A long-drawn legal battle with drug manufacturers will come to an end, as the Health Ministry has banned the manufacture, sale and distribution of 328 fixed dose combinations (FDCs) of drugs with immediate effect while restricted another six.
A fixed dose medicine is a combination of two or more active ingredients in fixed dosage ratio. The banned medicines include brands such as Piramal’s Saridon, Alkem Laboratories’ Taxim AZ and Macleods Pharma’s Panderm Plus cream, combination diabetes drug Gluconorm PG and antibiotic Lupidiclox, an official statement said.
As per the ministry these drugs have been “irrational” and “unsafe” and thus they have been trying for the past two years to get these drugs banned, as per media reports on Thursday.
In 2016, the Government had banned 344 FDCs but their manufacturers contested the ban in various high courts and the Supreme Court. Last year in Decembler, the SC asked for the matter to be examined by the Drugs Technical Advisory Board (DTAB).
The DTAB report said there was no therapeutic justification for the ingredients in 328 of the FDCs and recommended banning them. It recommended restricted manufacture and sale subject to certain conditions of six FDCs. The SC ruled that the Government could not use the DTAB report on 15 drugs to prohibit them. This exception covered several popular cough syrups, painkillers and cold medication with sales amounting to over Rs. 740 crore annually. But it also told the ministry that it could still look into the safety of these 15 drugs with a fresh investigation if it still wanted to ban them, as per India.com.
DTAB further 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.”
Meanwhile, The All India Drug Action Network, a civil society group 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,” it said in a statement.
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, as stated by PTI.
Reacting to the ban, several drug companies have claimed that they have anyway either phased out such drugs or changed the combination.
As per the recent decision by the Ministry of Health, 6,000 medicine brands with a combined market size of Rs. 2,000-2,500 crore may soon vanish from the drug market in the country.
According to IIFL analyst Abhishek Sharma, the ban may not have any significant impact because the brands are small.
“This is doing more good than harm and the step is in right direction,” Sharma said, adding that this was in the offing for long and many companies have launched other variants to remain compliant.