamol Tablets. The petitioner being aggrieved filed this Constitutional petition challenging the impugned test reports

dated 01.06.2013, 11.06.2013 by respondent No.8 and 30.08.2013 by respondent No.9.

3.The learned counsel for the petitioner argued that the test report prepared by respondent No.8 is illegal and without jurisdiction, as “friability test” is not applicable to Paracetamol Tablets. Further submits that as per Section 3 Sub Clause-Z the specification provided in British pharmacopoeia is to be followed and in the said specification “friability test” is not applicable to Paracetamole Tablets, as the same are not in loose packing but in blister packing. Further submits that respondent No.8 was neither duly notified nor she has been appointed for specific area and specific drugs as required under section 16 of the Drugs Act, 1976, therefore, the test conducted by respondent No.8 is without lawful authority. Reliance is placed on the cases reported as Salim Siddiqui Versus The State (1987 SCMR 2100), Provincial Quality Control Board and others Versus Irza Pharma and others (1992 MLD 481), Drug Inspector Versus F.A. Zuberi and others (NLR 1989 TD 378) and the judgment dated 13.05.2002 passed in Civil Revision No.666 of 1989. The learned counsel for the petitioner contends that even the test carried on by respondent No.9 is violative of section 22 (5) of the Drugs Act, 1976.

4.Conversely, the learned A.A.G raised a preliminary objection that under section 19 Sub Section (6) of the Drugs Act, 1976, the petitioner has an alternative remedy before the Provincial Quality Control Board which will also provide an opportunity of defence and personal hearing to the petitioner before deciding the subject case. The learned counsel for the respondent adds that as per the contract between the parties

the drugs / Paracetamol Tablets of the petitioner were to be tested for the purpose of quality control, accordingly on 23.5.2013, the Drug Inspector took 5 samples from 4 Batches of Paracetamol Tablets for test/analysis and all those samples were declared sub standard. On the request of the petitioner the drug samples were sent to the Laboratory of National Institution of Health, Islamabad under section 22 (5) of the Drugs Act, 1976 and again out of 5, 4 samples were declared sub-standard. Further contends that respondent No.8 is duly notified under section 16 of the Drugs Act, 1976 and lawfully issued her report under section 22 (1) and (2) of the Drugs Act, 1976. Contends that as the drug is sub standard, the petitioner is bound to replace the sub-standard drugs supplied. Adds that as per British pharmacopoeia the friability test is applicable to Paracetamol Tablets. Further contends that the issue raised in this petition relates to a factual controversy and enforcement of contractual obligation, for which this Constitutional petition is not maintainable.

5.I have given my anxious consideration to the arguments of the learned counsel for the parties and have gone through the record, appended herewith.

6.It is an admitted position between the parties that the petitioner was awarded a contract for supply of 9965000 Paracetamol Tablets and as per the terms and conditions of the contract as well as the provisions of Drugs Act, 1976 the respondents are bound to carry out a test/analysis to find out, whether the drug is according to the specification or the same is sub-standard. According to the record on 23.05.2013 Provincial Inspector of Drugs took 5 samples having 4 Batches of Paracetamol Tablets 500 m.g supplied by the

petitioner. The said Batches No. 43, 44, 45 and 46 were taken from the premises of Government Medical Store Depott. Lahore. The said samples were analyzed by the Government Analyst Punjab and according to the report of test/analysis by Government Analyst Punjab dated 01.06.2013 and 11.06.2013 all those 5 samples were found sub-standard. On the request of the petitioner itself, the drug samples were sent to the National Institution of Health, Islamabad (NIH), under section 22 (5) of the Drugs Act, 1976 and according to the certificate of test/analysis by the Drug Control and Traditional Medicines Division, National Institution of Health, Islamabad (NIH), dated 30.08.2013, out of those 5 samples 4were found of sub-standard quality on the basis of test performed.

7.As per provisions of section 22 (1) and (2) of the Drugs Act, 1976, the Government Analyst could carry out the test, where as under section 22 (5) of the Drugs Act, 1976, the NIH being the Federal Drug Laboratory, its report is a conclusive evidence and sitting in Constitutional jurisdiction I have no reason to disagree or substitute with the report of the Testing Laboratory in Punjab or NIH, Islamabad, who are the expert statutory authorities in this matter. The only question, which can be looked into in Constitutional jurisdiction is whether the said authority or person appointed there under, were legally competent and the law has been followed in carrying out the aforesaid tests. The case of the petitioner is that “friability test” is not applicable to Paracetamol Tablets. This question can be determined by going through the relevant legal provisions on the subject. Under section 3 (z) of the Drugs Act, 1976 the specification when applied to a drug means such specification as may be prescribed or when the specification

are not prescribed, the specification as contained in the most recent edition of any of the publication mentioned therein including the British pharmacopoeia will apply. For ready reference the provisions of Section 3 (z) ibid are reproduced hereunder:-

(z)“specifications” when applied to a drug mean--

(i)such specifications as may be prescribed; or

(ii)when the specifications are not prescribed, the specifications as contained in the most recent edition of any of the following publications, namely :---

