Plethico Pharmaceuticals And ... vs State Of Maharashtra
2001 Latest Caselaw 939 Bom

JUDGMENT

J.N. Patel, J.

1. Heard Mr. Kulkarni learned counsel for the applicant and Mr. Yengal, A.P.P. for State.

2. Applicant is prosecuted for having committed offences under Sections 18(a)(i) read with Sections 17, 17-A and 17-B of the Drugs and Cosmetics Act, 1940, punishable under Section 27 of the said Act. The Drug Inspector Mr. V.K. Biyani visited the establishment M/s Shah Hiralal Tejulal Medical Stores, at Post Balapur, District : Akola, on 3-5-1991 and was taken sample of Ampicillin and Cloxacillin for oral suspension 2-PEN, out of Batch No. 0056, Manufacturing Date 10/90, Expiry Date 2/92 of which M/s Plenthico Pharmaceuticals, A. B. Road, Manglia (M.P.) are the manufacturers. On 4-5-1991 the said drug samples were sent to Government Analyst, Maharashtra State, Mumbal for necessary analysis. The Government Analyst submitted his report in form No. 13 vide No. M-2321 of 1991 dated 17-7-1991 and declared that the sample 2-PEN, Batch No. 0056 to be not of standard quality for the reason that the content of Cloxacillin in the sample is less than the lebelled amount (42.61%). The said Test Report was then forwarded to the partner of the firm Mr. Jayeshkumar Shah, who disclosed that the said drugs were purchased from M/s Trimurti Sales, Akola and therefore, two other samples were sent to M/s Trimurti Sales, Akola so also to the applicant who was the manufacturer, as required under Sections 23(4)(iii) and 25(2) of the Drugs and Cosmetics Act, 1942. After receipt of the prosecution order the Drug Inspector filed complaint in the Court of Judicial Magistrate First Class, Balapur, District : Akola, which came to be registered as Criminal Case No. 209 of 1991 in which he prosecuted the applicants for having contravened Section 18(a)(i) read with Sections 17, 17A, 17B of the Drugs and Cosmetics Act and Rules thereunder which is punishable under Section 27 of the said Act.

3. It is the case of the applicants that after receipt of report of the Government Analyst, Maharashtra State Drugs Control Laboratory, Bombay - 51 the applicants applied to the Drug Inspector to forward another sample i.e. counterpart of it to the Central Drugs Laboratory. Therefore, the complainant filed an application Ex.2 before the Trial Court for forwarding the said sample to the Central Drugs Laboratory for analysis. The Director, Central Drugs Laboratory, Calcutta sent his report to the Court under his letter dated 6-5-1992. The report discloses, as can be seen from the Certificate of Test issued by the Central Drugs Laboratory in form No. 2 which is in accordance with the Drugs Rules, 1945, that

the sample conforms to the claim with respect to the above tests. It is on receipt of this test report from the Director, Central Drugs Laboratory, applicant moved the Court for discharge as no offence was made out, recalling issuance of process and discharging the case of prosecution as no case of contravention of Section 18-A(1) read with Sections 17A and 17B of Drugs and Cosmetics Act, 1940 was made out. The learned Magistrate vide order dated 25-3-1996 set aside the order dated 24-12-1991 issuing process against the applicant and directed that the complaint stands dismissed under Section 203 of Criminal Procedure Code.

4. The complainant aggrieved by the decision of the learned Magistrate approached the Court of Sessions at Akola by preferring Criminal Revision No. 213 of 1996. The learned Addl. Sessions Judge by his order dated 18-2-1999 quashed and set aside the order of the learned Magistrate and directed that, the matter be proceeded further in accordance with law. The applicants have challenged the said order before this court under Section 401 read with 397 of Criminal Procedure Code by preferring this revision.

5. Mr. Kulkarni, the learned counsel before the court for the applicants-accused, submits that now it is settled law that once the Central Drugs Laboratory examines the sample and gives a report which exonerates the applicants, the report of the Government Analyst of State of Maharashtra will have to be ignored and it is only the results of the tests carried out by the Central Drugs Laboratory which can be taken into consideration and the report of the State Analyst would stand displaced. In order to substantiate his contention Mr. Kulkarni has referred to the case of Calcutta Municipal Corporation v. Pawan Kumar Saraf and Anr. .

