' SYED RAIDER AL! PIRZADA, J.-This is an appeal from the judgment of the Drug Court given on 13th March, 1980, whereby the learned Drug Court convicted the appellants under section 23(1), (a), (v) read with section 27(4) and sentenced to each of them to pay a fine of Rs, 4,000 each or in default to further undergo simple imprisonment for three months. The male appellants, namely, Muhammad Amin Khan, Ahmed Nini and Sadrul Huda Khan were also to undergo imprisonment till the rising of the Court.
2. The facts of the case briefly are that on 3rd July, 1977 at 11.00 a. In. P. W. No, 1 the Drug Inspector for Queens Road, Saddar and Aram Bagh area inspected the sales depot of Messrs Muller & Phipps (Pak.) Limited on Queens Road, Karachi. One Muhammad Aijaz Khan, Manager, was incharge of the depot at the time of his visit. He found among others drugs at the depot Resydral tablets, batch No, 524, manufactured by Messrs Zafa Pharamaceutieal Laboratories Limited Karachi. He took a sample of this drug. He took four bottles of these tablets which were stocked there and prepared form No, 17 for intimation to the person from whom the sample was taken. The form No, 17 was produced as Exh. 7/1. He then gave one bottle of the tablets to manager and obtained his receipt therefrom. The receipt was produced as Exh. 7/2. On 4th July, 1977, he sent second bottle of the said drug to the Director, Central Drugs Laboratories, Karachi, for examination and report. He received the report dated 10th December, 1977 of that laboratory. The report of the Director indicated that the tablets were of sub-standard as defined in the Drugs Act, 1976. The Inspector enquired from the Director regarding the delay in forwarding the report. The copy of the letter was produced as Exh.
7/4. The report of the Director was produced at Exh. 7/5. According to the reply the delay in finalising the report was due to the late furnishing by the manufacturers their method of testing of the drug in question. He sent copy of the report to Messrs Muller & Phipps (Pak.) Limited. Copy of the letter was produced as Exh. 7/6. He also wrote another letter Exh. 7/7, asking him for the warranty in respect of the drug. Their reply and invoice were produced as Exhs. 7/8 and 7/9. The invoice has a warranty printed on it. After receipt of the invoice and warranty he contracted Messrs Zafa Pharmaceutical Laboratories and forwarded the sample and the report as Exhs. 7/10 and 7/11. The reply of Messrs Zafa Pharmaceutical was produced as Exh. 7/12. He referred the matter to the Provincial Quality Control Board by his letter dated 21st Jaunary, 1978 as Exh. 7/13 for sanction and prosecution of the appellants. The sanction of the Board authorising him to prosecute the appellants is Exh. 7/14. A complaint was lodged by the Inspector of Drugs and the appellants were tried for the offence punishable under section 23(1), (a), (v) read with section 27(4)/7 of the Drugs Act XXXI of 1976. The Inspector of Drugs also sent under the orders of the Drugs Court a sample of the drug to the Federal Laboratory, Islamabad. The report from that laboratory was received by him which was exhibited as Exh. 7/16. The report of the Federal Drugs Laboratory indicated that the tablets were of sub-standard quality.
3. The trial Court framed the charge. The charge was that Resydral tablets, batch No, 524 which were not of standard quality. After taking the evidence in the case the Drugs Court came to the conclusion that the drug is sub-standard and found the charge was made out against the appellants and convicted them as mentioned above.
4. In appeal before us the learned counsel for the appellants Nos. 2 to 4 and the appellant No, 1 raised five contentions. Firstly, they contended that the Director, Central Laboratory, Karachi, did not submit the report Exh. 7/3 within sixty days of the receipt by him as provided under section 22(2) of the said Act. Secondly, they contended that the sample which was sent to the Federal Drugs Laboratory, Islamabad, was not sealed nor bore any mark with distinguishing number and other requisite as required under rule 14, clauses 1, 2 and 3. Thirdly, the tablets tested by the Control Laboratory, Karachi, were of pink colour, whereas the sample that was sent to the Federal Laboratory was of cream colour and as such the two tablets tested at Karachi and Islamabad, were of different materials. Fourthly, Dihydrallazine Sulphate was tested by the Central Laboratory, Karachi, whereas Dihydrallazine only was tested by the Federal Laboratory, Islamabad. The Dihydrallazine Sulphate and Dihydrallazine are two different as one is the base and the other is the product. Fifthly, whether the report was admissible in evidence ?
5. We have heard the learned counsel for the appellants Nos. 2 to 3 and the appellant No, 1 in person as well as the learned counsel for the state at length in this appeal.
6. We will first take up the first contention whether the report as submitted by the Central Laboratory, Karachi, beyond the period rescribed by section 22(2) of the said Act ? We would at this stage uote the relevant words of section 22(2) of the said Act. Section 22(2) ins as follows :- "(1) The Government analyst to whom a sample of any drug has been submitted for test and analysis under subsection (3) of specification 19 shall deliver to the Inspector submitting it a signed report in quadruplicate in the prescribed form and forward one copy thereof to the authority as may be prescribed.
(2) The Government analyst as far as may be, shall submit the report referred to in subsection (1) within sixty days the drug and, if he is not able to do so for reasons to the inspector in writing and shall endorse its copy to the Board concerned who shall have the sample tested from the same or any other analyst or a Government drug testing laboratory or any other laboratory and shall ensure the receipt of result of such test and analysis within a further period as may be prescribed and shall make the test report available to Inspector for further action."
