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Cases Nos. 2 and 3 of 1978, heard on 7th November, 1978.

------S. 23(1) (a) (v)--Benefit of doubt--Complaint against accused for manufacturing for sale substandard Ampicillin Dry Syrup containing 89% Ampicillin against U. S. P. limits of 90% to 120% and thus violating provisions of Drugs Act-Accused, however, explaining carton of drug containing instructions for its keeping in a cool and dark place and as per WHO pamphlet loss of activity of international standard if drug stored at temperature less than 20 C and such requirements having not been fulfilled, there appeared a slight discrepancy in quantum of active agent Ampicillin according to B. P. to be in a well closed container at a temperature mot exceeding 25 C but climatic conditions in Pakistan ranging from 30 C to 40 C-Drug after purchase remain ing in normal temperature and possibility of deficiency in contents as required by B. P. existing-Accused given benefit of doubt and acquitted, in circumstances.-[Benefit of doubts.

Munawwar Malik, Special Prosecutor for the Complainant.

N. K. Jatoi for Respondents Nos. 1 and 2.

Date of hearing: 7th November, 1978.

The accused named, above, who are respectively the Managing Director, the Chief Chemist and Quality Control Incharge of Schazoo Laboratories Limited, Lahore, were charged with manufacturing for the purposes of sale a drug, namely. Ampicillin Dry Syrup, which has been found to be substandard for the purposes of the Drugs Act, 1976. However, during the course of the trial, it transpired that the manufacture of the drug in question took place at Lahore, outside the jurisdiction of this Court, though the sale of the drug to the Distributors of Shazoo Laboratories, Ltd., took place at Karachi. Accordingly, the charge against the accused was amended and they were charged for selling the sub-standard drug, namely, Ampicillin Dry Syrup, in contravention of the provisions of sub-clause (v) of clause (a) of subsection (1) of section 23 of the Drugs Act, 1976. To this amended charge, like the original charge, the accused have pleaded not guilty.

2. The prosecution case, shortly stated, is that on 1-6-1977, Drug Inspector Ghulam Rasool Halepota, took a sample of Ampicillin Dry Syrup, batch No. ACS-14, manufactured by Schazoo Laboratories, Lahore, from Qamar Medical Store, in P. I. B. Colony, Karachi. The sample, which consisted of 4 bottles of the syrup, was taken in accordance with the provisions of sections 18 and 19 of the Drugs Act. One portion of the sample was sent to the Central Drugs Laboratories, Karachi, whose report is to the effect that it was sub-standard and did not comply with the B. P. standard. It may be pointed out that according to U. S. Pharamacopoea, 18th Revised Edition, the drug must contain 90 to 120% of the active agent, Ampicillin.

3. Since the drug was found to be sub-standard by the Central Drugs Laboratory, the Drug Inspector contacted Qamaruzzaman, the Proprietor of Qamar Medical Stole, who produced an invoice and a warranty, showing that he had purchased the :aid drug from National Agencies: on 19-5-1977, that is some 11 days before the sample of this drug was purchased by the Drug Inspector. The Drug Inspector next contended National Agencies which produced the invoice and the warranty, dated 16-5-1977, from Pharmasales International, the Distributors of Schazoo Laboratories at Karachi. It is, however, not clear whether National Agencies sold the drug in question to Qamar Medical Store from this consignment or the earlier consignment obtained by it from Pharmasales in February 1977, as according to Ahmed Abdul Ghaffar, the partner of National Agencies, no record is maintained with them to show from what consignment any particular goods are sold to any individual seller. Furthermore, he conceded that in the presence of old stock from previous consignments, they still acquire new consign ments so as not to be out of stock of the products in which they trade. The Drug Inspector also contacted Pharmasales which produced invoice and warranty, dated 18-2-1977, from the Schazoo Laboratories, regarding sale of the drug in question.

4. The Drug Inspector reported the matter to the Provincial Quality Control Board and after obtaining its sanction filed a complaint against the accused.

