(1.) This writ petition is instituted by M/s Indian Immunologicals Limited, a subsidiary company of National Dairy Development Board, questioning the legality and validity of the orders passed on 18.07.2011 by the third Respondent-Joint Director & Licensing Authority, Drugs Control Administration, Government of Andhra Pradesh, Hyderabad, canceling the drug manufacturing license of measles vaccine (Abhay-M) in exercise of power available under Rule 85(2) of the Drugs and Cosmetics Rules, 1945.
(2.) It is stated that the Petitioner was initially established in the year 1983 as a unit of the National Dairy Development Board exclusively for purpose of manufacturing "Foot and Mouth Disease Vaccine". National Dairy Development Board is created in terms of National Dairy Development Board Act, 1987. Subsequently, the Petitioner was incorporated as a company on 08.10.1999 under the provisions of the Companies Act, 1956, and it is a wholly owned subsidiary of National Dairy Development Board. The essential purpose for which the Petitioner company was incorporated was to manufacture and provide various types of vaccines and make them available to the community at an affordable price. The Petitioner company is said to be the second company in the world to develop and launch "Purified Vero Cell Rabies Vaccine". It is asserted that so far no product manufacture by the Petitioner company has come for adverse notice in respect of the standard quality composition thereof. It is stated that the Petitioner company has been granted a license on 16.09.2005 to manufacture various vaccines for utilization of human beings and for their distribution both in domestic market as well as abroad. Initially, the license has been granted for a period of five years valid up to 16.04.2011 and has renewal since been applied for, the Petitioner company is treated to have been granted the necessary renewal.
(3.) Only two companies in our country are stated to be the manufacturers of measles vaccine, one is the Petitioner and the other, a private company, Serum Institute of India (SII), Pune, Maharashtra State. From the year 2008 onwards, it is stated that the Petitioner company has been supplying the measles vaccine manufactured by it to the Central Government for implementing Universal Immunization Programme undertaken by it. It is stated that upon administering the measles vaccine on 21.08.2010, at Mohanlal Gunj, Lucknow, Uttar Pradesh State, four children died in quick time thereafter. It is stated that the Petitioner company has failed to inform this adverse circumstance to the licensing authority. However, the third Respondent along with several officers of the Drugs Control Administration of the State Government as well as officers of the Central Drugs Standard Control Organisation have conducted inspection of the facilities of the Petitioner company on 17.03.2011 and again from 21.03.2011 to 23.03.2011. This inspection followed another adverse event following immunization of measles vaccine in March 2011 at Gandhidham in Gujarat State. The inspection team appears to have noticed certain discrepancies in the manufacturing facility of the Petitioner company and left certain observations in the inspection notes, for securing corrective measures by the Petitioner company. Apart from sending the vaccine samples collected from the field, samples of vaccines available with the Petitioner have been collected by the inspection team and sent for testing at the Central Drug Testing Laboratory, Kasauli, Himachal Pradesh. In the meantime, pending receipt of the report from the Central Laboratory; the Drugs Inspector of the Drugs Controller Administration of Government of Andhra Pradesh issued orders on 17.03.2011 and 22.03.2011 in terms of Section 22(1)(c) of the Drugs and Cosmetics Act, 1940, directing the Petitioner company not to dispose of the stocks mentioned therein for a period of twenty days and subsequently the said period is extended. It is further averred that the third Respondent-Joint Director along with the officers of the Central Drugs Standard Control Organization along with a vaccine expert from the Central Drugs Laboratory, Kasauli, Himachal Pradesh have once again conducted inspection of the facilities of the Petitioner on 06.04.2011 and 07.04.2011. It is stated that no critical observations were noticed and no major departure from Good Manufacturing Practices (GMP) were noticed. However, certain observations have been made for making further improvement of the standards of manufacture of vaccines. However, the third Respondent-Joint Director, issued a show cause notice and served it on the. Petitioner on 08.04.2011 calling for the explanation of the Petitioner for various alleged violations mentioned in the said show cause notice. But, without waiting for the reply from the Petitioner, the third Respondent passed orders to stop production of vaccines by the Petitioner company exercising the power available under Rule 85(2) of the Drugs and Cosmetics Rules, 1945. At that stage, stung by the "Stop Production Orders", the Petitioner herein moved W.P. No. 10301 of 2011 and entertaining the said writ petition, this Court passed an order on 15.04.2011 suspending the operation of the "Stop Production Order" subject to the condition that the Petitioner company shall not however supply the vaccines manufactured by it. The Respondents in the said writ petition were directed to finalise the action after receipt of the explanation from the Petitioner company. The writ Petitioner has drawn its explanation on 16.05.2011 and submitted the same. Once again the Respondents 3 and 4 inspected the premises of the Petitioner on 15.06.2011 to 17.06.2011 and 20.06.2011. Thereafter, the impugned order signed' on 18.07.2011 has been served on the Petitioner on 19.07.2011, canceling the product drug manufacturing license of Measles Vaccine (Abhay-M) granted to the Petitioner earlier under Drug License in Form-28-D. Hence this writ petition has been filed.