High Court Of Calcutta
J.K.Biswas, J.
Wockhardt Limited : Appellant
Versus
Senior Chief Medical Officer : Respondent
W.P.No. 20832 (W) of 2011 W.P.No. 21692(W) Of 2011
Decided On : Dec 20, 2011
DRUGS AND COSMETICS ACT, 1940 - SECTION 25(3) - SHOW CAUSE NOTICE - DRUG SAMPLE TEST REPORT - ADMISSIBILITY OF EVIDENCE - JURISDICTION - WEST BENGAL HIGH COURT - The court held that the petitioners are entitled to adduce evidence before the Inspector in controversion of the test report under Section 25(3) of the Drugs and Cosmetics Act, 1940, and that until the final order is passed by the Inspector, no further steps shall be taken by the respondents in connection with the show cause notices.
Fact of the Case:
The petitioners, manufacturers of Zedex Cough Syrup, challenged two show cause notices issued by the Sr. Chief Medical Officer (SAG), I/C, Govt. Medical Store Depot, Kolkata, and the State Drugs Controller, Himachal Pradesh, respectively, based on a test report declaring the drug as "Not of Standard Quality."
Finding of the Court:
The court held that the show cause notices were issued on the basis of the test report obtained from the Government Analyst in Kolkata, and that the Inspector who obtained the report had initiated proceedings and the proceedings were pending before him. Therefore, the petitioners were entitled to adduce evidence before him in controversion of the report under Section 25(3) of the Drugs and Cosmetics Act, 1940.
Issues: 1. Whether the petitioners are entitled to adduce evidence before the Inspector in controversion of the test report under Section 25(3) of the Drugs and Cosmetics Act, 1940? 2. Whether the West Bengal High Court has jurisdiction to entertain the writ petition challenging the show cause notice issued by the licensing authority from Himachal Pradesh?
Ratio Decidendi: 1. Section 25(3) of the Drugs and Cosmetics Act, 1940 entitles the petitioners to adduce evidence before the Inspector in controversion of the test report. 2. Since the show cause notice issued by the licensing authority from Himachal Pradesh was based on the test report obtained in Kolkata and supplied from Kolkata, the West Bengal High Court has jurisdiction to entertain the writ petition.
Final Decision: The court ordered the Inspector to give the petitioners reasonable opportunity of adducing evidence before him in controversion of the report and to give final decision in the proceedings. Until the final decision is given and communicated by the Inspector, no further steps shall be taken by the respondents in connection with the show cause notices.
1. THE petitioners in W.P. No. 20832(W) of 2011 under Art.226 dated November 29, 2011 are also the petitioners in W.P.No. 21962(W) of 2011 under Art. 226 dated December 14, 2001.
2. WHILE in WP 20832 the petitioners have questioned a show cause notice dated October 3, 2010 issued by the Sr. Chief Medical Officer (SAG), I/C, Govt. Medical Store Depot, Kolkata-22 and the things stated, in a letter of the Drugs Inspector, CDSCO, East Zone, Kolkata dated October 24, 2011, in WP 21692 they have questioned a show cause notice dated November 21, 2011 issued by the State Drugs Controller, Licensing Authority-cum-Controlling Authority, Himachal Pradesh.
3. WITH WP 21692 the petitioners have produced a copy of a letter of the Drugs Inspector, CDSCO, East Zone, Kolkata dated November 21, 2011, relevant parts whereof are quoted below:
"Now, a original copy of test report issued by Govt. Analyst, CDL, Kolkata and a sealed portion of the sample of the subject are being sent to you under section 25(3) of Drugs and Cosmetics Act 1940 for your comments. You are also requested to send the details of records of manufacturing, testing and sale/distribution of the subject drug alongwith your comments within 28 days from the date of dispatch of this letter to the undersigned."
4. IT is evident from the documents produced with the petitions and the affidavit filed by the Inspector in compliance with the order dated December 13, 2011 in WP 20832 that everything started from a test report on sample of one Zedex Cough Syrup manufactured by the first petitioner. In the letters issued by the Inspector it was mentioned that the Government Analyst, CDL, Kolkata had declared the drug as " Not of Standard Quality ."
5. IT is evident from the show cause notice dated October 3, 2011 that the proceedings for black listing the first petitioner were initiated by the Directorate General of Health Services of the Ministry of Health and Family Welfare of the Government of India on the basis of the test report, a copy whereof was forwarded to the directorate by the Inspector who issued the letter dated October 24, 2011.
6. IT is evident from the show cause notice dated November 21, 2011 that proceedings for cancellation of the first petitioner's license under the Drugs and Cosmetics Rules, 1945 have been initiated by the licensing authority on the basis of the test report, a copy whereof was supplied to him by the Directorate General of Health Services of the Ministry of Health and Family Welfare of the Government of India that issued the show cause notice dated October 3, 2011 proposing to deregister the first petitioner and debar it from supplying the drug to the organization and depots named in the notice.
7. FROM the letter dated November 21, 2011 of the Inspector it is evident that the Inspector who has been consistently contending and has now filed affidavit in compliance with an order passed in WP 20832 that no proceedings initiated by him were pending before him, has lastly informed the first petitioner that he was sending the original test report and a sealed portion of the sample to the first petitioner under sub-s.(3) of s.25 of the Drugs and Cosmetics Act, 1940 for the first petitioner's comments.
8. SUB-section (3) of s.25 of the Drugs and Cosmetics Act, 1940 is quoted below:
"(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 18A 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."
9. MR. Mukherjee appearing for the petitioners has submitted that for undisclosed reasons the Inspector collectin
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