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2014 DIGILAW 262 (KAR)

State of Karnataka v. Anchor Pharma Private Limited

2014-02-28

N.ANANDA

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JUDGMENT N. Ananda, J. 1. The respondents (accused 1 to 3) were tried for contravention of Sections 18-A and 27-A of the Drugs and Cosmetics Act, 1940 (for short, "the Act") and they were acquitted. I have heard learned Government Advocate for the State and learned Counsel for accused. 2. It is the case of prosecution that first accused being the manufacturer, second accused being the manufacturing chemist of first accused and third accused being the Analytical Chemist and Quality Control Manager of first accused namely M/s. Anchor Pharma Private Limited, Daman had manufactured prochloperazine tablets bearing Batch No. A2/094 M/D: 11/02 E/D: 10/05 and they were of sub-standard quality. The Assistant Controller of Drugs Udupi Circle purchased the aforestated drugs from M/s. Prabhu Pharma, situated at Business Complex, behind CPC, Udupi on 16-6-2003 and sent the samples for chemical examination and found that tablets manufactured by accused 1 to 3 are not of standard quality. 3. The learned Trial Judge has held that the Assistant Controller of Drugs who had purchased the alleged sub-standard drugs from M/s. Prabhu Pharma had not followed the mandatory provisions of Section 23 of the Act. Therefore, accused were deprived of getting the sample tested from the Central Laboratory. 4. As could be seen from the evidence of P.W. 2-K. Nagaraj, who at the relevant time was working as the Assistant Controller of Drugs and who had purchased the prochloperazine drugs from M/s. Prabhu Pharma on 16-6-2003, we find that, along with the report he had not sent one of the samples to the accused who are alleged to have manufactured sub-standard drugs. 5. In a decision in the case of M/s. Agarwal Medical and General Stores vs. State of Madhya Pradesh and Others, AIR 1973 MP 255 (DB), a Division Bench of Madhya Pradesh High Court has held: "22. As regards the second contention, Section 23(3) lays down the procedure for obtaining a sample for the purpose of test or analysis. A part of the sample has to be supplied to the person whose name, address and other particulars are disclosed under Section 18-A. As required by sub-section (4)(iii) of this section, read with Section 18-A, it was the duty of the Drugs Inspector to supply to the petitioner the third portion of the sample. A part of the sample has to be supplied to the person whose name, address and other particulars are disclosed under Section 18-A. As required by sub-section (4)(iii) of this section, read with Section 18-A, it was the duty of the Drugs Inspector to supply to the petitioner the third portion of the sample. Learned Government Advocate has filed an affidavit to the effect that one part was retained by the Drugs Inspector and two parts were given to the Chemist, "with the instructions to send one part to the warranty, that is, Agarwal Medical and General Stores" vide memo dated April 11, 1972, and that the said sample was sent thrice through a messenger by Dass Chemist, as per his directions, but the sample sent was refused by the petitioner. Thereafter, the same was sent by registered parcel on July 6, 1972, but the packet was refused. It is argued that the only reasonable opportunity contemplated by the Act is that the licensee may challenge the report of the Analyst under Section 25(4) of the Act, and for that purpose a portion of the sample is supplied to the licensee. It is urged that there was substantial compliance with the requirements of Section 23 read with Section 18-A. In our opinion, this argument cannot be accepted because the statute enjoins the Inspector to send the third portion of the sample to the petitioner. There is nothing to show that the petitioner could have knowledge that the sample was sent to it by the Inspector. On the registered parcel packet also, the sender's name is 'Dass Chemist' not the Drugs Inspector. In the peculiar situation that had developed by the date when the registered parcel was sent by Dass Chemist, it was neither unreasonable nor unnatural for the petitioner to refuse to accept any parcel from Dass Chemist. The rule has been succinctly stated in Jagadish Swarup's Legislation and Interpretation (1968) at page 275, para 12.6, as follows: "Where powers, rights or immunities are granted with direction that certain regulations, formalities or conditions shall be complied with, it is neither unjust nor inconvenient to exact a rigorous observance of them as essential to the acquisition of the right or authority conferred. If a statute directs a thing to be done in a certain way, that thing shall not, even if there be no negative words, be done in any other way. The statute shall be deemed to have prohibited the doing of that thing in any other way. Thus where an Act requires a particular officer to issue a notice, the person to whom the notice is issued is not bound to give any attention to the notice if it is issued by any other person." Dharandra Krishna vs. Nihar Ganguly, AIR 1943 Cal. 266; Stephens Ex parte, (1876) 3 Ch. D. 659; Patna Improvement Trust vs. Shrimati Lakshmi Devi, 1963 Supp. (2) SCR 812 : AIR 1963 SC 1077 ; Chotabhai Jethabhai Patel vs. State of Madhya Pradesh, AIR 1966 MP 34 ; Chuni Lal Mansa Ram and Others vs. Ratti Ram Shiv Narain and Others, AIR 1965 Punj. 340; Punjab National Bank vs. Bunder Insptr. K. Port Trust, AIR 1921 Sind 142 at pages 143 and 144. Thus, there was no compliance with the requirements of Section 23(4)(iii), read with Section 18-Aof the Act. Further, in any event, the fact remains that no opportunity was given to the petitioner to show cause why its licence should not be cancelled on the ground that the drug was found to be spurious. In not giving a show-cause notice, the petitioner was denied an opportunity to defend itself. There was violation of the principles of natural justice. The show-cause notice merely required it to produce the documents of purchase of the drug in question." 6. It is the case of prosecution that accused 1 had manufactured sub-standard drugs (prochloperazine tablets bearing Batch No. A2/094 M/D: 11/02 E/D 10/05) and accused 2 was the Manufacturing Chemist of first accused and accused 3 was the Analytical Chemist and Quality Control Manager of first accused namely M/s. Anchor Pharma Private Limited, Daman. 7. It is needless to state that provisions of Sections 23 and 25 of the Act provide safeguard to the accused. The Drugs Inspector or the concerned Officer while seizing/ purchasing drug should provide a sample of seized/purchased drug to accused. After the report relating to analysis of drugs is received by the complainant/prosecution, a copy of the report shall be sent to the accused before the expiry period of drug. The Drugs Inspector or the concerned Officer while seizing/ purchasing drug should provide a sample of seized/purchased drug to accused. After the report relating to analysis of drugs is received by the complainant/prosecution, a copy of the report shall be sent to the accused before the expiry period of drug. If the accused so desires, he can request the complainant/prosecution to send the sample given to him to the Central Laboratory for examination and opinion. In the case on hand, this mandatory procedure has been violated by P.W. 2. The learned Trial Judge on proper appreciation of evidence and bearing in mind the relevant provisions of law has acquitted the accused. There are no reasons to interfere with the impugned judgment. The appeal is dismissed. Appeal Dismissed.