All Kerala Scientific and Surgical Dealers Association v. State of Kerala
2001-06-21
G.SIVARAJAN
body2001
DigiLaw.ai
ORDER :- The matter arises under the Poisons Act, 1919 (herein after referred to as the Act) and the Kerala Poisons Rules, 1996 (for short 'the Rules'). The petitioners are licensed wholesale dealers holding license for sale and distribution of poisons. They have challenged the provisions of the Kerala Poisons Rules, 1996 as violative of their fundamental rights. They have sought for quashing the said rules as also for a direction to the 1st respondent to modify the said rules in the light of the Kerala Poisons Rules, 1960. The petitioners are mainly aggrieved by the provisions of Rule 7 of the Rules requiring professionals and educational and scientific establishments to take permit from the Licensing Authority to obtain poisons from wholesale dealers for their own bona fide professional use or for the use in the institution or other establishment. According to them, the said rule is arbitrary and discriminatory and infringes their fundamental rights under Article 19(1)(g) of the Constitution of India. They also contend that the said rule has no nexus with the objects sought to be achieved. According to them, the said rule imposes a restriction on the right to purchase poisons by the professionals and educational and scientific establishments only from the wholesale dealers without a permit issued by the Licensing Authority and no permit is required for them to purchase poisons from retail dealers or from dealers outside the State. This rule, according to the petitioners, if implemented, will adversely affect their business, in that their professional and educational and scientific establishments who were purchasing poisons from the wholesale dealers in view of the requirement of taking permit, will not purchase poisons from wholesale dealers and will only purchase the same from retail dealers and outside dealers since there is no requirement for getting permit for such purchases. That apart, according to them the requirement of the aforesaid categories of persons may be sudden and unpredictable depending largely on the progress of their research and it may not be possible for them to approach the licensing authority for a permit to buy a particular poison or a preparation containing poison whenever the need for that item arise.
That apart, according to them the requirement of the aforesaid categories of persons may be sudden and unpredictable depending largely on the progress of their research and it may not be possible for them to approach the licensing authority for a permit to buy a particular poison or a preparation containing poison whenever the need for that item arise. In such circumstances, they may purchase poisons either from retail dealers or may approach dealers in other State to supply them with the necessary requirements resulting in a sharp decline in the business of the petitioners and other wholesale dealers. The petitioners have also alleged that many of the provisions in the Rules are ambiguous and some of them are impracticable also. It is further stated that dealers are facing difficulties in complying with certain stipulations in the Rules. It is further stated that though the All Kerala Scientific and Surgical Dealers Association, by a letter dated 24-7-1996, sought to bring to the notice of the Government the practical difficulties that will have to be faced by professionals, educational and scientific institutions in obtaining a permit and thus forcing them to approach dealers outside the State, adversely affecting the legitimate business interests of wholesale dealers within the State and which will also result in a fall of revenue to the State Government, no action has been taken by the Government of Kerala to mitigate the difficulties of the dealers of poisonous substances in the State nor have any steps been taken to clarify the ambiguities and uncertainties in the Kerala Poison Rules, 1996. 2. A counter-affidavit is filed on behalf of respondents 1 and 2. The reason for issuing the Poisons Rules, 1996 is stated as follows : The Poisons Rules, 1960 covered 127 substances and their preparations as poisons. The rules prescribed for licenses for possession for sale of poisons. The licenses were granted and renewed by the Drugs Control Department, initially, the Drugs Controller was the only licensing authority in the State. Later, in the seventies, the three regional offices were vested with the work and the three Regional Drugs Inspectors were notified as the licensing authorities. There were about 1000 licensees in the State at the end of 1995. Permits were also issued for legitimate use of poisons.
