' This is a petition under section 561-A, Cr. P. C. By Searle (Pakistan) Limited, petitioner-Company, for the quashment of proceedings pending against it under section 23/27 of the Drugs Act, 1976, read with rule 32 of the Drugs (Licensing, Registering and Advertising) Rules, 1976, in the Drugs Court, Punjab, Lahore.
2. The brief facts of the case are that on 17-7-1982 Mr. Zahid Maqbool Baig, Inspector of Drugs, Sialkot, inspected the business premises of a retail chemist named Messrs Butt Medical Stores in Sialkot and seized Nilever Drops B. No, 010 manufactured by the petitioner-Company (commercial pack) and Nilever Drops B. No, 006 manufactured by the petitioner-Company (Physician's sample), in both of which bottles contained in the carton packs, the contents were 15 ml. On 18-7.1982, the said Inspector of Drugs wrote to the petitioner- Company intimating the result of his inspection, where he had found the two bottles containing the same contents, and stated that the contents of the product for sale in the market as well as that meant for the Physician's Sample were the same, that he then invited the attention of the petitioner-Company to rule 32 of the Drugs (Licensing, Registering and Advertising) Rules, 1976, under which it was essential that the 'quantity' in the sample was to be less, that he then intimated that the Company had contravened the said rule and he called upon the Company to explain its position within a week from the receipt of the letter, failing which action would be taken against it. On 28.7-1982, the petitioner-Company answered the letter of the Inspector of Drugs and stated that its record showed that the whole lot of contents of Batch 006 was inspected as the 'Physician's Sample', that the contents of the 'Physician's Samples' were 10 ml. Only, which was proved by the attached packaging record, card, that the labels and cartons were over-printed by the following phrase:- ''Red uced Pack Physician's Sample Not for Sale." and that in the disputed case, the sample pack was in reduced size of carton, to differentiate it from the commercial pack. The petitioner-Company, therefore, claimed that it had not contravened any provisions of the Drugs Rules, 1976, pertaining to the Physician's Sample. The petitioner-Company also averred that some foul play had occurred outside its premises, where the screw cap of the disputed bottle had been opened and the contents of the bottle raised to 15 ml. By some dilutant or Nilever Drop liquid itself, from some other bottle, in order to malign the good name of the Company.
3. On 15-11-1982, the Inspector of Drugs filed a complaint under section 23/27 of the Drugs Act against the petitioner-Company, mentioning the same facts as above stated and called for the punishment of the petitioner- Company and two of its Officers. Para. 2 of the complaint, which is relevant, may be reproduced here with advantage:- "Messrs Searle (Pakistan) Ltd., Karachi, were asked to explain as to why they have filed the Physicians pack with 15 ml. Contents, whereas the commercial pack is also filed with the same quantity e. 15 ml. Whereas the law provides the contents in the Thysican's Sample must be reduced quantity."
Being aggrieved by the lodgment of the aforesaid criminal case against it, the petitioner-Company filed a petition under section 249-A, Cr. P. C. Before the Drugs Court for quashment of the case before it, which application was rejected. The petitioner-Company thereupon moved a petition under section 561-A before this Court, which is now before me for disposal.