5. At the trial, the prosecution have examined Drug Inspector, Ghulam Rasool Halepota; P. W. Qamaruzzaman, the proprietor of Qamar Medical Stores; Ahmed Abdul Ghaffar, partner of National Agencies and Muhammad Ishaque, Branch Manager of Pharamasales. All of them have supported the prosecution case. It may be pointed out that as the accused were not satisfied with the report of the Central Drug Laboratory, Karachi, a sample of the drug was sent for re-testing and report to the National Health Laboratories, Islamabad, as provided by subsection (2) of section 22 of the Drugs Act. The said report has been produced by the Drug Inspector which also shows that the Ampicillin contents of the drug was 89% as against U. S. P. limits of 90 to 120%.

6. The accused have admitted manufacturing the drug in question and selling the same to their Distributor, Pharmasales. Accused Zakaur Rahman, the Chief Chemist of Schazoo Laboratories, has explained that the drug is required to be kept in cool and dark place and in order to compensate for the deterioration of the drug due to adverse climatic conditions in Pakistan, they were manufacturing the drug with a potency of 15% above the required limit. He gave two possible explanations for the sample being found sub-standard. His first explanation was that a proper reference standard may not be available with either the Central Drugs Laboratory, Karachi, or even the National Health Laboratories, Islamabad. His second explanation was that the drug is required to be kept in a cool and dark place and as these requirements had not been fulfilled in the case of the sample in question the reports show a slight deficiency in the quantum of the active agent. In support of his first contention, he has submitted a Pamphlet issued by National Biological Standard Board under the supervision of W. H. O., which indicates that there can be loss of activity of international standards if they are stored at temperatures less the 20 C. The other two accused have adopted the explanation given by accused Zakaur Rahman. No defence was led by the accused.

7. The points which arise for determination in the case are :-

(i) Whether the Schazoo Laboratories sold the drug, Ampicillin Dry Syrup, to Pharmasales, Karachi. and ultimately a sample of that drug was taken by the Drug Inspector, Ghulam Rasool Halepota

(ii) Whether the accused are the Directors and the employees of Schazoo Laboratories, Limited

(iii) Whether the drug sold was sub-standard

8. Points (i) and (ii) in ,the affirmative. Point No. (iii) is as follows:-

9. Point No. (i).---On the point of sale of the drug, Ampicillin Dry Syrup by Schazoo Laboratories, Ltd., to Pharmasales and its subsequent sale to International Agencies, Qamar Medical Store and finally to Drug Inspector Ghulam Rasool, we have the evidence of Muhammad Ishaque, Branch Manager, Pharmasales; Ahmed Abdul Ghaffar, partner of National Agencies; Qamaruzzaman, proprietor Qamar Medical Store and finally the Drug Inspector. As already stated, all of them have supported the prosecution case and have produced the invoices and the warranties issued by M/s. Schazoo Laboratories, Pharmasales, Karachi, and the National Agencies. The accused themselves, in their statements in Court, have not denied this position.

10. Point No. (ii).-It is also not disputed that the 3 accused are respectively the Managing Director, the Chief Chemist and the Quality Control Incharge of Schazoo Laboratories,, In fact each of them. In their statements have conceded this position.

11. Point No. (iii).-The real issue which falls to be determined in the instant case is whether the sample of the drug in question sent to the National Health Laboratories was sub-standard and the accused is guilty of selling a sub-standard drug.

12. As already stated, according to U. S. P., the permissible varia tion in the drug in question is between 90% and 120%. However, accord ing to the report of the National Health Laboratories, the sample of the drug tested by it contained only 89% of Ampicillin. Subsection (5) of section 22 of the Drugs Act provides that the report of the Central Drugs Laboratory, and the National Health Laboratories is such a Laboratory, is conclusive evidence of the facts stated therein. As such the report of the National Health Laboratories is conclusive evidence of the fact that at the time of testing of the drug in question by the said Laboratory 51 was sub-standard.

13. We have, however, to consider the question whether the accused sold a sub-standard drug. We have examined the case from this angle because in the case of drugs not only there is an expiry date in respect of large number of them, after which the potency of the drug not only rapidly deteriorates but the drub can be harmful for use, but further in respect of certain drugs rigorous conditions for their storage are described in the B. P. and other standard pharmacopoeas.

