No Right of Re-testing Due to Delay and Prior CDL Testing: Delhi High Court Upholds Summoning in Drug Misbranding Case

No Right of Re-testing Due to Delay and Prior CDL Testing: Delhi High Court Upholds Summoning in Drug Misbranding Case

M/S ZEE LABORATRIES v. UNION OF INDIA & ANR

2025 DHC 5070

June 27th, 2025

In this case, the Petitioner, M/s. Zee Laboratories a Partnership Firm engaged in the manufacturing of Pharmaceutical products, having its manufacturing unit at Paonta Sahib, District Sirmour, Himachal Pradesh.

The Petitioner manufactures drug, "KETZY EYE DROPS” (KetorolacTromethamine 0.5% Ophthalmic Solution)" licensed with State of HimachalPradesh. The Complainant/Respondent No.2 asserted in its aforesaid two Complaints, both dated 10.08.2015, that Sh. Rajeev Mukul and Sh. Tarun Kumar are the Partners of the Petitioner Firm and responsible persons for its affairs at the time of manufacture of drugs in question. They were also in charge and responsible for the conduct of the business of the Firm.

On 26.09.2013, Drugs Inspector Dharmvir Singh, inspected Guru Gobind Singh Govt. Hospital, Raghubir Nagar New Delhi (GGSGH) and took three samples of the drug "KETZY EYE DROPS”, on Form-17 for testing and analysis under Section 23 of the D&C Act and Drugs and Cosmetics Rules, 1945

Further, Report of sample of Batch No. EEZ652 from Central Drugs Laboratory, Kolkata was received on 27.12.2012 wherein the Sample was reported to be as “Not of Standard Quality” with a reason “Extractable Volume”. Vide Corrigendum Letter dated 31.12.2013, the date of Test Report was corrected to 27.12.2013 instead of 27.12.2012.

The Sample of Batch No. EEZ651 & EEZ653 from Central Drugs Laboratory, Kolkata was received on 03.02.2014 wherein it was reported as “Not of Standard Quality” with a reason that “the samples do not conform to claim with respect to the sterility test.”

The copy of the Test Reports was forwarded by the Complainant/Respondent No.2, to Dr. Alka Gabrayal, Medical Officer Incharge, GGSGH, under Section 25(2) of the D&C Act along with the Show Cause Notice under Section 18A and 18B of the D&C Act, vide Letter dated 06.01.2014 and Letter dated 07.02.2014 with a request to disclose the name, address and the particulars of the person from whom.

In Response, the Show Cause Notice, Dr. Alka Gabrayal disclosed the particulars in Form 18A and 18B of the D&C Act, vide Letter dated 08.01.2014. It was informed that the Eye Drop Drug had been manufactured by the Petitioner Firm in Himachal Pradesh and had been received by her on 16.06.2012

The Complainant/Respondent No.2 were then issued a Show Cause Notice under Section 18B of Drugs & Cosmetics Act and a Notice dated 09.01.2014 and dated 10.02.2014, respectively, along with the original copy of the Test Report dated 27.12.2013 and 03.02.2014 along with one sealed sample portion as required under Sections 25(2) & 23(4)(iii) of the D&C Act respectively, to the Petitioner Firm.

The Complainant/Respondent No.2 also directed the Petitioner Firm to stop the sale of drug in question and withdraw the stock of the sample drug from the market, where they had been sold and also directed to submit the certified copies of documents pertaining to manufacturing, testing and also to furnish distribution details relating to drug and constitution details of the Firm and recall status of the subject drug. Moreover, Petitioner Firm responded via letter dated 09.01.2014, which was received by the Complainant/Respondent No.2 on 25.02.2014, stating that the control sample in their possession was complying the test for Extractable Volume and All Tests were within the limit.

The prosecution was launched against the (Petitioner/accused persons) in accordance with Office Order dated 13.06.2014 from the Controlling Authority. The Complaints, were filed under Section 18(a)(i) read with Section 16 and punishable under Section 27(d) of the Drug and Cosmetics Act.

Aggrieved by the Summoning Order dated 07.12.2015, the Petitioner approached the High Court of Delhi for quashing of the same under Section-482 CrPC, 1973

A major contention of the Petitioner was that it has the right of Re-testing of samples under Section 25 D&C Act, 1940. Further, it was argued that of the Partners of the Manufacturing Firm were liable as they were involved in day to day conduct of the business.

Decision

The High Court observed that the sample of Batch No. EEZ652 was collected on 26.09.2013 and was sent to Central Drugs Laboratory, Kolkata for testing on the next day on 27.09.2013. The Report from the Central Drugs Laboratory was received on 27.12.2013 (though in this Report the date of Report was mentioned as 27.12.2012 which got corrected on 31.12.2013). Within five days of 31.12.2013, the Report was sent on 06.01.2014, to the Hospital from where the sample was collected and on 09.01.2014, to the Petitioner who were the manufacturers of the drug.

The Court in this case referred to the Case of State of Haryana v. Brij Lal Mittal, (1998) 5 SCC 343 wherein the Apex Court observed as under:

Para 5-. “From a bare perusal of sub-section (3) it is manifest that the report of the Government Analyst 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 or other particulars have been disclosed under Section 18-A (in this case the manufacturers) has within 28 days of the receipt 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. Sub-section (4) also makes it abundantly clear that the right to get the sample tested by the Central Government Laboratory (so as to make its report override the report of the Analyst) through the court accrues to a person accused in the case only if he had earlier notified in accordance with sub-section (3) his intention of adducing evidence in controversion of the report of the Government Analyst. To put it differently, unless requirement of sub- section (3) is complied with by the person concerned he cannot avail of his right under sub-section (4).”

The High Court ruled that Section 25(4) becomes operative only after the compliance of Section 25(3) of Drugs and Cosmetics Act, 1940, quoted as under:

Para 65-“Section 25(4) becomes operative only after the compliance of Section 25(3); since there is no compliance and option had not been given within the statutory period under Section 25(3), the right of re-testing under Section 25(4) would not accrue on the Petitioner.”

Further, the Court dealt with the issue of Director’s liability and observed as under:

Para 73-“ In the case of Maksud Saiyed vs. State of Gujarat and Others (2008) 5 SCC 668 it was observed that while levelling the charges against the Company, it is obligatory on the part of the Complainant to make requisite allegation in the Complaint as to the role of the directors for making him vicariously liable.”

Para 74. “In the present case, though this contention may have some merit, but considering that the present Petition has been filed only by the firm M/s. Zee Laboratories through an authorized representative and not by the Partners, this aspect cannot be considered, but is left open to be considered during the trial.”

Finally, the Delhi High Court held that no grounds were made out for quashing of the Summoning Order dated 07.12.2015 in Criminal Complaint No.15/4 of 2015 and 16/4 of 2015 and Petition was, dismissed and the pending Applications were disposed of by the said Court .

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