Skip to content


K.L. Chaturvedi Vs. State of Madhya Pradesh and ors. - Court Judgment

SooperKanoon Citation
SubjectCriminal
CourtMadhya Pradesh High Court
Decided On
Judge
Reported in1960CriLJ1614
AppellantK.L. Chaturvedi
RespondentState of Madhya Pradesh and ors.
Cases ReferredState Board of Pharmacy v. Mathews
Excerpt:
.....rules contained in part hi of the drugs rules, 1945, a certificate in form 4 declaring the correct formula of the medicine' which was thereafter kept in safe keeping in the personal custody of the director. legislature is ordinarily the sole judge how best it will carr out its policy. it is further well established that the test of reasonableness is in the fact that the means adopted by the legislature have a fairly appropriate connection with the end to be achieved. 'it cannot well be doubted that it is a common right of the people to be informed, so far as that is reasonably practicable, if the substances exposed for sale as food contain ingredients which are actually hurtful, or which they believe to be so and which therefore they would not knowingly purchase or use. worst; its..........proprietary medicine, 'germs killer' without disclosing on the carton or label of the drugs its true formula or list of ingredients.2. the relevant facts may shortly be stated as follows: the petitioner is the manufacturer of a medicinal preparation which he manufactures, stocks, exhibits, distributes and sells under an invented proprietary name 'germs killer' since before the year 1928. the name 'germs killer1 of the said medicine has been registered under the trade marks act. the medicine is manufactured and sold by the petitioner for the external treatment of skin diseases.3. it is not disputed that the said medicinal-preparation is a drug within the meaning of section 3(b) of the drugs act of 1940 (act xxiii of 1940), wherein the word 'drug' is defined to include:all medicines for.....
Judgment:
ORDER

T.P. Naik, J.

1. This petition under Article 228 of the Constitution is founded on the contention T that the Drugs Act, 1940, as amended by the Drugs (Amendment) Act, 1955, was unconstitutional and void, as it unreasonably restricted the fundamental right of the petitioner to manufacture and sell his patent' and proprietary medicine, 'Germs Killer' without disclosing on the carton or label of the drugs Its true formula Or list of ingredients.

2. The relevant facts may shortly be stated as follows: The petitioner is the manufacturer of a medicinal preparation which he manufactures, stocks, exhibits, distributes and sells under an invented proprietary name 'Germs Killer' since before the year 1928. The name 'Germs Killer1 of the said medicine has been registered under the Trade Marks Act. The medicine is manufactured and sold by the petitioner for the external treatment of skin diseases.

3. It is not disputed that the said medicinal-preparation is a drug within the meaning of Section 3(b) of the Drugs Act of 1940 (Act XXIII of 1940), wherein the word 'drug' is defined to include:

All medicines for internal or external use of human beings or animals, and all substances' intended to be used for or in the treatment, mitigation or prevention of disease in human beings or animals, other than medicines and substances exclusively used or prepared for use in accordance with the Ayurvedlc or Unani systems of medicine.'' The petitioner had obtained a licence for the manufacture and sale of the 'Drug' as required by the rules framed Under Section 33 (b) of the Act. Urider the Act, as it then existed, Section 18 thereof provided as follows:

Prohibition of manufacture and sale of certain drugs.- From such date as may be fixed by the State Government by notification in the official Gazette in this behalf, no person shall himself or by any other person on his behalf-

(a) manufacture for sale, or sell, or stock or exhibit for sale, or distribute-....(iii) Any patent or proprietary medicine, unless there-is displayed in the prescribed manner on the label or container thereof either the true formula or list: of ingredients contained in it in a manner readily intelligible to members of the medical profession,, or the number of the certificate of registration granted, in the manner prescribed by the Central Government, in respect of such medicine by the Central Drugs Laboratory after being correctly informed of the formula of such medicine;

Explanation:- The formula or list of ingredients mentioned in Sub-clause (iii) of clause (a) 1 shall be deemed to be true and a sufficient compliance with that sub-clause if, without disclosing a full and detailed receipt of the ingredients, it Indicates correctly all the potent or poisonous substances contained therein together with an approximate statement of the composition of the medicine.