14. It was argued on behalf of the accused by Mr. N. K. Jatoi that it was specifically stated on the carton of drug in question that it should be kept in a cool and dark place. According to the learned counsel by cool place was meant a place having a temperature not exceeding 15 C. The learned counsel for appellant tried to support his contention by inviting our intention to page 8 of the General Notice in B. P., where appellant in it is stated that the temperature of a cool place is not to exceed 15 C. We are, however, not impressed by this submission or reference as the British Pharmcopoea, at page 30, provides that the storage of Ampicillin should be in a well-closed container at a temperature not exceeding 25 C.

15. It was submitted by the learned counsel for the accused that even if this temperature be taken as the normal storage temperature of Ampicillin Dry Powder, the temperature in Karachi in the month of May and other summer months is far higher ranging from 30 C to 40 C and that such high temperatures would clearly affect the potency of the drug, unless special measures are adopted to store the same in accordance with the conditions stated on the carton of the drug. Though the learned counsel did not refer us to any definite authority in this behalf, the facts that the B. P. provides that the storage of the drug should be at temperatures lower than 25'C and the instructions regarding the storage of the drug in a cool and dark place 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. The examination of the proprietor of National Agencies, and Qamar Medical Store show that the drug was stored under ordinary conditions, that is in room temperature and not under specially cooled conditions. Furthermore after the sample of the drug was taken, it was kept for about 18 months, first in the office of the Secretary of the Provincial Quality Control Board and later in the Court room, again in normal room temperature and exposed to the normal light. In the Court room itself, the sample was kept in a steel cupboard where the temperature could even be higher than the normal room temperature, without free ventilation and circulation of air. As such, it is clear that at least after the drug was purchased by the Drug 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 Ampicillin 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, the variation from the B. P. standard was only 1 in 90. However, we should not be understood as saying that we consider that a minor varia tion from the B. P. standard can be condoned or is considered by us not to amount to an offence. We may added that a sample of the said drug, having the same batch number, was tested by the Government Analyst of Punjab and according to his report, dated 27-8-1978, the sample was found to conform to the stated formula. This report has been produced by the Drug Inspector to whom a copy of report was supplied by the accused. The fact that one sample of the same batch was found to confirm to the standard suggests to us that the samples of the same batch which have not conformed to the standard laid down had probably been subjected to adverse climatic conditions. We are however, careful to point out that the report of the National Health Laboratories, Islamabad, prevails over the report of the Government Analyst, Lahore, and we have referred to the report of the Government Analyst at Lahore only to show that a drug which was tested in August 1977 shortly after the Drug Inspector had acquired the sample as the drug from Qamar Medical Stores, was found to conform to the standard. 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. However, think that manufacturers of drugs, which may deteriorate due to adverse climatic conditions should take into consideration these condi tions in the manufacture of drugs and also the possibility that the people do not clearly understand what is meant by a cool place. It would perhaps the better that they should repeat the B. P. standard itself, that is specify the temperature at which the drug is to be kept, for what may be cool place to people in Pakistan will not be a cool place according to the B. P. standard, which specifically defines a cool place as a place having a temperature less than 15 C. Such temperature, in most places in Pakistan, can only be obtained by means of air-conditioning or other methods of cooling. Since we are of opinion that there is a reasonable possibility of the sample which was obtained by the Drug Inspector and subsequently sent to the Central Health Laboratory having deteriorated, after the acquisition of the. sample, we would give the benefit of doubt to the accused acid acquit all 3 of them. We may state here that even the A learned. Special Public Prosecutor conceded that there was a possibility of the deterioration of the drug due to whether conditions after the sale of the drug to the Drug Inspector. Before closing the judgment, we may clarify that though accused Zakaur Rehman had contended that tests, by different Laboratories can vary upto plus minus 8% and in support of', his contention, he referred us to U. S. P., 18th Edition, page 915, we are' not persuaded to accept this position, firstly, because the reference in the' U. S. P. is in regard to vitamins, which belong to a totally different group of drugs from antibiotic, and secondly, under subsection (5) of section 22 of the Drugs Act, the report of the National Health Labora tories, Islamabad, is deemed to be conclusive evidence of the facts stated therein.

Accused acquitted.

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