1992 PLP 481 (MLD)

SH. RIAZ AHMAD, J.‑‑‑ The appellants have filed these intra‑Court appeals (I.CA. No.127 of 1988 and 128 of 1989) to assail the judgment, dated 11th of June, 1989, whereby, a learned single Judge of this Court declared the Test Report made by the Analyst in respect of the drugs manufactured by the respondents to be vague and incapable of being acted upon as well as contrary to the various provisions of the Drugs Act, 1976.

2. Brief facts giving rise to the institution of this appeal are, that the respondent is engaged in the manufacturing of drugs under the licence and the registration granted to it by the Central Licensing Board and the Registration Board established under the Drugs Act, 1976. The Provincial Drug Inspector took samples of some of the injections manufactured by the respondent, and sent the same to the Drug Testing Laboratory/Government Analyst for test. The Analyst declared that the samples conformed to the stated specifications chemically, but did not conform to the physical specifications of injections being adulterated with particles and fibres, vide reports Annexures `A' to `H' in the case of Irza Pharma while in respect of Sharex Laboratories `A' to `AA'. As a consequence of these reports, the appellants ordered the prosecution of the respondents under the relevant provisions of the Drugs Act.

3. The respondents then challenged the aforesaid reports of the Analyst as well as the order of the petitioner No.l by way of filing Writ Petition No.6337 of 1988 and Writ Petition No.674 of 1989 and the same were accepted, vide the order impugned, dated 11‑6‑1989 and the reports of the Analyst and the consequential order of the prosecution of the respondents were declared to be illegal and without lawful authority and jurisdiction.

4. The crucial question for determination is what is the nature of the questioned reports made by the Analyst within the meanings of the Drugs Act and what is meant by Analyst when it is reported that the samples of the Drugs manufactured by the respondent conformed to the stated specifications chemically but did not conform to the physical specifications of injections being adulterated with particles. For the determination of this question, reference to the provisions of Drugs Act is necessary, because the phrase adulterated with particles is not known to the Drugs Act. An other important question would be, whether in the light of the report, the drugs manufactured by the respondent can be declared to be adulterated or substandard. To resolve this controversy, as stated above, reference to section 3 of the Drugs Act would be relevant and necessary. The adulterated drugs, as defined by the Drugs Act, read as hereunder: ‑‑ "Adulterated drug" means a drug (i) which consists in whole or in part of any filthy, putrid or decomposed substance, or which contains any foreign matter, vermin, worm, rodent or insect; or (ii) which has been manufactured, packed or held under unsanitary conditions whereby it may have been contaminated with dirt, filth or any other foreign matter, or whereby, it may have been rendered injurious to health; or (iii) the container of which releases any poisonous or deleterious substance which may render the contents injurious to health; or (iv) which bears or contains as an ingredient a substance other than the prescribed substance; or (v) with which any substance has been mixed or packed so as to reduce its quality or strength or for which any substance has been substituted wholly or in part.

5. Besides the definition of the adulterated drug, the Drugs Act also defines the spurious drugs, and the said definition reads as under: ‑‑ (i) which purports to be a drug, but does not contain the active ingredient of that drug; or (ii) which purports to be the product of a manufacturer, place or country of whom it is not truly a product; or (iii) which is imported or exported or sold or offered or exposed for sale under a particular name while actually it is another drug; or (iv) the label of which bears the name of an individual or company purported to be its manufacturer or producer which individual or company is fictitious or does not exist. The scheme of the law after defining the adulterated drugs and the spurious drugs, then defines the substandard drugs, and the same is reproduced as hereunder:‑‑ substandard drug means a drug which is not of specifications."

