New Delhi: India’s chief drug advisory body has formed an expert committee to review 344 fixed dose combination (FDC) drugs banned in 2015, according to three people aware of the matter.
At its meeting on Monday, the Drugs Technical Advisory Board (DTAB) formed the committee under Nilima Shirsagar, retired dean of Mumbai’s KEM Hospital. The panel will review the safety, efficacy and therapeutic justification of these drugs before recommending any action.
In December, the Supreme Court had asked DTAB to review whether these drugs should continue to be sold. The 344 FDCs were banned on the recommendation of the Kokate committee, which was set up to study their safety and efficacy. An FDC drug contains two or more active ingredients in a fixed dosage ratio. In its report submitted on 20 January 2015, the expert committee under Chandrakant Kokate, vice-chancellor of KLE University, Karnataka, had deemed these FDCs irrational, and said they posed health risks.
“An expert committee has been constituted and will examine the Kokate committee findings.The Kokate committee had done a thorough examination; the expert committee will reassess the 344 drugs," said one of the three people cited above, all of whom spoke on condition of anonymity.
The new recommendations of the expert sub-committee will be made to the central government within six months, the Supreme Court had ruled in December. 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 ban affected around 6,000 brands, including ones from Pfizer Ltd, Wockhardt Ltd, Alkem Laboratories Ltd, Cipla Ltd, Sanofi India Ltd and Sun Pharmaceutical Industries Ltd. Drug makers immediately challenged the ban in high courts across the country, with the Delhi high court alone receiving over 450 petitions seeking interim relief. The firms claimed that the government did not consult statutory bodies before banning these drugs.
On 1 December 2016, justice Rajiv Sahai Endlaw of the Delhi high court quashed the ban, holding that the government had failed to consult statutory authorities like DTAB and the Drugs Consultative Committee before enforcing the ban.
In January 2017, the government filed an appeal in the Supreme Court, citing health risks and lack of therapeutic justification. On 31 March, the court stayed proceedings in all high courts against the ban.
FDC drugs are used to treat cough, cold and allergies. Some of the medicines on which the ban on sale was lifted by the Delhi high court included Pfizer’s Corex cough syrup; Glaxo’s Piriton expectorant and Crocin Cold; P&G’s Vicks Action 500 Extra; Reckitt’s D’Cold; Piramal’s Saridon; Glenmark’s Ascoril and Alex cough syrups; Abbott’s Phensedyl cough syrup, and Alembic’s Glycodin cough syrup.
Welcoming the action of the court, industry experts had said the court’s directive clears the way for the government to take steps to weed out large numbers of irrational, unscientific and hazardous FDCs prevalent in India.