' This is an appeal from the judgment of the Drug Court given on 28-1-1982 whereby the learned Drug Court convicted the appellant under S. 27(2)(6) of the Drugs Act, 1976, sentenced each of them to undergo imprisonment till rising of the court and to pay a fine of Rs,5,000 each or in default to further undergo rigorous imprisonment for two months, and also sentenced each of them to undergo imprisonment till the rising of court and to pay fine Rs,5,000 each or in default to further undergo R.I. Two months under 27(4) of the said Act.
2. The facts of the case briefly are that on 12-1-1980 P.W. No,1, the Drug Inspector, Hyderabad, when he visited the shop of M/s. Pak Traders Hyderabad he took four bottles as sample of drug namely Gonapan suspension Batch No,02068 labelled as manufactured by M/s. Reko Pharmacol Ltd., Lahore. He took four bottles of the drug 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. He then gave one bottle of the drug to the shopkeeper and obtained his receipt therefrom. The receipt was produced as Exh.
8. On 13-1-1980 he sent second bottle of the said drug to the Director, Central Drugs Laboratory, Karachi for examination and report as Exh.
18. He received the report dated 6-4-1980 of that laboratory. The report was produced as Exh.
22. The report of the Director of Central Drugs Laboratory indicated that the suspension was substandard as defined in the Drugs Act, 1976. He sent copy of the report to Messrs Reko Pharmacol Limited which was produced as Exh.23. The appellants challenged the report of the Central Drugs Laboratory and, therefore, the Provincial Quality Control Board sent another sample of the drug to National Health Laboratories, Government of Pakistan, Islamabad who sent their report (Exh .26) which indicated that the drug was substandard in respect of its poor physical condition "which may be due to improper storage". The Drug Inspector referred the matter to the Provincial Quality Control Board by his letter dated 26-4-1980 as Exh.24 for sanction and prosecution of the appellants. The Drug Inspector issued a show-cause notice, dated 25-5-1980 to Messrs Reko Pharmacol Ltd. And copy thereof was produced as Exh.25. The sanction of the Board authorising him to prosecute the appellant is Exh.27. A complaint was lodged by Inspector of Drugs and the appellants were tried for the offence punishable under sections 23(1)(a)(v) and (x) read with sections 27(2)06) and (4) of the Drug Act XXXI of 1976.
3. The trial court framed the charge. The charge was that Gonapan suspension, batch No,02068 was not of'standard quality. After taking the evidence in the case the Drug Court came to the conclusion that the drug was substandard and found charge was made out against the appellants and convicted them as mentioned above.
4. In appeal before us the learned counsel for the appellants raised several contentions. Firstly, he contended that the Director, Central Drugs Laboratorty, 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, he contended that the report Exh. 26 which was sent by the National Health Laboratories, Islamabad, was not submitted in the prescribed form 6 and other requisites as required under rule 16 were not followed. Thirdly, the suspension tested by the National Health Laboratories, was inadmissible in evidence on account of passage of time, the sample having deteriorated due to adverse climatic condition.
5. We have heard the learned counsel for the appellants 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 of the Central Laboratory, Karachi was submitted beyond the period prescribed by section 22(2) of the said Act. We would at this stage quote the relevant words of section 22(2) of the said Act. Section 22(2) runs as follows:- "The Government analyst to whom a sample of any drug has been submitted for test and analysis under subsection (3) of section 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 of the receipt by him of the sample of the drug and, if he is not able to do so for reasons beyond his control shall communicate the 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 the result of such test and analysis within a further period as may be prescribed and shall make the test report available to the Inspector for further action."
7. S. 22(1) of the said Act provides that the Government Analyst to whom a sample of the drug has been submitted for test and analysis under S.19(3) shall deliver to the Inspector of Drugs a signed report in quadruplicate in the prescribed form. Admittedly, the sample was received by the Inspector of Drugs on 6-4-1980 i,e, after lapse of 75 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 Analysis) Rules, 1976, the period can further extended beyond sixty days. In the instant case the Director of Central Drugs Laboratory tested the drug and the report was sent on 6-4-1980.
8. A.R. Akhtar, learned counsel for the appellants, has contended that the analyst could not have himself extended the period further. 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 necessary permission was obtained from the Quality Control Board.
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 and in the instant case this has not been done as such the provisions were not complied with. In the circumstances, 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 his report beyond the prescribed period without obtaining extension from the Board.
9. As regards the second contention of the learned counsel for the appellants regarding the report of the National Health Laboratories, Islamabad, it is pertinent to reproduce rules 15 and 16 of the relevant Drug Rules and form 6.
' Rules 15 and 16 run as follows:- ' Rule 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 a reasonable 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."
' Rules 16:- "Report of result of test of analysis--
(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) 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."
' Form No,6 runs as under:-Form No,6 (See rule 16).
