MMC HEALTHCARE (HP) PVT LTD , SOLAN-KALKA STATE HIGHWAY Vs. STATE REPRESENTED BY DRUGS INSPECTOR, VALASARAVAKKAM RANGE

JUDGEMENT

(1.) This Criminal Original Petition to quash the proceedings in C.C.No.55 of 2017 pending on the file of the Court of Chief Judicial Magistrate, Thiruvallur.

(2.) It is stated in the affidavit filed in support of this petition that the first petitioner is the manufacturer of drugs and pharmaceuticals for the last several years with valid manufacturing licenses issued by the Drugs Controller of Himachal Pradesh State. The petitioner-company follows Good Manufacturing Practices (GMP) Standards for its manufacturing unit. The respondent allegedly drew a sample of DEFLAWIN (Deflazacort Tablets 6mg) manufactured by the petitioner-company for analysis from M/s.Sri Devi Medical Distributors Pvt. Ltd., Alapakkam, Porur, Chennai on 30.09.2015 and sent the same for analysis to the Government Analyst, Drugs Testing Laboratory, Chennai, who, by Report bearing No.04803-D/2015-16 dated 28.06.2016 declared the sample as "not of standard quality" for the reason that the sample does not conform to label claim with respect to the content of Deflazacort (5.25%) as defined in the Drugs and Cosmetics Act, 1940 and the rules thereunder, as it is a violation of Section 18(a)(i) of the Drugs and Consmetics Act 1940 and Rules 1945. A show cause memo dated 30.06.2016 was issued to M/s.Sri Devi Medical Distributors Pvt.Ltd, asking why action should not be taken against them and also requesting them to disclose the name and address of the person from whom the subject drug was procured, as per Section 18A of the Drugs and Cosmetics Act, 1940, for which a reply was sent by M/s.Devi Medical Distributors Pvt.Ltd., stating that they have purchased the said drug from the first petitioner herein. Further the respondent issued a show cause memo dated 04.07.2016 to M/s.MMC Healthcare Limited asking why action should not be taken for contravention of Section 18(a)(i) of the Act for having stocked and sold the subject drug which is not of standard quality, and also requesting them to furnish the name and address of the person from whom the subject drug was purchased for which they received a reply from M/s.MMC Healthcare Limited that the said batch of drug was purchased from the first petitioner herein. By show cause notices dated 21.07.2016 and 22.08.2016, the respondent asked the first petitioner as to why action should not be taken for contravention of Section 18(a)(i) of the Act for having manufactured the said drug for sale and distribution, without standard quality. The petitioners also sent a reply dated 01.09.2016 stating that the drug is a "Patent and Proprietary Medicine" and the manufacturer's method of analysis has to be followed and that the sample analysed as per the method of analysis of the first petitioner passes all the tests. Relevant Analysis Reports have been enclosed along with the said communication. They also requested the respondent to send the fourth portion of the sample to Central Drugs Laboratory, Kolkata along with the method of analysis sent by the first petitioner and also intimated that the petitioners intend to adduce evidence to that effect. Having not satisfied with the said reply, the respondent proceeded to file the impugned complaint before the Chief Judicial Magistrate, Thiruvallur, by concluding that the petitioners have contravened the provisions of law.

(3.) It is also stated that the respondent has caused the Court sample portion of the drug DEFLAWIN (Deflazacort Tablets 6mg) manufactured by the first petitioner, to the Central Drugs Laboratory, Kolkata for analysis under Section 25(3) of the Act and a report dated 21.04.2017 was received stating that the sample conforms to claim with respect to Assay of "Deflazacort". Stating that the conclusion arrived at by the Central Drugs Laboratory, Kolkata is conclusive and binding on the parties and no offence under Section 27(d) of the Act is made out, the petitioners have come up with the present Criminal Original Petition to quash the impugned proceedings.