The Ministry of Health has hereon banned the sale, manufacture and distribution of over 328 fixed-dose combinations (FDCs) in India. Additionally, restrictions have been placed on six others. There has been a long-drawn battle in the court between manufacturers of these drugs and the ministry, which has been pushing hard to get these ‘unsafe’ drugs banned permanently.
In March 2016, the government had imposed a ban on 300-odd FDCs. The Supreme Court of India had directed the Drugs Technical Advisory Board (DTAB) to examine the matter and table a report. The board concluded that there is no therapeutic justification for the ingredients used in these FDCs, and indicated that this contains potential risk to those who consume it. Hence, a ban was recommended by them.
The court ruled that the government cannot use the report to prohibit 15 of the 344 drugs in the original list since they have been manufactured in the country prior to 1988. This exception saved the industry about Rs 740 crore annually.
All India Drug Action Network welcomed the move, and said “The banned FDCs account for about Rs 2,500 crore and represent only the tip of the iceberg. In our estimate, the market for unsafe, problematic FDCs in India is at least one-fourth of the total pharma market which is valued at Rs 1.3 trillion.”
Based on the recommendations of the Kokate Committee, it sought the review of all the FDCs in market, in terms of keeping patient safety in mind. The committee was constituted by the Ministry of Health.
Since then, many companies have already phased out drugs or changed the combination.
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