The expression 'Patent or proprietary medicine' was defined in Section 3 (d) to mean:

a drug which is a remedy or prescription prepared for internal or external use of human beings Or animals, and which is not for the time being recognized by the Permanent Commission on Biological Standardization of the World' Health Organization or in the latest edition of the British Pharmacopoeia or the British Pharmaceutical Codex or any other pharmacopoeia authorized in this behalf by the Central Government after consultation-with the Board:

4. The drug in question was a patent or proprietary medicine as defined above and consequently the petitioner could not manufacture for sale, or sell, or stock or exhibit for sale or distribute the: aforesaid patent and proprietary medicine 'Germs' Killer', unless he displayed in the prescribed manner on the label or container either (i) its true formula or (ii) the list of ingredients contained in it is a routine readily intelligible to members of the medical profession, or (vi). the number of the certificate of registration granted, in the manner prescribed by the Central Government, in respect of such medicine by the Central Drugs Laboratory after being correctly informed of the formula of such medicine.

5. Section 6(2) (b) and (c) provided that the Central Government may, after consultation with the Drugs Technical Advisory Board constituted Under Section 5(2) of the Act, make rules prescribing the procedure for the grant of certificate of registration by the Central Drugs Laboratory in respect of patent and proprietary medicines which do not display on the label Or container the true formula or list of ingredients contained therein as -required by Section 18(a) (iii) of the Act. The petitioner did not display the true formula or a list of ingredients as envisaged above but obtained a certificate of registration as provided by the alternative contained in the latter part of Section 18 (a) (iii). While obtaining the certificate of registration he was required to submit in a sealed cover to the Central Drugs Laboratory vide rules contained in part HI of the Drugs Rules, 1945, 'a certificate in Form 4 declaring the correct formula of the medicine' which was thereafter kept in safe keeping in the personal custody of the Director.

6. So far the petitioner states he had no grievance. He had disclosed the true formula to the Central Drugs Laboratory and obtained the registration number CDL/1059 with respect to his patent and proprietary medicine 'Germs Killer'. He had also obtained a licence as required by the Act for file manufacture and sale of his proprietary medicine and was manufacturing and Belling 4t without disclosing its true formula or list of ingredients on the label Or container as required by the first part of Section 18(a) (iii) of the Act.

7. His trouble began with the coming into force of the Drugs (Amendment) Act, 1955 (Act No. XI of 1955) whereby, inter alia, clauses (b) and (c) of Sub-section 2 of Section 6 were deleted, &$ also the latter part of Section 18 (a) (iii). Section I8(a) (iii), as amended, reads:

any patent or proprietary medicine, unless there is displayed in the prescribed manner on the table or container thereof the true formula or list of ingredients contained in it in a manner readily Intelligible to the members of the medical profession;

it would be observed that whereas formerly the petitioner could choose not to disclose the true formula or list of Ingredients, provided he had obtained a certificate of registration from the Central Drugs Laboratory, now, under the amended provisions, the disclosure of the true formula or the list of ingredients on the label or container of his patent or proprietary medicine 'Germs Killer' was obligatory on him.

8. After the amending Act (No. XI of 1955) had come into force, the Director of Health Services by his memorandum, dated 21st February 1957, informed the petitioner in answer to his letter dated 13th January, 1957 that in case of patent and proprietary medicines true formulae will have to be disclosed (Annexure 4). Further correspondence followed, when the aforesaid direction was reiterated: (Annexures 5 and 7). In issuing the certificate of renewal (Annexure 6), it as again mads clear that the license was being Issued, 'subject to the condition of disclosing the true formula on the cartons and labels of the drugs'.

9. The learned Counsel for the petitiwaer, therefore, contends that by this compulsory disclosure he is being 'coerced to reveal to his rival manufacturers his precious trade secret which in fact and law constitutes his property and, which, even otherwise, he has every right to safeguard without violation', and that this also caused irreparable injury to his established trade or busiaess'.

10. The reliefs prayed for in the petition are:

(1) Adjudging that the provisions of the Drugs Act (No. XXIII of 1940) in so far as they have v been amended, as stated in paragraph 5 of the petition are unconstitutional and void.

2. Quashing the condition in the certificate (Annexure 6) to the effect that the renewal was subject to the condition of the petitioner having to disclqse the true formula on the cartons and labels of his medicinal preparation 'Germs Killer'.

3. Mandating the respondents not to give effect to the provisions of the Drugs Act (No. XXIII of 1940), as amended by the Drugs (Amendment) Act, (No. XI of 1955) in the manner and to the extent objected to by the petitioner in paragraph 8 of the petition.

