New Delhi: Calling for another round of confrontation with the pharma companies, the government has now targeted another set of 500 combination drugs which will probably be banned if they do not clear the phase IV trials.
The central drug regulator has sent letters to nearly 300 companies in this respect. The companies mentioned are the ones that have asked for marketing approvals on their fixed dose combinations(FDC) drugs.
Show-cause notice has been served to some of these companies asking for trials under phase IV-post marketing study- as evidence to show their products are safe and effective, as reported by TOI.
While some have been served notice, some of the renowned companies like Pfizer have been granted No Objection Cirtificate (NOC). This has again raised eyebrows from the pharma sector.
The government had earlier banned 344 combination drugs in this cue, which laid heavy impact on the market of several companies including Abbott. A gazette notification issued by Health Ministry’s issued on March 12 banned 344 fixed dose drug combinations while criminalizing their circulation in the market.
Many of these popular brands of over the counter anti-pyretic (used to prevent or reduce fever) and anti-inflammatory drugs were sold for years. However, the experts appointed by the Health Ministry before coming to the decision that they impose a ban, pointed to the many side-effects of these drugs; elaborating on their fatality and lack of therapeutic justification for sale. Finally, the report of the expert committee appointed by the government that led to it imposing a ban.
An FDC is a combination drug of two or more therapeutic ingredients packed in a single dose.
Talking of the business statistics, the banned FDC market was noted in June at Rs. 3,535 crore according to a market research agency IMS Health. Reduction of sales of these drugs were reported between May and June as falling at high rates, with some seeing up to 30% drop in sales, reported the daily.