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2010 DIGILAW 429 (MAD)

Dr. G. P. Hahnemann v. The Drug Controller of Tamil Nadu, Teynampet, Chennai & Others

2010-02-01

V.DHANAPALAN

body2010
Judgment : 1. Theprayer in the Writ Petition is for a Writ of Mandamus to forbear the respondents and their subordinate officials from interfering with the right of the petitioner to keep homeopathic dilutions in 500 millilitres pound pack. .2. According to the petitioner, he is a qualified Homeopathic Doctor and a member of the Central Council for Homeopathy. The said Council has been constituted by the Central Government. While so, the Central Government has amended Rule 106B of Drugs and Cosmetic Rules,1945 (hereinafter referred to as the Act) and in terms thereof, no homeopathic medicines containing more than 12% ethyl alcohol shall be packed and sold in packing or bottles more than 30 millilitres except that it may be sold to hospital / dispensaries in packing or bottles of not more than 100 millilitres. The said Rule was challenged by some of the Pharmaceuticals before the High Court of Allahabad and the High Court of Delhi and on 112. 2004, an order of interim stay was also granted initially by the High Court of Allahabad. It is also stated that in view of the amendment, the Drug Inspectors are conducting inspection and causing unnecessary harassment to Homeopathic Clinics and also Medical Shops. On inquiry, it was stated by the respondents that a legal notice was received from one Bhatia and Associates by the Drug Controller of Tamil Nadu and they have been instructed to carry out searches in all clinics and shops. .3. A counter affidavit has been filed by the respondents, in which it is stated that as per Rule 106B of the Act, packing and selling of more than 30 ml and 100 ml bottles of Homeopathic medicines containing more than 12% ethyl Alcohol is an offence under the Act. It is further stated in the counter affidavit that more than 12% ethyl alcohol may be misused as an alternative for alcoholic drinks and in order to save human lives from misuse of alcohol the amendment came to be passed. It is also stated that the issue in question went up to the Supreme Court and the same was dismissed. The relevant portion rendered in the case of R.S.Bhargava Pharmacy Vs. Union of India, reported in 2008(2) Drugs Cases 9DC0 509, is usefully extracted below:- .“...... It is also stated that the issue in question went up to the Supreme Court and the same was dismissed. The relevant portion rendered in the case of R.S.Bhargava Pharmacy Vs. Union of India, reported in 2008(2) Drugs Cases 9DC0 509, is usefully extracted below:- .“...... We have no hesitation in holding that the restriction placed upon the use of containers for sale of homeopathic medicines with more than 12% ethyl alcohol content and the same is a reasonable restriction and is intended to prevent misuse of such preparations by those who purchase the same across the counters. The experience of such preparations having been misused in the past leading to loss of valuable human lives was, in our view, sufficient for the rule making authority to act in public interest and regulate the sale of such medicines by stipulating that they would not be sold in containers more than 30 ml capacity. The rule, it is noteworthy, does not require such small containers to be used in case the supply is meant for hospitals and dispensaries in which event the packing of bottles could be of 100 ml also. Having regard to the purpose sought to be achieved by the Act and the Rules framed thereunder, the restriction contained in Rule 106B qua homeopathic medicines with more than 12% ethyl alcohol content cannot be said to be either unreasonable or otherwise violative of the rights guaranteed to the petitioners under Article 19(1)(g) of the Constitution. Our answer to question No.3 is in the negative. In the result, these petitions fail and are hereby dismissed without any order as to costs.” 4. Thelearned counsel for the petitioner would also submit that since the petitioner has already purchased Homeopathic medicines in 500 ml pound packs in view of the interim stay initially granted by the Allahabad High Court and Delhi High Court, at this length of time, the respondents should not conduct inspection in the guise of amendment of the Rule. These packs could neither be destroyed nor returned back to the parties concerned. However, in spite of the above, the respondents are not amenable to the request of the petitioner and they are invoking Rule 106B of the Act. These packs could neither be destroyed nor returned back to the parties concerned. However, in spite of the above, the respondents are not amenable to the request of the petitioner and they are invoking Rule 106B of the Act. Hence, the respondents should permit the petitioner to keep the same in the shelf as of now and the same should be permitted to be sold after the disposal of the Writ Petition. 4. 1. He would further submit that the respondents have no authority to carry out inspection in the petitioners premises without any power vested on them and it is the violation of statutory and fundamental rights guaranteed under Article 19(1)(g) of the Constitution of India. In any event, they can have no power to search and seizure without any written orders by the competent authorities. .5. Per contra, the learned Special Government Pleader has refuted the above contentions of the learned counsel for the petitioner and he has submitted that there is no search and seizure as alleged by the petitioner. The Drug Inspector is empowered under Section 22 of the Drugs and Cosmetic Act 1940 to carry out necessary inspection for the enforcement of the Act. The amendment has been made in the interest of public and the respondents are bound to implement the rule of amendment in letter and spirit. Misuse of the Homeopathic