(1)the Pakistan Pharmacopoeia;

(2)the International pharmacopoeia ;

(3)The European pharmacopoeia ;

(4)The United States pharmacopoeia

(5)The British pharmacopoeia ;

(6)The British pharmacopoeia Codex;

(7)The United States National Formulary; and (8) Such other publication as may be prescribed: Provided that, if the specifications do not appear in the most recent edition of any such publication, the specifications, appearing in the next preceding edition of such publication in which the specifications appear shall apply; or 8. It is an admitted position between the parties that no specification of Paracetamol Tablets has been prescribed, therefore, the specification provided in British pharmacopoeia is applicable. According to British pharmacopoeia placed on record by both the parties, several categories of tablets for oral use, may be distinguished as under:- uncoated tablets;

coated tablets;

effervescent tablets;

soluble tablets;

dispersible tablets;

orodispersible tablets;

gastro resistant tablets;

modified release tablets;

tablets for under section in the month;

oral lyophillistes

9.The production process of the aforesaid tablets provided in the British pharmacopoeia also prescribe a “friability test” of unquoted tablets. The relevant portion of British pharmacopoeia is reproduced hereunder:-

PRODUCTION.

Tablets are usually prepared by compressing uniform volumes of particles aggregates produced by granulation methods. In the manufacture of tablets, means are taken to ensure that they possess a suitable mechanical strength to avoid crumbling or breaking on handling or subsequent processing. This may be demonstrated using the tests described in chapters 2.9.7. Friability of uncoated tablets and 2.9.8. Resistance to crushing of tablets. Chewable tablets are prepared to ensure that they are easily crushed by chewing.

(underlining is by me to add emphasis)

It is an admitted position which is also described in test report that Paracetamol Tablet is a white uncoated Tablet. As per production formula in British pharmacopoeia ibid, the “Friability test” is applicable to uncoated tablets. The arguments of the petitioner that no “friability test” is prescribed in British pharmacopoeia for Paracetamol Tablets and same is not applicable to Paracetamol being in blister packing is contrary to the aforesaid contents of British pharmacopoeia wherein beside tests in Chapter 2.9.7 and 2.9.8 for uncoated tablets a “friability test” may be carried out.

10.The next arguments of the learned counsel for the petitioner that respondent No.8 is not notified, and therefore, had no jurisdiction to carry out the test, is also contrary to the record. According to the record respondent No.8 was duly notified by Govt. of the Punjab through a Notification dated

17.07.2012 under section 16 of the Drugs Act, 1976. The said notification was also gazetted in Punjab Weekly Gazette dated 18.07.2012. According to said notification the respondent No.2 has been given jurisdiction for Lahore and Sahiwal Division and for the purpose of test/analysis of samples and the Classes of drugs number 1, 2, 3, 4 and 5 of the Drugs (specifications) Rules 1978 framed under Drugs Act, 1976 has been specified in the said notification. Therefore, it cannot be said that the notification of respondent No.8 is violative of section 16 of the Drugs Act, 1976. All the case law relied upon by the petitioner relates to cases where Notification was either not notified or gazatted or it was in violation of section 16 of the Drugs Act, 1976, which defect is not found in notification dated 17.07.2012, therefore, the case law relied upon by the petitioner are not applicable to the facts and circumstances of this case. Further the test by NIH Islamabad was also carried out on the request of the petitioner itself hence the petitioner is estopped to challenge the same and it cannot be said that test was not valid. In any case under section 22 (5) of the Drugs Act, 1976, the NIH Islamabad is competent to carry out test and its report is a conclusive evidence.

11.The factual controversy whether the drug was according to the specification or it was sub-standard cannot be resolved in this Constitutional jurisdiction. This issue can only be resolved by the Expert / Competent Authority under the law who have already given their finding. As per clause 19 (6) of the Drugs Act, 1976 if the Provincial Inspector, find any contravention of the Act, he will refer the case to Provincial Quality Control Board to obtain orders. It is expedient to reproduce Section 19(6) of the Drugs Act, 1976, as under:-

(6)The Provincial Inspector on finding any contravention of this Act shall, unless the Board otherwise directs, always refer the case to the Provincial Quality Control Board and seek orders as to the action to be taken in respect of such contravention.

In view of the above provisions, if the petitioner has any grievance in the matter, regarding quality of his drug, he will have an opportunity to present his case before the Provincial Quality Control Board under section 19(6) ibid. In report and parawise comments the respondents have also admitted that petitioner can agitate his grievance before the Provincial Quality Control Board.

12 Further in view of the dispute on the quality of drug, direction from this Court to the respondents to release the payment of the petitioner cannot be issued which otherwise is an enforcement of contractual obligation. It is settled law that contractual obligation cannot be enforced through Constitutional jurisdiction and for the recovery of amount, the petitioner has other remedies available under the law.

13.In view of the above discussion, I find no merit and substance in this writ petition and the same is dismissed, with no order as to costs.

(Abid Aziz Sheikh) Judge.

Approved for reporting.

Judge.

M.Ashraf.