11. The only question that arises for consideration is whether the Drugs Act of 1940, as amended by the amending Act (No. XI of 1955), is ultra vires and unconstitutional by reason of the, fact that the provisions now contained in it violate article 19(1)(g) of the Constitution.

12. The amended Act makes it obligatory on the petitioner to disclose on the label or container of his patent and proprietary medicine the true formula or list of ingredients contained in it in a manner readily intelligible to the members of the medical profession, The Explanation further makes it clear that it would be deemed to be true and sufficient compliance with the Act if, without discloing a' full and detail receipt of the ingredients, it indicates correctly all the potent or poisonous substances contained therein together with an approximate statement of the composition of the medicine.

13. Under item No. 19 of the Concurrent List III of the Seventh Schedule of the Constitution, the Parliament has the power to legislate on drugs. It has, therefore, power to regulate their manufacture, sale, stocking or exhibiting for sale,

14. It is not disputed, nor can it be disputed, that the State has the power of imposing reasonable restrictions on the exercise of any of the rights conferred under article 19(1) of the Constitution in the interest of the general public. The only question, therefore, is whether the Drugs Act, 1940, as amended, can be justified on the ground of 'reasonable restrictions'.

15. The petitioner concedes that the restrictions put by the original Act of 1940 were reasonable, and his argument is that such further restriction as have been put by the arterialized, Act, are not justifiable, 'Reasonable restrictions is the interest of the general public' is an expression of wide import. Ours is a welfare State and consequently it becomes all the more important for it to so exercise its legislative power as to subserve to its ultimate objective. All legislation directed to the preservation and protection of safety, health, morals and general welfare of the people would thus be in the 'interest of the general public. It cannot further be denied that preserving its people from imposition, fraud and deceipt would also be a legitimate object of its policy, as it would undoubtedly be in the interest of the general pub-lie.

16. It is also a fundamental principle of Constitutional law that the Courts are not the arbiter of legislative wisdom. Legislature is ordinarily the sole judge how best it will Carr out its policy. If any complaint has to be made on that score, the complaint must be made elsewhere and not in the law Courts, It is again an established principle of law that:

It must be presumed that a legislature understands and correctly appreciates the need o its own people, that its Jaws are directed to problems made manifest by experience and that its discriminations are based upon adequate grounds.

(See Middleton v. Texas Power and Light Co., (1912) 249 US 152 at p. 157. and Charanjit Lal v. Union of India : [1950]1SCR869 . The legislature will, therefore, be presumed to have enacted the laws for the greater welfare of the people with full consciousness of the need of the particular legislation at the particular time. This presumption being there, a heavy onus lies on those who challenge the constitutionality of the legislation on that ground. The Supreme Court has in A.I.R. 1951 SC 41 (supra) held that:

The presumption is always in favour of the constitutionality of an enactment, and the burden is upon him who attacks it to show that there has been a clear transgression of the constitutional principles ......The onus is, therefore, on the petitioner to show that the legislation which is impugned is arbitrary and unreasonable.

It is further well established that the test of reasonableness is in the fact that the means adopted by the legislature have a fairly appropriate connection with the end to be achieved.

17. Drugs are potent things. Modern scientific discoveries of recent years have vastly added to their numbers. With the growing consciousness of the people in their efficiency, the need has arisen that the State see to it that the drugs of standard purity and quality are put in the market, that there is no mis-branding and that spurious drugs are not put into the hands of the unwary. With this end in view the Drugs Act, 1940 provided certain reasonable restrictions in the exercise of the power to regulate their manufacture, sale, stocking Or exhibiting for sale of drugs by the persons concerned. That was the first step in that direction.

18. Now, by the amendment, more restrictions have been put. The obligation to inform the State Government of the true formula or list of ingredients of the drug concerned is replaced by the obligation to vouchsafe this information to all and sundry by displaying it on the cartons or labels of the patent or proprietary medicines.

19. I may, at this stage, at once dispose of the objection that this amended provision was calculated to disclose to the rival manufacturers the petitioner's trade secret. The learned Counsel for the petitioner admits the right of the State to know the true formula or list of ingredients, but contends that no useful purpose, except harm to the petitioner or to other similarly situated Post sons, can be served by such indiscriminate disclosure. The Explanation to Section 18 of the Drugs Act would show that the petitioner need not disclose the true formula or list of ingredients but only 'all the potent or poisonous substances contained in the' drug together with an approximate statement of the composition of the medicine'. Pull and detailed receipt of the ingredients is not insisted upon, and consequently I do not see how the proprietary right in the receipt is destroyed. The learned Counsel for the petitioner could give no convincing reason bow his proprietary right in the medicine is jeopardized by the disclosure of the ingredients.

