EARNEST AND COMPANY Vs. THE PRINCIPAL SECRETARY TO GOVT. OF M.P., PUBLIC HEALTH AND FAMILY WELFARE AND ORS.

JUDGEMENT

(1.) The petitioner is a drug manufacturing company. In 1985, vide supply order dated 6.3.1985, the Director General Supplies and Disposals placed an order for supply of five lacs of Ampicillin Capsules, which were supplied by the petitioner, vide Batch Nos. 96 and 97, manufactured in April 19S5, with life guarantee of two years expiring in April 1987 (See Annexures-A & B, filed and relied upon by the petitioner). According to the petitioner, this bulk was air-lifted to Gauhati on 20.5.1985

(2.) Drug Inspector, Manipur, Imphal, drew a sample from Batch No. 96 on 3.8.1985 It was sent for analysis to the Government of India Drug Laboratory, Calcutta, and the Government Analyst submitted his report, Annexure C, stating that the sample was not of standard quality, as it did not conform to I.P. With respect to ' Assay" which was found to be 73.3% of the claim of 250 mg. with a varying limit of 92.5 to 107.5%. A similar report, Annexure-D, was submitted by the Government Analyst, Central Drug Laboratory, Calcutta, in respect of yet another sample taken by the Drug Inspector, Manipur, Imphal, from Batch No. 97 of 21.5.1986.

(3.) As both these samples failed, the Director of Medical Health Service, Manipur, informed the Drug Controller, Madhya Pradesh, requesting an action against the manufacturers of sub-standard drug. The petitioner was informed of the reports received from the Central Drugs Laboratory.