NEW DELHI: The Centre has prohibited the manufacturing, sale and distribution of 14 fixed-dose combination drugs due to a lack of therapeutic justification and because of their potential risks to humans.
These medicines, which include cough syrups, anti-allergy drugs and pain-relief drugs, have been banned with immediate effect on the advice of an expert committee’s recommendation that they are a risk to health.
According to experts, FDCs mix two or more active ingredients in a fixed ratio.
The FDCs that have been banned include Nimesulide+ Paracetamol dispersible tablets, Pholcodine+ Promethazine, Chlorpheniramine Maleate + Codeine Syrup, Amoxicillin+ Bromhexine and Ammomium Chloride + Bromhexine + Dextromethorphan amongst others.
These medicines were a part of the 344 plus five FDCs (Fixed Dose Combinations) which were earlier banned by the Union Health Ministry in March 2016. But, many affected manufacturers of the banned FDCs 344 plus five medicines challenged the decision in Delhi High Court. They contested the ban order on the ground that their medicines were manufactured before 1988 when the rule mandating marketing approval by the CDSCO for every drug came into force.
The Delhi High Court gave a stay and the matter went to the Supreme Court. The apex court gave a final order in December 2017 ordering the matter to be looked into again by the government. The Centre then appointed another expert committee which in July 2018 essentially reiterated the recommendations of the earlier committee, spelling out the reasons for the ban in greater clarity.
After two court judgments and two expert committees reiterated the ban, a third committee was appointed to examine specifically the 15 FDCs approved before September 1988. This committee also gave a nod for the ban.
Reacting to the ban, Chinu Srinivasan, co-convenor of the All-India Drug Action Network (AIDAN), and one of the early interveners said, "This is a most welcome news. The law of the land and the science of pharmacology have won and have worked for the safety of the people. These FDCs are irrational and unscientific, the expert committees have said clearly. These manufacturers were not able to prove the merit of their medicines."
Explaining the long-drawn battle against banning these medicines, Srinivasan said that all manufacturers are required to get marketing approval for new drugs from the Central Drugs Standard Control Organisation (CDSCO) before obtaining manufacturing licenses from state drug administrations.
But in the case of the 344 plus five FDCs, he said, the manufacturers secured manufacturing licences from states without getting mandatory marketing license from the CDSCO which can be obtained only after their safety and efficacy is proved by submitting relevant data.
According to Dr Gopal Dabade of AIDAN, Nimulside is used to reduce fever and pain but should not be given to children and hence the government has banned this drug combination with paracetamol for children.
The Union Health Ministry in its notification said that the matter was examined by an Expert Committee which furnished its report on April 1, 2022, to the central government and the Drugs Technical Advisory Board (DTAB) agreed to this expert committee report.
"There is no therapeutic justification for this FDC and the FDC may involve risk to human beings. Hence, in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26A of the Drugs and Cosmetics Act, 1940. In view of the above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under Section 26A is recommended," the notification said.
Section 26A gives powers to the centre to regulate or restrict, manufacture etc. of drugs in public interest, by notification in the Official Gazette.
"And whereas, on the basis of the recommendations of the Expert Committee and the Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to regulate by way of prohibition the manufacture for sale, sale and distribution for human use of the said drug in the country," said the notifications by the ministry on June 2.