The Supreme Court has asked the official expert agency the Drugs Technical Advisory Board (DTAB) to review 329 fixed dose combination (FDC) medicines that the health board had found around a year ago to be fit for being banned.
According to the ministry the safety, therapeutic justification and efficacy of these drugs had been established as being irrational.
The court’s directive came in a hearing challenging a Delhi High Court order that had rejected the government ban citing technical reasons.
FDC Volumes In Market Affected By Uncertainty
The directive has come at time that these products are beginning to see improved availability in the market after volumes had dropped due to uncertainty supporting their status.
According to AIOCD-AWACS , pharmaceutical market intelligence agency these specific FDCs grew by 10.3 per cent in October 2017 as against a decline of 19.4 per cent witnessed in the last 12 months when seen on a moving annual total (MAT) basis.
The SC directive will allow drug companies to continue selling the specified medicines until the DTAB gives in its report.
But it will also give the government an opportunity to further build its case for eliminating the numerous irrational and unscientific combination medicines that are being sold in the country currently. Using this SC order DTAB will be able to bring in all such dangerous FDCs under regulatory scrutiny.
Only Small Percentage of Unscientific FDC Medicines Banned
The government ban had covered just a small percent of the over 40,000 FDC brands that being sold currently in the country
- Srinivasan, co-convenor of All India Drug Action Network (AIDAN), the civil society group that ahd filed plea with the SC on the matter highlighted that the 344 FDCs in question account for just 5 percent of the total FDCs present in India, of which nearly half can be considered irrational.
He further added that that the government must “proactively take advantage of the space afforded by this order” eliminate all irrational FDCs keeping in mind patient safety
Ban Effected On Recommendation of Kokate committee
AIDAN had filed a Special Leave Petition, alongside the government’s petition, in the Supreme Court that challenged the Delhi High Court’s order quashing the ban of 344 FDCs in December 2016 . The Delhi HC had revoked the ban on the grounds that the government had not consulted with the statutory body Drugs Technical Advisory Board (DTAB) .
The 344 FDCs had been banned on the recommendations given by Kokate committee that had been appointed by the government to examine the safety and efficacy of FDC products not possessing regulatory approval from the government.
The committee had listed these products as being irrational based on which the government had subsequently issued an order banning them.
DTAB To Review Kokate Report Findings
The SC in its order said that under Section 26 (A) of the Drugs and Cosmetics Act, the government need not consult the DTAB mandatorily before banning a medicine. It noted that the government can justify in issuing a ban even in cases when the drug has been banned in other countries.
The SC also addressed the alleged anomalies in the Kokate report pointed out by the companies.
It has asked the DTAB to examine the Kokate committee findings either on its own or by appointing a sub-committee of experts , hearing all parties concerned. The DTAB must submit its findings and recommendations to the Union Government within six months based on which further action can be taken as needed.
Clear Reasons For Banning Drugs To Be Given
The court has asked that the DTAB committee clearly provide reasons against each of the FDCs for banning it – whether it lacks therapeutic justification or has issues with respect to safety or efficacy. The committee must also recommend if the drug should be prohibited, or be just restricted and regulated.
According to experts, the court order allows the government to take action against unscientific and hazardous FDCs available in consultation with expert bodies.
