Any penalty under the Drugs and Cosmetics Act, 1940 can be rendered as void if there is an unexplained delay on the part of drug authorities in examining a sample. - Synopsis
Lakshay Parmar 11 Aug 2020

Case: Medipol Pharmaceutical India Pvt. Ltd. v/s Post Graduate Institute of Medical Education & Research (Civil Appeal No. 2903 of 2020)

The Hon’ble Supreme Court of India in this case has noted that any penalty under the Drugs and Cosmetics Act, 1940 can be rendered as void if there is an unexplained delay on the part of drug authorities in examining a sample.

In an appeal filed by Medipol Pharmaceutical which was blacklisted and also the writ petition filed by the company in Punjab & Haryana HC was also dismissed. In this case, the bench comprising Justices R.F. Nariman and Navin Sinha has observed that while testing of a sample, there was a considerable delay of 8 months. The said sample was tested 8 months beyond its shelf life.

The Apex Court in this regard have stated that in case of a considerable unexplained delay in testing, which must largely be attributed to the Government Authorities, can result in the penalty awarded to an individual under the said Act as void. An individual who is sought to be penalized under the relevant provisions has the right to have the sample tested in a timely manner by appropriate government authorities and in failure of the timely testing; the penalty rendered can be declared void.

The court 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. 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 Supreme Court while setting aside the blacklisting order also said that the state should act fairly and not in an arbitrary manner. 

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