4. I have heard the arguments of the learned counsel for the petitioner and the State and have also perused the record. The learned counsel for the petitioner has shown me the commercial pack and the Physician's pack of the Nilever Drops. The carton packing of Nilever Drops (commercial pack) is slightly larger, whereas the carton packing of the Nilever Drops of the (Physician's Sample pack) is slightly smaller. On the carton packing of the Physician's Sample, the words "Reduced Pack-Physician's Sample-Not for Sale" appear. The bottles in the two packs appear to be of the same size. The labels on the two bottles are the same and both mention the contents as 15 ml. The bottle in the Physician's Sample pack contains the same words "Reduced Pack-Physician's Sample-Not for Sale". It is conceded by the learned counsel for the State that the Physician's Sample is in the reduced pack. The dispute is about the contents in the two bottles. According to the learned counsel for the State, the bottle in the Physician's Sample pack should have contained contents less than 15 ml. Which is the normal contents of a bottle in the commercial pack. The dispute is about the quantity of the drug in the Physician's Sample. According to the learned counsel for the petitioner, under rule 32 of the Drugs Rules, what is required is that the quantity to be distributed should be "reasonable quantity". In this connection, it is submitted that rule 32 calls upon manufacturers and distributors to provide physicians and medical institutions with samples of their drugs in reasonable quantity and in the reduced packings and what is intended is not that the Physician's Sample should contain lesser quantity of the drug, as is contained in commercial packs, but that the Physician's Sample should be in smaller size packing's, as opposed to the size of the normal commercial packs, that the same should be marked with the words "Physician's Sample--Not for Sale" and that these Physician's Samples should be distributed not in large quantity, but in reasonable quantity. On behalf of the State, it is submitted in rebuttal that the words 'reasonable quantity' mean reduced quantity as compared to the normal quantity found in a commercial pack, as the intention of the rule is to prevent chemists from selling Physician's Samples on the retail counter. It is also submitted that the State should be allowed to prove that the drug in the pack was in an unreasonably large quantity.
5. In order to understand the dispute, rule 32 of the Drugs Rules may be reproduced with advantage:- "32. Samples of drugs may be provided to the physicians or dentists or Pharmacists or Veterinarians or a medical institution in a reasonable quantity and in reduced packings marked with the words 'Physician's Sample-Not for Sale'."
In the first place, the rule is directory and not mandatory. However,' even for the sake of argument, if I were to accept the proposition that the provisions therein relating to 'reasonable quantity' and 'reduced packing' are to be read as mandatory provisions, directing manufacturers and distributors of drugs to comply with the said provisions, what is intended is that Physician's Samples must be in 'reduced packings', and that such samples may be provided to the physicians or medical institution in reasonable quantity.
6. It is admitted in this case that the Physician's Sample is in a reduced packing, as the outer carton of this pack is smaller than the commercial pack and also bears the words "Reduced Pack -Physician's Sample-Not for Sale". The Company, therefore, has complied with the provisions as regards 'reduced packing'. The words "reasonable quantity' are not relatable to the words 'reduced packing', but to the quantity of smaples which may by supplied to the physician on the medical institution. This is obvious when one notes the word "and" separating the two expressions and not the word "in". In short, what the rule requires is that where the drug is commercially vended in bottles, not packed in cartons, the Physician's Sample should be in a bottle slightly lesser in size than the bottle in which the same product is commercially vended, for the bottle itself in such a case would constitute the packing. But where the same is vended in bottles packed in cartons, the carton pack of the Physician's Sample should be slightly smaller than the normal carton pack in which said drug is commercially vended, for the outer carton now would constitute the packing. The word "packing" in this rule is relatable to the outer covering in which the drug is packed i. e. The manner in which the medicine is vended commercially and presented to the customer. It has no relationship with the quantity of the drug. Drugs Rules, 1976, has no chapter dealing with "Labelling and Packing".
' The old Drugs Rules, 1945, deals with this subject See Part IX "Labelling and Packing". Rule 96 inter alia states that the !Able on the container of any drug should be in a conspicuous position on the innermost container in which the drug is packed and on every other covering in which that container is packed. Rule 103 specifies certain distinct matters which have to be written or printed on the label of both the container and the carton containing the drug. If the medicine is vended in a carton pack, whatever may be the size of the bottle therein, the "packing" would be the carton pack and not the bottle therein. If the words "reduced packing" to be treated as reduced quantity of drug in the pack, it would lead to absurdities. If three tablets together constitute one complete course, it is not expected that the Physician's Sample pack should contain two tablets. If one bottle of nosal drops commercially vended in 5 ml. Bottles is perhaps what the manufacturer considers to be an adequate quantity for a three day course, it is not expected that the manufacturer should supply 4 ml. Of the said drops in Physician's Samples. The samples are intended to advertise the drugs as vended, and not to create difficulties in the way of doctors who would like to try them out. If such an interpretation is permitted, thousands of cases would be lodged by unscrupulous Drugs Inspectors trying to claim what should be the adequate reduced quantity in a sample pack and manufacturers and dealers would be at the mercy of frivolous indictment. In the instant case, it is admitted that the Physician's Sample carton pack was of a smaller size. This fulfils the requirement of "reduced packing", as contemplated in rule 32.