' CERTIFICATE OF TEST OR ANALYSIS BY THE FEDERAL DRUGS LABORATORY/GOVERNMENT ANALYST.
' Certified that the samples, bearing number....Purporting to be a sample of .... Received on with memorandum No,...Dated.... From.... Has been tested/analysed and that the result of such test/analysis is as stated below:
2. The condition of the seal on the packet on was as follows: ' In the opinion of undersigned the sample is not/is adulterated/ substandard/misbranded/soureion, as defined in Drugs Act, 1976, for the reason given below:- ' Director, Federal-I Drugs Laboratory or other authorised officer Director/Government Analyst.
' Details of results of the test or analysis: (with protocols of test applied).
' Director, Federal Drugs Laboratory of other authorised officer/ Government Analyst"
We have seen the original report in this case. It is not in the prescribed form. Rules 15 and 16 have also not been complied with.
10. The words of sections 19(2) and 22(2) and (4) and rules 14(1), (2) and (3) and 15 and 16 and Form 6 of the Drugs (Federal Inspector, Federal Drug Laboratory or Federal Government Analyst) Rules, 1976 require that the provisions of the said Act and Rules should be observed with complete strictness and where the dispatch of the samples and submission of the report are not in accordance with the legal provisions the appellants cannot be convicted on such report. Where statutory powers are conferred and specific provisions are made in the statute as to the manner in which the powers are to be exercised, they should be exercised by the authority strictly in the manner specified in the statute. In this case the provisions of rule 14 and section 22(9) expressly required the inspection 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 Gonapan suspension and the laboratory concerned after testing the drug was required to submit the report in the prescribed form No,6 to the Drug Inspector. We are of the opinion that the directions contained in section 19(2) and rules 15 and 16 and also from No,6 in regard to making and submission of the test reports are not directory but are mandatory and the Drug Court could not convict the appellants as it had not been established that the sample which was collected on 13-1-1980 from M/s. Pak Traders Hyderabad Limited and sent to the Federal Laboratory, Islamabad, and found by the Analyst to be substandard was in fact the very sample alleged to have been taken from the said shop. The importance of the strict observance in regard to the submission of the report in the prescribed manner is emphasised in the form.
11. The other contention of the appellants is whether the report of National Health Laboratories (Exh.
26) was admissible in evidence to prove that the Gonapen Suspension manufactured by Messrs Reko Pharmacol Ltd. Lahore is substandard. According to Exh. 26 the sample tested is substandard for the reason that "suspension has become semisolid probably due to dehydration of the sample with the result it does not come out of the bottle. Due to this condition of the sample the potency and PH could not be tested. "Then the conclusion is that "the sample is of substandard quality in respect of its poor physical condition which may be due to improper storage."
' The learned counsel for the appellants contended that the drug was purchased by Khalid Brothers from Messrs Reko Pharmacology Ltd. On 16-12-1978 as per invoice No,132 dated 16-12-1980. Messrs Reko Pharmacol Ltd. Were not satisfied with the report Exh.22 of the Central Drug Laboratory Karachi as such a sample of the drug was sent for retesting and report to the National Health Laboratories, Islamabad as provided by subsection (2) of section 22 of the Drugs Act. The said sample was retested. As noted the said report has been produced as Exh.26 which shows that the Drug is of substandard quality in respect of its poor physical condition which may be due to improper storage. It was argued on behalf of the appellants that it was specifically stated on the carton of drug in question that it should be "kept in cool and dry place". The instructions regarding the protection of the drug from heat and exposure to light are conspicuously printed on the carton of the drug and which 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 drug had been purchased from Reko Pharmacol Ltd. It was kept for about 1/ years in the shop.
The Inspector took the sample bottles from the shelf in the shop. It is not clear from the record that after the purchasing of the drug from the manufacturers whether it was stored under the conditions laid down by the B.P. Or as stated on the carton, or under adverse conditions, which could have slightly affected the potency of the drug resulting in E the drug becoming semi-solid probably due to deydration of the sample with the result it could not come out of the bottle. We have been pursuaded to this view only by reason of the fact that according to the report of National Health Laboratories, the drug could not be tested and it was substandard probably due to improper storage.
We are of the opinion that there is a reasonable possibility of the sample, which was obtained by the Drug Inspector and subsequently sent to the National Health Laboratories, having deteriorated due to its improper storage after the drug had been purchased from Reko Pharmacal F Ltd. And in the circumstance the appellants are entitled to the benefit of doubt. We may state that even the learned State counsel conceded that there was a possibility of the deterioration of the drug due to weather conditions after purchasing the drug from the manufacturers.
12. As a result, Criminal Appeal No,45 of 1982 is allowed and the conviction and sentence of the appellants by the Drug Court are set aside. The fine, if recovered from the appellants, is ordered to be refunded to the appellants. revisions by the competent authorities. Therefore, it is advisable to consult the official sources or legal professionals for the most up-to-date and accurate information.