1989 Supreme(MP) 738

IN THE HIGH COURT OF MADHYA PRADESH
V.D. GYANI, A.G. QURESHI, JJ.
Earnest & Co. (M/s.) – Appellant
Vs.
The Principal Secretary to Govt. of M.P. – Respondent
M. P. No. 1185 of 1988 (1)
Decided on : 18-07-1989

Headnote:Drugs and Cosmetics Act, 1940 – S.18 (a) (i) – drugs found of substandard on test – cancellation of manufacturing licence is legal.

        Short Note

       1. Drugs 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 'Assary' 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.

       2. As both these samples failed, the Director of Medical Health Services Manipur, informed the Drug Controller, Madhya Pradesh, requesting an action against the manufacturers of substandard drug. The petitioner was also informed of the reports received from the Central Drugs Laboratory.

       3. The Drug Controller of Madhya Pradesh, respondent No.2, issued notices, Annexures H and I dated 3 – 10 – 1987, calling upon the petitioner to show cause as to why his manufacturing licence should not be cancelled, In view of the aforesaid two test reports. The action was proposed under section 18 (a) (i) of the Drugs and Cosmetics Act, 1940. As no reply was submitted by the petitioner the respondent – Drug Controller, Madhya Pradesh respondent No.2. cancelled the petitioner's manufacturing licence, vide order dated 2 – 11 – 1987 (Annexures – K and L).

       4. The petitioner preferred an appeal to the State Government, which also stood dismissed under rule 85 (2) of the rules framed under the Act, vide order dated 10th of May, 1988. It is these orders, Annexures – K, L (dated 2 – 11 – 1987 passed by the Drug Controller) and the appellate order, which is the subject matter of challenge in this petition.

       5. Held: Counsel for the petitioner urged that (1) it could be due to time gap between the date of manufacture, taking of sample and analysis; improper maintenance and want of precautionary measures, could well have resulted in non – conformity of the sample to I.P. with respect to 'Assary' (2); No proper opportunity was given to the petitioner for showing cause, by the Licencing Authority; (3) Non – consideration of two rulings; 1970 JLJ S. Note 73 and 1970 JLJ 572, by the appellate authority.

       6. The first two points urged by the petitioner are closely inter – linked. If, as urged, there was any 'defect, either in maintenance of stock of medicine, it was for the petitioner to place such facts before the authority, who had issued the show cause notice. Admittedly, no such facts were placed before the Licencing Authority, the Drug Controller, as is evident from the orders, Annexures – K and L.

       7. The petitioner's case is that he wanted fifteen days time for submitting his reply to the show cause notice. Reference was made in this connection to Annexure – J. All that this letter says is that the petitioner was trying to find out certain relevant documents, which were misplaced. The show – cause notices dated 3 – 10 – 1987 Annexures – H and I, were admittedly received by the petitioner and even if that fifteen days time, as prayed for, is to be calculated, making all margin for receipt of the show – cause notices Annexures – H and I, there was enough time for the petitioner for submitting his reply to the show – cause notices, had he so intended, but what is evident from Annexure – J, the letter addressed to the Drug Controller, is that he expected acceptance of the request for extension of fifteen days time. Reasonable time was granted to the petitioner to file his reply to the show – cause notices, but he did not choose to file any.

       8. As for time gap, suffice, is to note that the life of drug in question was guaranteed for two years and the sampling and analysis was done within that period, far ahead of the date of expiry, no legitimate grievance can, therefore, be made on that count. It is not a case where the petitioner's licence has been cancelled without affording him an opportunity to show cause and even before the show – cause notices were issued. the petitioner was fully aware of the fact that the drug Ampicillin supplied by him was found to be sub – standard, as the Drug Inspector Manipur, Imphal, vide his letter dated 24 – 5 – 1986 Annexure – E, addressed to the Drug Controller, M.P. Bhopal, endorsing the same to the petitioner and letter dated 29 – 5 – 1986, Annexure – F, addressed to the petitioner and admittedly received by him, is evident from his letter dated 3 – 7 – 1986, Annexure – G. It was not something visited as a surprise. The ground of pilferage. or negligence in maintenance, which is now being urged, was also urged before the appellate authority and the same has been properly considered, as can be seen from the appellate order, Annexure – O. Opportunity was in fact given to the petitioner. It is wrong on the part of the petitioner to say that no proper opportunity was given for showing cause. It is he who did not avail of it. 1970 JLJ SN 73 and 1970 JLJ 572 distinguished.

       Petition dismissed.