The Kerala High Court has once again extended the time limit to the chemists and druggists in the state to return the banned brands of fixed dose combinations (FDCs) to the manufacturers.
Earlier, on March 17 the court had given two weeks time to All Kerala Chemists and Druggists Association (AKCDA) who had approached the court seeking a time frame to return the banned combination drugs.
However, the chemists fraternity could not complete the work of returning all the 2000 brands containing the banned FDCs. Hence the association approached the court again with a prayer to extend the date which was sanctioned for three months, said A N Mohan, president of the association.
Meanwhile, the drugs control administration in Kerala has started inspection of all the retail stores and wholesale depots to ensure that the banned FDCs are not circulated in the market, said B Hariprasad, state drugs controller.
The Drugs Controller General of India (DCGI) on March 10 banned 344 FDC drugs through a gazette notification. The action of the DCGI was on the basis of an expert committee, appointed by the Union health ministry, which examined the safety and efficacy of the fixed dose combination drugs and sent a report to the government.
Following the ban, several associations of manufacturers and traders approached various courts in the country including Delhi High Court, which had stayed the ban till 21st of March. But defending its decision for the ban, the government argued that the stay for brands using the banned FDCs would compromise the safety of patients. However, the court said it would hear all arguments before reaching a final decision.
The petitioning associations and group of manufacturing companies were waiting for the decision of the Delhi High Court when the hearing on the case came on 28th of March. But the court declined to vacate the stay despite request from the government.
A N Mohan said, “We have to do a lot of work to complete the process of returning the stocks. There are more than 2000 brands in the market and their stocks in the trade channels are huge. To sort out and return to the concerned companies, the work entails huge manpower and paperwork. Now we got sufficient time and will complete the work within the time-limit.”