New Delhi: The Health Ministry taking a severe stand on some of the fixed dose drug compositions by imposing a ban on them has pointed out that this is related to the unapproved formulae that go behind the manufacture of these combinations.Fixed-dose combination drugs those that are
combination of two or more active drugs in a fixed ratio into a single dosage.
The ministry has highlighted the fact that the banned fixed dose compositions were disallowed sale by the USFDA and for these formulations, the companies have no access to the markets in the US. However, the fact remains that they have continued to to sell these products with or without the consent of the central government in India.
According to dna the ministry officials have reported that these fixed dose drug combinations as unsafe, dangerous and even lethal. It has been observed that despite approval of the Central Drugs Standard Control Organisation (CDSCO) being mandatory since 1961 , a huge proportion of unapproved FDC are being sold over the counter in the country.
Defending the ban the health ministry has made clear that before imposing the ban the companies had been given a chance to explain, however some hadn’t even bothered to explain.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,” it added.
According to the health department show cause notices were issued to the defaulters to give them ample opportunity to explain. It was only after this that the ban was initiated after much deliberation. The central government after thoroughly examining the expert committee’s report on the drugs expressed its satisfaction on the conclusions drawn.
The central Government made clear its stance saying, ‘It is necessary and expedient in the public interest to regulate by way of prohibition of manufacture for sale, sale and distribution for human use of the said drugs in the country.’
The companies have complied and Pfizer , Abbot Laboratories & Proctor and Gamble did suspend manufacture and sale of their respective drugs only to take a stay a day later.
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