medicines made of alcohol for any other purpose than medicinal cure will have serious consequences in human lives. He would emphasis the fact that judgments of the High Court referred to above, will bind on the petitioner and therefore, prima facie, no case is made out by the petitioner and the Writ Petition is liable to be dismissed. .I have considered the submissions on either side and perused the materials available on record and the documents annexed in the typed set of papers and also analysed the relevant provisions of law. 6. The analysis of the fact would reveal that the Central Government has amended Rule 106B of Drugs and Cosmetics Rule 1945 and as per the amendment, no homeopathic medicines containing more than 12% ethyl alcohol shall be packed and sold in packing or bottles more than 30 millilitres except that it may be sold to hospital / dispensaries in packing or bottles of not more than 100 millilitres. Aggrieved by the same, some of the pharmaceuticals challenged the said amendment before the High Court of Delhi and High Court of Allahabad. It is the case of the petitioner that the Drug Inspectors are conducting inspection and causing unnecessary harassment to Homeopathic Clinics and also Medical Shops. It was informed to the petitioner that a legal notice was received from one Bhatia and Associates by the Drug Controller of Tamil Nadu and they have been instructed to carry out searches in all clinics and shops. It is also stated that they had already purchased the homeopathic medicines containing more than 12% ethyl alcohol due to the interim stay order of the High Courts. However, the contention was refuted by the learned counsel for the respondents on the premise that they would misuse of alcohol and in order to safeguard the human lives the Central Government with an avowed object has passed the present amendment. 7. While hearing the matter, the learned counsel on either side have produced a copy of the judgment reported in 2008(2) Drugs Cases (DC) 509, in the case of R.S.Bhargava Pharmacy Vs. Union of India and would submit that the issue involved in this Writ Petition came up before the High Court of Delhi and the High Court of Delhi has gone into the issue in detail, including the constitutional validity of the Rule and scanned various judgments in this regard and ultimately dismissed those writ petitions. The learned counsel for the petitioner also fairly submits that the orders in the above case went against him and submits that he had the knowledge of the order of the High Court of Delhi. Therefore, the benefit of the orders to give protection does not arise at this point of time. .8. Coming to the question of jurisdiction, as rightly contended by the learned Special Government Pleader, as per Section 22 of the Act, the respondents have every right to carry out inspection in view of the amendment in Rule 106B of the Act. It is to be noted that the said amendment came to be passed in the interest of public at large and the same cannot be questioned by the petitioner at any cost. 9. Though the petitioner claims that such homeopathic medicines containing more than 12% ethyl alcohol was purchased several months ago, the petitioner did not disclose the actual date of such purchase. 9. Though the petitioner claims that such homeopathic medicines containing more than 12% ethyl alcohol was purchased several months ago, the petitioner did not disclose the actual date of such purchase. The petitioner wants to keep 500 ml pack in their shelf. But as per the condition of licence in Form 20C & 20D of the Drugs and Cosmetics Act 1940 and the Rules 1945, licence is required to sell, stock or exhibit or offer for sale or distribute homeopathic medicine by retail or wholesale agencies. Hence, the request of the petitioner that they should be permitted to keep in the shelf cannot be permitted, as it is in violation of the Act. The judgment was delivered as early as in the year 2008 itself and the same is binding on them. 10. Apart from that, it is pertinent to note that it is not as if the order came to be passed without considering the relevant facts and circumstances of the case. In fact, in the case of Ramakrishna Pharmaceuticals Vs Union of India and others made in W.P.No.21636 of 1994, the High Court of Andhra Pradesh held that the Rule 106B was ameneded on the recommendations of the Sub-Committee of the Board, which comprised of Advisor (Homeopathy) as a Special Invitee and thereafter, the order came to be passed. Therefore, this Court is in entire agreement with the judgments rendered by both High Courts. 11. The Constitution of India mandates that the right to carry on any trade, occupation or profession guaranteed under Article 19(1)(g) of the Constitution is not absolute in terms. Reasonable restrictions can be placed upon the said right in the interest of general public. It is also significant to note that the rights under Article 19(1) are not absolute but qualified. The qualifications are stated in Clauses (2) to (6) of Article 19. The fundamental rights guaranteed in Article 19(1)(a) to (g) are, therefore, to be read along with the said qualifications. Even the rights guaranteed under the Constitutions of the other civilized countries are not absolute, but are read subject to the implied limitations on them. Those implied limitations are made explicit by Clauses (2) to (6) of Article 19 of our Constitution. 12. Even the rights guaranteed under the Constitutions of the other civilized countries are not absolute, but are read subject to the implied limitations on them. Those implied limitations are made explicit by Clauses (2) to (6) of Article 19 of our Constitution. 