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Aidan calls for swift action on 15 FDCs excluded from ban notification
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Our Bureau, New Delhi
September 17 , 2018
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The Central government’s decision to ban 328 fixed dose combination (FDC) drugs and regulate the remaining 6 FDCs is one step towards rectifying the “grave situation” of a pharmaceutical market brimming with innumerable irrational cocktail medications, say health rights advocacy groups.
The health ministry had banned these FDCs - drugs containing two or more active pharmaceutical ingredients in a fixed dosage ratio - after an expert committee headed by Prof CK Kokate declared them unsafe. Drug makers challenged the ban in high courts across the country. In January this year, the ministry moved the apex court challenging a Delhi high court order that quashed the ban. The Drug Technical Advisory Board (DTAB) panel was constituted in accordance with the top court’s order to re-examine the issue. All India Drug Action Network (Aidan), a consortium of non-profits in the health sector, had also filed a petition in the top court against the Delhi high court order.
The ministry this week has banned the manufacture, sale and distribution of 328 FDC drugs with immediate effect.
“It reinforces our constant demand for approval and use of only rational medicines in India. Rationality needs to be demonstrated by safety, efficacy and therapeutic justification. None of the FDCs meets the criteria of a rational and safe FDC. The people of India have been made the consumers of unsafe medicines for too long,” Aidan said in a statement.
In the legal battle in which Aidan was a petitioner, the Supreme Court ruled that as long as the government is satisfied that a drug has unacceptable safety, efficacy and/or therapeutic justification, it may ban or regulate or restrict it in public interest. The court further clarified that for such satisfaction to be obtained, consultation with the DTAB is not mandatory.
The civil society group also urged the government to take swift action on the 15 FDCs that were excluded from the notification on the basis of safety and efficacy considerations. “We note however, that the FDCs under scrutiny account for approximately Rs.2,500 crore in sales and represent only the tip of the iceberg. In our estimation, the market of unsafe, problematic FDCs in India is at least one fourth of the total pharma market valued at Rs.1.3 trillion,” it said.
According to Aidan, the task that remains is combating the continued prevalence of a very large number of FDCs of doubtful scientific validity which have somehow slipped through the net and been approved wrongly by the government. Review of all such FDCs in the market is required in the interest of patient safety as such a step had been recommended by the Kokate Committee, it says.
“We are appalled at the pharma industry's disinformation and claims that the recommendations of the sub-committee will deal a huge blow to it. We ask how an important action in favour of safe medicines can be construed as a "blow" and object to such misleading propaganda,” the network added.
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