- (1.) BY The Court.- Heard Shri Jitendra Narain Misra holding brief of Shri S.K. Kalia, learned counsel for the petitioner. Learned Standing Counsel appears for the respondents.
(2.) THIS writ petition is directed against the cancellation of the license given to the petitioner on Form 25-D under Rule 154 of the Drugs and Cosmetic Rules, 1945 made under the Drugs and Cosmetics Act, 1940 for manufacture of Ayurvedic medicines. The order was stayed by the Court. The counter and rejoinder affidavits have been filed by the parties. Brief facts giving rise to this writ petition are that a surprise inspection was caused at the manufacturing facility of the petitioner on 13.10.1998. The Minister of State Shri Ganga Bax Singh Ji; Dr. Raksha Goswami, Incharge Director, Ayurved and Unani Services Directorate, U.P. Lucknow; Shri R.P. Goswami, Joint Director, Ayurved Unani Services Directorate, U.P.; Shri Awadhesh Kumar Misra, Drug Inspector Headquarter, Ayurved Unani Services Directorate, U.P. Lucknow and Dr. R.C. Tripathi, Regional Ayurved Unani Officer, Kanpur were present at the time of inspection. The inspection report indicated that there was no board displayed outside the premises of the firm. Ms. Anuradha Vaish, engaged as technical expert of the firm was shown to be present in the attendance register but was absent. The other person Shri M.P. Shukla was also not present. There was no facility of 'yavkut' of medicines kept in the factory and that there was no facility to disinfect the containers of the medicines in the manufacturing facility. There was discrepancy in the stock register of the raw material and the stocks of raw material actually stored in the godown. The inspecting party took samples of medicines. The brass seals were put in the presence of Shri Radhe Lal Vaish, one of the partners of the firm. The inspecting party offerred the price of the samples to Shri Vaish but that he refused to accept it. The copy of the sample has been handed over to them. The details of the samples taken were given in Form 17 under Rule 56 and 145A to the partners of the firm.
(3.) A show cause notice dated 29.10.1998 was issued to the petitioner to reply within 15 days as to why the petitioner's license No.A1104/84 for manufacturing drugs be not cancelled on the ground (1) the premises in which the medicines were being manufactured did not have sufficient arrangement for cleanliness and there was no arrangement for disinfecting and drying of the containers, in violation of Rule 157 (1) of the Drugs and Cosmetics Rules, 1945; (2) the raw material of manufacturing medicines was not properly stored and there was no arrangement to identify them. The checking report of the raw material was not shown tot he inspecting officer to verify whether the 'kachchi aushadhia' were of requisite quality, thereby violating Rule 160 of the Drugs and Cosmetics Rules, 1945 and (3) an information was given that Km. Anuradha Vaish was engaged as technical staff in place of Vaidya Mahendra Prasad Shukla. On the documents made available at the time of inspection it was found that Km. Anuradha Vaish is a graduate in Chemistry and Botany but that her experience of manufacturing medicines was doubtful in as much as the certificate given by Shri Mahendra Prasad Shukla is dated 13th April, 1948 and in this manner the petitioner has not complied with Rule 157 (2) of the Drugs and Cosmetics Rules, 1945.;