12. It is pertinent to note that clause (6) of Article 19 protects a law which imposes in the interest of general public a reasonable restriction on the exercise of the right conferred by sub-clause (g) of clause(1) of Art.19. In case of dispute to determine the reasonableness of the restriction imposed by the law. In determining that question, this Court cannot proceed on a general notion of what is reasonable in the abstract or even on a consideration of what is reasonable from the point of view of the person or persons on whom the restrictions are imposed. The right conferred by sub-clause (g) is expressed in general language and if there had been no qualifying provision like clause (6), the right so conferred would have been an absolute one. To the person who has this right any restriction will be irksome and may well be regarded by him as unreasonable. But the question cannot be decided on that basis. What the Court has to do is to consider whether the restrictions imposed are reasonable in the interests of the general public. 13. The expression reasonable restriction signifies that the limitation imposed on a person in enjoyment of the right should not be arbitrary or of an excessive nature, beyond what is required in the interests of the public. The test of reasonableness, wherever prescribed, should be applied to each individual statute impugned and no abstract standard, or general pattern of reasonableness can be laid down as applicable in all cases. The restriction which arbitrarily or excessively invades the right cannot be said to contain the quality of reasonableness and unless it strikes a proper balance between the freedom guaranteed in Article 19(1)(g) and the social control permitted under Article 19 (6). 14. The restriction which arbitrarily or excessively invades the right cannot be said to contain the quality of reasonableness and unless it strikes a proper balance between the freedom guaranteed in Article 19(1)(g) and the social control permitted under Article 19 (6). 14. Inthe instant case, the power to legislate with regard to intoxicating liquor carries with it the power to regulate the manufacture, sale and possession of medicinal preparations containing alcohol, not for the purpose of interfering with the right of citizens in the matter of consumption or use for bona fide medicinal preparations but for preventing intoxicating liquors from being passed on under the guise of medicinal preparations. It was within the competence of the legislature to prevent the noxious use of such preparations. 15. The Supreme Court considered the issue in question in Southern Pharmaceuticals and Chemicals, Trichur and others vs. State of Kerala and others, AIR 1981 SC 1863 and held as follows:- “The power to legislate with regard to intoxicating liquor carries with it the power to regulate the manufacture, sale and possession of medicinal preparations containing alcohol, not for the purpose of interfering with the right of citizens in the matter of consumption or use for bona fide medicinal and toilet preparations, but for preventing intoxicating liquors from being passed on under the guise of medicinal preparations. It was within the competence of the State legislature to prevent the noxious use of such preparations, i.e.their use as a substitute for alcoholic beverages” Similarly, the Delhi High court has also taken note of the above ruling of the Supreme Court and dismissed the Writ Petition. 16. The above position has been carefully considered by the Supreme Court in various decisions holding that the restriction placed upon the use of containers for sale of homeopathic medicines with more than 12% alcohol content in the same is reasonable restriction and is intended to prevent misuse of such preparations by those who purchase the same across the counters. The experience of such preparations having been misused in the past leading to loss of valuable human lives was considered by the Supreme Court as well as by various High Courts as stated supra. Therefore, the rule making authority to act in public interest and to regulate the sale of such medicines by stipulating that they should not be sold in containers more than 30ml capacity. 17. Therefore, the rule making authority to act in public interest and to regulate the sale of such medicines by stipulating that they should not be sold in containers more than 30ml capacity. 17. Therefore, the power of the respondents to implement the law laid down by the legislature with an intend to protect the public interest and to regulate the sale of such medicines with 30 ml capacity to be used in case the supply is meant for hospitals and dispensaries in which event the packing of bottles could be 100 ml also. 18. In view of the above and having regard to the purpose sought to be achieved by the Act and the Rules framed thereunder, the restriction contained in Rule 106B and the action taken thereon by the respondents that qua homeopathic medicine with more than 12% alcohol content cannot be said to be either unreasonable or otherwise violative of the right guaranteed to the petitioners under Article 19(1)(g) of the Constitution. Therefore, the action of the respondents cannot be faulted with and the Writ Petition deserves no consideration and the same is liable to be dismissed. 19. In the light of the enlightened judgments of the Supreme Court reported in AIR 1981 SC 1863 , Southern Pharmaceuticals and Chemicals, Trichur and others vs. State of Kerala and others and the decision of the Delhi High Court reported in 2008(2) Drugs cases (DC) 509, R.S. Bhargava Pharmacy Vs Union of India, I have no hesitation to hold that the respondents have acted in accordance with law and the same does not call for interference by this Court. In the absence of any prohibition, the authority is well under his powers to conduct search and seizure. Therefore, the prayer sought for in this Writ Petition cannot be granted and the Writ Petition is liable to be dismissed. 20. Inthe result, the Writ Petition stands dismissed. Consequently, connected M.Ps are closed. No costs.