According to IIFL analyst Abhishek Sharma, the ban may not have any significant impact because the brands are small
The Union health ministry's decision to prohibit manufacture for sale or distribution of 328 fixed dose combinations may not see a significant impact on the industry, according to experts.
On Wednesday, the Ministry of Health and Family Welfare has prohibited the manufacture for sale or distribution for human use of 328 fixed dose combinations (FDCs) with immediate effect. It also restricted the manufacture, sale or distribution of six FDCs subject to certain conditions.
The ban, which is across therapy areas, is expected to have an impact of around Rs 2,000 crore, according to Daara Patel, secretary general of Indian Drug Manufacturers' Association. The total size of the Indian pharmaceutical industry is around Rs1.18-1.2 lakh crore.
A fixed dose medicine is a combination of two or more active ingredients in fixed dosage ratio.
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.
In a notification on March 10, 2016, the central government had banned manufacture, sale and distribution of 344 FDCs under section 26A of the Drugs and Cosmetics Act, 1940. Subsequently, it had prohibited five more FDCs in addition to the 344 under the same provisions.
The matter was later contested by the affected manufacturers. In compliance with the directions given by the Supreme Court on December 15, 2017, the matter was examined by Drugs Technical Advisory Board (DTAB) constituted under section 5 of the Drugs and Cosmetics Act, 1940, which furnished its report on these drugs to the central government.
According to DTAB recommendation, there is no therapeutic justification for the ingredients contained in 328 FDCs and that these FDCs may involve risk to human beings. DTAB recommended that it is necessary to prohibit the manufacture, sale or distribution of these FDCs in the larger public interest. With regard to six FDCs, it recommended that their manufacture, sale and distribution be restricted subject to certain conditions based on their therapeutic justification.
However, fifteen FDCs out of the 344 prohibited on the March 10, 2016, which were claimed to be manufactured prior to September 21, 1988, have been kept out of the purview of current notifications after the Supreme Court told the ministry it could not ban these 15 FDCs on the basis of DTAB's report, but that the government was free to look into the issue of their safety afresh. This order exempted several cold and cough and depression medicines such as Reckitt's D'Cold, Abbott's Phensedyl cough syrup.
Last year, the court had repealed the ban on 15 FDCs and directed DTAB to look at the remaining 334 FDCs and recommend the ones to regulate, restrict or impose an outright ban, despite the ministry arguing that the ban was on account of the drugs being "irrational" and "unsafe for consumption".
A wide number of brands from pharma companies such as Piramal, Alkem Laboratories, Sanofi India Ltd are available in the market. The impact, however, is expected to be limited.
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