Supreme Court Issues Notice In Plea Seeking Guidelines Against Manufacturing And Selling Of Fake Pharma Drugs

The Supreme Court on Friday (November 29) agreed to consider the issue of lack of procedural guidelines in initiating criminal proceedings against the offence of manufacturing, storing and selling of counterfeited drugs.

The bench of Justice JB Pardiwala and Justice R Mahadevan issued notice in the petition.

The petition has been filed by the Indian Pharmaceutical Alliance (IPA) seeking directions to the Union to frame procedural guidelines to initiate criminal proceedings against persons selling/manufacturing fake drugs and medicines.

IPA states that the serious life threat such dubious drugs could cause to the patients, and the rampant manufacturing and selling in the market affected the pharmaceutical industry, violating Article 21 and 19(1)(g) of the Constitution.

The IPA has filed the petition in light of non-action by the Central drugs Standard Control Organisation (CDSCO), FDA (Food and Drug Administration), and Police in arresting persons allegedly involved in the manufacturing, storing and selling of counterfeit goods.

The plea cites an incident of September 8, 2024 where the custom department raided certain premises in Kolkata and apprehended two individuals for using the premises to package, store and supply fake/spurious branded and generic drugs.

The list of such branded drugs included Montek LC Batch no. 2094A. Pantocid SID2041A, Ursocol 300 GTE1350A and Sompraz D40, batch no. SIE2116A (One box), of M/s Sun Pharmaceutical Industries Limited and Telma AM, Telma 40, Clavam, Shelcal, Augmentin.

However, while the FDA, CDSCO, and Kolkata Police (on insistence of the IPA and Customs Department) carried out joint inspection of the premises and locked the area, no criminal proceedings were taken against the accused persons.

The reliefs sought by the petitioner include :

A. Issue a writ of mandamus or any other appropriate writ directing the Respondent No. 3(CDSCO) and its officers to conduct proper Investigation either by themselves or with the assistance of the local police into complaints of Manufacturing, Selling and Supplying Counterfeit/Spurious Drugs; and

B. Direct the Respondent Nos. 1, 2 and 3 (UOI, Ministry of Health & Family Welfare and CDSCO) to formulate guidelines towards registration of FIR and procedure for arrest of accused persons for commission of offences of selling and manufacturing of counterfeit/spurious drugs punishable under chapter IV of the Drugs and Cosmetic Act, 1940, Bharatiya Nyaya Sanhita, 2023/ Indian Penal Code, 1860 and the Trade Marks Act, 1999; and

C. Direct the Respondent Nos. 2 and 3 to provide necessary equipment and infrastructure and training to the Drug Inspector to effect arrest of the accused persons for commission of offences of selling and manufacturing of counterfeit/spurious drugs punishable under chapter IV of the Drugs and Cosmetic Act, 1940; and/or

D. To grant such other and further writs, orders or directions which this Hon'ble court may be pleased to grant in the interest of justice and the circumstances of the case.

The matter is likely to be heard in January 2025.

Counsels for the petitioner : Advocate Shyam Kumar and AOR Nikhil Jain

Case Details : INDIAN PHARMACEUTICAL ALLIANCE vs. UNION OF INDIA| W.P.(C) No. 000746 / 2024