The Ministry of Health on Wednesday banned the manufacture for sale or distribution of 328 fixed-dose combination (FDC) drugs with immediate effect.
Besides, it has also restricted the manufacture, sale or distribution of six FDCs subject to certain conditions, an official statement said. The banned medicines include brands like Piramal’s Saridon, Alkem Laboratories’ Taxim AZ and Macleods Pharma’s Panderm Plus cream.
Government sources said the move means that around 6,000 medicine brands belonging to different companies and with a combined market size of Rs 2,000-2,500 crore may soon vanish from the drug market in the country. FDCs are two or more drugs combined in a fixed ratio into a single dosage form.
The Health Ministry, through its notification published on March 10, 2016, had prohibited the manufacture for sale and distribution for human use of 349 FDCs under Section 26 A of the Drugs and Cosmetics Act, 1940.
But the matter was contested by the affected manufacturers in various high courts and the Supreme Court. Complying with the Supreme Court verdict in December last year, an expert panel formed by the Drugs Technical Advisory Board (DTAB), in its report to the Centre, stated that there is no therapeutic justification for the ingredients contained in 328 FDCs and that these FDCs may involve risk to human beings, the statement stated.
DTAB said these combinations may lead to overuse. According to the technical body, there is no need to expose the patients to that many ingredients when one will do the work. The notification stated, “Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC…any kind of regulation or restriction to allow for any use in patients is not justifiable.”
The Board recommended that it is necessary to prohibit the manufacture, sale or distribution of these FDCs under the Drugs and Cosmetics Act, 1940 in the larger public interest.
The health ministry has banned the manufacture, sale and distribution of 328 fixed dose combinations (FDCs) of drugs with immediate effect and restricted another six. This brings to an end a protracted legal battle between manufacturers of these combination drugs and the ministry, which has been working since 2016 to get these “irrational” and “unsafe” drugs banned.
Among the roughly 6,000 brands estimated to be affected by the ban are popular drugs like the painkiller Saridon, the skin cream Panderm, combination diabetes drug Gluconorm PG, antibiotic Lupidiclox and antibacterial Taxim AZ.
The government had banned 344 FDCs on March 10, 2016 and later added five more to this list. However, manufacturers of these drugs contested the ban in various high courts and the Supreme Court. The SC on December 15, 2017 asked for the matter to be examined by the Drugs Technical Advisory Board. DTAB concluded in its report that there was no therapeutic justification for the ingredients in 328 FDCs and that these could be a risk to people. The board recommended banning them.
In the case of six other FDCs, the board recommended restricted manufacture and sale subject to certain conditions based on their therapeutic justification. The SC ruled that the government could not use the DTAB report to prohibit 15 of the 344 drugs in the original list as these have been manufactured in India since before 1988. This exception covered several popular cough syrups, painkillers and cold medication with sales amounting to over Rs 740 crore annually. However, the court told the ministry that it could still look into the safety of these 15 drugs by initiating a fresh investigation if it wanted to ban them.
The All India Drug Action Network, a civil society group working on safety and access to medicines which was one of the petitioners in the Supreme Court case, welcomed the ban and sought swift action from the government on the 15 excluded FDCs. “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,” said AIDAN in a statement. It also sought a review of all FDCs in the market in the interest of patient safety as recommended by the Kokate Committee, constituted by the health ministry to examine FDCs.