Supreme Court Refuses to Entertain Petition Seeking General Directions To Stop Re-use Of Expired Medicines By Re-stamping Instead Of Marking With Indelible Ink

A bench comprising Justices Indira Banerjee and J.K. Maheshwari heard the petitioner-in-person who alleged that the manufacturers are re-using expired medicines on a regular basis simply by removing the original manufacturing details and re-stamping them.

Previously, the Petitioner had approached the Delhi High Court, which vide order dated 27.02.2020 had refused to grant 'lump sum general directions to the respondents', but had stated that as and when any breach is pointed out to the court against specific manufacturers it would consider to initiate action.

At the outset Advocate Amit Sahni, the petitioner-in-person submitted that he seeks the Apex Court's indulgence to, inter alia, replace the existing practice of stamping drugs in violation of the mandate of Rule 96 of the Drugs and Cosmetic Rules, 1945, which casts a duty on the manufacturers to print the manufacturing and expiry date with indelible ink.

"This matter I had made a representation to the respondents to stop reuse of expired medicines. After that I had filed a WP. Two prayers were sought. One was to act upon my representation and two was to replace the existing mechanism of stamping the drug, which can be easily erased with aftershave lotions etc. Rule 96 of Drugs and Cosmetic Rules, 1947 provide that manufacturing and expiry date are to be printed with indelible ink. It is common knowledge that all manufacturers are manufacturing drugs and stamping them instead of marking them with indelible ink. This is re-stamped to show that these drugs are not expired and for the purpose of increasing price."

To demonstrate the modus operandi of the manufacturers, Mr. Sahni had submitted additional documents with details of medicines containing the original stamp and the details of the medicines which had been re-stamped by him.

"I have placed on record additional documents which I also placed before HC just for the purpose of demonstrating My Lords. At page 9 of my additional doc, Annexure P-14 I have tried to demonstrate, one is original stamped medicine and the other is re-stamped. Re-stamped is by me."

The Bench was not included to grant general relief in the matter -

"In that case you have to lodge a complaint. How can it be general. All the provisions are there."

As the Bench opined that there were ample statutory safeguards, Mr. Sahni alleged that the statutory provisions in the said regard are not being enforced by the manufacturers.

"The respondents are not enforcing it."

The Bench stated -

"If they are not enforcing in a particular case, then you have to come. It cannot be general. It is a waste of judicial time."

Mr. Sahni, urged the Court to refer to the additional documents -

"Pg 9 of the additional document if My lord sees, then I'll leave it to My Lords. On the right side is the original stamp, on the left side the stamping is done by me to show how easily it can be removed and it can be re-stamped. As a layman we could do it."

Finding no fault with the order of the High Court, the Bench remarked -

"The court has very rightly said that you may approach the authorities concerned in respect of a particular manufacturer."

The Bench further emphasised -

"Sorry. It is the correct order. We find no grounds to interfere with the judgment and order of the Delhi High Court impugned in this Special Leave Petition. As held by the HC as and when any beach is pointed out with specific details action might be initiated.

[Case Title: Amit Sahni v Union of India]