Panel finds dosage discrepancies in several FDCs

New Delhi: The group of experts who recommended the continuation of the prohibition of dose combinations The FDC found that many ADFs were formulated without due diligence, with dosage discrepancies that could lead to toxicity. [19659003Themajorityofpharmaceuticalcompaniesdidnotproducethe"safetyandefficacy"dataoftheirownAFDafterreviewing349drugbadociationsThegroupofexpertsfromtheHealthCareRecommendationAssociation343betweenthetwo"Otherunderefined"andother"restricted"

According to the experts, the pharmaceutical companies the products were examined provided "irrelevant" data that relied on biased studies. "In CDFs where there is a Sing does not match between ingredients, the use of FDC would result in toxicity. An inability to adjust the individual ingredient doses is particularly risky, if an ingredient has a narrow safety margin, "reads the summary of the report, reviewed by Mint .

The report was submitted to the Technical Advisory Council on Drugs (DTAB) at a meeting on Wednesday. "The subcommittee worked very hard on that. He was well received by the DTAB, who will now decide what to do next, "said Nilima Kshirsagar, chairman of the panel of experts.

During the review process, the panel of experts reviewed approximately 812 submissions for 184 FDCs by a non-governmental organization, the All India Drugs Action Network (AIDAN), testimonials from 467 companies for 156 FDC and scientific literature reviews and standard therapeutic guidelines by national and international organizations.

While pharmaceutical experts claim that the report will bring a huge blow to the pharmaceutical industry, AIDAN said the problems it highlights are just the tip of the day. 39; iceberg.

"This reinforces our consistent demand for the approval and use of only rational drugs in India, rationality must be demonstrated by safety, efficacy, and therapeutic justification. meets the criteria of a rational and safe FDC.The Indian people has become too long a consumer of dangerous drugs and it is a step forward to remedy the serious situation of a pharmaceutical market overflowing with This issue has been decisively resolved with the recommendations of the subcommittee headed by Dr. Kshirsagar, but we note that the FDCs examined represent about 2,500 crore of turnover and represent only The tip of the iceberg: In our opinion, the dangerous and problematic CDF market in India accounts for at least a quarter of the total pharmaceutical market estimated at $ 1.3 trillion Said AIDAN in a statement.

An FDC drug contains two or more active ingredients in a fixed dosage ratio. The ADF ban included painkillers, anti-diabetic, respiratory and gastrointestinal medications.

It covered about 6,000 brands of major pharmaceutical companies, including Pfizer Ltd., Wockhardt Ltd., Alkem Laboratories Ltd., Cipla Ltd., Sanofi India Ltd. and Sun Pharmaceutical Industries Ltd.

In his report submitted on January 20, 2015, the committee headed by Chandrakant Kokate, Vice Chancellor of KLE University, Karnataka, had deemed these FDCs irrational and prohibited them. Last December, the Supreme Court referred the case to the DTAB for further consideration to determine whether these drugs should continue to be marketed, prompting some companies and pharmaceutical groups to legally challenge the government notification banning ADF.

The apex court referred the case to DTAB for further consideration on whether these drugs should continue to be marketed. The Supreme Court suggested that the DTAB should decide whether the manufacture and sale of these drugs should be regulated, restricted or downright prohibited and submit its report and recommendations to the government within six months.

A panel of experts was then formed under the chairmanship of Kshirsagar, Professor and Head of Clinical Pharmacology, GS Medical College KEM Hospital, Mumbai, to review safety, efficacy, and therapeutic justification. of these drugs.