BAHOLA LABORATORIES Vs. UNION OF INDIA

JUDGEMENT

(1.) The above writ petition has been filed for the following reliefs:--

(2.) The petitioner is a manufacturer of homoeopathic medicine and claims to be as such from the year 1975. It is also claimed that homoeopathic medicines are manufactured as per the standards laid down by the Homoeopathic Pharmacopoeia of India, that the petitioner is holding a valid licence issued under Rule 85-B of the Drugs and Cosmetics Rules, 1945, hereinafter referred to as "the Rules" to manufacture homoeopathic medicine, that the licence is being renewed from time to time and that the current licence is valid upto 31.12.1996. The petitioner also claims to have obtained the licence under , Rule 139-A of the rules and the same was being renewed from time to time and the validity of the current licence is upto 31.12.1996. The further claim of the petitioner is that they are also manufacturing various medicines such as mother tinctures, dilutions, ointments, tablets, liquid preparations and eye preparations and that the mother tinctures is prepared by powdering a herb and mixing the same with nine parts of 95% ethyl alcohol in the manner set out in detail, which in my view, is not necessary to be referred to in such greater detail for the purpose of appreciating the grievance of the petitioner. The relevant fact that requires to be mentioned is that a dilution is said to be prepared by adding mother tincture with 89% of ethyl alcohol in the manner prescribed by the Homoeopathic Pharmacopoeia, that the sales of the petitioner is more than 60 lakhs per annum and 60% of the same is of mother tinctures and dilutions. The next fact that requires to be noticed is that all these years, the mother tinctures and dilutions are sold in a container of 540 ml, and the same is used to be sold to dealers, who in their turn, should also have a licence under Rule 57-C of the Rules. A general claim is also made that the entire industries generally pack mother tinctures and dilutions in bottles of 450 ml. for the reason that it will be most convenient for the manufacturers as also for the dealers and so far, there had been no complaint against the petitioner by anybody. The occasion for the filing of the above writ petition is said to be the letter dated 25.8.1994 communicated by the 5th respondent intimating the petitioner about the amendments to the rules of which Rule 106-B of the Rules is one which is being challenged now.

(3.) Rule 106-B of the Rules which is under challenge reads as hereunder:--