6. It is an admitted fact that the questioned reports in this case clearly reveal that the samples taken conform to the stated specifications chemically, and therefore, it is obvious and clear, that the samples of the drugs do not fall within the definition of the substandard drugs. As observed earlier, that whether in the light of the reports, can the samples be considered to fall within the mischief of the adulterated or spurious drugs. After careful consideration of the relevant facts, and after considering the contentions raised by both sides, it is obvious that even the drugs can neither be considered as adulterated nor spurious. There is nothing on the record to show, as to what is the nature of the particles found in the samples, and what are its consequences. If we allow these reports to hold the field, we would thereby give a long handle to the functionaries under the Statute to victimize anyone they choose. We cannot allow the way of arbitrariness and the capricious course of action to be adopted by the functionaries so as to render the lives of the citizens miserable. It is well settled that when the law requires a particular thing to be done, it should be done in that way, or not at all. The learned single Judge rightly held that the term substandard drug with particles is not known to the Drugs Act; and that is true. We have reproduced earlier the definition of the adulterated, spurious and substandard drugs. To hold the samples as spurious or adulterated drugs, it was incumbent upon the Government Analyst to state so, or to declare the same as filthy, putrid or decomposed or to contain vermin, worm, rodent or insect or the same had been prepared under the unsanitary conditions so as to be contaminated with dirt, filth or any foreign matter, whereby it could have been rendered injurious to the health. A careful perusal of the definition of the adulterated drug clearly lays down the test and a report which does not conform to the test provided by law cannot be considered to be valid and legal report. Similarly, we have also considered the reports of the Government Analyst within the meanings of the definition of the spurious drugs, but the same also fall outside the category of the said definition.

7. The learned Single Judge of this Court while delivering the judgment impugned also made reference to section 32(2) of the Drugs Act which reads as follows: ‑‑ "A drug shall not be' deemed to be misbranded or adulterated or substandard only by reason of the fact that there has been added thereto some innocuous substance or ingredient because the same is required for the manufacture or preparation of the drug fit for carriage or consumption, and not to increase the bulk, weight or measure of the drug, or to control its inferior quality or other defect or there is a decomposed substance which is the result of natural process or decomposition: Provided that such decomposition is not due to any negligence on the part of the manufacturer of the drug or the dealer thereof and that it does not render the 'drug injurious to health or does not make it substandard."

8. From the aforesaid definition it is evident, that the Law Makers have taken note of the eventualities, implications and also the nature of the manufacturing of the drugs while making the law. Hence, the law and its intention, as envisaged by the Drugs Act is very sacred and clear. Unfortunately, in our country functionaries under the law misuse the same, which is nothing but malice in law. Can we allow such course to perpetuate so as to leave room for rampant corruption? The obvious answer is in the negative. On the other hand, this Court under its Constitutional jurisdiction, as enjoined by the Constitution has to protect the observance of law as well as the $ the bona fide exercise of the duties of the functionaries under the Statute. In this behalf, we are fortified in our view by the observations of the Supreme Court while commenting upon Article 2 of 1962 Constitution, now Article 4 of 1973 Constitution in the case reported as Malik Ghulam Jillani v. The Federation of Pakistan P L D 1967 SC

373. The relevant observations are added as hereunder: ‑‑ "Under the Constitution of Pakistan a wholly different state of affairs prevails. Power is expressly given by Article 98 to the Superior Court to probe into the exercise of public power by executive authorities, how high so ever, to determine whether they have acted with lawful authority. The judicial power is reduced to a nullity if laws are so worded or interpreted that the executive authorities may make what statutory rules they please thereunder and may use this freedom to make themselves the final judges of their own `satisfaction' for imposing restraints on the enjoyment of the fundamental rights of citizens. Article 2 of the Constitution could be deprived of all its content through this process and the Courts would cease to be guardians of the nation's liberties." In this view of the matter, we are not impressed by the legality of the reports, and also the contention that another efficacious remedy is available to the respondent by reverting to the Federal Testing Laboratory. When the basic test report does not conform with the provision of law, it is wholly without jurisdiction and incapable to be acted upon. Hence, asking the respondent to choose the aforesaid remedy is nothing but to perpetuate the tyranny. "Hence, we repel the contention, and we also disapprove the action taken otherwise than law which is nothing but amounts to tyranny of law, and the citizens are to be saved there from. Resultantly, we hold that the view of the matter taken by the learned single Judge of this Court is not open to any exception. Hence, we I do not find any substance in this appeal, which is dismissed accordingly. AA./P‑5/L Appeal dismissed.