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A FINAL DECISION ON FDCs

Ramesh Shankar, Mumbai
Wednesday, December 27, 2017, 08:00 Hrs  [IST]

In a landmark judgment, the Supreme Court has clearly drawn a pathway to the Indian drug regulators to prohibit irrational and unsafe drugs in the interest of patient safety in the country. After several months of litigation, the apex court has recently referred the vexed issue of prohibition of 344 FDCs to the union health ministry's expert body on technical matters, the Drugs Technical Advisory Board, for a fresh review of their safety, efficacy and therapeutic justification. As per the court order, the issue will now be thoroughly examined either by the DTAB itself or by a sub-committee constituted by it. After hearing all stakeholders concerned, the DTAB will then decide whether the manufacture and sale of these drugs should be regulated, restricted or outright banned. The court has asked the DTAB to submit a report with its recommendations to the govt within 6-month. The court, however, kept out of the purview of its order the 15 FDCs which were licensed prior to 1988. The apex court also held that status quo be maintained in the case of the remaining 329 FDCs till the time the issue is examined by the DTAB. Now the companies can manufacture and market these 344 FDCs till the DTAB takes a final stand on the issue.

Safety and efficacy of FDCs has been a major issue between the regulators and the industry for several years in the country. The present tussle began when the union health ministry on March 10, 2016, prohibited 344 FDCs for human use under Section 26 A of D&C Act 1940 citing health risks and lack of therapeutic justification. These FDCs were banned on the recommendation of the government-appointment Kokate committee, set up to look into safety and efficacy of FDCs that lacked regulatory approval from the central government. The Kokate committee had found these FDCs irrational and accordingly the government notified a ban on them. Several major Indian and multinational companies were affected by the ban of these FDCs which included widely sold pain-killers, anti-diabetics, respiratory therapies and popular brands such as Corex, Phensedyl, D'Cold Total, Vicks Action 500 Extra and Saridon. Taken aback by the ban, the industry knocked at the doors of various high courts in the country.  Subsequently in December 2016, the Delhi high court set aside the controversial notification that banned 344 FDCs on the grounds that the government failed to consult statutory bodies like DTAB and the Drugs Consultative Committee before banning these drugs. But in January 2017, the central government filed an appeal against the Delhi high court ruling and on 31 March 2017, the apex court stayed proceedings in all high courts against the ban on 344 FDCs. After hearing arguments and counter-arguments from the industry and the government, the apex court on December 14, 2017 clearly clarified the pathway for banning of unsafe drugs in the country. The court also clarified that for the exercise of powers under Section 26 (A) of the D&C 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 if it finds that the drug has been banned in other countries. After several years of debate, the court order is a turning point on the FDC issue as it gives a clear direction to the regulators to ban irrational drugs. Now, the government should proactively take advantage of the space provided by Supreme Court order to weed out irrational, unscientific and hazardous FDCs in the interest of patient safety.

 

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pradeep Awasthi Jan 2, 2018 8:34 AM
The Supreme court has taken a right move by putting a prohibition on irrational,unsafe and hazardous formulation of FDCs which are manufactured and marketed by several Indian and multinational pharma companies in best interest of public health. There is no doubt to the fact that there many irrational FDC being marketed by several pharma companies without approval of central government and statutory regulators,which are harmful to the public health.

The decision of supreme Court to keep the issue of FDC under review of Drug Technical advisory board and statutory regulators to better scrutinize the rationale,safety and efficacy of FDCs and submit its recommendations to the government is the corrective step to draw a final decision on this most debatable matter,As there are so many formulation in recent past which were banned because of danger to the public health.


 
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