Later, in the seventies, the three regional offices were vested with the work and the three Regional Drugs Inspectors were notified as the licensing authorities. There were about 1000 licensees in the State at the end of 1995. Permits were also issued for legitimate use of poisons. Considering the fact that several provisions of the existing rules needed change, it was decided to substitute the Rules of 1960 with fresh rules. Prescribing very rigid conditions for selling poisons would place establishments like educational institutions, laboratories etc. in a disadvantageous position and concessions for sale to such establishments could pave way for illicit selling defeating the very purposes of the regulatory measures. The only way out was to adopt a system of issuing permit for such bona fide users. Such a provision existed in the Poisons Rules, 1960 also and the same provision was adopted with the modifications that separate form and fees were prescribed. A draft notification dated 14-11-1995 of the new rules was published in the Kerala Gazette Extraordinary dated 22-11-1995. After considering all the objections and suggestions in the matter, Government published the new rules under notification dated 13-3-1996 in the Kerala Gazette extraordinary dated 13-3-1996. The implementation of the new rules has already begun and retail and wholesale licenses have been granted to several applicants. Permits have also been granted to several establishments including educational institutions/Government institutions. There have been no complaints of delays or inactions leading to non-availability of essential items in educational institutions etc. Regarding the need for issuing the new rules it is stated that at the time when the old rules were made, the use of the poisons were limited and most of them were those handled by Chemists against the prescription of Registered Medical Practitioners, that with the growth of industries and trade, poisons also have found several applications and need different sale outlets, that the role of Registered Medical Practitioners and the Chemists in the matter became extinct, that most of the provisions of the Rules of 1960 especially Rules 11, 14, 16, 17, 18, 21 etc.
needed major changes and other rules also required timely modifications, that one of the poisons Methyl Alcohol commonly known as Methanol has several uses such as laboratory regent, industrial solvent etc., that though the material had no use as a drug, it was sold widely through medical shops to hospitals, clinics and other such establishments, that in spite of its highly hazardous nature, its use as an adulterant of liquors such as arrack also increased, that most of the liquor tragedies of the State are those caused by use of illicit liquor containing Methyl Alcohol and that Methyl Alcohol is a substance controlled by the Kerala Poisons Rules only. The 8th Subject Committee of the 9th Legislative Assembly took a serious note of these state of affairs and suggested that the rules should be amended suitably. It is further stated that Rule 13 of the 1960 Rules provided for issue of permits and that the 1996 Rules are also framed with the same object, but meant to help its application more purposeful. It is stated that the 1996 Rules provide for purchase of poisons from licensed wholesalers only, that the said rule does not provide purchase of poisons by permit holders from retailers, that if the rules of other States do not place restrictions in the sale of poisons, the permit holders could procure poisons from outside the State, but in such a case they would be violating the condition that they could procure the poisons from licensed wholesalers only. It is also stated that the averment that the permit holders could procure their requirements from retailers or from sources outside the State, has no merits and that the present provisions, in fact, would serve the interests of the petitioners better. The various averments regarding the impracticability, hardship and the ambiguity alleged by the petitioners arc denied in the counter-affidavit. It is further stated that there is no discriminatory provision which is disadvantageous to the wholesalers, that the wholesalers are at liberty to procure poisons from any source as no inter-State regulation is provided, that the retailers and permit holders can procure their requirements from licensed wholesalers only and that there is no reason to believe that the permit holders whom the petitioners themselves describe as responsible persons, would resort to unethical and illegal practices.
It is stated that the petitioners' Association has not made any petition to the Drugs Control Department in the matter, that the petitioners' Association being one of dealers of surgical items, members used to deal in Methyl Alcohol preparations known as 'SURGICOL', that in most of the liquor tragedies in the State it was this item which had been misused, that the new rules has placed this item in a separate group which enables better regulation, that the Police and Excise Departments are also vested with powers of inspection under the new rules and that there has so far been no report of any illicit sale of these items under the new rules. Most of the permit holders and license holders could be reputed persons and institutions also, but however, insisting such institutions and persons to obtain licenses and permits is not a measure either to curb their liberty or to question the honesty and integrity but is a measure to ensure that these persons and institutions do not fall prey to unscrupulous elements. If institutions and persons are exempted from the requirements of permits, unscrupulous elements could procure poisons from wholesalers including the petitioners in the name of such institutions and persons and they could also act as agents for supplying poisons such as methyl alcohol and chloral hydrates to unscrupulous elements in the name of sale to reputed institutions 3. Learned counsel appearing for the petitioners submits that the Kerala Poisons Rules of 1960 had been in force for a period of more than 35 years and that the provisions of the said Rules themselves contained stringent provisions for regulating the possession and sale of poisons. The counsel submits that the 1996 Rules caused stringent conditions regarding the possession and sale of poisons which does not have any rationale nexus with the objects sought to be achieved. The counsel further submits that Rule 7 of the Kerala Poisons Rules, 1996, which obliges the professionals and educational and scientific establishments to obtain permits from the Licensing Authority for purchase of poisons from the wholesale dealers for their own bona fide professional use or for use in the institution or other establishment, is an unreasonable restriction imposed which has adversely affected the business of the petitioners.
