India plans to suspend sale of medicines that are banned in one of the six major global drug markets for harmful side-effects, said two senior government officials.
According to a health ministry official, if a drug is banned by the US, UK, Canada, Japan, European Union or Australia, its sales will be stopped in India until clinical data proves that it will not have adverse effect on patients in the country. These embargoes will be triggered by future action of international regulators, and will not automatically apply to drugs that have already been banned in the developed countries.
Drug Controller General of India GN Singh confirmed such a move was on the anvil. “We are in the process of streamlining a mechanism through which our drug regulatory system takes an initial cue from the decisions of leading drug regulators globally on banned drugs. These drug regulators already have in place robust systems to generate and analyse volumes of data on adverse drug reactions to reach decision on drug bans,” said Singh.
The proposal to link medicine bans in the country to the verdicts of regulators in developed countries is significant as India at present does not have a sound system in place to filter and shunt drugs that trigger serious side-effects.
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