Despite the ban order issued against the manufacture and marketing of the drugs, Terbinafine and Astemizole, by the DCGI following a Delhi High Court intervention, some of the major brands of these drugs like Terfed (Cipla) and Stemiz (Zydus Cadila) are still being stocked and sold across drug retail outlets in Mumbai.
It is learnt neither the regulators nor the manufacturers of these brands and even the trade associations have taken serious initiative to educate the retailers about the ban of these drugs. The market sources said that manufacturers of these drugs have not taken necessary initiative to see that these drugs are eliminated from the shelves of the retailers.
None of the retail chemists in Mumbai city area, who were asked about the ban of these drugs by Pharmabiz.com, were aware of the same. Interestingly, the whole sale and retail traders Associations, who are responsible to make their members informed about the banned drugs as and when it happens, are not fully aware of the ban Terfinadine and Astemizole.
When contacted, a senior office bearer of the AIOCD himself was unaware of the matter. Another office bearer from RDCA appeared confused over the date of the ban.
However, the senior officials at the Central Drug Standards Control Organisation and the State FDA, said that since the manufacturers were strictly warned to stop the production of these drugs immediately after the ban, there are no more fresh batches coming to the market.
Still, the stocks remaining at the distributor or with the retailer themselves may not have been completely withdrawn by the companies. "If the case is so, there will be strict action against the manufacturers," they assured. Anyway, the retailers might be selling these brands due to lack of awareness about the ban or as the retailer may not have received the replacement or refund yet for the stock they purchased.
However, the drug control mechanism, manufacturers and the traders' and manufacturers' Associations cannot escape from the responsibility of keeping the trade channel informed about drug bans, the sources said. However, since these drugs were not banned with a cause of dangerous toxic effects or adverse reactions, but because of the irrelevance today, the drug control officials may not have taken it with too serious a need to ensure the products are stopped from public use with immediate effect, the sources said.
The market sources said that the circulation of these banned drugs in the market will continue till the manufacturers and wholesalers take serious initiative to educate and create ethical and legal awareness among the retailer community.
DCGI had originally banned these drugs with a fresh notification in September 2001 from marketing with effect from August 2003. However, following the Delhi High Court intervention against the extended time for actual withdrawal, the DCGI issued another notification on February 26, 2003, making the market withdrawal from April 1, 2003.
In view of the concern expressed by the Delhi High Court, during course of hearing of a public interest litigation filed by Social jurist, A Lawyers Group about safety of these formulations, Ministry of Health & Family Welfare, Govt. of India, has decided to amend the above Gazette Notification as to prohibit the manufacture of these drugs for human use with immediate effect and sale and distribution thereof with effect from April 1, 2003.
With this, the department has asked manufacturers to stop forthwith manufacture of formulations of these drugs and make arrangements to withdraw the stocks from the market in such a way that these drugs are not offered for sale with effect from the date mentioned above.
It may be recalled that the court had directed CDSCO to examine the matter that as it was prima facie of the view that in case the government felt satisfied that one particular drug deserved to be prohibited from being marketed and used, "the same ought to have been done with immediate effect and the withdrawal should not to be postponed further actual withdrawal from the market. "