6. Mr. Yengal, the learned A.P.P. submits that in view of the fact that the Central Drugs Laboratory found the sample drawn in respect of the drugs manufactured by the applicants to conform to the Standard prescribed then there was no justification in continuing with the prosecution of the applicants and therefore, the learned Additional Sessions Judge ought not to have interfered in the matter.

7. The premise on the basis of which the learned Additional Sessions Judge found that the order passed by the learned Magistrate deserves to be quashed and set aside is holding that the report of the Central Drugs Laboratory can at the most be considered as opinion evidence of the Medical Officer. And, that it is not necessary for the Court to have accepted the same, and on the basis of that it was not proper on the part of trial Court to recall issuance of process and dismiss the case under Section 203 of Criminal Procedure Code. It appears that the learned Additional Sessions Judge fell into error in treating the report of the Central Drugs Laboratory as merely opinion evidence, when the very basis of prosecution of the applicants/accused was the report of the Government Analyst of State of Maharashtra.

8. The very foundation of the prosecution of the applicants is on the basis that they have manufactured sub-standard drugs of which samples were drawn as the complainant came to this conclusion on the basis of the report of the Public Analyst, State of Maharashtra. Section 25 of the Drugs & Cosmetics Act, 1940 lays down in respect of the reports of the Government Analyst and reads as under:

"25. Reports of Government Analysts. -- (1) The Government Analyst to whom a sample of any drug (or cosmetic) has been submitted for test or analysis under Sub-section (4) of Section 23, shall deliver to the Inspector submitting it a signed report in triplicate in the prescribed form.

(2) The Inspector on receipt thereof shall deliver one copy of the report to the person from whom the sample was taken (and another copy to the person, if any, whose name, address and other particulars have been disclosed under Section 18-(A), and shall retain the third copy for use in any prosecution in respect of the sample.

(3) Any document purporting to be a report signed by a Government Analyst under this Chapter shall be evidence of the facts stated therein, and such evidence shall be conclusive unless the person from whom the sample was taken (or the person whose name, address and other particulars have been disclosed under Section 18-(A) has, within twenty-eight days of the receipt of a copy of the report, notified in writing the Inspector or the Court before which any proceedings in respect of the sample are pending that he intends to adduce evidence in controversion of the report.

(4) Unless the sample has already been tested or analysed in the Central Drugs Laboratory, where a person has under Sub-section (3) notified his intention of adducing evidence in controversion of a Government Analyst's report, the Court may, of its own motion or in its discretion at the request either of the complainant or the accused cause the sample of the drug (or cosmetic) produced before the Magistrate under Sub-section

(4) of Section 23 to be sent for test or analysis to the said Laboratory, which shall make the test or analysis and report in writing signed by, or under the authority of, the Director of the Central Drugs Laboratory the result thereof, and such report shall be conclusive evidence of the facts stated therein.

(5) The costs of the test or analysis made by the Central Drugs Laboratory under Sub-section (4) shall be paid by the complainant or accused as the Court shall direct."

Sub-section (4) of Section 25 is quite clear that the report signed by, or under the authority of Director of the Central Drugs Laboratory shall be conclusive evidence of the facts stated therein and would have an edge over the report of the Public Analyst of the State.

In the case of the Calcutta Municipal Corporation (cited supra), Supreme Court while considering the provisions of the Prevention of Food Adulteration Act, 1954 which are pari materia to the provisions of the Drugs & Cosmetics Act, 1940 have held that:

'Thus the legal impact of a Certificate of the Director of Central Food Laboratory is threefold. It annuls or replaces the report of the Public Analyst, it gains finality regarding the quality and standard of the food article involved in the case and it becomes irrefutable so far as the facts stated therein are concerned."

9. Therefore, it will have to be kept in mind while dealing with cases under Drugs Act and so also other provision of law which provide for prosecution, that provision like Sub-section (4) of Section 25 have intervening effect on the report of the Government Analyst if the sample is sent for test or analysis to the Central Drugs Laboratory as it is the report of the Central Drugs Laboratory which will have to be considered as conclusive evidence of the facts stated therein. In the present case the report of the Central Drugs Laboratory being favourable to the applicants that the 'Drug' in question was of the required standard offence for which applicants are prosecuted, does not survive.

The prosecution against the applicants therefore, quashed and set aside, as a result of which the applicants stand discharged.

The impugned order is quashed and set aside and that of the trial Court is upheld.