Panel finds dosing mismatches in many FDCs3 min read . Updated: 27 Jul 2018, 12:01 AM IST
The committee found that most pharma firms had not generated the 'safety and efficacy data' of their own FDCs
New Delhi: The expert panel which recommended a continuation of the ban on fixed dose combinations (FDCs) has found that many FDCs were formulated without due diligence, with dosing mismatches that could result in toxicity.
The committee found that most pharma companies had not generated the “safety and efficacy data" of their own FDCs. After reviewing 349 fixed drug combinations (FDCs), the expert panel of the health ministry on Wednesday recommended that 343 of them be “prohibited" and the remaining six “restricted or regulated".
According to the experts, the pharma companies whose products were under scrutiny provided “irrelevant" data that relied on biased studies. “In FDCs where there is a dosing mismatch among the ingredients, FDC use would result in toxicity. An inability to adjust doses of individual ingredients is specially risky, if an ingredient has a narrow safety margin," reads the executive summary of the report, reviewed by Mint.
The report was submitted to the Drug Technical Advisory Board (DTAB) in a meeting on Wednesday. “The subcommittee has worked very hard on it. It was well received by the DTAB which will now decide the next course of action," said Nilima Kshirsagar, chairperson of the expert committee.
During the review process, the expert panel went through about 812 representations for 184 FDCs by a non-government organization, the All India Drugs’ Action Network (AIDAN), testimonies from 467 companies for 156 FDCs and publically available literature in scientific journals and standard treatment guidelines by national and international organizations.
While the pharma experts are claiming that the report will deal a huge blow to the pharmaceutical industry, AIDAN said the problems it highlights are just the tip of the iceberg.
“It reinforces our constant demand for approval, and use, of only rational medicines in India. Rationality needs to be demonstrated by safety, efficacy and therapeutic justification. None of the FDCs meet the criteria of a rational and safe FDC. The people of India have been made the consumers of unsafe medicines for too long and this is one step towards rectifying the grave situation of a pharma market brimming with innumerable irrational FDCs. That issue has been settled decisively with the recommendations of the sub-committee led by Dr. Kshirsagar. We note however, that the FDCs under scrutiny account for approximately ₹ 2,500 crore in sales and represent only the tip of the iceberg. In our estimation, the market of unsafe, problematic FDCs in India is at least one fourth of the total pharma market valued at ₹ 1.3 trillion," AIDAN said in a statement.
An FDC drug contains two or more active ingredients in a fixed dosage ratio. The ban on FDCs included painkillers, anti-diabetic, respiratory and gastro-intestinal medicines.
It covered about 6,000 brands from major pharma companies, including Pfizer Ltd, Wockhardt Ltd, Alkem Laboratories Ltd, Cipla Ltd, Sanofi India Ltd and Sun Pharmaceutical Industries Ltd.
In its report submitted on 20 January 2015, the committee led by Chandrakant Kokate, vice-chancellor of KLE University, Karnataka, had deemed these FDCs irrational, and banned them. Last December, the apex court referred the matter to DTAB for a fresh review on whether these drugs should continue to be marketed, prompting some of the companies and the pharma groups to legally challenge the government’s notification banning FDCs.
Last December, the apex court referred the matter to DTAB for a fresh review on whether these drugs should continue to be marketed. The Supreme Court suggested that DTAB decide whether the manufacture and sale of these drugs should be regulated, restricted or banned outright, and submit its report and recommendations to the government within six months.
An expert panel was then formed under the chairmanship of Kshirsagar, professor and head clinical pharmacology, G.S. Medical College KEM hospital, Mumbai, to review the safety, efficacy and therapeutic justification of these drugs.