1985 P Cr (PLP)

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 circum stances, 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

4. 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 l6:‑ "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 despatch 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 Drue 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 infact 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 semi solid 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 Pharmacol 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 1j 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 deyhration 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 o 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 Ltd. and in the circumstance the appellants are entitled to the benefit of doubt. We may state that even the learned State counsel concede 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. M. Y. H. Appeal allowed.