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It has been observed by the Supreme Court that in case of unexplained delay on the part of Drug authorities to test a sample can render any penalty under Drugs and Cosmetics Act, 1940, as void, based upon the said analysis of the sample.
An appeal filed by Medipol Pharmaceutical India Pvt. Ltd., blacklisted was considered by a bench of the Supreme Court comprising of Justice R F Nariman and Navin Sinha. Earlier the Punjab and Haryana High Court dismissed a writ petition filed before it by the company.
The apex court bench, in an appeal, observed that in the said case the drug sample being sent and tested 8 months beyond the shelf life of the product resulted in considerable delay. After judgement being surveyed on this issue in delaying of sample testing under Drugs and Cosmetics Act, Prevention of Food Alteration Act, Insecticides Act, it was observed by the bench,
“A valuable right is granted to a person who is sought to be penalized under these Acts to have the 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 judgements lay down that if owing to the delay which is pre dominantly 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 same sample being tested, cannot then be sustained.”
After considering the facts of the case by the bench, it further observed,
“We have seen that on the facts of this case, the sample drawn and analysed 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 Cosmetic Act kicks in on the facts of the case, which would necessarily render any penalty based upon the said analysis as void”
The Court set aside the blacklisting order only after uncovering the fact that it is arbitrary and irrational on the part of the State.
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