The ban on 344 fixed dose drugs has lead to the suspension of some popular over the counter medicines in India.
The Health Ministry has banned 344 'Fixed Dose Combination' (FDC) drugs, leading to an immediate suspension of the manufacturing and sale of some popular medicines in India.
What are Fixed Dose Combination drugs and why has the Ministry banned them?
Fixed Dose Combination drugs (FDC)
Fixed-dose combination drugs are when a pharmaceutical combines two or more active drugs in a fixed ratio into a single dosage.
Why has the government banned 344 combinations of FDC?
The degree of safety and FDC drugs' effects on humans has been long under question -- a report by The Hindu says that there are millions of such unapproved formulae in the Indian markets that are unsafe, dangerous and even lethal.
According to the report, it was made mandatory for FDCs to get an approval from the Central Drugs Standard Control Organisaton (CDSCO) since 1961, however, there's still a huge proportion of unapproved FDC drugs often sold over the counter in the country.
A Reuters investigation revealed in December that a unit of Abbott in India was selling a combination of the antibiotics cefixime and azithromycin without approval from the central government.
The combination is not approved for sale in major pharmaceutical markets, including the United States, United Kingdom, Germany, France and Japan.
After the ban, the company was forced to immediately stop the manufacture and sale of its powerful antibiotic.
What has the Health Ministry and Government said?
The Ministry, while banning over 300 drug combinations said that the pose a "risk" to humans and there are safer alternatives available in the market.
The Department said that it had the best of scientists on board to study the effects of these drugs. "We have tried to bring objectivity to the issue by roping in the best of scientists to study the effects," the Ministry said.
The order hasn't come out of the blue. The government says that the companies were first issued showcause notices and even given a chance to present their case, but some companies hadn't even bothered to respond to the notice.
After a thorough examination by the expert committee, the Central government said that it was satisfied with the recommendations of the expert committee.
Immediate fallout of the order
Pfizer said it was suspending the manufacturing and sale of its popular Corex cough syrup which contains a combination of Chlopheniramine Maleate and Codeine syrup. However, after moving the Delhi High Court over the order, the HC has provided interim relief to the company until the next hearing date which hasn't been announced yet.
The court also issued a notice to the Health ministry directing it to file a status report after taking instruction on the findings of the expert committee
Abbott India suspended a powerful antibiotic that is marketed by the US company Abbott Laboratories in India.
Procter & Gamble has stopped the manufacturing and sale of Vicks Action 500 Extra which contains a combination of paracetamol, phenylephrine and caffeine.
"Our product 'Vicks Action 500 Extra' has the same fixed dose combination and gets covered under notification. we have discontinued the manufacture and sale of all SKUs of 'Vicks Action 500 Extra with immediate effect," the company said.
Health Ministry stays Centre's order
In a relief to pharma companies, the Health Ministry on Tuesday stayed the Centre's order observing that come of the drugs have been in the market for 28 years, saying that "how come 344 drugs uddenly became harmful". The interim relief will be applicable till the next hearing date -- March 21.
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