FDCs are two or more active drugs manufactured as a single-dose. The sub-committee said of the 349 FDCs under review, 343 of them must be banned. “For most FDCs, their use would lead to unnecessary overuse, and the patients would be exposed to risk of multiple ingredients when one would suffice,” the report submitted by the sub-committee to Ministry of Health and Family Welfare (MoHFW) said.
The ban, if enforced by a gazetted notification by the MoHFW, is expected to affect major pharma companies like Abbott Healthcare (Phensedyl cough syrup), Paras Pharma (D Cold Total), Pfizer (Corex), Piramal (Saridon) and P&G’s (Vicks Action 500 extra). They majorly sell cough expectorants and tablets in different FDC forms in a range of prices. There are also anti-diabetic, antibotics and dermatological drugs in the list.
The FDCs under scrutiny estimatedly account for₹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 lakh crore,” said Malini Aisola from the All India Drug Action Network (AIDAN).
Dosage mismatch
In certain FDCs, where there is a dosage mismatch among the ingredients, it would result in toxicity or contrarily lack of any effect on the patient. “An inability to adjust doses of individual ingredients is especially risky, if an ingredient has narrow safety margin,” the report said. During the review, some pharma companies offered to alter the indication on the drug packs for the use of the drug, or carry out more studies in support of their FDCs, but the sub-committee struck such offers down. “They were advised to follow the Drugs and Cosmetics Act for new drugs,” the report said.
According to the reports published in thehindubusinessline.com most pharma companies have not generated data on their own, and the published literature they have submitted to justify the FDC is not epidemiologically relevant to India and relied on a few biased studies. Indications mentioned on the FDC drug packs were too broad and absurd, the report said.
In all, 41 meetings were held by the DTAB sub-committee and co-opted experts since the Supreme Court order in December last year and they reviewed all information received from 467 pharma companies, civil society representations, publicly available literature in peer-reviewed journals, relying more on meta-analysis, and standard treatment guidelines followed in India by national and international organisations, including the World Health Organisation (WHO), to check if the FDCs under question should be taken off the shelf in the Indian market.
Last year, the Parliamentary Standing Committee on Health and Family Welfare had observed that some state licensing authorities had issued manufacturing licences for several fixed dose combinations (FDCs) without prior clearance from Central Drugs Standard Control Organization (CDSCO), resulting in availability of many FDCs, which have not been tested for efficacy and safety, putting patients at risk.
CDSCO had earlier banned the use of 349 FDCs, against which the pharma companies had moved various courts, and finally the Supreme Court gave its judgment in December last year pursuant to which the Drug Technical Advisory Board (DTAB) appointed a sub-committee to relook at FDCs and give their its recommendations.