TRIDOSS LABORATORIES PVT. LTD. Vs. DRUG CONTROLLER

JUDGEMENT

(1.) Upon hearing the learned counsels, the Court made the following Order.

(2.) The petitioners in all the three Writ Petitions are Limited Companies duly incorporated under the Companies Act, 2013 and are engaged in manufacturing of Drugs in the State of Uttarakhand. Among other drugs, they also manufacture different compositions, wherein the Providone Iodine Ointment is used as 10% of the total volume of the Ointment/liquid.

(3.) It is the case of the petitioners that in the year 1972, the Central Drugs Standard Control Organization, which is a part of the Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India, approved Providone Iodine to be used as a ingredient containing 10% of the solution and Betadine Gargle containing 0.5% of the Providone Iodine. It also provided for Betadine Gargle Ointment containing 10 % of Providone Iodine. This approval has been granted by the Government of India in the month of November, 1972. However, on 6/1/2016, the Drugs Controller General of India, by virtue of Annexure-1, i.e. F. No. 04-01/2015-DC (Misc. 62), directed all the State Licensing Authority that the licenses (Product Permission) granted in favour of the manufacturers to produce the Ointment containing Providone Iodine containing 10% weight/weight (W/W) be cancelled and all the ointments be recalled from the market. It is further seen from the aforesaid circulars that it was brought to the notice of the Directorate that the Firms were manufacturing Providone Iodine Ointment 10% W/W. The Drugs Controller General of India was, therefore, of the opinion that the ointment containing Providone Iodine Ointment 10% weight/weight is not yet approved by the State Directorate, and the said formulation falls under the category of "new drugs" under Rule 122-B of the Drugs and Cosmetic Rules 1945. Therefore, the Controller General further directed that for its manufacture, all the applicants should submit Application Form-41 of the Drugs and Cosmetic Rules to the Central Directorate with requisite fees along with necessary documents of grant of approval. The Central authority mentioned in the Circular that grant of license without permission from the Licensing Authority under Rule 21(b) of the DCG (I) is in contravention of the Drugs and Cosmetic Act and Rules made there under as well as it would be loss of revenue of the Central Government. Therefore, in the interest of public Health, the licensing authority of the all the State were requested to cancel license (product permission) and recall all the ointments from the market.