7. Section 22(1) of the said Act provides that the Government Analyst to whom a sample of any drug has been submitted for test and analysis under section 19(3) shall deliver to the Inspector of Drugs a signed report in quadruplicate in the prescribed form. Admittedly, the sample was received by P. W. No, 3 on 4th July, 1977 and the report was received by the Inspector of Drugs on 10th December, 1977, i,e,, after a lapse of 160 days as such it was contended that it had no legal value. It is contended that if the Government Analyst is not able to submit the report within 60 days from the date of receipt of the sample then under rule 16(3) of the Drugs (Federal Inspector)
Federal Drug Laboratory and Federal Government Analysts Rules, 1976, the period can further be extended beyond sixty days. Dr. Zahid Hussain Khan, the Director of Control Drugs Laboratory was examined as prosecution witness No, 3 before the Drugs Court. He deposed that he addressed a letter dated 18th July, 1977 Exhs. 9/1 to the Inspector of Drugs for sending the complete method of testing of the drug. As he did not receive a reply from the Inspector of Drugs, he sent a reminder dated 19th October, 1977 as Exhs. 9/2. A copy of the reminder was enclosed to the warrantors. The warrantors sent the method of testing as Exh. 9/3.
8. Mr. Nabi Raza, learned counsel for the appellants, has contended that the analyst could not have himself extended the further period. The Drug Court observed as follows : "From evidence of Dr. Zahid Hussain, it is clear that within 60 days of the receipt of the sample, he intimated the Drug Inspector, that he will not be able to analyse the drug without the protocols of the testing. The witness is silent, whether he endorsed the copy of his letter to the .Acts quality control board, but under the law all the official acts are presumed to have been correctly done, unless otherwise proved. Therefore, it will be presumed that the quality control board as required under subsection (2) of section 22."
We have perused copies of letter dated 28th July, 1977 and 16th October, 1977 which were exhibited as Exhs 9/land 9/2, respectively. It is clear from both the letters that copies thereof were not endorsed to the Quality Control Board. The burden is on the prosecution to prove that necessary permission of the Quality Control Board for extension of time was obtained. In the absence of any documentary evidence, it cannot be presumed that the copy of the letter was endorsed to the Quality Control Board but the P. W. No, 3 has admitted in cross-examination that he did not send the intimation to the Board that the results could not be obtained within 60 days. Subsection (2) of section 22 of the said Act provides that the analyst shall communicate the reasons to the Inspector in writing and shall endorse its copy to the Board as such the provisions were not complied with.
The delay was on the part of the Inspector of Drugs who kept silent from 28th July, 1977 till 16th October, 1977 as he did not contact the manufacturers or warrantors in this behalf. The Inspector did not communicate about submisston of testing method to the manufacturers. We are of the view that the report shall not be conclusive as provided under section 22(4). In our opinion violation of the provisions of law has been committed by the Drug Analyst in submitting this report without obtaining extension from the Board.
9. As regards the second contention of the learned counsel for the appellants Nos. 2 to 5 regarding the sample which was sent to the Federal Laboratory, Islamabad, was not sealed and did not bear any mark with distinguishing number as required under rules 14(1), (2) and (3) of the Drug Rules.
Rules 14 and 15 run as follows : Section 14. "(1) Samples for test or analysis shall be sent to the officer for the time being incharge of the Federal Laboratory by registered post in a sealed packet, together with memorandum in form No, 5, in case the sample is being sent under subsection (5) of section 22.
(2) The packet, as well as the outer cover, shall be marked with a distinguishing number.
(3) In case of submission of samples under subsection (5) of section 22 a copy of the memorandum in form 5 and specimen impression of the seal used to seal the packet and a sample of the cloth and thread, if used, shall be sent to the officer for the time being incharge of the Federal Laboratory."
Section 15. "On receipt of the packet, it shall be opened by the officer for the time being incharge of the laboratory, a Government analyst or responsible officer authorised in writing by any of them in this behalf who shall record the conditions of the seals on the packet, on the form accompanying sample, and on a register maintained for the purpose."
10. It is pertinent to reproduce the report dated 20th September, 1978 the Exh. 7/6.
"Certificate of test or Analysts by the Drugs Control and Research Division, National Health Laboratories, Islamabad.
' Certified that the sample (a) bearing number nil, purporting to be a sample of Resydral tablets received on 28th June, 1978 with memorandum S.
0. (DC) 1-38/78-Drugs Controller, Karachi, dated 24th June, 1978 from Drugs Controller, Karachi.
' Case No, 15 of 1978 dated 17th June, 1977 has been tested/analysed and the result of such test/analysis is stated below : Dihydrallazine : {{TABLE TEXT}} Stated Found Limited Percentage 10 mg/tab.
5.58 mg/tab. 9 mg to 11 mg/tab.
55.9% 'Does not comply with the specifications provided by the manufacturer.
' The condition of the sample of the packet. On receipt was as follows : Satisfactory : ' In the opinion of the undersigned the sample is not/is adulterated/ sub- standard/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 : Zara 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% ' 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 Islamabad, slamabad, 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 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 D 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 obervance 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. 7/18 which shows that the Dibydrallazine 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 pursuaded 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 F 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 conditions 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 possibility of the deterioration of the drugs due due to weather conditions after obtaining of the drug by the Drug Inspector.
19. For these feasot3s 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.