Landmark decision of the Supreme Court clarifies pathway for banning of unsafe drugs

14 December 2017, New Delhi.

The All India Drug Action Network (AIDAN) welcomes the pronouncement in Union of India & Anr. vs. Pfizer & Anr. (SLP(C) 7061 of 2017) delivered today by Justices Nariman and Kaul as a major step towards weeding out of irrational, unscientific fixed-dose combination (FDC) drugs in India.

AIDAN filed a Special Leave Petition in the Supreme Court, alongside the Government’s own petition, challenging an order of the Delhi High Court that quashed the ban of 344 FDCs in December 2016 on the grounds that the statutory Drugs Technical Advisory Board (DTAB) had not been consulted by the Government.

The 344 FDCs in question 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 pharmaceutical companies represented by eminent lawyers such as Mr. P. Chidambaram, Mr. Kapil Sibal and Mr. Gopal Subramaniam were dealt a blow when the bench mentioned that:

  • For the exercise of powers under Section 26 (A) of the Drugs and Cosmetics Act, the DTAB need not be mandatorily consulted by the Government in order to be convinced of reasons for banning a medicine. The Court remarked that the Government could be justified in declaring a ban even if it finds that the drug has been banned in other countries.
  • Regarding the alleged perversities and anomalies pointed out by the companies in the Kokate report, the Hon’ble Court mentioned that the DTAB, on its own or through a sub-committee of experts appointed by it, should examine the Kokate committee findings hearing all parties including AIDAN. The recommendations of the DTAB or its expert sub-committee should be made to the Central Government within six months, which will further act if and where necessary. The Court also declared that it will direct the committee to clearly specify reasons against each of the FDCs as to whether it has safety or efficacy problems or lacks therapeutic justification and whether it recommends that the said drug be prohibited, restricted or regulated.
  • The DTAB or sub-committee will not consider a small number of FDCs, which were notified for banning on the basis of the Kokate committee report but which the pharma companies claimed were approved prior to September 1988. However, the Government is free to de novo look into such FDCs.
  • The question of the ban on 294 FDCs, stayed by the Madras High Court in 2008, was also deliberated and the Court asked the Government to take suitable action.

“The 344 FDCs account for only about 5% of the value of total FDCs in India, approximately half of which are considered to be irrational. The Government should proactively take advantage of the space afforded by this order to weed out other irrational FDCs in the interest patient safety,” said Mr. S. Srinivasan, co-convenor of AIDAN.

The Court’s remarks clear the ground for the Government to rapidly take steps after due consultation with expert bodies or consideration any other information to weed out large numbers of irrational, unscientific and hazardous FDCs that are unjustifiably prevalent in India.

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