IN THE HIGH COURT OF KERALA AT ERNAKULAM PRESENT : THE HONOURABLE MR. JUSTICE T.R.RAMACHANDRAN NAIR MONDAY, THE 17TH MAY 2010 / 27TH VAISAKHA 1932 OP.No. 14746 of 2002(E) ----------------------- PETITIONER: --------------- SECRETARY AYURVEDA SASTRA PARISHAD, IRINJALAKUDA, NOW AT VAIDYAPEEDAM AYURVEDA CHIKILSALAYA, P.O.CHITTOOR, PALAGHAT DISTRICT. BY ADV. SRI.K.S.MENON RESPONDENTS: --------------- 1. STATE OF KERALA, REPRESENTED BY THE SECRETARY, HEALTH AND FAMILY WELFARE, TRIVANDRUM. 2. UNION OF INDIA, REPRESENTED BY THE SECRETARY, MINISTRY OF HEALTH AND FAMILY WELFARE DEPARTMENT OF HEALTH, NEW DELHI. ADV. SRI.THOMAS MATHEW NELLIMOOTTIL FOR R2 GOVERNMENT PLEADER SHRI.A.J.VARGHESE FOR R1 THIS ORIGINAL PETITION HAVING BEEN FINALLY HEARD ON 17/05/2010, THE COURT ON THE SAME DAY DELIVERED THE FOLLOWING: OP.No. 14746 of 2002(E) APPENDIX PETITIONER'S EXHIBITS:- EXHIBIT P1 : Registration Certificate No.383/2002, dtd.17/4/2002. EXHIBIT P2: Notification dtd.23/6/2000. RESPONDENTS' EXHIBITS:- EXHIBIT R1(a): Notification No.SRO No.605/85 dt.1/4/1985. EXHIBIT R1(b): Notification of draft amendment rules. EXHIBIT R2(a): Judgment dtd.11/7/2002 of Hon'ble High Court of U.P., Allahabad in Civil Misc. W.P.26968/2002. True copy P.A. to Judge T.R.RAMACHANDRAN NAIR, J. ------------------------------------- O.P.No.14746 of 2002 -------------------------------------- Dated this the 17th day of May, 2010 JUDGMENT The petitioner challenges Ext.P2 notification issued by the second respondent bringing into force the Amendments of Drugs and Cosmetic Rules 1945. The same is titled, Drugs and Cosmetics Amendment Rules, 2000. 2. The petitioner claims to be Secretary, Ayurveda Sastra Parishad, Irinjalakuda. It is contented that the introduction of new Rules for manufacturing and sale of Ayurveda medicines in large scale by prescribing various conditions make it impossible for an ordinary physician to manufacture medicine and sell it. The system of Ayurveda, the petitioner contends, was existing from time immemorial and various practices have been developed from time to time which do not contemplate manufacture by using specific utensils. It is also pointed out that large investments will be required to comply with the provisions of the Rules. 3. The second respondent has filed a detailed counter affidavit. The necessity to frame the Rules has been explained therein. It is pointed out that due to the non availability of O.P.No.14746/2002 : 2 : uniform, fungus free, infection free and with different activities from company to company for sale in the country and export, introduction of minimum norms of Good Manufacturing Practices became unavoidable to the Government of India. It is pointed out that draft notification was submitted among all the stake holders, Ayurvedic Associations in different parts of the country for their comments. 4. It is explained in paragraph 5 that the physicians are not supposed to sell the drugs in open market, but to dispense to their patients based on the diagnosis of ailment. The requirements of manufacturing licence for the manufacturing of medicines to sell in the market was introduced long back in the Act and the physicians are exempted from very beginning which is still continuing and the Goods Manufacturing Practices is not applicable to physicians who prepare the Ayurveda, Siddha and Unani Drugs for their patients and not for sale in the Market. 5. Reliance is placed on Ext.R2(a) judgment of the Alahabad High Court. The challenge against the Rules has O.P.No.14746/2002 : 3 : been repelled by the said High Court. The State Government also has filed a detailed counter affidavit explaining various aspects. 6. It is clear from the averments in the counter affidavit that Ayurveda Practitioners who are not manufacturing any medicines are not covered by the Rules. It is therefore clear that manufacturing process and the norms for the same will not apply to such individual medical practitioners, who are not selling any medicines in the open market. As explained by second respondent it is clear that the apprehension of the petitioner that the medical practitioners will be prejudiced by the introduction of the Rules is not correct as the Good Manufacturing Practices do not apply to them. On that reason, the petitioner is not justified in raising such contentions. 7. It is clear that the Good Manufacturing Practices have been notified for ensuring quality of Ayurveda, Siddha, Unani medicines in the country. There should be uniformity as far as manufacturing methods are concerned. It is evident that the individual practitioners may be depending on the O.P.No.14746/2002 : 4 : medicines available in the open market for dispensing it to the patients. Therefore only in the interest of the patients also that the Rules have been framed to govern the manufacturing process. Viewed in that angle also the contentions raised by the petitioner cannot be accepted. 8. There is no proper contention that Central Government lacks power to frame Rules. The sufficiency of the power has been explained in the counter affidavit filed by the second respondent also. The possibility of misuse cannot be a ground to set aside a statutory rule. For all these reasons this writ petition is dismissed. No costs. T.R.RAMACHANDRAN NAIR, JUDGE skj