Claris Lifescience Limited vs The State of Gujarat and Another

Jayant Patel, J.—Rule. Mr. Pujari, learned AGP wavies service of notice of Rule for respondents No. 1 and 2. With the consent of the learned Counsel appearing for both the sides, the matter is finally heard.

The short facts of the case appear to be that the sample of Dextrose Injection I.P. (10% W/v) was taken by the respondent No. 2 belonging to the petitioner, which is a product manufactured by the petitioner. As per the provisions of the Drugs and Cosmetics Act, 1940 (hereinafter referred to as the ''Act'') read with the Rules one portion of the sample was given to the petitioner, another was retained by the Inspector for sending it to the laboratory at the State level and third portion was retained for production in the Court. It appears that the sample, which was retained by respondent No. 2 has been sent for laboratory testing and it is found that the same is not meeting with the requisite parameters. The show-cause notice has been issued by respondent No. 2 to show cause as to why the prosecution should not be filed. The petitioner had intimated to respondent No. 2 that as per the provisions of Section 25(3) of the Act, the sample also be tested by the Central Laboratory. No orders are passed by respondent No. 2, nor any action for sending the said sample to the Central Laboratory for testing. It is the contention of the petitioner that the expiry date of the said drug is 31.12.2008. Under these circumstances, the present petition.

The petitioner has challenged the show-cause notice Annexure ''A'', which Mr. Soparkar, during the course of the hearing, has declared that the petitioner is not pressing the said relief and the petitioner shall appear before the concerned authority. However, he submitted that he is pressing for prayer 7(A) only for seeking directions to the respondent to send the sample for testing by Central Drug Laboratory, Kolkata.

Heard Mr. Soparkar, learned Counsel with Mr. Bhatt for the petitioner and Mr. Pujari, learned AGP for the State authorities.

It appears that as per the Scheme of the Act read with the Rules and more particularly Section 25 of the Act, the right is provided to the person concerned to request the Inspector or the Court before whom the proceedings in respect of the contravention are pending if he intends to adduce evidence in contravention of the report. Sub-section (4) of Section 25 of the Act provides that in such circumstances if the intention is notified, the Magistrate shall direct for testing or analysis by or under the authority of the Director of Central Drug Laboratory. The said aspect is with the express provisions of the statute that such report shall be conclusive evidence on the facts stated therein.

As the complaint is not filed in the present case before the learned Magistrate, the petitioner would not be in a position to seek appropriate orders of the learned Magistrate. Considering the peculiar facts and circumstances, in the present case that the drug his to expire on 31.12.2008, if the retesting is not undertaken by the Central Drug Laboratory, it may not be possible for all time to come. Therefore, keeping in view the availability of the right to the person concerned as provided u/s 25 of the Act and the peculiar facts and circumstances as referred to herein above, no prejudice will be caused, if the sample, which is in possession of the Drug Inspector, may be for Court purpose, is sent to the Central Drug Laboratory. It appears that in the present case no orders are passed by the Drug Inspector for sending the sample to the Central Drug Laboratory, may be on the ground that there is no order of the learned Magistrate. However, if the matter is kept as it is until the prosecution is filed and is brought before the Magistrate, in the meantime the drug may expire. Therefore, the right, if any, in future at the prosecution may be lost for all time to come for getting the drug tested through Central Drug Laboratory. Hence, it appears that the matter can be considered for sending the sample for testing through Central Drug Laboratory.

It may be recorded that this Court (Coram: (Ms.) H.N. Devani, J.) in Special Criminal Application No. 342 of 2007 in case of Zest Pharma v. State of Gujarat and Anr. vide its decision dated 28.12.2007 had observed that until the complaint is filed before the Magistrate, such power could not be exercised by the Magistrate and, therefore, the application was rightly rejected by the Magistrate. However, in the very decision, this Court took the view that no prejudice is caused if the drug sent for testing to the Central Drug Laboratory under the provisions of Section 25 of the Act.

In view of the above, respondent No. 2 is directed to sent the sample for testing from amongst the samples taken by him for laboratory testing or for production in the Court, to the Central Drug Laboratory, Kolkata under the provisions of Section 25 of the Act within two weeks from the date of receipt of the order of this Court at the cost of the petitioner.

It is also clarified that it would be open to the respondents to proceed in pursuance of the show-cause notice in accordance with law and the present order shall not operate as a bar in taking decision as to whether the proceedings should be launched based on the report of the State Laboratory or not.

The petition is allowed to the aforesaid extent. Rule made absolute accordingly. No order as to costs.