Considerable Unexplained Delay By Drug Authorities To Test A Sample Can Render Proceedings Under Drugs & Cosmetics Act Void: SC [Read Judgment]

The Supreme Court has observed that considerable unexplained delay on the part of Drug authorities to test a sample can render any penalty under Drugs and Cosmetics Act, 1940, based upon the said analysis of the sample, as void.

The bench comprising Justices RF Nariman and Navin Sinha was considering an appeal filed by Medipol Pharmaceutical India Pvt. Ltd. which was blacklisted. The writ petition filed by the company before the Punjab and Haryana High court was dismissed.

In appeal, the Apex Court bench observed that there was a considerable delay which resulted in the sample being sent and tested 8 months beyond the shelf life of the product in this case. Surveying judgments on the issue of delay in sample testing under Drugs and Cosmetics Act, Prevention of Food Adulteration Act and Insecticides Act, the bench observed:

"A valuable right is granted to a person who is sought to be penalized under these Acts to have a sample tested by the Government Analyst that is found against such person, to be tested by a superior or appellate authority, namely, the Central Drugs Laboratory. These judgments lay down that if owing to delay which is predominantly attributable to the State or any of its entities, owing to which an article which deteriorates with time is tested as not containing the requisite standard, any prosecution or penalty inflictable by virtue of such sample being tested, cannot then be sustained."

Taking note of the facts of the case, the bench further observed:

"We have seen that on the facts of this case, the sample drawn and analyzed by the Government Analyst was delayed for a considerable period resulting in the sample being drawn towards the end of its shelf life. Even insofar as the samples sent to the Central Drugs Laboratory, there was a considerable delay which resulted in the sample being sent and tested 8 months beyond the shelf life of the product in this case. It is thus clear that the valuable right granted by Section 25 of the Drugs and Cosmetics Act kicks in on the facts of this case, which would necessarily render any penalty based upon the said analysis of the sample as void."

The court also observed that, while exercising its power to blacklist a company, the State has to act fairly and rationally without in any way being arbitrary. In this case, the court found that it was arbitrary and therefore set aside the blacklisting order. 

Case details
Case no.: CIVIL APPEAL NO. 2903 OF 2020
Case name: MEDIPOL PHARMACEUTICAL INDIA PVT. LTD.  vs. POST GRADUATE INSTITUTE OF MEDICAL EDUCATION & RESEARCH 
Coram: Justices RF Nariman and Navin Sinha
  

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