The Ministry of Health and Family Welfare imposed a ban on the manufacture, sales and distribution of, as many as 328 fixed-dose combination drugs in the country and restricted 6 others.
The Ministry of Health and Family Welfare imposed a ban on the manufacture, sales and distribution of, as many as 328 fixed-dose combination drugs in the country and restricted 6 others. The ban has been imposed with immediate effect. The ban marked the end of a long legal battle, that has been going on between the Ministry and the manufacturer of these medicines since 2016 to get these ‘unsafe’ drugs banned.
About 6000 brands are likely to be affected by the decision including pain reliever Saridon, antibiotic Lupidiclox, skin care cream Panderm, antibacterial drug Taxim AZ and diabetes drug Gluconorm PG.
The Health Ministry had banned 350 fixed-dose combination drugs (FDCs) in 2016, which led to the legal battle between the ministry and the manufactures of these drugs. The battle went through several high courts and finally was taken up by the Supreme Court, last year.
On December 15, 2017, the Supreme Court ordered the Drugs Technical Advisory Board (DTAB) to examine the drugs. After the examination, DATB concluded that the drugs might cause risk to people, as there is no therapeutic justification for the components used in 328 of the banned FDCs, reported TOI.
DTAB also recommended restricted manufacture and sale of six other FDCs, which are to be administered based on their therapeutic justification.
However, SC also prevented the ban of 15 of all the drugs that were proposed to be banned. It ruled that the government could not use the STAB report to ban drugs that have been in use since before 1988. The drugs that have been exempted from the ban include popular cough syrups and cough and cold medicines and even painkillers. These medications which have been removed from the ban generate a revenue of around Rs 740 crore annually. SC, however, has suggested the ministry to launch a fresh investigation on these 15 drugs to assure its safety.
One of the petitioners of the ban, the All India Drug Action Network, has welcomed the decision and requested faster action on the 15 exempted ones. They have informed in a statement that, the banned drugs creates an annual revenue of around 2500 crores and that the market for FDCs accounts for one-fourth of the total pharmaceutical market of India.
The TOI report also mentioned that any of the manufacturers of the banned drugs, have claimed that they have changed the drug combination of the banned FDCs in the past few years.