1984 P Cr (PLP)

In the opinion of the undersigned the sample is not/is adulterated/ substandard/misbranded/superiors, as defined in the Drugs Act, 1976 for the reasons given below: Dihydrallazine 55.9%. The sample is of sub‑standard quality. (Sd.) Illegible 20th September, 1978 Chief Drugs Control and Research Division, National Health Laboratories (or) other authorised officer/Govt. Analyst. Details of results of test or analysis: (With protocols of test applied). Test report No. 012/78. Nomenclature: Resydral tablets. Batch No.

525. Date of manufacture: Nil. Manufacturer: Zafa Pharmaceutical Laboratories Ltd., Karachi. Description: Cream coloured uncoated tablets with mark "ZAFA" on one side and disectional line on the other side. Identification: Dihydrallazine identified. Disintegration time: Determined 3 minutes, limit max. 15 minutes, complied with the B.P. 1973. Wt. variation: Complies with B. P.

73. Assay: Dihydrallazine: Stated Found Limit Percentage 10 mg/tab. 5.59 mg/tab. 9 mg to 11 mg/tab. 55.9 /a Does not comply with the specifications provided by the manufacturer. Conclusion: The sample is of sub‑standard quality in respect of tests performed. (Sd.) Illegible 20th August, 1978 Chief Control & Research Division, National Health Laboratories (or) other authorised officer/Govt. Analyst."

11. We have seen the original form No. 6 and in first line it is mentioned "certified that the sample (a) bearing number nil." In the report it has been mentioned that Dihydrallazine tablets did not comply with the specifications provided by the manufacturers. In the opinion of the analyst the sample is sub‑standard as defined in the Drugs Act 1976 for the reasons "Dihydrallazine 55.9% against the limit prescribed by the manufacturer which is 90% to 110%. The colour of tablet was cream whereas the description given by the Central Laboratory was light pink and the result of test was "Dihydrallazine Sulphate 147.9%" instead of 90% to 110%. It is not clear from the report whether the Federal Laboratory, Islamabad, tested and analysed "Dihydrallazine or "Dihydrallazine Sulphate". It is pertinent to note that no protocols were provided with the report. It is contended by the appellants that tablets can fade but pink colour of tablets cannot change to cream. Section 19(2) provides that the Inspector shall effectively seal and suitably mark the sample. In the Central Laboratory report "sample number S. 829" which in the report of the Federal Laboratory sample "number is shown nil". This shows that the Inspector had not marked all the samples with "S. 829." The Inspector of Drugs admitted in his cross‑examination that he marked all the four samples. We are of the opinion that the sample which was sent to the Federal Laboratory was not probably the sample which was sealed and marked by him on 3rd July, 1977. We are further of the opinion that the Federal Laboratory tested and analysed Dihydrallazine tablets only instead of testing and B analysing "Dihydrallazine Sulphate" tablets. The findings of the learned trial Court that the number written on the sample might have become "dim" or "illegible" in these 12 months cannot be ruled as not in accordance with the law. The appellants cannot be convicted on mere presumptions.

12. The words of sections 19(2), 22(2) and (4) and rules 13(1), (2) and 15 of the Drugs (Federal Inspector, Federal Drug Laboratory or Federal Government Analysis) Rules, 1976 are plain and imperative and it is essential that the provisions of the said Act and rules should be observed with complete strictness and where the despatch of the samples, submission of the report are not in accordance with the provisions, the appellants cannot be prosecuted and are not to be convicted on such report where statutory powers are conferred and specific provision is made in the statute as the manner in which the powers are to be exercised, they should be exercised by the authority and in the manner specified in the statute and in strict conformity with the provisions thereof. In this case the provisions of clauses 1, 2 and 3 of rule 14 and section 19(2) expressly authorise the Inspector to collect 4 bottles of the samples and to seal and suitably mark the same and despatch to the Central Laboratory or the Federal Laboratory for testing and analysing the tablets and in our opinion the sample which was despatched to the Federal Laboratory was not the same. We are of the opinion that the direction contained in section 19(2) and rules 14 and 15 in regard to marking of the samples is not directory but is mandatory and in the absence of "nil mark" the o Drug Court cannot convict the appellants that the sample which was collected on 3rd July, 1977 from Messrs Muller & Phipps (Pak.) Limited, sent to the Federal Laboratory, Islamabad, and found by the Analyst to be sub‑standard was in fact the very sample alleged to have been taken from the said depot. The importance of the strict observance in regard to the marking of the sample is emphasized in the form.

13. The fifth contention of the appellants is whether the report was admissible in evidence to prove that the tablets manufactured by Messrs Zafa Pharmaceutical Laboratory are sub‑standard. Subsection (4) of section 22 of the Act states that the report of the Analyst shall be admissible as evidence of the facts stated therein and such evidence shall be conclusive unless the accused person adduced evidence to the contrary in the manner laid down in it. The report has, however, to be in the form prescribed before it can be admissible in evidence. The contention of the appellants is that the report was not admissible in evidence. The contention was not accepted by the learned Drugs Court. Rule 16 of the Act runs as under "(1) After test of analysis the result thereof together with full protocols of the test applied, shall be supplied forthwith to the sender in form 6. (2) The Government Analyst shall, for the purpose of subsection (1) of section 22 forward a copy of the report to the registration board in the case of a registered drug and to the Central Licensing Board in all other cases. (3) For the purpose of subsection (2) of section 22, the further period within which the report should be made available to the Inspector shall be sixty days."