Counsel also submitted that many of the provisions are ambiguous, some of them are impracticable and the implementation of the new Rules causes great hardship to the petitioners and other dealers. 4. Sri K. Gopalakrishna Kurup, learned State Prosecutor appearing for the respondents submits that the new Rules are necessitated to meet the dealing of poisonous articles by unscrupulous elements and to prevent the liquor tragedies happening in the State. He submitted that as per the provisions of the new Rules, all licensed retail dealers, educational and scientific establishments and professionals can purchase poisons only from wholesale dealers in the State and therefore, there is no justification in the contention of the petitioners that the requirement of obtaining permits by professionals and educational and scientific establishments will adversely affect the business of the wholesale dealers. The State Prosecutor, on the basis of the averments in the counter-affidavit, further submits that if the professionals and educational and scientific establishments purchase poisons from outside the State and keep the same inside the State for their use, the same will be in violation of the Rules and that if the Rules of the outside State do not require any license for obtaining poison, the State Legislature is helpless in the matter. He finally submitted that if the petitioners have any suggestions in regard to the working of the new Rules, certainly it is for them to bring it to the notice of the Government in which case Government will certainly consider the same and take appropriate measures in that matter. 5. The Poisons Act, 1919 (a Central enactment) is for regulating the importation, possession and sale of poisons. Section 2 of the Act confers power on the State Governments to make rules for regulating within the whole or any part of the territories under its administration the possession for sale and the sale, whether wholesale or retail, of any specified poison. Sub-section (2) thereof provides that such rules may provide for the grant of licenses to possess any specified poison for sale, wholesale or retail, and fixing of the fee (if any) to be charged for such licenses; the classes of persons to whom alone such licenses may be granted; and the classes of persons to whom alone any such poison may be sold.
Section 8 gives power to the State Government to make rules generally to carry out the purposes and objects of the Act in addition to that contained in Section 2. It is in exercise of the powers conferred in State Government under Sections 2 and 8 of the Act the State Government had issued the Kerala Poisons Rules, 1960. Rule 4 of the said Rules provided that unless exempted under the provisions of the Act, no person shall sell or possess for sale- any poison specified in Schedule I except under and in accordance with the conditions of a license issued for such purpose by the Licensing Authority. However, the proviso to the said rule states that a person holding a valid license under the Dangerous Drugs Act. 1930 or the Drugs Act, 1940 and the rules issued thereunder shall not be required to take a license under these rules to sell or possess for sale any substance mentioned in Schedules E and H of the Drugs Rules, 1945 or any 'dangerous drugs' as defined in the Dangerous Drugs Act, 1930. Rule 14 provided that a license holder, shall not sell any poison to any person except, on the presentation of a prescription issued by a registered medical practitioner or on presentation of a permit issued by the licensing authority for the purchase of the poison or to a wholesale or retail licensee known to him personally. Rule 15 also provided that permits for legitimate use of poisons will be granted by the licensing authority, on presentation of a written application to the licensing authority setting forth the purpose of the purchase, names of poisons and the quantity of each such poison required. Rules 16 to 20 provide for the maintenance of registers by the license holder and the details to be entered in such register and the manner of keeping the poisons. The Kerala Poisons Rules, 1960 was substituted by the Kerala Poisons Rules, 1996. The experience in the implementation of the 1960 Rules and the nefarious use of poisons with the growth of industries and trade necessitated major-changes to the 1960 Rules and it is after due deliberation of the matter the 8th Subject Committee of the 9th Legislative Assembly took a serious note of the state of affairs then obtained and suggested that the rules should be amended suitably.
