Central government’s satisfaction may be based on a number of factors, one of which may be advice tendered to it by the DTAB under Section 5, the bench observed.
In an important judgment, the Supreme Court has held that to exercise powers under Section 26A of the Drugs and Cosmetics Act, the Drugs Technical Advisory Board (DTAB) need not be mandatorily consulted by the government in order to be convinced of reasons for banning a medicine.
A bench of Justice RF Nariman and Justice Sanjay Kishan Kaul observed that the government could be justified in declaring a ban even if it finds that the drug has been banned in other countries. The bench also referred 344 fixed combination drugs to the DTAB for a fresh review of their safety, efficacy and therapeutic justification before recommending an action.
The bench was considering a special leave petition filed by the Union of India and the All-India Drug Action Network, and a batch of Transfer petitions, challenging an order of the Delhi High Court that quashed the ban of 344 FDCs in December 2016 on the ground of lack of mandatory consultations with the Drug Testing Advisory Board and the Drug Consultative Committee, statutory requirements under Section 26A.
FDC, a ‘cocktail’ drug, which contains two or more therapeutic ingredients, packed into a single dose, were banned on the recommendation of the government-appointment Kokate committee, which was set up to look into safety and efficacy of FDCs that lacked regulatory approval from the Central Government. The Kokate committee had deemed these FDCs irrational and accordingly the Government notified a ban on them.
The bench observed that, so long as the Central Government’s satisfaction can be said to be based on relevant material, it is not possible to say that not having consulted the DTAB, the power exercised under the said Section would be non-est.
To illustrate the above, the bench illustrated it with two examples as follows:
The bench further said:”No doubt, it would be desirable for the Central Government to take its advice on technical matters arising out of the administration of the Drugs Act, but this does not lead to the conclusion that if such advice is not taken power under Section 26A cannot be exercised. Indeed, the Central Government’s satisfaction may be based on a number of factors, one of which may be advice tendered to it by the DTAB under Section 5.”
The court also observed that sufficient indicators in the Section 26A to eschew any ground of arbitrariness as it states that the power can only be exercised based on satisfaction of material that is relevant to form an opinion that the drug in question falls within any of the three categories outlined by the Section and that, further, it is necessary or expedient to either regulate, restrict or prohibit manufacture, sale or distribution of the said drug in public interest.