20. Now, I come to the question whether the petitioner has a constitutional right to sell his patent or proprietary medicine to all und sundry without disclosing on the carton or label of its container the true formula or list of ingredients.

21. It has long been realised that the purchasers have a right to know what they purchase and pay for in the market. The State realised that it is a necessary part of its governmental function to see that the purchasers are not cheated, imposed upon or deceived. It, therefore, now imposes conditions requiring articles of commerce to be sold for what they are worth so that the buyer has knowledge of what he is purchasing. This right has been given judicial recognition in the United States in various cases. It was observed in Palmer v. State, (1883) 48 Am. Rep. 429, in respect of sale of goods:

Those who buy food have a right to know what they buy, and to have the means of judging for themselves a4 to its quality and value.

Later, in Stole v. Thompson, 46 NW 410 which was a case dealing with baking powder, the Court said:

The statute does not prohibit the manufacture or sale of baking powder containing alum, but requires the fact, when alum is a constituent of it, to be disclosed in the manner specified. We have no doubt that it is within the power of the legislature to impose this requirement. ....The Use of such compounds, generally designated as 'baking powder.' has become very common if not almost universal, in the preparation of food. 'It cannot well be doubted that it is a common right of the people to be informed, so far as that is reasonably practicable, if the substances exposed for sale as food contain ingredients which are actually hurtful, or which they believe to be so and which therefore they would not knowingly purchase or use.' It may be that, if the fact were open to discovery by common observation, statutory regulation would be unnecessary to protect the people from imposition, and that the purchaser should be left to purchase and use the commodity or not according to his own judgment, But we suppose that the presence of alum in such compounds is not open to detection by the use of means available to people in general, and that in the absence of statutory regulation the people have practically no choice but to purchase and use such goods as are offered to them, or to wholly avoid the use of such preparations. One of the grounds justifying the interference by the legislature to regulate the carrying on of ordinary business affairs is the fact that unless a preventive remedy be applied people will in general, or very commonly, be imposed upon, the circumstances being such, that ordinary personal caution will be ineffectual to guard against it.

In this case, it was further observed:

No man has the right, protected by the Constitution from legislative interference, to keep secret the composition of such goods in order that others may be induced to purchase and use what they would consider to be hurtful, and what they would not knowingly purchase or use. The owner of such property may be legally required, as a matter of proper police regulation for the benefit of the people in general, to sell it for what it actually is, and upon its own merits, and is not entitled, as a matter of constitutional right, to the benefit of any additional market value which he may secure by concealing its true character.

22. In State v. Aslesen, 1892-36 Am. St. Rep. 820, dealing with the question whether lard substitutes should be labelled, it was said:

No man has a constitutional right to keep secret the composition of substances which he sells to the public as articles of food. Such regulations do certainly have some real or substantial relation to the objects aimed at, to wit, as expressed in the title of the Act, to prevent fraud, and 'to preserve the public health'. They do not impair any fundamental rights of life, liberty, or property.

In Corn Products Refining Co. v. Eddy, (1912) 249 US 427 at p. 431: 63 Law Ed 689 the court Said:

