' Accused Elyas Fazal Ellahi, who is the proprietor of Eiffal-Chem. (Pakistan), Karachi, has been tried on the charge of manufacturing, for the purposes of sale, Chloroquine Phosphate Injection, Batch No, 315, which has been found to be sub-standard and to have furnished false warranty in respect of the said drug.
2. The prosecution case, shortly stated, is that on 11-5-1976 Drugs Inspector, Altaf Hussain, obtained three samples of Chloroquine Phosphate injection, Batch No, 315, manufactured by Eiffal-Chem.
(Pakistan), from Khairpur Medical Store and sent one sample of the drug to the Government Analyst, as he suspected the said drug to be sub-standard. The Government Analyst, after analysis, found the sample to be sub-standard, in that it contained suspended particles. The Drugs Inspector thereupon sent a copy of the said Report to the Khairpur Medical Store, which sent him invoice, dated 6-5-1976, issued by Messrs Eiffal-Chem. (Pakistan) containing the the warrantly that the drug did not contravene any provision of the Drugs Act.
3. The prosecution has examined the Drugs Inspector, Altaf Hussain, and a sales-man of Khairpur Medical Store by name Shahbaz Dino. The Drugs Inspector has testified that he had taken three samples of the drug in question from the Khairpur Medical Store and had sent one sample to the Government Analyst. He has produced report of the Government Analyst, which shows that the drug contained suspended particles. So far as P. W. Shahbaz Dino is concerned he has stated that samples of the drug in question were taken from him by the Drugs Inspector and the said drug was purchased by them from Eiffal-Chem. (Pakistan) under invoice dated 6-5-1976, which has a printed warranty thereon.
4. The accused, in his statement to Court, has not disputed the prosecution allegations and admitted that the drug in question was manufactured by his Firm and that he had sold the same to Khairpur Medical Store under invoice and warranty. His contention, however was that it was impossible to prepare any solution which would be wholly free from suspended particles and that the presence of such particles does not necessarily make any drug "sub-standard" for the purpose of the Drugs Ordinance, 1976.
5. The only point thus which falls to be considered is whether the drug in question was sub- standard. Section 3 of the Drugs Ordinance, 1976, defines "sub-standard drug" as a "drug which is not of the required specification". The term "specification", when applied to a drug, has been defined as :-
(a) such specifications as may be prescribed ;
(b) when the specification are not prescribed, the specifications contained in the most recent edition of certain specified publications, including the British Pharmacopoeia ; and
(c) if no specifications are either prescribed or contained in any of the publications referred to in the preceding sub-clause the specifications approved for the purpose of registration under the Ordinance.
6. It as conceded by Mr. Munawar Malik, the learned Special Prosecutor, that in respect of the drug in question no specifications have been prescribed under the Ordinance nor he has been able to show us any specifications approved for the purpose of its registration under the Ordinance. We have therefore to consider the specifications as contained in the British Pharmacopoeia (hereinafter referred to as B. P.). According to the B. P.
1973. Edition, the number of permissible particles in one (milli-litre) of liquid ca be up to one thousand particles of two Ural and up to one hundred particles of two Uml and up to one hundred particles not exceeding 5 Upl. In the instant case, it is not known what was the size of the particles found by the Government Analyst in the sample sent to him and what were the number o those particles. It is also not known whether these particles were ingredients of the drug (precipitates) or impurities.
7. In view of the above position, we are unable to hold that the drug in question as "sub-standard" for the purpose of the Drug Ordinance, 1976. We accordingly give the benefit of doubt to the accused and acquit him under section 245 (1), Cr. P. C. His bail bond will stand discharged .