38.6c New Delhi, India, Tuesday, June 25, 2024

Substantial Unexplained Delay By Drug Authorities In Testing A Sample Can Render Proceedings Under Drugs & Cosmetics Act As Void As Per The Recent Supreme Court Judgement

By LawStreet News Network      12 August, 2020 11:09 AM      0 Comments
Drug Authorities Substantial Unexplained

The Hon’ble Supreme Court of India on Wednesday, August 5th, 2020 passed their judgement for the case, Medipol Pharmaceutical India Pvt. Ltd. v/s Post-Graduate Institute of Medical Education & Research, where they observed that in case there is a substantial unexplained delay in examining a sample by the Drug Authorities then any penalty under Drugs and Cosmetics Act,1940 can be rendered as void referring to the evaluation and result of the sample. 

Medipol Pharmaceuticals, a pharma company which was blacklisted for 2 years, initially filed a write petition in Punjab and Harayana High Court which was dismissed, therefore, the company filed an appeal in the Supreme Court of India. The 2- judge bench comprising of Justice R.F. Nariman and Justice Navin Sinha, in the appeal, observed that there was a substantial delay due to which the sample that was sent for testing was beyond its shelf-life by 8 months.

The Apex Court after contemplating precedents concerning the issue of delay in sample analysis under the Drug and Cosmetics Act, Prevention of Food Adulteration Act and Insecticides Act, observed that “they lay down that a valuable right is granted to a person who is penalized under these Acts to have a sample tested by the Government Analyst that is found against such person. The sample is 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 imposable by virtue of such sample being tested, cannot then be sustained.” 

It was further observed by the bench, that, “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 bench set aside the blacklisting order also observed that the State can’t act arbitrarily in any form and they must be rational and just while employing their power of blacklisting a company. 


Share this article:

User Avatar

Leave a feedback about this

Trending Judiciary
Kejriwal moves SC against Delhi HC order blocking his release in Liquor Policy case; plea seeking urgent hearing likely to be mentioned today

Kejriwal moves SC against Delhi HC order halting his bail in liquor policy case; urgent hearing plea likely to be mentioned today.

24 June, 2024 10:47 AM
Trending Executive
UAPA Tribunal confirms ban upon two J&K outfits

UAPA Tribunal confirms ban on ‘Muslim League J&K’ and ‘Tehreek-e-Hurriyat J&K’ for secessionist activities under Section 3(1) of the anti-terror law.

24 June, 2024 11:10 AM


Trending Executive
MK Stalin Urges Amit Shah to Withdraw New Criminal Laws

Tamil Nadu CM Stalin urges Home Minister Amit Shah to withdraw new criminal laws, citing lack of consultation and fundamental errors in the enactments.

19 June, 2024 11:16 AM
Trending Judiciary
Calcutta HC mandates 1% reservation for transgenders in West Bengal Public Employment [Read Order]

Calcutta HC directs 1% reservation for transgenders in West Bengal public employment, ensuring equal opportunities and implementing Supreme Court’s 2014 mandate.

19 June, 2024 11:33 AM
Trending Judiciary
Supreme Court to organise Special Lok Adalat from July 29 to Aug 03, to mark its 75th anniversary [Read Press Release]

Supreme Court to organize Special Lok Adalat from July 29 to August 03 to facilitate amicable settlements of pending cases, marking its 75th anniversary.

19 June, 2024 11:50 AM
Trending News Updates
Post Office Act 2023 comes into force, repeals 125 year old legislation [Read New Post Office Act]

India enacts the Post Office Act 2023, replacing the 125-year-old Indian Post Office Act of 1898, to modernize and regulate postal services.

19 June, 2024 12:29 PM


Join Group

Signup for Our Newsletter

Get Exclusive access to members only content by email