India bans more than 300 combination drugs sold illegally
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New Delhi: India has banned the manufacture and sale of more than 300 combination medicines, including two widely used cough syrups, being sold without government approval, a senior health ministry official said on Saturday.
The move is aimed at curbing the misuse of such medicines in India, where nearly half the drugs sold in 2014 were so called "fixed dose combinations."
Combination drugs are used worldwide to improve patients' compliance, as it is easier to get patients to take one drug rather than several. But inconsistent enforcement of drug laws in India has led to the proliferation of hundreds of such medicines entering the market based on approval from regulators of individual states, rather than the central government.
In 2014, India set up a committee to review more than 6,000 combinations that had entered the market based only on state regulators' approval. Policymakers gave pharmaceutical companies a chance to retroactively prove the safety and efficacy of these drugs by submitting data on their drugs.
The committee was tasked with classifying the drugs into rational, irrational, and those that need further studies, said KL Sharma, a joint secretary at the health ministry.
The move is aimed at curbing the misuse of such medicines in India, where nearly half the drugs sold in 2014 were so called "fixed dose combinations."
Combination drugs are used worldwide to improve patients' compliance, as it is easier to get patients to take one drug rather than several. But inconsistent enforcement of drug laws in India has led to the proliferation of hundreds of such medicines entering the market based on approval from regulators of individual states, rather than the central government.
In 2014, India set up a committee to review more than 6,000 combinations that had entered the market based only on state regulators' approval. Policymakers gave pharmaceutical companies a chance to retroactively prove the safety and efficacy of these drugs by submitting data on their drugs.
The committee was tasked with classifying the drugs into rational, irrational, and those that need further studies, said KL Sharma, a joint secretary at the health ministry.
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