Letters Patent Appeal No.183 OF 2008 (Being aggrieved by and dissatisfied with the Judgment and order dated 21.1.2008 passed by a learned Single Judge in C.W.J.C. No. 15284 of 2006.) 01. GAYA ZILA AUSHADHI NIRMATA KALYAN SANGH THROUGH ITS SECRETARY SHRI KAILASHPATI SHARMA, ANAND PRINTING PRESS (NEAR SHYAM TALKIES), MANPUR, GAYA. 02. KAILASHPATI SHARMA, S/O SHRI SHIDHI SHARMA, SECRETARY, GAYA ZILA AUSHADHI NIRMATA KALYAN SANGH, ANAND PRINTING PRESS (NEAR SHYAM TALKIES), MANPUR, GAYA ----------------PETITIONERS/APPELLANTS Versus 01. THE STATE OF BIHAR 02. MINISTER, HEALTH-CUM-APPELLATE AUTHORITY, GOVERNMENT OF BIHAR 03. STATE DRUG CONTROLLER-CUM-CHIEF LICENCING AUTHORITY, BIHAR, DIRECTORATE OF HEALTH SERVICES (EURG CONTROL ADMINISTRATION), PATNA. 04. DRUG INSPEPCTOR, (WHOLE SALE & MANUFACTURING) GAYA. 05. THE UNION OF INDIA, THROUGH THE SECRETARY, MINISTRY OF AGRICULTURE, DEPARTMENT OF ANIMAL HUSBANDARY, DAIRYING AND FISHERIES, KRISHI BHAWAN, NEW DELHI. 06. THE DRUG CONTROLLER GENERAL OF INDIA, DIRECTORATE GENERAL OF HEALTH SERVICES MINISTRY OF HEALTH & FAMILY WELFARE, NIRMAN BHAWAN, NEW DELHI-11. ---------------(RESPONDENTS) For the Appellants:- Mr Vinod Kumar Kanth, Sr. Advocate & Mr. Alok Anand, Advocate For the Respondents:- None - 2 - P R E S E N T THE HON'BLE MR. JUSTICE CHANDRAMAULI KUMAR PRASAD THE HON'BLE DR. JUSTICE RAVI RANJAN Prasad & Ranjan, ACJ,J. Writ petitioners/appellants, aggrieved by the order dated 21.1.2008 passed in C.W.J.C. No. 15284 of 2006 dismissing the writ application have preferred this appeal under Clause-10 of the Letters Patent. Short facts giving rise to the present appeal are that the writ petitioners-appellants, hereinafter referred to as the petitioners, are registered cooperative society of Drugs and Medicines Manufacturers at Gaya in the State of Bihar. Besides other medicines, they also manufacture Oxytocin for veterinary use. By notification dated 3rd of April, 2001, third proviso was added to Rule 105(2) of the Drugs and Cosmetics Rules, 1945, providing for packing of Oxytocin injection in single unit blister pack. In the writ application they had challenged the validity and applicability of the third proviso aforesaid to Oxytocin injection. It was contended before the learned Single Judge that third proviso, in sum and substance excludes the application of the first proviso, so far as the Oxytocin injection is concerned and in the face of it, third proviso - 3 - shall not cover Oxytocin injection intended for veterinary use but it shall be covered by first proviso. The learned single Judge has negatived this contention in the following words:- “In my view, the two principles that would normally apply would be that if injectables were contemplated in the earlier substantive part of the rule then the third proviso would be an exclusion from exclusion. The first proviso excludes to veterinary medicines. The third proviso excludes by implication the exclusion of veterinary medicines in so far as a single drug Oxitocin is concerned. The second principle that would equally apply that a specific mention of a special condition excludes the application of general conditions. Here, what is being taken out from the application of Rule 105 is a special drug Oxitocin in injectable form. The general exception would thus stand curtailed to the said extent. Even it substantive parts of Rule 105 were to apply to Oxitocin injectables, the same would be excluded by virtue of the third proviso. Third proviso is an exception to the exception - 4 - as provided in the first proviso. In my view, the submission that third proviso, when it deals with Oxitocin, should be limited to Oxitocin meant for human use only would be rewriting the proviso a power which this Court lacks. It is for the legislature to amend the provision. In my view, the third proviso cannot be limited in its application because Oxitocin injection meant only for human and inapplicable so far as veterinary usage is concerned.” (Underlining ours) Mr. V.K. Kanth, Senior Advocate appearing on behalf of the appellants contends that insertion of the third proviso in Rule 105 (2) of the Drugs and Cosmetics Rules, 1945, hereinafter referred to as the Rules is beyond the rule making power conferred under Section 33 (2) (i) of the Drugs and Cosmetics Act, 1940, hereinafter referred to as the Act. He contends that Section 33 (2) (i) of the Act inter alia confers the power to make rules in respect of the packing material which comes into direct contact