It is, however, urged that since plaintiffs syrup is a proprietary food, made under a secret formula and sold under its own distinctive name, and since it contains no deleterious or injurious ingredients, the effect of the regulation in requiring plaintiff to disclose upon the label the ingredients and their proportions amounts to a taking of its property without due process of law. Evidently the purpose of the requirement is to secure freedom from adulteration and misbranding; the mischief of misbranding being that purchasers may be misled with respect to the wholesomeness or food value of the compound. And it is too plain for argument that a manufacturer or vendor has no constitutional right to sell goods without giving to the purchaser fair information of what it is that is being sold. The right of manufacturer to maintain secrecy as to his compounds and processes must be held subject to the right of the State In the exercise of its police power and in promotion of fair dealing, to require that the nature of the product be fairly set forth. Health and M. Mfg. Co. v. Worst; (1907) 207 US 338 at p. 353: 52 Law Ed 236 at p. 243; Savage v. Jones, (1911) 225 US 501 at p. 524: 56 Law Ed , 1182 at p. 1191; Stanard Stock Food Co. v. Wright, (1911) 225 US 540 at pp. 548, 549: 56 Law Ed 1197 at pp. 1200, 1201; Schmidinger v. Chicago, (1912) 226 US 578 at p. 588: 57 Law Ed 364 at p. , 368; Armour and Co. v. North Dakota, (1915) 240 US 510 at pp. 514, 515: 60 Law Ed 771, 775 Hutchinson Ice Cream Co. v. Iowa, (1916) 242 US 153 at p. 159: 61 Law Ed 217 at p. 221 and Hebe Co. v. Shaw, (1918) 248 US 297 at p. 303 Similarly, in 1911-225 US 501 at p 524, the Court said:The evident purpose of the statute is to pie-vent fraud and imposition in the sale of food for domestic animals, a matter of great importance to the people of the State. Its requirement were directed to that end, and they were not Uri reasonable. It was not aimed at interstate commerce, but, without discrimination, sought to promote fair dealing in the described articles of food. The practice of selling feeding stuffs under general descriptions gave opportunity for abuses which the legislature of Indiana determined to correct, and to safeguard against deception it inquired a disclosure of the ingredients contained in the composition. The bill complains of the injury to manufacturers if they are forced to reveal their secret formulae and processes. We need not here express an opinion upon this question, in the breadth suggested, as the statute does not compel a disclosure of formulas of manner of combination. It does not demand a statement of the ingredients, and also of the minimum percentage of crude fat and crude protein, and of the maximum percentage of crude fiber, a requirement of obvious propriety in connection with substances purveyed as feeding stuffs.

23. This labelling provision has thus been approved as a reasonable restriction on the right of the individual for products such as agricultural seed, articles of food, baking powder, butter or cheese compound, cotton-seed meal, feeding stuff, fertilizer, lard, linseed oil, oleomargarine, paint, poison, syrup and woolen articles: (see Annotation on the point in 57 ALR 686 to p. 692), In Fougera . and Co. v. City of New York, (1918) 1 ALR 1467 at p. 1472. Justice Cardozo, dealing with the provisions of an Act, which required the registration of the name of the ingredients in the Department of health, observed:

The argument is made that the ordinance is an arbitrary exercise of the power of Government. We do not think so. Its purpose and effect are well within the limits of the police power. The purpose is the preservation of the public health and safety, (1911) 225 US 501: 56 Law Ed 1182, (1892) 36 Am St. Rep. 620, State Board of Pharmacy v. Mathews, 197 NY 553: 26 LRA (NS) 1093: 90 NE 966. The form of protection is publicity. There must be disclosure of the truth to responsible officials, who will prevent or punish the sale of Fraudulent or noxious compounds. If that is not a legitimate public aim, we are at a loss to know where one may be found. It is not important that the ordinance fails to compel disclosure to all the world. Laws are not invalid because they fall .short of the maximum of attainable efficiency. Disclosure to all the world, as in (1911) 225 US Soy. 50 Law Ed. 1182 (Supra) might' make the protection more complete, but it would also make the hardship more severe. Something less, therefore, has been expected. Disclosure is to be made to the health officers of the city and to them- only. It fraud or other' wrong is discovered, then and then only exposure will result, 'No man has a constitutional right to keep secret the composition of substances which he sells' to the public as articles of food'. (1892) 36 Am. St. Rep, 620 (supra,'. If that is true of food, it is even more plainly true of drugs. A danger exists, and the only question is whether the means of correction are appropriate. We cannot say that the means have no relation o the end. The public health is safeguarded by disclosure to public officers charged by law with its protection. We are not called upon to approve His wisdom of the ordinance. We stop when we salisly ourselves that it has a reasonable relation to the end to be attained.

24. In my opinion, the principles enunciated in the aforesaid cases apply equally well to the 'drug' in 'question. They amply show that the disclosures which have now been made obligatory under the amended Drugs Act, 1940 are for the preservation of health and safety of the purchasers, and there is nothing on record to displace the presumption regarding its constitutionality on the ground that it is arbitrary and unreasonable, the burden of proving which lay heavily on the petitioner. In my opinion, the legislature in its wisdom wanted disclosure to all the world and was not satisfied by its disclosure to the Central Drugs Laboratory alone. That is a matter on which the Court cannot sit in judgment. I am satisfied that the amended provision has a reasonable relation with the object to be attained, which is the safety, health and well being of the people.

25. The petition, therefore, fails and dismissed with costs. Counsel's fee Rs. 100/-.


Save Judgments// Add Notes // Store Search Result sets // Organize Client Files //