14. Rule 16 provides that after test of analysis the result thereof together with full protocols of the test applied shall be supplied forthwith to the Inspector in form

6. It appears that the Inspector, who obtained samples from the depot of Messrs Muller & Phipps (Pak.) Limited, duly forwarded samples to the Central Laboratory, Karachi, on 4th July, 1977 and also to the Federal Laboratory, Islamabad, on 18th June, 1978. Now, the reports of the Analysts did not state the protocols of tests. It is said that rule 16 on form 6 indicated that the protocols of test applied had to be stated in the report. The contention is that in the absence of the protocols the reports were not in the prescribed form and were hence not admissible in evidence. It appears that protocols of test means the details of the process of tests. On 4th July, 1977 the Inspector sent second bottle of the said drug to the Director, Central Drug Laboratory, Karachi, for examination and report and also under the orders of the Drugs Court a‑ sample of the drug to the Federal Drugs Laboratory, Islamabad.

15. The Inspector on his letter to the Analyst no doubt stated that the samples were sent to him for examination and report. The Analyst performed test and found that the sample is not of standard quality with regard to the tests performed as per Exh. 7/3. The Analyst of the Federal Laboratory, Islamabad, also performed tests and the last line of Exh. 7/16 reads as under "Conclusion.‑

The sample is of sub‑standard quality in respect of test performed."

16. Now, in the present case the reports gave the results of the tests. The reports did not give the results of analysis. The reports stated that in the case of Central Laboratory it is " 147.9%" while in the report of Federal Laboratory Dihydrallazine is 55.9%". That being so in our view the reports are not in the prescribed forms and not admissible in evidence and no reliance can be placed on them.

17. The learned counsel for the appellants Nos. 2 to 4 contended that the drug was purchased by Messrs Muller & Phipps (Pakistan) Limited from Messrs ZAFA Pharmaceutical Laboratories Limited on 19th October, 1976 which produced the invoice No. A/MP/977 and the warranty dated 19th October, 1976. The Drugs Inspector took the sample on 3rd July, 1977. Messrs Zafa Pharmaceutical Laboratories Limited were not satisfied with the report Exh. 1‑7/10 of the Central Drug Laboratory, Karachi, as such a sample of the drug was sent for re‑testing and report to the National Health Laboratories, Islamabad on 24th June, 1978 as provided by subsection (2) of section 22 of the Drugs Act. The said sample was received on 28th June, 1978 and it was re‑tested on 20th August, 1978. The said report has been produced as Exh. 7118 which shows that the Dihydrallazine is 55.9%.

18. It was argued on behalf of the appellants that it was specifically stated on the carton of drug in question that it should be protected from "heat, light and moisture". The instructions regarding the protection of the drug "from heat, light and moisture" are conspicuously printed on the carton of the drug indicate that there could be a slight fall in the potency of the drug if the drug is kept in an excessively hot place or in a place which is exposed to light. After the sample the drug was taken, it was kept for about 11 months in the office of the Provincial Quality Control Board. It is not clear from the record that after taking of the sample by the Drugs Inspector it was stored not under the conditions laid down by the B. P. or as stated on the carton but under adverse conditions, which we consider could have slightly affected the potency of the drug and, therefore, resulted in the drug not having Dihydrallazine contents as required by B. P. We have been persuaded to this view only by reason of the fact that according to the report of National Health Laboratories, found 55.9 mg/tablets as against stated 10 mg/tablets. We may add that a sample of the said drug, having the same batch number was tested by Messrs Zafa Pharmaceutical Laboratories Limited and found that the product is of standard quality. The letter was produced by the Drugs Inspector as Exh. 7/2. The fact that one sample of the same batch was found to conform to the standard suggest to us that the samples of the same which have not conformed to the standard laid down had probably been subjected to adverse climatic conditions. The potency and state of certain drugs, thus, appear to some extent to depend upon the condi tions in which the drug is required to be stored and has actually been stored prior to the test by concerned laboratories. Since we are of the opinion that there is a reasonable possibility of the sample which was obtained by the Drugs Inspector and subsequently, sent to the National Health Laboratories having deteriorated after the acquisition of the same we give the benefit of doubt to the appellants and acquit all of them. We may state that even the learned State counsel conceded that there was u possibility of the deterioration of the drugs due to weather conditions after obtaining of the drug by the Drug Inspector.

19. For these reasons by a short order dated March, 1984 the appeal was allowed and the appellants were "acquitted. The fine, if recovered, be refunded to the appellants. M. Y. H. Appeal allowed.