It was noted that one of the poisons, methyl alcohol commonly known as methanol, though the same has no use as a drug was sold widely through medical shops to hospitals, clinics and other such establishments and that its use as an adulterant of liquors such as arrack also increased. It was further noted that most of the liquor tragedies of the State are those caused by the use of illicit liquor containing methyl alcohol. A draft of the proposed rule was published in the Kerala Gazette Extraordinary dated 22-11-1995 and it is only after considering all the objections and suggestions received that the Government published the new rules - the Kerala Poisons Rule, 1996 - in the Gazette Extraordinary dated 13-6-1996. 6. The main contention of the petitioners, as already noted, is that Rule 7 of the Rules casts an obligation on the professionals and educational and scientific establishments to obtain permits from the licensing authority for purchasing poison from the wholesale dealers for their bona fide professional use or use in the institution or other establishment and that due to the said requirement, the professionals and educational and scientific establishments will be forced to purchase poison from the retail dealers and from outside the State, which affects the business of the wholesale dealers like the petitioners. In this context, it is relevant to refer to the other provisions of the Rules. Rule 2 (b) defines 'dealer' as a person or persons possessing a license for sale or distribution either retail or wholesale of poison and includes a firm or company or department or any other establishment. Rule 2 (e) defines license as a license issued by the Licensing Authority for retail or wholesale sale of poisons. As per Rule 2 (h), 'permit' means a permit issued by the Licensing Authority under Rule 7. Rule 2 (i) defines 'poison' as any substance specified in Schedule I or Schedule II or any substances claimed to or found to contain any of the substance specified in Schedule I or Schedule II. Rule 2 (j) defines 'retail sale or distribution' as sale or supply to a consumer and includes any supply otherwise than by wholesale. Rule 2(1) defines 'wholesale' as any sale or distribution for the purpose of resale or for further distribution and includes supplies to hospitals, dispensaries and educational or commercial establishments.
Rule 2 (j) defines 'retail sale or distribution' as sale or supply to a consumer and includes any supply otherwise than by wholesale. Rule 2(1) defines 'wholesale' as any sale or distribution for the purpose of resale or for further distribution and includes supplies to hospitals, dispensaries and educational or commercial establishments. Rule 3 provides that no person shall possess for sale or for distribution or sell any poison except under and in accordance with the conditions of a license issued for the purpose. Rule 5 provides for wholesale license and Rule 6 provides for retail sale license. Rule 7 provides for permits. Rule 8 deals with the forms of license and permits. Rule 9 deals with duration of license or permit and Rule 10 deals with the conditions for grant or renewal of a license or a permit. Schedule I contains a list of 3 items of poisons, viz., Chloral Hydrate, Cyanides and Methyl Alcohol. Schedule II contains a list of 113 items of poisons. As per Rule 3, no person shall possess for sale or for distribution or sell any poison except under and in accordance with the conditions of a license issued for the purpose. The license, as already noted, means a license issued by the Licensing Authority for retail or wholesale sale of poisons. The retail sale or the distribution, as already stated, means the sale or supply to a consumer and includes any supply otherwise than by wholesale. The wholesale, as already noted, means any sale or distribution for the purpose of resale or for further distribution and includes supplied to hospitals, dispensaries and educational or commercial establishments. 7. Now coming to Rule 7, it provides that the licensing authority may issue permits to enable professionals and educational and scientific establishments to obtain poisons from wholesale dealers for their own bona fide professional use or for use in the institution or other establishment. From a reading of the provisions of Rule 7, it would appear that if professionals and educational and scientific establishments have to obtain poisons from wholesale dealers for their own bona fide professional use or for use in the institution or other establishment, they have to obtain a permit from the licensing authority. The definition of wholesale includes supplies to hospitals, dispensaries and educational or commercial establishments. However, the definition of retail sale or distribution does not include the said categories.