with the drugs and blister pack required to be done in the case of Oxytocin injection does not come with direct contact - 5 - with the drugs and, therefore, it is beyond the rule making power. Section 33 (2) (i) of the Act which is relevant for the purpose reads as follows:- 33. Power of central government to make rules:- (1) x x x x x (2).Without prejudice to the generality of foregoing power, such rules may:- x x x x x “Prescribe the conditions to be observed in the packing in bottles, packages, and other containers of drugs [or cosmetics], [including the use of packing material which comes into direct contact with the drugs] and prohibit the sale, stocking or exhibition for sale, or distribution of drugs [or cosmetics] packed in contravention of such conditions; x x x x x From the plain reading of aforesaid provision it is evident that the rule may prescribe the conditions to be observed in packing and that includes the use of packing material which comes under the direct contact with the drugs. Thus it includes the material which comes under the direct contact with the drugs but does not exclude the - 6 - material which does not come in contact thereof. In our opinion it would not mean that such of the other materials which are used in packaging of Oxytocin injection cannot be prescribed by the Rules. Accordingly, we negative this submission of Mr. Kanth. Mr. Kanth, then draws our attention to Item No.3 of the first proviso of Rule 105 (2) of the Rules and contends that Oxytocin injection intended for veterinary use is covered under first proviso to Rule 105(2) of the Rules and hence the third proviso providing for single unit blister packing of Oxytocin injection shall succumb to the first proviso. In support of the submission reliance has been placed on the decisions of the Supreme Court in the case of Dwarka Prasad Versus Dwarka Das Saraf, AIR 1975 SC 1758. Our attention has been drawn to the following passage from the said judgment:- x x x x x “A proviso must be limited to the subject matter of the enacting clause. It is a settled rule of construction that a proviso must prima facie be read and considered in relation to the principal matter to which it is a proviso. It is not a separate or independent enactment. „Words are dependent on the principal enacting words, to which they are taked as a proviso. They cannot be read as - 7 - divorced from their contexts‟ (1912 A.C. 544). If the rule of construction is that prima facie a proviso should be limited in its operation to the subject matter of the enacting clause, the stand we have taken is sound. To expand the enacting clause, inflated by the proviso, sins against the fundamental rule of construction that a proviso must be considered in relation to the principal matter to which it stands as a proviso. A proviso ordinarily is but a proviso, although the golden rule is to read the whole section, inclusive of the proviso, in such manner that they mutually through light on each other and result in a harmonious construction.” x x x x x Reliance has also been placed in the case of Mohan Kumar Singhania and Others Versus Union of India and Others, 1992 Supplementary (1) SCC 594, in which it has been held as follows:- “In conclusion, we hold that the second proviso to Rule 4 of CSE Rules does not travel beyond the intent of the main rule putting any unjustifiable embargo and that the proviso is not ultra vires Regulation 4 (iii-a) of Regulations, 1955 on the ground it makes the candidates ineligible who are otherwise eligible in terms of clauses (i) to (iii) of the said Regulation and that the proviso to Rule 17 is not invalid.” We do not find any substance in this submission of Mr. Kanth also and the authority relied on in no way supports his contention. Rule 105 of the Rules which is - 8 - relevant for the purpose reads as follows:- “105- packing of drugs- (1) x x x x x (2) The pack sizes of drugs not covered by the Schedule P1 shall be as given below: Unless specified otherwise in Schedule P1, (i) The pack sizes for Tablets/Capsules shall be- Where the number of Tablets (coated or uncoated)/ Capsules (hard or soft gelatine) is less than 10, such packing shall be made by the integral number. For numbers above 10, the pack sizes of Tablets/Capsules shall contain multiples of 5. (ii) The pack sizes for liquid Oral preparations shall be 30 ml. (paediatric only) 60 ml. /100 ml./200 ml. /450 ml. (iii) The pack sizes for paediatric Oral Drops shall be 5 ml./10 ml./ 15 ml. (iv) The pack sizes for Eye/Ear/Nasal Drops shall be 3 ml./5 ml./ 10 ml. (v) The pack sizes for Eye Ointment shall be 3 gm/5 gm / 10 gm:” Provided that the provisions of the pack sizes covered under this rule shall not apply to – 1. Pack sizes or dosage forms not covered by the foregoing provisions of this rule. 2. The imported formulations in finished form. 3. Preparations intended for Veterinary use. 4. Preparations intended for Export. 