Govt may ban 400 more drugs
Delhi High Court grants temporary relief to Abbott, others from earlier government ban on 350-odd medicines
NEW DELHI: Just three days after the health ministry banned 344 fixed- dose combination medicines, the government on Tuesday indicated that it may ban another 400 such combinations over the coming six months on grounds of harmful side-effects.
The government is trying to clean up the sector, where lax regulation has led to the proliferation of harmful drugs whose usage led to anti-microbial resistance and even organ-failure because of high toxicity.
India is one of the world’s largest markets for fixed dose combination drugs, but many of these are not approved for sale in their countries of origin.
“I would say 90% are irrational (not cleared by the regulator) and we have no business letting our people consume all sorts of funny combinations that are no longer in use globally,” said CM Gulhati, editor, Monthly Index of Medical Specialities (MIMS).
The Delhi High Court on Tuesday g ranted interim injunction to Abbott India (for cough syrup Phensedyl), and domestic companies Glenmark Pharmaceuticals and Macleods Pharmaceuticals, on the government’s order to ban combination drugs. Pfizer India had on Monday won a similar reprieve on a ban on its cough syrup Corex.
Meanwhile, FMCG fir m Procter & Gamble ( P& G) on Tuesday said it will discontinue manufacture and sale of its popular brand Vicks Action 500 Extra with immediate effect following the government ban.
Fixed-dose combination drugs, or FDCs, combine two or more drugs in a single pill. “Products were approved at the state level despite our issuing warnings to states’ drug licensing authorities, but to no avail,” a health ministry official said.
He said the health ministry had issued a public notice in 2013, asking drug manufacturers to declare FDC medicines.
“Only 6,600 responded out of 15,000 pharma units that are active in India,” the official said. “Now that we have taken action they are rushing to courts for respite.”
A fresh list is being scrutinised by the committee experts. “We have been working on it for years and there’s absolutely no therapeutic justification for most of these fixed dose combinations,” the official said.
The medicines were broadly divided into four categories. Two of them — rational (approved) and irrational (not approved) use were significant. The medicines under the irrational category were taken up for immediate scrutiny.
“It has been a comprehensive exercise that took into account the entire literature on fixed dose combination medicines available in Indian markets. It’s an on-going process and some combinations may even require clinical trials,” the official added.
“We must check efficient drug regulators in western countries, namely the US and the UK, to see what is safe and what’s not. It may not be an ideal solution as Indians are a different race but some reference point to begin with,” Gulhati said.