The definition of wholesale includes supplies to hospitals, dispensaries and educational or commercial establishments. However, the definition of retail sale or distribution does not include the said categories. But, it would appear from the said definitions that there is no prohibition against the sale of poison to the categories specified in Section 7. However, the stand taken by the respondents in the counter-affidavit is that the professionals and educational and scientific establishments can obtain poison only from the wholesale dealers and that too by producing a permit obtained under Section 7 of the Rules. The petitioners also understand the position as above as could be seen from their own statements in the O.P. The petitioners' case is that because of the insistence of a permit for obtaining poison from wholesale dealers the professionals and educational and scientific establishments may resort to purchase poison from outside the dealers which will cause loss of business to the wholesale dealers and also loss of revenue to the State. The petitioners' further case is that there is no rationale in insisting for obtaining a permit by the aforesaid category of persons only and that such a requirement is arbitrary and violates Articles 14 and 19 of the Constitution of India. It must be noted that the Poisons Act, 1919 is enacted for regulating the importation, possession and sale of poisons and that the provisions of the Act (Sections 2 and 8) had given specific powers to the State Government to make rules for regulating the possession for sale and sale of poisons. It also provides for making rules for the classes of persons to whom alone any such poison may be sold. The Act also provides for making rules generally to carry out the purposes and objects of the Act. Admittedly Rule 7, which requires the professionals and educational and scientific establishments to get permit to obtain poison from wholesale dealers for their own use, is for the purpose of regulating the possession of poison which is one of the objects for which the Act is enacted. It is to give effect to the purposes of the said Act, the rules are issued.
It is to give effect to the purposes of the said Act, the rules are issued. In that view of the matter it cannot be said that Rule 7 of the Rules, which provides for obtaining permit by professionals and educational and scientific establishments for purchasing poison from wholesale dealers for their own use, is illegal or ultra vires. According to the respondents, such a rule was necessitated only as a measure to see that the persons and institutions mentioned in the said rule do not fall prey to unscrupulous elements who will procure poisons from wholesale dealers including the petitioners in the name of such institutions and persons. In the light of the liquor tragedies which have occurred by the use of methyl alcohol and chloral hydrate, the provision for permit for purchase of poisons from wholesale dealers is absolutely necessary to carry out the purposes of the Act. 8. The apprehension of the petitioners and other wholesale dealers of poison is that by the insistence of a permit for obtaining poison by professionals and educational and scientific establishments they may resort to purchase it from retail dealers, is without any factual foundation as stated by the respondents in their counter. The said categories of persons can purchase poison only from the licensed wholesale dealers. The retail dealers have also necessarily to purchase poison from the licensed wholesale dealers. So long as the provisions do not suffer from any of the vices pointed out by the petitioners, the fact that the implementation of such a provision will, in a way, affect the business of the petitioners or other wholesale dealers cannot be a ground for striking down the said provision. In the above circumstances, I do not find any merit in the O.P. However, if the petitioners feel that any hardship is being caused to the wholesale dealers or to the persons who are specified in Rule 7 of the Rules, certainly it is open to the petitioners to bring it to the notice of the Government so that the Government can consider the same and if necessary, to make appropriate modification to the rules. 9. Without prejudice to the above, this Original Petition is dismissed. 10.
9. Without prejudice to the above, this Original Petition is dismissed. 10. Immediately after the pronouncement of the judgment, the learned counsel appearing for the petitioners submits that members of the 1st petitioner Association are licensed wholesale dealers only under the 1960 Rules and that they did not take any license under the 1996 Rules in view of the stay order passed in the case. Counsel submitted that there was a stay of operation of the 1996 Rules till the disposal of this Original Petition. He accordingly submitted that some time may be given to the petitioners to obtain license under the 1996 Rules. I find that the submission is reasonable. 11. In the above circumstances, I grant two months' time to all the members of the 1st petitioner Association including petitioners 2 to 4 to obtain license under the 1996 Rules, if they are already licensed dealers under the 1960 Rules. No proceedings will be taken against those members on the ground that they are not licensees under the 1996 Rules, for two months. Petition dismissed.