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1994 (5) TMI 162

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..... h for company's expansion- cum -diversification with regard to IV fluids manufactured by the respondent. It is the case of the complainants that the representations made by the respondent-company about their expansion- cum -diversifi-cation project and of the quality, grade composition, style and model as well as the need for and usefulness of the IV fluids manufactured by it in the prospectus or otherwise were false and misleading. 3. The main thrust of the complainants' grievance is that the representa- tions made by the respondent in its prospectus that the technology adopted by it for the manufacture of IV fluids called 'Form-Fill-Seal (FFS)' is 'the most modern', 'the latest', 'conforming to international quality standards', etc., were not only false and misleading but were calculated to disparage the conventional and worldwide accepted tech- nology of manufacture of IV fluids packed in bottles which are the goods being manufactured by the members of the complainant association, attracting clause ( x ) of section 36A(1). In fact at the end of the day this was the sole ground on which the impugned claims/representations made by the respondent in its prospectus were assailed .....

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..... rt later. 6. It seem unnecessary to enter into the merits of the preliminary objections raised by the respondent as to the maintainability of the complaint, as, in our opinion, the complaint is liable to be dismissed in any case even on merits. Referring to some of the extracts of the prospectus quoted below, Ms. Indira Jai Singh, the learned senior counsel for the complainant, submitted that the representations implicit therein tanta- mount to unfair trade practice inasmuch as false and misleading as representations are, they clearly tend to disparage the IV fluids being manufactured by complainants and their members by the using the conventional technology which is still in vogue throughout the world. The relevant portions of the prospectus which the learned counsel mainly stressed are extracted below: " Manufacturing process [ for LVPs and SVPs ] - The company has the world's latest and widely accepted state of the art Form-Fill-Seal (FFS) technology, imported from Rommelag AG Switzerland. The FFS technology involves forming, filling, sealing and coding of the containers in a single multi-stage operation within the closed sterile environment of the chamber of the FFS mac .....

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..... The first and the main contention of Ms. Indira Jai Singh was that Indian Pharmacopoeia has prescribed clear guidelines with regard to the manufacture of IV fluids, the methods and standards of sterilization as well as the degree of the care and caution which must be invested in the process for ensuring that there is no possibility of contamination in a vital product like IV fluids. That being so, it was urged, any technology which conforms to the standards and specifications laid down by the Indian Pharmacopoeia must be held to be as good as any other process of manufacture adopted by the respondent or others which goes by the name of FFS. The supposed superiority claimed by the respondent in the prospectus and elsewhere in the manufacture of IV fluids, the learned counsel contended, is hence totally out of place and must be held to be calculated only to mislead the consumers. 8. We regret our inability to accept the contention. Indian Pharmacopoeia simply lays down the minimum standards and guidelines to which all Pharmaceuticals must conform. That, however, does not mean a manu- facturer cannot undertake, introduce and effect further improvements over and above those prescri .....

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..... be seen that in this process of manufacture, human touch or manual operation does not enter at any stage. Contrasted to this, the conventional process of manufacture of IV fluids by employing the open technology in PVC or polypropylene bottles or pouches or glass containers with stoppers does seem to involve inevitably manual handling with the possibility of the solution getting exposed to the environment not being ruled out. It is in this respect that the respondent claims that the technology employed by it is the more advanced, invulnerable to con- tamination, etc. 12. The respondent further asserts in its reply that the IV fluids manufac- tured with FFS technology is recognised and used worldwide in approxi- mately 65 countries because it is considered fool-proof and immune from any possibility of contamination. 13. This contention, therefore, that having regard to the nature of the product and the fact that Indian Pharmacopoeia lays down stringent tests and guidelines for ensuring that the IV fluids are not amenable to contamination, the superiority claimed by the respondent in the prospec- tus and elsewhere must be held to be false and misleading aimed solely at dispa .....

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..... is the latest. The respondent has asserted that FFS evolved by Rommelag is a technical procedure used by hospitals and pharmaceutical companies worldwide and that it is for this reason that it is preferred by hospitals in nearly 65 countries. This claim has not been demonstrated by the complainant to be false or misleading, so as to attract section 36A(1). In support of the respondent's claim it has filed a certificate issued by Kennet Bioservices of UK stating that "I confirm that I would be pleased to assist you with the procedures necessary to obtain product registration in the European Community, and to carry out GMP audits at your facilities prior to inspections. I am very familiar with the Rommelag technology, which I consider to be technology for the 21st century." 16. The second submission of the learned counsel for the complainant thus also fails. 17. The next ground on which the prospectus was assailed was that the respondent itself having admitted in its reply that the technology (FFS) was developed over two decades ago, it renders the claim that its technology is the latest' or the 'most modern' completely false and misleading. The submission has to be rejec .....

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..... cture of goods has certain special advantages or that the technology has received wide approval both within the country and across the world or that it is the latest or the most modern does not by itself tantamount to disparagement of the products of another, unless the representations are demonstrably false or prove to be so. Disparagement, in our view, is a stronger word and a term of wider import than a simple claim to superiority by reason of technological break- through and the like. The expression, in our view, implied 'discrediting' or 'running down' or painting the products or others in black or grossly unfavourable light, directly or by necessary implication by making false and misleading assertions. 21. Judged from this angle, we do not think the respondents have not transgressed the limits of fairness or propriety in the context of the provisions of section 36A(1)( x ). 22. Before concluding we must add that the Commission has already ordered upon another complaint an enquiry against the impugned public issue. Any observations made herein should not, therefore, be construed as a pronouncement on the transparency or otherwise of the public issue - an aspect we wer .....

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