5. Vitamins/Tonics/ Cough Preparations / Antacids/ Laxatives in Liquid Oral forms, Unit dose (including applicaps). 6. Pack sizes of dosage forms meant for retail sale to Hospitals, Registered - 9 - Medical Practitioners, Nursing Homes. 7. Physician‟s Samples. 8. Pack sizes of Large Volume intravenous Fluids: Provided also that pack sizes of any of the new drug as and when approved by the licensing authority appointed under Rule 21 and if not covered under this rule, shall be examined for the purpose of approval with specific justification by the said licensing authority.] [Provided further that Oxytocin injection meant for sale shall be in single unit blister pack only.]” First proviso to Rule 105 (2) of the Rules provides that provisions of the pack sizes covered under this Rule shall not apply to preparation intended for veterinary use. In our opinion the first proviso operates in the field of pack-size whereas the third proviso provides for the manner in which Oxytocin injection meant for sale is to be packed. The third proviso, therefore, cannot be said to be repugnant to first proviso. The purpose of proviso is varied and ordinarily its purposes are as follows:- “(1) qualifying or excepting certain provisions from the main enactment; (2) it may entirely change the very concept of the intendment of the enactment by insisting on certain mandatory conditions to be fulfilled in order to make the enactment workable; - 10 - (3) it may be so embedded in the Act itself as to become an integral part of the enactment and thus acquire the tenor and colour of the substantive enactment itself; and (4) it may be used merely to act as an optional addenda to the enactment with the sole object of explaining the real intendment of the statutory provision.” When we apply the principle aforesaid in respect of the third proviso to the Rule there is no difficulty in holding that it is integral part of the rule and has the tenor and colour of substantive provision Now referring to the decisions relied on by the petitioners, same in no way support the contention. In the case of Dwarka Das (Supra) the Supreme Court has observed that “golden rule is to read the whole section, inclusive of the proviso in such manner that they mutually throw light on each other and result in a harmonious contention. What is being suggested by the petitioners is to ignore the third proviso altogether, which is against the very principle of interpretation. As regards the judgment of the Supreme Court in the case of Mohan Kumar Singhania (Supra), we are of the opinion that same instead of supporting the petitioner‟s case goes against them. In - 11 - this case a proviso making candidates ineligible otherwise eligible has been held to be valid in law. Mr. Kanth, lastly, submits that there is no rational of providing single unit blister pack for Oxytocin injection. According to him petitioners make Oxytocin in single unit glass container and providing blister packing over the same would not serve any purpose. The rule making authority which has power to make rule on consideration of the material had inserted the proviso. It is well settled that the Court in exercise of power of judicial review shall not hold a rule to be irrational and strike it down, only on the ground that a rule providing for more rational conditions ought to have been made. It does not appeal to us that single unit blister packing does not serve any purpose. It will surely prevent the unscrupulous person to tamper with Oxytocin injection. This Court in exercise of power of judicial review will not go into the wisdom behind making the said Rule, unless it is shown that the Rule made is palpably arbitrary. The rule in question does not come within the aforesaid exception. We are of the opinion that the learned - 12 - Single Judge has not committed any error while dismissing the writ application. We do not find any merit in the appeal and it is dismissed accordingly. Patna High Court Dated 6th day of January, 2009 P.K./A.F.R. (Chandramauli Kr. Prasad, ACJ.) (Dr. Ravi Ranjan, J.)