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VIBHU BAKHRU, J

1. The petitioners have filed the present petition impugning the notification No. S.O. 4379 (E) 07.09.2018 (hereafter 'the impugned notification') issued by respondent no.1 (Central Government) under Section 26A of the Drugs and Cosmetics Act, 1940 (hereafter 'the Act'). By the impugned notification, the Central Government has prohibited the manufacture for sale, sale or distribution for human use of the Fixed Dose Combination (FDC) of the formulations Aceclofenac + Paracetamol + Rabeprazol (hereafter referred to as 'the said FDC').

3. The respondents dispute the aforesaid grounds. They contend that exercise of power under Section 26A of the Act is legislative in nature and principles of natural justice have no application. It is contended that respondent no.1 (Central Government) is neither obliged to afford the petitioners any hearing nor indicate any reasons for its satisfaction to issue such orders.

4. Briefly stated, the controversy in this case arises in the following factual context:

4.1 Petitioner no.1 distributes and markets a drug under the name 'Aceproxyvon Tablet 10 T'. The said drug combines the dosage of Aceclofenac 100 mg, Paracetamol 325 mg and Rabeprazole 10 mg.

"The Committee noted that Aceclofenac + Paracetamol and Aceclofenac + Rabeprazole is already approved by DCG(I) earlier. As these are already being marketed and no ADR [adverse drug reaction] has been reported so far, the Committee opined that the firms shall generate data through Phase IV Trial within one year and accordingly protocol shall be submitted before the committee within 3 months....."

Paracetamol belongs to the class of centrally acting analgesic and antipyretic with minimal anti-

inflammatory properties. Paracetamol reduces fever by inhibiting the formulation and release of prostaglandins in the CNS and by inhibition endogenous pyrogens at the hypothalamic thermoregulator center. The maximum serum concentration after oral administration is achieved in 1 hour and has a half life of 2.25 hours. When used alone the recommended dosing is 650 to 1000 mg orally every 4 to 6 hours as needed; maximum 4000 mg/24 hours. However, the purpose of combining pracetamol with NSAIDs is solely to enhance the analgesic effect. Several randomised control trials and a systematic review concluded that a combination of paracetamol and an NSAID may offer superior analgesia compared with either drug alone.