7. It is also suggested that the words 'reasonable quantity' refer to the drug in the sample pack and if it is the same or in any larger quantity, as contained in the commercial pack, the petitioner-Company is liable. It seems that the words 'reasonable quantity', as appearing in rule 32, are being equated with reduced quantity of the drug to be found in the packing. This view is incorrect. For reasons already stated in para. 6 above, manufacturers and dealers cannot be left at the mercy of Drugs Inspectors to determine whether the quantity of drug in each sample is reasonable. The legislature could not have intended such a preposterous situation. The right to determine what is a reasonable quantity, if it is in relation to the drug in a single sample pack, should obviously be with the manufacturer or dealer, for he has to determine what quantity should be offered, which in the given circumstances, a physician, after putting it to test use, for the number of days that is required and necessary, could determine whether it is effective. Every sample cannot be put at the mercy of the Drugs Inspector and this, I think, was not the intention of the law-maker. The argument that 'reasonable quantity' must mean a quantity less than what is to be found in a commercial pack, is introducing words in the rule which are not there. How can, under the present rule, it be said that if the sample pack had 14'95 ml. Of Nilever Drops, it would be treated as reasonable quantity, but if it had 15 ml. Of the same product, it ipso facto became an unreasonably large quantity. The word 'quantity' in this rule is not used against the basic unit of the contents found in a commercial pack, so that if the sample pack exceeds the same, it becomes unreasonable but if it stands reduced by 0.1 ml.
0.1 mg., it at once becomes reasonable. The words 'reasonable quantity', therefore, obviously can only have reference to the samples of the drug that can be placed in the physician's hands so that he can, after putting it to use in the manner and for the number of days as I prescribed in the pamphlet covering the drug, he can fairly determin whether it is effective. In the instant case, the dispute is over on Physician's Sample pack. It is not the case that it was offered to a physician and, even if it was, it could hardly be stated that it contained an unreasonably large amount of the drug. Taking all circumstances into consideration, I hold that the words 'reduced quantity' refer to the number!, or quantity of the samples that are to be supplied to a physician or are medical institution by a manufacturer or dealer but not the contents of the drug in the sample pack.
8. This is a case where the only allegation alleged against the petitioner-Company is that its sample pack contained 15 ml. Of the and that under rule 32 the contents should have been less than 15 ml. It has not been urged in the complaint that 15 ml. Is an unreasonable quantity or that an unreasonably large quantity of samples was supplied to any physician or institution. Apart from the case set up by the Drug Inspector, no fresh case can be permitted to be argued against the petitioner-Company, in that behalf.
9. Since the case of the Inspector of Drugs is based on an erroneous view of the law, no case stands made out against the petitioner-Company for violation of rule 32, which may entail any punishment under section 27(4) of the Act. Since there is no allegation that the Physician' Sample was 'sold' by the petitioner-Company to anyone in contravention of any of the provisions of the Act or the rules, no offence stands mad out for violation of section 23(1)(x) of the Act, as to entail any punishment under section 27(4) either.
10. For the foregoing reasons, this petition is accepted and the proceedings pending against the petitioner- Company under section 23/27 of the Drugs Act, 1976, read with section 32 of the Drugs Rules, are hereby quashed.