COMMON CAUSE Vs. DRUG CONTROLLER OF INDIA

JUDGEMENT

(1.) In pursuance of the directions issued by us on the last date of hearing of this case, the Ministry of Health and Family Welfare, Government of India constituted an Expert Committee to review the provisions of the existing Drugs & Cosmetics Act and Rules as well as the administrative set up for the purpose of ensuring the quality and safety of Intra-Venous Fluids. Mr. H.K Saxena, learned Advocate appearing on behalf of the Drug Controller of India placed before us today a copy of the report prepared by the Expert Committee. It contains the recommendations of the committee as to the steps to be taken for achieving the goal of protecting the public against any possibility of contamination of I. V. Fluids which are either marketed for sale in pharmaceutical shops or supplied to hospitals for administering to patients Shri H.D Shourie appearing on behalf of the petitioner stated before us, with his usual fairness, that by and large, the recommendations of the committee if effectively implemented by the Central and State Governments will go a long way to ensure the safety and quality of I. V. Fluids. Mr. Saxena assures us on behalf of the Drug Controller of India that the Government of India would take all necessary effective action through the Central Drug Control set up and it also will take all possible steps to see diet all the State Government too implement the recommendations of the Expert Committee without delay.

(2.) Mr. Shourie drew our attention a document which he produced before us today a copy of a circular dated 20th April, 1989 issued by the Drug Controllers of India to all the Drug Controller of the State Governments-the contents of which go to show that the existing strength of the field staff of the inspectorate wings of the Drugs Control Organizations in various states is woefully inadequate having regard to the enormous increase both in the number of Drug formulations which are marketed and in the number of drug manufacturing units and outlets which have come into existence during the last 10 years. We feel greatly concerned that such an unsatisfactory state of affairs should exist in our country with respect to a matter which is of such fundamental importance and vital concern to the health, life and safety of the people. We are making this observation in the hope that it will alert to the Government and State Government the need for taking immediate action to remedy the situation by augmenting the strength of the drug control staff at the different level in each state and also to provide adequate laboratory facilities in every state for testing the quality and potency of drugs.

(3.) The assurance given to us by Shri Saxena on behalf of the Government of India concerning the steps which the Government of India will take to implement the recommendations contained in the report of the Expert Committee and to ensure that similar action is also taken by different State Governments is hereby recorded.