A Drug Was Expected To Work And Be Safe Till The Expiry Date: HC

Bengaluru, 4 Oct 2018: A pharma manufacturing company, whose cough syrup was found to be “not of standard quality”, claimed in the High Court that it was tested on the last day of the expiry date and therefore it should be absolved of the case filed against it under the Drugs and Cosmetics Act.

The HC rejected the contention of the company and said, “Any drug for human consumption approaching the date of expiry is required to be in consumable condition and worth for consumption in all respects till the completion of its expiry period. As such, a drug nearing expiry date, for the purpose of its testing also, cannot be considered that the drug may not answer the tests as it could have had, the same being tested at the earlier date. Therefore, merely because the drug under question was tested just two days prior to expiry of its shelf life by that itself, it cannot be considered that the report given by the Central Drug Testing Laboratory (CDTL) cannot be an accurate report, as such, the argument of learned counsel for the petitioner on this point is not acceptable.

The case is against Vapi Care Pharma Pvt. Ltd from Himachal Pradesh and its officers Kamal J Shah, Sudhir Kumar Singh and Shashikanth Surwase. The case was filed by the Drugs Control Department, Bengaluru. The drug in question is Zoxil CV Dry Syrup.

An inspector of the department visited Shree Maruthi Chemist in Bengaluru on September 13, 2011 and took a sample of the syrup. It was sent for testing to the Government Analyst, Drugs Testing Laboratory, Bengaluru. In the test report on January 16, 2012 the analyst found the drug “”not of standard quality” with respect to “Assay” for Amoxyllin and Clavulanate acid.”

The company did not agree with the result and requested the sample to be sent to the CDTL in Kolkata. The CDTL test found the sample to be ‘sub-standard’. The test was conducted on February 27, 2012. A criminal case followed. This is what was challenged before the High Court.

The company’s advocate argued that since the drug was tested by CDTL “just two days prior to its expiry, the test report cannot be accepted.” The HC noted, “In the instant case, according to the petitioners/accused, the expiry date of the alleged sample was ‘February, 2012’, as such, the last date of expiration was 29.02.2012 (2012 was a leap year). Therefore, when the drug was subjected to a test by CDTL on 27.02.2012 it was two days prior to the date of expiry.” However, the HC reasoned that a drug was expected to work and be safe till the expiry date.

The petition by the company also challenged the managing director, manufacturing chemist and analytical chemist of the company being made parties to the criminal case. It was argued that these three were not involved in the manufacturing and standard of the drug. The High Court said that it was an issue for the trial court to decide. Since the case dates from the 2012, the HC directed the lower court to dispose the matter at the earliest. Bangalore Mirror